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Subject: Phase III Study of Efaproxiral As an Adjunct to Whole-Brain Radiation Therapy for Brain Metastases -- Suh et al. 24 (1): 106 -- Journal of Clinical Oncology
Date: Mon, 15 May 2006 17:16:01 +0200
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      <H2>Phase III Study of Efaproxiral As an Adjunct to Whole-Brain =
Radiation=20
      Therapy for Brain Metastases </H2><STRONG></NOBR><NOBR>John H.=20
      Suh<SUP></SUP></NOBR>, <NOBR>Baldassarre Stea<SUP></SUP></NOBR>,=20
      <NOBR>Abdenour Nabid<SUP></SUP></NOBR>, <NOBR>John J.=20
      Kresl<SUP></SUP></NOBR>, <NOBR>Andr=E9 Fortin<SUP></SUP></NOBR>,=20
      <NOBR>Jean-Philippe Mercier<SUP></SUP></NOBR>, <NOBR>Neil=20
      Senzer<SUP></SUP></NOBR>, <NOBR>Eric L. Chang<SUP></SUP></NOBR>,=20
      <NOBR>Adam P. Boyd<SUP></SUP></NOBR>, <NOBR>Pablo J.=20
      Cagnoni<SUP></SUP></NOBR>, <NOBR>Edward Shaw<SUP></SUP></NOBR> =
</STRONG>
      <P><FONT size=3D-1>From the Cleveland Clinic, Cleveland, OH; =
University of=20
      Arizona Health Sciences Center, Tucson; Barrow Neurological =
Institute,=20
      Arizona Oncology Services, Phoenix, AZ; US Oncology Research Inc, =
Dallas;=20
      The University of Texas M.D. Anderson Cancer Center, Houston, TX; =
Allos=20
      Therapeutics Inc, Westminster, CO; Wake Forest University School =
of=20
      Medicine, Winston-Salem, NC; Centre Hospitalier Universitaire de=20
      Sherbrooke, Sherbrooke; H=F4tel-Dieu de Qu=E9bec du Centre =
Hospitalier de=20
      Qu=E9bec CHUQ, Qu=E9bec City; and Hospital Maisonneuve-Rosemont, =
Montr=E9al,=20
      Qu=E9bec, Canada </FONT>
      <P><FONT size=3D-1>Address reprint requests to John H. Suh, MD, =
Cleveland=20
      Clinic Foundation, Brain Tumor Institute, Department of Radiation=20
      Oncology, T28, 9500 Euclid Ave, Cleveland, OH 44195; e-mail: <SPAN =

      id=3Dem0>suhj{at}ccf.org</SPAN>
      <SCRIPT type=3Dtext/javascript><!--=0A=
 var u =3D "suhj", d =3D "ccf.org"; =
document.getElementById("em0").innerHTML =3D '<a href=3D"mailto:' + u + =
'@' + d + '">' + u + '@' + d + '<\/a>'//--></SCRIPT>
      </FONT>
      <P><A name=3DABS><!-- null --></A><BR clear=3Dright>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"100%" =
bgColor=3D#e1e1e1>
        <TBODY>
        <TR>
          <TD vAlign=3Dcenter align=3Dleft width=3D"5%" =
bgColor=3D#ffffff><IMG=20
            height=3D21 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/rarrow.gif" =
width=3D10></TD>
          <TH vAlign=3Dcenter align=3Dleft width=3D"95%"><FONT =
size=3D+2>&nbsp;&nbsp;=20
            ABSTRACT </FONT></TH></TR></TBODY></TABLE>
      <TABLE cellPadding=3D5 align=3Dright border=3D1>
        <TBODY>
        <TR>
          <TH align=3Dleft><FONT size=3D-1><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#top"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>TOP<BR></A><IMG height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/dot.gif" width=3D11 =
border=3D0><FONT=20
            color=3D#464c53>ABSTRACT</FONT><BR><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC1"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>INTRODUCTION<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC2"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>PATIENTS AND METHODS<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC3"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>RESULTS<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC4"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>DISCUSSION<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC5"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Appendix<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC6"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Authors' Disclosures of...<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC7"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Author Contributions<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#BIBL"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            =
border=3D0>REFERENCES<BR></A></FONT></TH></TR></TBODY></TABLE>&nbsp;<BR>P=
URPOSE:=20
      To determine whether efaproxiral, an allosteric modifier of<SUP>=20
      </SUP>hemoglobin, improves survival in patients with brain =
metastases<SUP>=20
      </SUP>when used as an adjunct to whole-brain radiation therapy=20
      (WBRT).<SUP> </SUP>
      <P>PATIENTS AND METHODS: Patients with brain metastases from solid =
tumors=20
      and a Karnofsky<SUP> </SUP>performance score of <IMG alt=3D&#8805; =

      src=3D"http://www.jco.org/math/ge.gif" border=3D0> 70 were =
randomly assigned=20
      to receive WBRT<SUP> </SUP>with supplemental oxygen and either =
efaproxiral=20
      at 75 or 100<SUP> </SUP>mg/kg (efaproxiral arm) or no efaproxiral =
(control=20
      arm). The<SUP> </SUP>primary end point was survival.<SUP> </SUP>
      <P>RESULTS: The study consisted of 515 eligible patients =
(efaproxiral=20
      arm,<SUP> </SUP>n =3D 265; control arm, n =3D 250). The median =
survival time=20
      (MST)<SUP> </SUP>was 5.4 months for the efaproxiral arm versus 4.4 =
months=20
      for<SUP> </SUP>the control arm (hazard ratio [HR] =3D 0.87; =
<I>P</I> =3D .16).=20
      For the<SUP> </SUP>subgroup of patients with non=96small-cell lung =
cancer=20
      (NSCLC)<SUP> </SUP>or breast cancer, the MST was 6.0 and 4.4 =
months,=20
      respectively<SUP> </SUP>(HR =3D 0.82; <I>P</I> =3D .07). Cox =
multiple=20
      regression analysis demonstrated<SUP> </SUP>a significant =
reduction in the=20
      risk of death for the efaproxiral<SUP> </SUP>arm in both primary=20
      populations. Further analysis indicated<SUP> </SUP>that the =
benefit may be=20
      restricted to the subgroup of patients<SUP> </SUP>with breast =
cancer.=20
      Response rates (radiographic complete response<SUP> </SUP>plus =
partial=20
      response) improved by 7% (<I>P</I> =3D .10) and 13% (<I>P</I> =
=3D<SUP>=20
      </SUP>.01) for all patients and for NSCLC and breast cancer =
patients<SUP>=20
      </SUP>in the efaproxiral arm, respectively. The most common =
severe<SUP>=20
      </SUP>adverse event in patients treated with efaproxiral was=20
      hypoxemia,<SUP> </SUP>which was reversible and effectively managed =
with=20
      supplemental<SUP> </SUP>oxygen in most patients.<SUP> </SUP>
      <P>CONCLUSION: The addition of efaproxiral, a noncytotoxic =
radiation=20
      sensitizer,<SUP> </SUP>to WBRT may improve response rates and =
survival in=20
      patients<SUP> </SUP>with brain metastases, particularly metastases =
from=20
      breast cancer.<SUP> </SUP>A confirmatory trial for breast cancer =
patients=20
      has been initiated.<SUP> </SUP>
      <P><A name=3DSEC1><!-- null --></A><BR clear=3Dright>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"100%" =
bgColor=3D#e1e1e1>
        <TBODY>
        <TR>
          <TD vAlign=3Dcenter align=3Dleft width=3D"5%" =
bgColor=3D#ffffff><IMG=20
            height=3D21 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/rarrow.gif" =
width=3D10></TD>
          <TH vAlign=3Dcenter align=3Dleft width=3D"95%"><FONT =
size=3D+2>&nbsp;&nbsp;=20
            INTRODUCTION </FONT></TH></TR></TBODY></TABLE>
      <TABLE cellPadding=3D5 align=3Dright border=3D1>
        <TBODY>
        <TR>
          <TH align=3Dleft><FONT size=3D-1><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#top"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>TOP<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#ABS"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>ABSTRACT<BR></A><IMG height=3D9 alt=3D" " =
hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/dot.gif" width=3D11 =
border=3D0><FONT=20
            color=3D#464c53>INTRODUCTION</FONT><BR><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC2"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>PATIENTS AND METHODS<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC3"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>RESULTS<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC4"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>DISCUSSION<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC5"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Appendix<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC6"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Authors' Disclosures of...<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC7"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Author Contributions<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#BIBL"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            =
border=3D0>REFERENCES<BR></A></FONT></TH></TR></TBODY></TABLE>&nbsp;<BR>B=
rain=20
      metastasis is the most common neurologic complication<SUP> =
</SUP>of=20
      cancer. It afflicts up to 170,000 individuals annually in<SUP> =
</SUP>the=20
      United States alone.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R1">1</A>,<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R2">2</A></SUP>=20
      Although extracranial systemic disease<SUP> </SUP>has a major =
impact on=20
      survival, brain metastases are the cause<SUP> </SUP>of death in =
one third=20
      to one half of affected patients.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R2">2</A>,<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R3">3</A></SUP>=20
      Treatment<SUP> </SUP>with corticosteroids can alleviate symptoms =
in the=20
      majority<SUP> </SUP>of patients but only for a limited time. =
Without=20
      further treatment,<SUP> </SUP>the median survival time (MST) is 1 =
to 2=20
      months,<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R4">4</A>-<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R6">6</A></SUP>=20
      emphasizing<SUP> </SUP>the need to improve local control and=20
      survival.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R7">7</A>-<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R10">10</A></SUP>=20
      Whole-brain<SUP> </SUP>radiation therapy (WBRT) has been the =
principal=20
      treatment, with<SUP> </SUP>local control/response rates of 50% to=20
      75%.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R11">11</A>-<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R15">15</A></SUP>=20
      Despite the<SUP> </SUP>use of WBRT, the prognosis for patients =
with brain=20
      metastases<SUP> </SUP>remains poor. Patients generally survive for =
only=20
      4.5 months<SUP> </SUP>after diagnosis, which has not changed over =
the last=20
      25 years.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R3">3</A>,<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R16">16</A>-<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R18">18</A></SUP><SUP>=20
      </SUP>
      <P>Selected patients with good performance status and a =
single<SUP>=20
      </SUP>brain metastasis seem to benefit from surgical resection =
if<SUP>=20
      </SUP>the lesion is located in a noneloquent area.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R7">7</A>,<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R19">19</A></SUP>=20
      Furthermore,<SUP> </SUP>the use of stereotactic radiosurgery (SRS) =

      provides a less invasive<SUP> </SUP>means of achieving a similar =
outcome=20
      to surgery for some patients.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R20">20</A>-<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R22">22</A></SUP><SUP>=20
      </SUP>The recent publication of the results of Radiation Therapy=20
      Oncology<SUP> </SUP>Group 9508, a phase III study evaluating WBRT =
with or=20
      without<SUP> </SUP>SRS, reported a significant survival benefit in =

      patients with<SUP> </SUP>a single brain metastasis who were =
randomly=20
      assigned to the<SUP> </SUP>SRS treatment arm.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R23">23</A></SUP>=20
      However, no survival advantage was observed<SUP> </SUP>with SRS in =

      patients with multiple brain metastases, despite<SUP> </SUP>better =
local=20
      control. Because the majority of patients with<SUP> </SUP>brain =
metastases=20
      are not ideal candidates for SRS because of<SUP> </SUP>their tumor =

      location, disease status, or number of lesions,<SUP> </SUP>WBRT =
remains=20
      the standard treatment in most patients. One potential<SUP> =
</SUP>approach=20
      to improving the benefits of WBRT is to combat hypoxia,<SUP> =
</SUP>a=20
      hallmark of brain tumors<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R24">24</A>,<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R25">25</A></SUP>=20
      and a well-recognized cause<SUP> </SUP>of radiation =
resistance.<SUP>=20
</SUP>
      <P>Hypoxic tumors are more resistant to cell damage caused by=20
      ionizing<SUP> </SUP>radiation.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R26">26</A></SUP>=20
      Therefore, tumor hypoxia adversely affects the<SUP> </SUP>clinical =

      prognosis of patients receiving radiation therapy.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R27">27</A>-<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R30">30</A></SUP><SUP>=20
      </SUP>Levels of oxygen have been measured in tumors from =
patients<SUP>=20
      </SUP>with various cancers, and the results have confirmed tumor=20
      hypoxia<SUP> </SUP>in many cancers including brain =
metastases,<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R24">24</A>,<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R25">25</A></SUP>=20
      breast cancer,<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R31">31</A></SUP><SUP>=20
      </SUP>glioblastoma multiforme,<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R24">24</A></SUP>=20
      squamous cell carcinomas of the uterine<SUP> </SUP>cervix,<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R32">32</A></SUP>=20
      and head and neck cancer.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R33">33</A></SUP>=20
      Several clinical studies<SUP> </SUP>have also demonstrated that =
tumors=20
      with a low median partial<SUP> </SUP>oxygen pressure =
(pO<SUB>2</SUB>) have=20
      a higher local failure rate after<SUP> </SUP>radiation =
therapy.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R32">32</A>,<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R33">33</A></SUP><SUP>=20
      </SUP>
      <P>Efaproxiral (Efaproxyn, RSR13; Allos Therapeutics Inc,=20
      Westminster,<SUP> </SUP>CO) is an allosteric modifier of =
hemoglobin and=20
      the first of<SUP> </SUP>a new class of pharmaceutical agents. =
Efaproxiral=20
      binds noncovalently<SUP> </SUP>in the central water cavity of the=20
      hemoglobin tetramer and affects<SUP> </SUP>the conformational =
structure of=20
      hemoglobin.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R34">34</A>,<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R35">35</A></SUP>=20
      This leads<SUP> </SUP>to a reduction in hemoglobin oxygen-binding=20
      affinity<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R36">36</A>-<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R41">41</A></SUP>=20
      and<SUP> </SUP>thereby facilitates the release of oxygen. By this=20
      mechanism,<SUP> </SUP>efaproxiral increases whole-blood =
pO<SUB>2</SUB> for=20
      50% hemoglobin saturation<SUP> </SUP>(p50), resulting in enhanced =
tumor=20
      oxygenation and radiation<SUP> </SUP>sensitivity.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R42">42</A>,<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R43">43</A></SUP>=20
      Unlike other agents that have been used to<SUP> </SUP>improve the=20
      effectiveness of WBRT, efaproxiral does not need<SUP> </SUP>to =
enter=20
      cancer cells to increase radiosensitivity because oxygen<SUP>=20
      </SUP>readily diffuses across the blood-brain barrier to =
decrease<SUP>=20
      </SUP>tumor hypoxia. Theoretically, efaproxiral has the =
potential<SUP>=20
      </SUP>to increase the effectiveness of WBRT.<SUP> </SUP>
      <P>Phase I studies in healthy volunteers and oncology =
patients<SUP>=20
      </SUP>confirmed the feasibility and safety of administering =
doses<SUP>=20
      </SUP>of efaproxiral at 75 or 100 mg/kg, either of which was=20
      sufficient<SUP> </SUP>to reach the desired pharmacodynamic end =
point (to=20
      increase<SUP> </SUP>whole-blood p50 by approximately 10 mmHg) and=20
      establish a strong<SUP> </SUP>correlation between efaproxiral=20
      concentration in RBCs and p50<SUP> </SUP>shift.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R44">44</A>,<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R45">45</A></SUP>=20
      A phase II study demonstrated that survival significantly<SUP>=20
      </SUP>improved in patients with brain metastases from solid =
tumors<SUP>=20
      </SUP>who were treated with 75 or 100 mg/kg of efaproxiral =
within<SUP>=20
      </SUP>30 minutes before standard WBRT versus a case-matched=20
      historical<SUP> </SUP>control group of recursive partitioning =
analysis=20
      (RPA) class<SUP> </SUP>II patients in the Radiation Therapy =
Oncology Group=20
      Brain Metastases<SUP> </SUP>Database.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R46">46</A></SUP><SUP>=20
      </SUP>
      <P>These encouraging results led us to perform the current =
phase<SUP>=20
      </SUP>III study, RT-009, which is also called the Radiation =
Enhancing<SUP>=20
      </SUP>Allosteric Compound for Hypoxic Brain Metastases (REACH) =
study.<SUP>=20
      </SUP>In this study, we tested the hypothesis that adding =
efaproxiral<SUP>=20
      </SUP>to WBRT plus supplemental oxygen would improve survival =
better<SUP>=20
      </SUP>than WBRT with supplemental oxygen alone.<SUP> </SUP>
      <P><A name=3DSEC2><!-- null --></A><BR clear=3Dright>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"100%" =
bgColor=3D#e1e1e1>
        <TBODY>
        <TR>
          <TD vAlign=3Dcenter align=3Dleft width=3D"5%" =
bgColor=3D#ffffff><IMG=20
            height=3D21 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/rarrow.gif" =
width=3D10></TD>
          <TH vAlign=3Dcenter align=3Dleft width=3D"95%"><FONT =
size=3D+2>&nbsp;&nbsp;=20
            PATIENTS AND METHODS </FONT></TH></TR></TBODY></TABLE>
      <TABLE cellPadding=3D5 align=3Dright border=3D1>
        <TBODY>
        <TR>
          <TH align=3Dleft><FONT size=3D-1><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#top"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>TOP<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#ABS"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>ABSTRACT<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC1"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>INTRODUCTION<BR></A><IMG height=3D9 alt=3D" " =
hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/dot.gif" width=3D11 =
border=3D0><FONT=20
            color=3D#464c53>PATIENTS AND METHODS</FONT><BR><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC3"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>RESULTS<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC4"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>DISCUSSION<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC5"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Appendix<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC6"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Authors' Disclosures of...<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC7"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Author Contributions<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#BIBL"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            =
border=3D0>REFERENCES<BR></A></FONT></TH></TR></TBODY></TABLE>&nbsp;<BR><=
STRONG>Eligibility=20
      Criteria</STRONG><BR>Enrollment was open to RPA class I or II =
patients=20
      with brain<SUP> </SUP>metastases originating from solid tumors, =
excluding=20
      small-cell<SUP> </SUP>lung cancer, germ cell tumors, and =
lymphomas.=20
      Additional eligibility<SUP> </SUP>criteria included no prior =
treatment for=20
      brain metastases (other<SUP> </SUP>than resection with measurable =
lesion=20
      remaining), age <IMG alt=3D&#8805; =
src=3D"http://www.jco.org/math/ge.gif" border=3D0>=20
      18 years,<SUP> </SUP>and adequate hematologic, hepatic, and renal =
function=20
      as defined<SUP> </SUP>by hemoglobin <IMG alt=3D&#8805;=20
      src=3D"http://www.jco.org/math/ge.gif" border=3D0> 10 g/dL, WBC =
count <IMG=20
      alt=3D&#8805; src=3D"http://www.jco.org/math/ge.gif" border=3D0> =
2,000 cells/=B5L,=20
      platelet<SUP> </SUP>count <IMG alt=3D&#8805; =
src=3D"http://www.jco.org/math/ge.gif"=20
      border=3D0> 75,000 cells/=B5L, creatinine <IMG alt=3D&#8804;=20
      src=3D"http://www.jco.org/math/le.gif" border=3D0> 2.0 mg/dL, =
bilirubin<SUP>=20
      </SUP><IMG alt=3D&#8804; src=3D"http://www.jco.org/math/le.gif" =
border=3D0> 2.0 mg/dL,=20
      and transaminases 3<FONT face=3Darial,helvetica>x</FONT> the upper =
limit of=20
      normal.<SUP> </SUP>Patients were required to have no other =
concurrent=20
      active malignancy,<SUP> </SUP>no planned therapy for brain =
metastases=20
      through the 1-month<SUP> </SUP>post-WBRT follow-up visit, and =
standard=20
      pulse oximetry (SpO<SUB>2</SUB>)<SUP> </SUP>measurement (resting =
and=20
      exercise) <IMG alt=3D&#8805; =
src=3D"http://www.jco.org/math/ge.gif" border=3D0> 90%.=20
      Women could not be<SUP> </SUP>breastfeeding or pregnant, and =
females of=20
      childbearing potential<SUP> </SUP>and all nonsterile males were =
required=20
      to use contraception.<SUP> </SUP>Patients were excluded if they =
had prior=20
      exposure to efaproxiral,<SUP> </SUP>had received chemotherapy =
within 7=20
      days, or had used investigational<SUP> </SUP>agents within 28 days =
before=20
      WBRT. Informed consent was obtained<SUP> </SUP>from all patients. =
Human=20
      experimentation guidelines of the appropriate<SUP> =
</SUP>regulatory=20
      authorities and the guidelines of the investigators'<SUP>=20
      </SUP>institutions were followed in the conduct of clinical =
research.<SUP>=20
      </SUP>
      <P><STRONG>Random Assignment</STRONG><BR>Patients were randomly =
assigned=20
      1:1 to receive standard WBRT<SUP> </SUP>plus supplemental oxygen =
and=20
      either efaproxiral (efaproxiral<SUP> </SUP>arm) or no efaproxiral =
(control=20
      arm) using permuted blocks within<SUP> </SUP>strata that were =
defined by=20
      RPA class and primary site.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R47">47</A></SUP>=20
      In<SUP> </SUP>total, there were four strata, as follows: (1) RPA =
class=20
      I;<SUP> </SUP>(2) RPA class II non=96small-cell lung cancer =
(NSCLC);=20
      (3)<SUP> </SUP>RPA class II breast cancer; and (4) RPA class II =
other=20
      cancer<SUP> </SUP>sites.<SUP> </SUP>
      <P><STRONG>Treatment</STRONG><BR>All patients received a standard =
2-week=20
      course of WBRT (3 Gy/fraction<SUP> </SUP>for 10 days) plus =
supplemental=20
      oxygen (4 L/min via nasal cannula).<SUP> </SUP>Oxygen was =
administered=20
      beginning 35 minutes before, during,<SUP> </SUP>and for at least =
15=20
      minutes after daily WBRT. Supplemental oxygen<SUP> </SUP>was =
administered=20
      to both arms to ensure that any treatment effect<SUP> =
</SUP>between=20
      treatment arms was attributable to efaproxiral. For<SUP> </SUP>the =

      efaproxiral arm, administration began on the first day of<SUP> =
</SUP>WBRT=20
      and continued every day (Monday through Friday) of the<SUP> =
</SUP>2-week=20
      WBRT course for a total of 10 doses. Efaproxiral was<SUP>=20
      </SUP>administered intravenously via a central venous access =
device<SUP>=20
      </SUP>over 30 minutes; the infusion was completed no more than =
30<SUP>=20
      </SUP>minutes before WBRT. The intended daily dose of =
efaproxiral<SUP>=20
      </SUP>was 75 or 100 mg/kg. The control arm received the same=20
      treatment<SUP> </SUP>without administration of efaproxiral; no =
placebo was=20
      administered.<SUP> </SUP>An amendment to the original study =
protocol=20
      revised the dosing<SUP> </SUP>guidelines, making the initial =
efaproxiral=20
      dose dependent on<SUP> </SUP>sex and body weight. If the =
SpO<SUB>2</SUB>=20
      while breathing room air at<SUP> </SUP>screening (at rest and =
during=20
      exercise) and on WBRT day 1 was<SUP> </SUP><IMG alt=3D&#8805;=20
      src=3D"http://www.jco.org/math/ge.gif" border=3D0> 93%, =
efaproxiral was=20
      administered as follows: males with a<SUP> </SUP>body weight of =
<IMG alt=3D&#8804;=20
      src=3D"http://www.jco.org/math/le.gif" border=3D0> 95 kg and =
females weighing=20
      <IMG alt=3D&#8804; src=3D"http://www.jco.org/math/le.gif" =
border=3D0> 70 kg were=20
      initially<SUP> </SUP>administered 100 mg/kg of efaproxiral; and =
males with=20
      a body<SUP> </SUP>weight of more than 95 kg and females weighing =
more than=20
      70<SUP> </SUP>kg were administered 75 mg/kg of efaproxiral. If the =

      SpO<SUB>2</SUB> while<SUP> </SUP>breathing room air on WBRT day 1 =
was less=20
      than 93%, efaproxiral<SUP> </SUP>was omitted that day. Dosing=20
      modifications were permitted based<SUP> </SUP>on SpO<SUB>2</SUB> =
and=20
      anticipated adverse events (AEs) that were temporally<SUP> =
</SUP>related=20
      to the administration of efaproxiral. Dose reductions<SUP> =
</SUP>to 50=20
      mg/kg were permitted through protocol exemptions on a<SUP>=20
      </SUP>case-by-case basis.<SUP> </SUP>
      <P><STRONG>Efficacy Assessments</STRONG><BR>The primary efficacy =
end point=20
      was overall survival, which was<SUP> </SUP>measured from the time =
of=20
      random assignment until death or January<SUP> </SUP>31, 2003, =
whichever=20
      occurred first. Response rate, which was<SUP> </SUP>defined as =
best=20
      response (complete plus partial response) after<SUP> </SUP>WBRT, =
was=20
      evaluated as a secondary end point. Radiographic assessments<SUP>=20
      </SUP>were performed by either magnetic resonance imaging or =
computed<SUP>=20
      </SUP>tomography (consistent testing was required throughout) at=20
      baseline,<SUP> </SUP>1 month after WBRT, 3 months after WBRT, and =
every 3=20
      months<SUP> </SUP>thereafter until progression or death. =
Neuroradiologists=20
      who<SUP> </SUP>were blinded to all other study data independently=20
      reviewed<SUP> </SUP>all scans. Response evaluations of up to three =

      indicator lesions<SUP> </SUP>(target lesions) were made relative =
to the=20
      baseline scan. A<SUP> </SUP>complete response was defined as =
complete=20
      resolution of all<SUP> </SUP>target lesions, and a partial =
response was=20
      defined as at least<SUP> </SUP>a 50% reduction in the sum of the=20
      bidimensional products of<SUP> </SUP>all indicator lesions. =
Progressive=20
      disease was defined as an<SUP> </SUP>increase in the bidimensional =
product=20
      of greater than 25% in<SUP> </SUP>at least one target lesion or =
the=20
      progression of any treated<SUP> </SUP>lesion that was not =
enumerated as a=20
      target lesion. The appearance<SUP> </SUP>of new lesions did not =
constitute=20
      disease progression. All other<SUP> </SUP>evaluations were =
reported as=20
      stable disease. Other secondary<SUP> </SUP>efficacy end points =
evaluated=20
      were radiologic and clinical progression,<SUP> </SUP>cause of =
death, and=20
      quality of life.<SUP> </SUP>
      <P><STRONG>Safety Assessments</STRONG><BR>All patients who =
received at=20
      least one dose of study treatment,<SUP> </SUP>defined as =
efaproxiral=20
      and/or WBRT, comprised the safety analysis<SUP> </SUP>population. =
An AE=20
      was considered treatment emergent if the AE<SUP> </SUP>increased =
in=20
      severity over the baseline severity grade and if<SUP> </SUP>the =
onset date=20
      was after the first administration of study treatment<SUP> =
</SUP>but no=20
      more than 7 days after the last dose of study treatment.<SUP> =
</SUP>All=20
      treatment-emergent AEs, with the exception of hypoxemia,<SUP> =
</SUP>were=20
      evaluated and assigned a grade using the National Cancer<SUP>=20
      </SUP>Institute Common Toxicity Criteria version 2.0.<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R48">48</A></SUP>=20
      The relationship<SUP> </SUP>of the event to efaproxiral was =
assessed by=20
      the investigator.<SUP> </SUP>Because all patients were to receive=20
      supplemental oxygen (considered<SUP> </SUP>grade 3 by the National =
Cancer=20
      Institute Common Toxicity Criteria),<SUP> </SUP>a sponsor-defined =
grading=20
      scale was designed for the AE of hypoxemia<SUP> </SUP>(<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#T1">Table=20
      1</A>).<SUP> </SUP>
      <P><A name=3DT1><!-- null --></A><BR clear=3Dall>
      <CENTER>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"95%">
        <TBODY>
        <TR bgColor=3D#e1e1e1>
          <TD>
            <TABLE cellSpacing=3D2 cellPadding=3D2>
              <TBODY>
              <TR bgColor=3D#e1e1e1>
                <TD vAlign=3Dtop align=3Dmiddle =
bgColor=3D#ffffff><STRONG>View this=20
                  table:</STRONG><BR><NOBR><A=20
                  =
href=3D"http://www.jco.org/cgi/content/full/24/1/106/T1">[in=20
                  this window]</A><BR><A=20
                  onmouseover=3D"window.status=3D'View table in a =
separate window'; return true"=20
                  onclick=3D"startTarget('T1', 500, 400); =
this.href=3D'/cgi/content-nw/full/24/1/106/T1'"=20
                  =
href=3D"http://www.jco.org/cgi/content-nw/full/24/1/106/T1"=20
                  target=3DT1>[in a new window]</A><BR>&nbsp;</NOBR> =
</TD>
                <TD vAlign=3Dtop align=3Dleft><B>Table 1.</B> Severity =
Grading for=20
                  Hypoxemia (sponsor defined per protocol)
                  =
<P></P></TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE></CENTER>&nbsp=
;<BR><STRONG>Statistical=20
      Considerations</STRONG><BR>The primary survival analysis was =
performed=20
      using a two-sided<SUP> </SUP>log-rank test (unadjusted for =
covariates) on=20
      two coprimary populations<SUP> </SUP>(all eligible patients and =
the=20
      eligible patients with NSCLC<SUP> </SUP>and breast cancer). The =
study=20
      design had 85% power to detect<SUP> </SUP>a difference in survival =

      assuming a true 35% MST increase in<SUP> </SUP>the treatment arm =
from 4.57=20
      to 6.17 months. The design parameters<SUP> </SUP>also resulted in =
75%=20
      power, assuming the same treatment effect,<SUP> </SUP>in the =
slightly=20
      smaller population of all eligible patients<SUP> </SUP>with =
NSCLC/breast=20
      cancer. For survival analysis, January 31,<SUP> </SUP>2003, was =
stipulated=20
      as the cutoff date for follow-up because<SUP> </SUP>it allowed for =
the=20
      prespecified number of events (at least 402<SUP> </SUP>deaths =
overall and=20
      308 deaths in the NSCLC/breast cancer populations)<SUP> </SUP>and=20
      permitted at least 6 months of follow-up on each patient.<SUP> =
</SUP>The=20
      covariate and treatment effects were estimated using the<SUP> =
</SUP>hazard=20
      ratio (HR) with a 95% CI and two types of Cox regression<SUP> =
</SUP>models=20
      (single regression, where only one covariate was entered<SUP> =
</SUP>into=20
      the model, and multiple regression, which included 16 =
baseline<SUP>=20
      </SUP>categoric covariates, in addition to the treatment arm). =
These<SUP>=20
      </SUP>covariates and their distribution are listed in <A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#T2">Table=20
      2</A>. Categoric<SUP> </SUP>covariates were analyzed using =
indicator=20
      variables for each<SUP> </SUP>level of the covariate. HRs for =
these=20
      nominal covariates compare<SUP> </SUP>the given level of the =
covariate=20
      with the reference level, which<SUP> </SUP>is indicated by 1.00 in =
<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#T3">Table=20
      3</A>. The Kaplan-Meier method<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R49">49</A></SUP>=20
      was<SUP> </SUP>used to estimate survival over time, censoring =
patients=20
      who<SUP> </SUP>remained alive as of January 31, 2003. Statistical=20
      significance<SUP> </SUP>was assessed using the Wald test statistic =
for=20
      two-level covariates<SUP> </SUP>and the likelihood ratio test for=20
      covariates with three or more<SUP> </SUP>levels. No approximation =
to the=20
      likelihood in the event of tied<SUP> </SUP>failure times was used. =
Tests=20
      of the proportional hazards assumption<SUP> </SUP>were made based =
on an=20
      inspection of the deviance residual plots<SUP> </SUP>as well as =
kernel=20
      smoothing plots of the hazard functions. Two-tailed<SUP> =
</SUP><I>P</I>=20
      &lt; .05 denoted statistical significance. SAS version 8.2<SUP> =
</SUP>(SAS=20
      Institute, Cary, NC) was used for all data analyses.<SUP> </SUP>
      <P><A name=3DT2><!-- null --></A><BR clear=3Dall>
      <CENTER>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"95%">
        <TBODY>
        <TR bgColor=3D#e1e1e1>
          <TD>
            <TABLE cellSpacing=3D2 cellPadding=3D2>
              <TBODY>
              <TR bgColor=3D#e1e1e1>
                <TD vAlign=3Dtop align=3Dmiddle =
bgColor=3D#ffffff><STRONG>View this=20
                  table:</STRONG><BR><NOBR><A=20
                  =
href=3D"http://www.jco.org/cgi/content/full/24/1/106/T2">[in=20
                  this window]</A><BR><A=20
                  onmouseover=3D"window.status=3D'View table in a =
separate window'; return true"=20
                  onclick=3D"startTarget('T2', 500, 400); =
this.href=3D'/cgi/content-nw/full/24/1/106/T2'"=20
                  =
href=3D"http://www.jco.org/cgi/content-nw/full/24/1/106/T2"=20
                  target=3DT2>[in a new window]</A><BR>&nbsp;</NOBR> =
</TD>
                <TD vAlign=3Dtop align=3Dleft><B>Table 2.</B> =
Distribution of=20
                  Prognostic Factors by Treatment Group (all eligible =
patients)
                  =
<P></P></TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE></CENTER>&nbsp=
;<BR><A=20
      name=3DT3><!-- null --></A><BR clear=3Dall>
      <CENTER>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"95%">
        <TBODY>
        <TR bgColor=3D#e1e1e1>
          <TD>
            <TABLE cellSpacing=3D2 cellPadding=3D2>
              <TBODY>
              <TR bgColor=3D#e1e1e1>
                <TD vAlign=3Dtop align=3Dmiddle =
bgColor=3D#ffffff><STRONG>View this=20
                  table:</STRONG><BR><NOBR><A=20
                  =
href=3D"http://www.jco.org/cgi/content/full/24/1/106/T3">[in=20
                  this window]</A><BR><A=20
                  onmouseover=3D"window.status=3D'View table in a =
separate window'; return true"=20
                  onclick=3D"startTarget('T3', 500, 400); =
this.href=3D'/cgi/content-nw/full/24/1/106/T3'"=20
                  =
href=3D"http://www.jco.org/cgi/content-nw/full/24/1/106/T3"=20
                  target=3DT3>[in a new window]</A><BR>&nbsp;</NOBR> =
</TD>
                <TD vAlign=3Dtop align=3Dleft><B>Table 3.</B> =
Univariable and=20
                  Multivariable Proportional Hazards Regression Analyses =
(all=20
                  eligible patients)
                  =
<P></P></TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE></CENTER>&nbsp=
;<BR>Treatment-arm=20
      comparisons of response rate in the brain, cause<SUP> </SUP>of =
death, and=20
      quality of life (assessed by the Spitzer Questionnaire<SUP> =
</SUP>and=20
      Karnofsky performance score [KPS]) were made using the <IMG =
alt=3D{chi}=20
      src=3D"http://www.jco.org/math/khgr.gif" =
border=3D0><SUP>2</SUP><SUP>=20
      </SUP>test. All end points were analyzed using a denominator of =
the<SUP>=20
      </SUP>entire eligible patient population (or eligible =
NSCLC/breast<SUP>=20
      </SUP>cancer population). Cause of death was assessed as =
neurologic<SUP>=20
      </SUP>(progressive disease in the brain and no extracranial=20
      progression),<SUP> </SUP>non-neurologic (no progressive disease in =
the=20
      brain), or indistinguishable<SUP> </SUP>(progressive disease in =
the brain=20
      and extracranial progression).<SUP> </SUP>If cause of death was =
missing,=20
      it was assumed to be neurologic<SUP> </SUP>progression. For the =
quality of=20
      life analyses, the percentage<SUP> </SUP>of patients in each arm =
with a=20
      stable or improving score (compared<SUP> </SUP>with baseline) was=20
      determined for each visit (1, 3, and 6 months<SUP> </SUP>after =
WBRT). This=20
      percentage was then used in a Cochran-Mantel-Haenszel<SUP> =
</SUP>test to=20
      obtain a composite <I>P</I> value over time. Time to =
radiographic<SUP>=20
      </SUP>or clinical tumor progression was reported by cumulative=20
      incidence<SUP> </SUP>estimates, and Gray's test<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R50">50</A></SUP>=20
      was used for treatment-arm comparisons.<SUP> </SUP>An additional,=20
      nonprespecified analysis was performed on progression-free<SUP>=20
      </SUP>survival (PFS), where death or radiographic progression in =
the<SUP>=20
      </SUP>brain constituted an event. This allowed for a =
conservative<SUP>=20
      </SUP>comparison of PFS between the treatment arms using the =
log-rank<SUP>=20
      </SUP>statistic. Clinical progression in the brain was based on =
at<SUP>=20
      </SUP>least one of the following occurring after WBRT day 10: an=20
      increase<SUP> </SUP>from baseline by 1 in neurologic function =
status=20
      score, a decrease<SUP> </SUP>from baseline by 3 in the Mini Mental =
State=20
      Examination score,<SUP> </SUP>or the use of subsequent therapy for =
brain=20
      metastases.<SUP> </SUP>
      <P><A name=3DSEC3><!-- null --></A><BR clear=3Dright>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"100%" =
bgColor=3D#e1e1e1>
        <TBODY>
        <TR>
          <TD vAlign=3Dcenter align=3Dleft width=3D"5%" =
bgColor=3D#ffffff><IMG=20
            height=3D21 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/rarrow.gif" =
width=3D10></TD>
          <TH vAlign=3Dcenter align=3Dleft width=3D"95%"><FONT =
size=3D+2>&nbsp;&nbsp;=20
            RESULTS </FONT></TH></TR></TBODY></TABLE>
      <TABLE cellPadding=3D5 align=3Dright border=3D1>
        <TBODY>
        <TR>
          <TH align=3Dleft><FONT size=3D-1><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#top"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>TOP<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#ABS"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>ABSTRACT<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC1"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>INTRODUCTION<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC2"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>PATIENTS AND METHODS<BR></A><IMG height=3D9 =
alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/dot.gif" width=3D11 =
border=3D0><FONT=20
            color=3D#464c53>RESULTS</FONT><BR><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC4"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>DISCUSSION<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC5"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Appendix<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC6"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Authors' Disclosures of...<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC7"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Author Contributions<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#BIBL"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            =
border=3D0>REFERENCES<BR></A></FONT></TH></TR></TBODY></TABLE>&nbsp;<BR><=
STRONG>Patient=20
      Characteristics and Disposition</STRONG><BR>There were 538 =
patients from=20
      82 clinical research sites and<SUP> </SUP>12 countries randomly =
assigned=20
      to this study. As assessed by<SUP> </SUP>independent review of =
prerandom=20
      assignment information, 23 patients<SUP> </SUP>(efaproxiral arm, n =
=3D 6;=20
      control arm, n =3D 17) were deemed to<SUP> </SUP>be in violation =
of major=20
      eligibility criteria; therefore, 515<SUP> </SUP>patients were =
included in=20
      the efficacy analyses for all eligible<SUP> </SUP>patients, of =
whom 397=20
      had NSCLC or breast cancer. <A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#T2">Table=20
      2</A> demonstrates<SUP> </SUP>that the treatment arms were =
generally well=20
      balanced for the<SUP> </SUP>efficacy population.<SUP> </SUP>
      <P>Five hundred twenty-nine patients received at least one =
dose<SUP>=20
      </SUP>of study treatment, making up the safety analysis =
population;<SUP>=20
      </SUP>of those patients, 266 patients (50%) were in the =
efaproxiral<SUP>=20
      </SUP>arm. Ninety-five percent of patients in the efaproxiral =
arm<SUP>=20
      </SUP>and 97% of patients in the control arm received all 10 =
doses<SUP>=20
      </SUP>of intended WBRT. Eighty-two percent (218 of 266 patients) =
of<SUP>=20
      </SUP>the patients in the efaproxiral arm received at least =
seven<SUP>=20
      </SUP>doses of efaproxiral, and the mean daily dose of =
efaproxiral<SUP>=20
      </SUP>was 83.6 mg/kg. No patients were lost to follow-up in the=20
      survival<SUP> </SUP>analysis of January 31, 2003.<SUP> </SUP>
      <P><STRONG>Survival</STRONG><BR>The survival analysis was =
performed with a=20
      median potential<SUP> </SUP>follow-up of 15.2 months (range, 6.1 =
to 35.3=20
      months). An inspection<SUP> </SUP>of the deviance residual plots =
as well=20
      as kernel smoothing plots<SUP> </SUP>of the hazard functions did =
not=20
      indicate departure from the<SUP> </SUP>proportional hazards =
assumptions.=20
      For the coprimary populations,<SUP> </SUP>Kaplan-Meier plots =
presenting=20
      the number of deaths and estimating<SUP> </SUP>survival over time =
are=20
      provided in <A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#F1">Figures=20
      1A and 1B</A>. For all<SUP> </SUP>eligible patients, the MST was =
4.4=20
      months for the control arm<SUP> </SUP>and 5.4 months for the =
efaproxiral=20
      arm (HR =3D 0.87; <I>P</I> =3D .16).<SUP> </SUP>For the =
NSCLC/breast cancer=20
      population, the MST was 4.4 months<SUP> </SUP>for the control arm =
and 6.0=20
      months for the efaproxiral arm (HR<SUP> </SUP>=3D 0.82; <I>P</I> =
=3D .07). The=20
      estimates for the treatment effect in<SUP> </SUP>these two =
coprimary=20
      populations were similar in a 12-month follow-up<SUP> =
</SUP>analysis, with=20
      slightly lower <I>P</I> values (<I>P</I> =3D .13 and <I>P</I> =3D =
.05<SUP>=20
      </SUP>for all eligible patients and NSCLC/breast cancer =
patients,<SUP>=20
      </SUP>respectively). In an exploratory analysis by primary tumor=20
      type,<SUP> </SUP>the largest efaproxiral treatment effect was =
observed in=20
      the<SUP> </SUP>107 patients with metastases from breast cancer (HR =
=3D=20
      0.51;<SUP> </SUP><I>P</I> =3D .003, unadjusted log-rank test). =
There did not=20
      seem to be<SUP> </SUP>a treatment benefit in the 290 patients with =
NSCLC=20
      (HR =3D 0.97;<SUP> </SUP><I>P</I> =3D .83, unadjusted log-rank =
test) or in the=20
      group of 118 patients<SUP> </SUP>with other tumor types (HR =3D =
1.12;=20
      <I>P</I> =3D .58, unadjusted log-rank<SUP> </SUP>test).<SUP> =
</SUP>
      <P><A name=3DF1><!-- null --></A><BR clear=3Dall>
      <CENTER>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"95%">
        <TBODY>
        <TR bgColor=3D#e1e1e1>
          <TD>
            <TABLE cellSpacing=3D2 cellPadding=3D2>
              <TBODY>
              <TR bgColor=3D#e1e1e1>
                <TD vAlign=3Dtop align=3Dmiddle bgColor=3D#ffffff><A=20
                  =
href=3D"http://www.jco.org/cgi/content/full/24/1/106/F1"><IMG=20
                  height=3D66 alt=3D" " hspace=3D10=20
                  =
src=3D"http://www.jco.org/content/vol24/issue1/images/small/zlj0010631120=
001.gif"=20
                  width=3D200 vspace=3D5 border=3D2></A><BR><STRONG>View =
larger=20
                  version</STRONG> (12K):<BR><NOBR><A=20
                  =
href=3D"http://www.jco.org/cgi/content/full/24/1/106/F1">[in=20
                  this window]</A><BR><A=20
                  onmouseover=3D"window.status=3D'View figure in a =
separate window'; return true"=20
                  onclick=3D"startTarget('F1', 590, 345); =
this.href=3D'/cgi/content-nw/full/24/1/106/F1'"=20
                  =
href=3D"http://www.jco.org/cgi/content-nw/full/24/1/106/F1"=20
                  target=3DF1>[in a new window]</A><BR>&nbsp;</NOBR> =
</TD>
                <TD vAlign=3Dtop align=3Dleft><B>Fig 1.</B> (A) =
Kaplan-Meier=20
                  survival curve (all eligible patients). (B) =
Kaplan-Meier=20
                  survival curve (eligible non=96small-cell lung cancer =
and breast=20
                  cancer patients). MST, median survival time; HR, =
hazard ratio.
                  =
<P></P></TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE></CENTER>&nbsp=
;<BR>To=20
      account for confounding factors and bias of the treatment<SUP>=20
      </SUP>effect estimate that may result from omission of strong=20
      covariates<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R51">51</A>,<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R52">52</A></SUP><SUP>=20
      </SUP>(attenuation) in this heterogeneous population, a Cox=20
      regression<SUP> </SUP>analysis was performed with 16 covariates, =
in=20
      addition to treatment<SUP> </SUP>arm (<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#T2">Table=20
      2</A>). These prognostic factors were based on the =
literature,<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R3">3</A>,<A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R53">53</A></SUP><SUP>=20
      </SUP>the conduct of the study, and the mechanism of action of =
the<SUP>=20
      </SUP>drug. The regression results for all eligible patients=20
      demonstrated<SUP> </SUP>a 26% reduction in the risk of death for =
patients=20
      in the efaproxiral<SUP> </SUP>arm (HR =3D 0.74; 95% CI, 0.64 to =
0.90;=20
      <I>P</I> =3D .003). KPS, number<SUP> </SUP>of extracranial =
metastatic sites,=20
      and sex had the highest statistical<SUP> </SUP>significance in the =

      multiple regression model. Eight covariates,<SUP> </SUP>including=20
      treatment arm, were statistically significant predictors<SUP> =
</SUP>of=20
      survival in the multiple regression model. HR estimates from<SUP>=20
      </SUP>both the univariable and multivariable models are listed =
in<SUP>=20
      </SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#T3">Table=20
      3</A>. Covariates with a <I>P</I> &gt; .2 are not listed. In =
the<SUP>=20
      </SUP>NSCLC/breast cancer population, the Cox multiple =
regression<SUP>=20
      </SUP>model yielded a 25% reduction in the risk of death (HR =3D =
0.75;<SUP>=20
      </SUP>95% CI, 0.60 to 0.94; <I>P</I> =3D .01) in patients treated =
in the=20
      efaproxiral<SUP> </SUP>arm.<SUP> </SUP>
      <P><STRONG>Response Rate and Other Secondary End =
Points</STRONG><BR>The=20
      point estimates of response rate (complete plus partial<SUP>=20
      </SUP>response) were 38% (96 of 250 patients) for the control =
arm<SUP>=20
      </SUP>and 46% (121 of 265 patients) for the efaproxiral arm =
(<I>P</I> =3D=20
      .10).<SUP> </SUP>Twice the number of patients had a complete =
response in=20
      the<SUP> </SUP>efaproxiral arm (n =3D 28) compared with the =
control arm (n=20
      =3D<SUP> </SUP>14). Evaluation of the NSCLC/breast cancer =
population=20
      established<SUP> </SUP>a 13% increase in the response rate in the=20
      efaproxiral arm (54%)<SUP> </SUP>versus the control arm (41%; =
<I>P</I> =3D=20
      .01). <A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#T4">Table=20
      4</A> demonstrates<SUP> </SUP>that the number of eligible patients =
with=20
      follow-up scans decreased<SUP> </SUP>rapidly over time as a result =
of=20
      short survival.<SUP> </SUP>
      <P><A name=3DT4><!-- null --></A><BR clear=3Dall>
      <CENTER>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"95%">
        <TBODY>
        <TR bgColor=3D#e1e1e1>
          <TD>
            <TABLE cellSpacing=3D2 cellPadding=3D2>
              <TBODY>
              <TR bgColor=3D#e1e1e1>
                <TD vAlign=3Dtop align=3Dmiddle =
bgColor=3D#ffffff><STRONG>View this=20
                  table:</STRONG><BR><NOBR><A=20
                  =
href=3D"http://www.jco.org/cgi/content/full/24/1/106/T4">[in=20
                  this window]</A><BR><A=20
                  onmouseover=3D"window.status=3D'View table in a =
separate window'; return true"=20
                  onclick=3D"startTarget('T4', 500, 400); =
this.href=3D'/cgi/content-nw/full/24/1/106/T4'"=20
                  =
href=3D"http://www.jco.org/cgi/content-nw/full/24/1/106/T4"=20
                  target=3DT4>[in a new window]</A><BR>&nbsp;</NOBR> =
</TD>
                <TD vAlign=3Dtop align=3Dleft><B>Table 4.</B> Follow-Up=20
                  Radiographic Scans
                  =
<P></P></TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE></CENTER>&nbsp=
;<BR>Other=20
      secondary efficacy end points included time to radiologic<SUP> =
</SUP>and=20
      clinical progression in the brain, cause of death, and =
quality<SUP>=20
      </SUP>of life. <A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#T5">Table=20
      5</A> shows that there was not a significant difference<SUP> =
</SUP>in the=20
      cumulative incidence at 1 year after random assignment<SUP> =
</SUP>of=20
      radiographic or clinical progression in the brain between<SUP> =
</SUP>the=20
      treatment groups for the eligible population or for the<SUP>=20
      </SUP>NSCLC/breast cancer population. <A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#F2">Figures=20
      2A and 2B</A> display the<SUP> </SUP>Kaplan-Meier plots of PFS for =
all=20
      eligible patients (<I>P</I> =3D .21)<SUP> </SUP>and the =
NSCLC/breast cancer=20
      population (<I>P</I> =3D .06).<SUP> </SUP>
      <P><A name=3DT5><!-- null --></A><BR clear=3Dall>
      <CENTER>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"95%">
        <TBODY>
        <TR bgColor=3D#e1e1e1>
          <TD>
            <TABLE cellSpacing=3D2 cellPadding=3D2>
              <TBODY>
              <TR bgColor=3D#e1e1e1>
                <TD vAlign=3Dtop align=3Dmiddle =
bgColor=3D#ffffff><STRONG>View this=20
                  table:</STRONG><BR><NOBR><A=20
                  =
href=3D"http://www.jco.org/cgi/content/full/24/1/106/T5">[in=20
                  this window]</A><BR><A=20
                  onmouseover=3D"window.status=3D'View table in a =
separate window'; return true"=20
                  onclick=3D"startTarget('T5', 500, 400); =
this.href=3D'/cgi/content-nw/full/24/1/106/T5'"=20
                  =
href=3D"http://www.jco.org/cgi/content-nw/full/24/1/106/T5"=20
                  target=3DT5>[in a new window]</A><BR>&nbsp;</NOBR> =
</TD>
                <TD vAlign=3Dtop align=3Dleft><B>Table 5.</B> =
Radiographic and=20
                  Clinical Progression
                  =
<P></P></TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE></CENTER>&nbsp=
;<BR><A=20
      name=3DF2><!-- null --></A><BR clear=3Dall>
      <CENTER>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"95%">
        <TBODY>
        <TR bgColor=3D#e1e1e1>
          <TD>
            <TABLE cellSpacing=3D2 cellPadding=3D2>
              <TBODY>
              <TR bgColor=3D#e1e1e1>
                <TD vAlign=3Dtop align=3Dmiddle bgColor=3D#ffffff><A=20
                  =
href=3D"http://www.jco.org/cgi/content/full/24/1/106/F2"><IMG=20
                  height=3D65 alt=3D" " hspace=3D10=20
                  =
src=3D"http://www.jco.org/content/vol24/issue1/images/small/zlj0010631120=
002.gif"=20
                  width=3D200 vspace=3D5 border=3D2></A><BR><STRONG>View =
larger=20
                  version</STRONG> (12K):<BR><NOBR><A=20
                  =
href=3D"http://www.jco.org/cgi/content/full/24/1/106/F2">[in=20
                  this window]</A><BR><A=20
                  onmouseover=3D"window.status=3D'View figure in a =
separate window'; return true"=20
                  onclick=3D"startTarget('F2', 590, 344); =
this.href=3D'/cgi/content-nw/full/24/1/106/F2'"=20
                  =
href=3D"http://www.jco.org/cgi/content-nw/full/24/1/106/F2"=20
                  target=3DF2>[in a new window]</A><BR>&nbsp;</NOBR> =
</TD>
                <TD vAlign=3Dtop align=3Dleft><B>Fig 2.</B> (A) =
Kaplan-Meier=20
                  radiographic progression-free survival (PFS) curve =
(all=20
                  eligible patients). (B) Kaplan-Meier radiographic PFS =
curve=20
                  (eligible non=96small-cell lung cancer and breast =
cancer=20
                  patients). HR, hazard ratio.
                  =
<P></P></TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE></CENTER>&nbsp=
;<BR>Of=20
      the 206 deaths in the control arm, 30 (15%) were a result<SUP> =
</SUP>of=20
      neurologic progression, 124 (60%) were a result of =
non-neurologic<SUP>=20
      </SUP>progression, and 52 (25%) were indistinguishable. Of the =
215<SUP>=20
      </SUP>deaths in the efaproxiral arm, 37 (17%) were a result of=20
      neurologic<SUP> </SUP>progression, 126 (59%) were a result of=20
      non-neurologic progression,<SUP> </SUP>and 52 (24%) were=20
      indistinguishable. The proportion of deaths<SUP> </SUP>caused by=20
      neurologic progression was not significantly different<SUP> =
</SUP>between=20
      the arms (<I>P</I> =3D .46). Similar results were observed =
for<SUP>=20
      </SUP>the NSCLC/breast cancer population.<SUP> </SUP>
      <P>The numbers and percentages of patients with stable or =
improving<SUP>=20
      </SUP>quality of life, as assessed by the Spitzer Questionnaire =
and<SUP>=20
      </SUP>KPS at 1, 3, and 6 months after WBRT, are listed in <A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#T6">Table=20
      6</A>.<SUP> </SUP>A larger percentage of patients in the =
efaproxiral arm=20
      had stable<SUP> </SUP>or improving quality-of-life scores over the =
course=20
      of the follow-up<SUP> </SUP>visits.<SUP> </SUP>
      <P><A name=3DT6><!-- null --></A><BR clear=3Dall>
      <CENTER>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"95%">
        <TBODY>
        <TR bgColor=3D#e1e1e1>
          <TD>
            <TABLE cellSpacing=3D2 cellPadding=3D2>
              <TBODY>
              <TR bgColor=3D#e1e1e1>
                <TD vAlign=3Dtop align=3Dmiddle =
bgColor=3D#ffffff><STRONG>View this=20
                  table:</STRONG><BR><NOBR><A=20
                  =
href=3D"http://www.jco.org/cgi/content/full/24/1/106/T6">[in=20
                  this window]</A><BR><A=20
                  onmouseover=3D"window.status=3D'View table in a =
separate window'; return true"=20
                  onclick=3D"startTarget('T6', 500, 400); =
this.href=3D'/cgi/content-nw/full/24/1/106/T6'"=20
                  =
href=3D"http://www.jco.org/cgi/content-nw/full/24/1/106/T6"=20
                  target=3DT6>[in a new window]</A><BR>&nbsp;</NOBR> =
</TD>
                <TD vAlign=3Dtop align=3Dleft><B>Table 6.</B> Proportion =
of=20
                  Patients With Stable or Improving Quality of Life by =
Visit and=20
                  Treatment Arm<SUP>*</SUP>
                  =
<P></P></TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE></CENTER>&nbsp=
;<BR><STRONG>AEs</STRONG><BR>The=20
      majority of treatment-emergent AEs were grade 1 (mild) to<SUP> =
</SUP>grade=20
      2 (moderate) in severity in both treatment arms. <A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#T7">Table=20
      7</A><SUP> </SUP>lists the most commonly reported (<IMG =
alt=3D&#8805;=20
      src=3D"http://www.jco.org/math/ge.gif" border=3D0> 3%) grade 3 or =
4=20
      treatment-emergent<SUP> </SUP>AEs for patients treated with =
efaproxiral.=20
      The most commonly<SUP> </SUP>reported grade 3 AE in =
efaproxiral-treated=20
      patients was hypoxemia,<SUP> </SUP>which was reported in 11% of =
patients=20
      (29 of 266 patients);<SUP> </SUP>however, no grade 4 hypoxemia was =

      reported. Hypoxemia was also<SUP> </SUP>the most commonly reported =
AE=20
      related to study drug (data not<SUP> </SUP>shown); most patients =
(73%)=20
      experiencing hypoxemia (any grade)<SUP> </SUP>as an AE were =
asymptomatic,=20
      and the only treatment required<SUP> </SUP>was supplemental =
oxygen.=20
      Overall, grade 4 AEs were reported<SUP> </SUP>at comparable =
frequencies in=20
      the two treatment arms (28 of 263<SUP> </SUP>patients in the =
control arm,=20
      11%; and 33 of 266 patients in<SUP> </SUP>the efaproxiral arm, =
12%). With=20
      few exceptions, all AEs were<SUP> </SUP>treatable; the majority of =
AEs=20
      were resolved by the 1-month<SUP> </SUP>follow-up period.<SUP> =
</SUP>
      <P><A name=3DT7><!-- null --></A><BR clear=3Dall>
      <CENTER>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"95%">
        <TBODY>
        <TR bgColor=3D#e1e1e1>
          <TD>
            <TABLE cellSpacing=3D2 cellPadding=3D2>
              <TBODY>
              <TR bgColor=3D#e1e1e1>
                <TD vAlign=3Dtop align=3Dmiddle =
bgColor=3D#ffffff><STRONG>View this=20
                  table:</STRONG><BR><NOBR><A=20
                  =
href=3D"http://www.jco.org/cgi/content/full/24/1/106/T7">[in=20
                  this window]</A><BR><A=20
                  onmouseover=3D"window.status=3D'View table in a =
separate window'; return true"=20
                  onclick=3D"startTarget('T7', 500, 400); =
this.href=3D'/cgi/content-nw/full/24/1/106/T7'"=20
                  =
href=3D"http://www.jco.org/cgi/content-nw/full/24/1/106/T7"=20
                  target=3DT7>[in a new window]</A><BR>&nbsp;</NOBR> =
</TD>
                <TD vAlign=3Dtop align=3Dleft><B>Table 7.</B> Most=20
                  Commonly<SUP>*</SUP> Reported Grade 3 or 4 =
Treatment-Emergent=20
                  Adverse Events Regardless of Causality
                  =
<P></P></TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE></CENTER>&nbsp=
;<BR><A=20
      name=3DSEC4><!-- null --></A><BR clear=3Dright>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"100%" =
bgColor=3D#e1e1e1>
        <TBODY>
        <TR>
          <TD vAlign=3Dcenter align=3Dleft width=3D"5%" =
bgColor=3D#ffffff><IMG=20
            height=3D21 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/rarrow.gif" =
width=3D10></TD>
          <TH vAlign=3Dcenter align=3Dleft width=3D"95%"><FONT =
size=3D+2>&nbsp;&nbsp;=20
            DISCUSSION </FONT></TH></TR></TBODY></TABLE>
      <TABLE cellPadding=3D5 align=3Dright border=3D1>
        <TBODY>
        <TR>
          <TH align=3Dleft><FONT size=3D-1><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#top"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>TOP<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#ABS"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>ABSTRACT<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC1"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>INTRODUCTION<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC2"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>PATIENTS AND METHODS<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC3"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>RESULTS<BR></A><IMG height=3D9 alt=3D" " =
hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/dot.gif" width=3D11 =
border=3D0><FONT=20
            color=3D#464c53>DISCUSSION</FONT><BR><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC5"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Appendix<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC6"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Authors' Disclosures of...<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC7"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Author Contributions<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#BIBL"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            =
border=3D0>REFERENCES<BR></A></FONT></TH></TR></TBODY></TABLE>&nbsp;<BR>T=
his=20
      phase III, randomized, clinical trial represents one of<SUP> =
</SUP>the=20
      largest studies ever conducted in patients with brain =
metastases.<SUP>=20
      </SUP>The results of this study suggest that efaproxiral, a=20
      noncytotoxic<SUP> </SUP>radiation sensitizer, may improve response =
rates=20
      to WBRT and<SUP> </SUP>survival in patients with brain metastases, =

      particularly metastases<SUP> </SUP>from breast cancer.<SUP> </SUP>
      <P>There are two main issues that result from the analysis of =
this<SUP>=20
      </SUP>trial. First, the results of the primary analysis did not=20
      demonstrate<SUP> </SUP>a convincing survival advantage for =
patients in the=20
      efaproxiral<SUP> </SUP>arm overall (HR =3D 0.87; 95% CI, 0.71 to =
1.05), but=20
      the multivariable<SUP> </SUP>analysis did indicate a treatment =
benefit (HR=20
      =3D 0.74; 95% CI,<SUP> </SUP>0.61 to 0.90). One plausible reason =
for the=20
      difference in the<SUP> </SUP>results is that the prognostic =
factors were=20
      not balanced by<SUP> </SUP>treatment group; however, an inspection =
of the=20
      distribution<SUP> </SUP>of prognostic factors in <A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#T2">Table=20
      2</A> does not seem to indicate this.<SUP> </SUP>It is possible =
that the=20
      individual effects of minor imbalances<SUP> </SUP>are small but, =
when=20
      considered together, have a cumulatively<SUP> </SUP>larger impact. =
An=20
      additional possibility is more technical in<SUP> </SUP>nature =
because the=20
      treatment effect estimate in the unadjusted<SUP> </SUP>analysis =
could be=20
      biased as a result of attenuation. As described<SUP> </SUP>by =
Akazawa et=20
      al<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R52">52</A></SUP>=20
      and Fleming and Lin,<SUP><A=20
      =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#R51">51</A></SUP>=20
      omission of strong<SUP> </SUP>covariates from the estimation of =
the=20
      treatment effect in clinical<SUP> </SUP>trials biases the =
treatment effect=20
      estimate towards the null<SUP> </SUP>hypothesis, effectively =
reducing the=20
      power for detecting a difference<SUP> </SUP>as a result of the=20
      intervention.<SUP> </SUP>
      <P>The second issue is in regards to the different treatment =
benefits<SUP>=20
      </SUP>observed by primary site. This may be related to different=20
      levels<SUP> </SUP>of hypoxia within different primary tumors or =
could=20
      simply be<SUP> </SUP>a random result of performing subset =
analyses. A=20
      confirmatory<SUP> </SUP>trial has been initiated in patients with =
brain=20
      metastases from<SUP> </SUP>breast cancer that should resolve this=20
      question.<SUP> </SUP>
      <P>Before commencing the study, it was hypothesized that an=20
      improvement<SUP> </SUP>in response would result in survival =
benefit;=20
      therefore, the<SUP> </SUP>response rate (best response) was =
analyzed as a=20
      secondary efficacy<SUP> </SUP>end point. The clearest evidence =
supporting=20
      the therapeutic<SUP> </SUP>advantage of efaproxiral administration =
is=20
      derived from the<SUP> </SUP>7% response rate improvement of the=20
      efaproxiral arm compared<SUP> </SUP>with the control arm. A =
statistically=20
      significant improvement<SUP> </SUP>(13% increase; <I>P</I> =3D =
.01) in the=20
      response rate was observed in<SUP> </SUP>the population of =
patients with=20
      brain metastases from NSCLC/breast<SUP> </SUP>cancer. The study =
did not=20
      show a decrease in neurologic death<SUP> </SUP>with the addition =
of=20
      efaproxiral, but this is not surprising<SUP> </SUP>given the =
difficulty in=20
      determining cause of death, the subjectivity<SUP> </SUP>involved =
in=20
      determination of causation, and extracranial disease<SUP>=20
      </SUP>involvement.<SUP> </SUP>
      <P>Although there was no observed difference between =
treatment<SUP>=20
      </SUP>arms in time to progression (both radiologic and clinical) =
in<SUP>=20
      </SUP>the brain, it is recognized that establishing differences =
in<SUP>=20
      </SUP>these end points is problematic when study patients have=20
      anticipated<SUP> </SUP>short survival times and infrequent end =
point=20
      evaluations. To<SUP> </SUP>have adequate power for evaluating this =
end=20
      point in future<SUP> </SUP>trials, it would be beneficial to =
perform scans=20
      at more frequent<SUP> </SUP>intervals. An alternative method may =
be to=20
      evaluate progression<SUP> </SUP>at a fixed time point after =
treatment, for=20
      example, at the 3-month<SUP> </SUP>follow-up visit. Either way, =
the high=20
      percentage of patients<SUP> </SUP>succumbing to systemic disease=20
      progression makes demonstrating<SUP> </SUP>an improvement in =
progression=20
      (or survival, for that matter)<SUP> </SUP>complicated.<SUP> </SUP>
      <P>Most AEs experienced by patients in this study were mild =
to<SUP>=20
      </SUP>moderate in severity, and the majority of AEs were =
reversible,<SUP>=20
      </SUP>resolving by the 1-month follow-up visit. A low frequency =
of<SUP>=20
      </SUP>grade 3 to 4 AEs was reported, with hypoxemia being the =
most<SUP>=20
      </SUP>commonly reported severe AE that was also efaproxiral =
related.<SUP>=20
      </SUP>Events of hypoxemia were not unexpected because it is a =
direct<SUP>=20
      </SUP>effect of the pharmacology of the drug (decreased=20
      oxygen-hemoglobin<SUP> </SUP>affinity and decreased oxygen uptake =
in the=20
      lungs). Significantly,<SUP> </SUP>no grade 4 events of hypoxemia =
were=20
      reported, and all events<SUP> </SUP>of hypoxemia were effectively =
managed=20
      with supplemental oxygen.<SUP> </SUP>
      <P>Although surgery and SRS have proven beneficial for some =
patients<SUP>=20
      </SUP>with brain metastases, the majority of patients are not =
ideal<SUP>=20
      </SUP>candidates for either option based on tumor location, =
number<SUP>=20
      </SUP>of intracranial lesions, and extent of extracranial =
disease.<SUP>=20
      </SUP>Efaproxiral in combination with WBRT presents a potential=20
      treatment<SUP> </SUP>option for these patients. Despite the =
disadvantage=20
      of a central<SUP> </SUP>intravenous administration, efaproxiral =
enhances=20
      the diffusion<SUP> </SUP>of oxygen across the blood-brain barrier =
and=20
      maintains the ability<SUP> </SUP>totreat multiple lesions =
independent of=20
      tumor location. It is<SUP> </SUP>also well tolerated. Furthermore, =
it=20
      should be feasible to combine<SUP> </SUP>efaproxiral with =
SRS.<SUP> </SUP>
      <P>In conclusion, efaproxiral is the first noncytotoxic =
radiation<SUP>=20
      </SUP>sensitizer that demonstrates a potential survival =
advantage<SUP>=20
      </SUP>as an adjunct to WBRT; however, the conclusion may be=20
      restricted<SUP> </SUP>to patients with primary breast cancer. =
Efaproxiral=20
      is generally<SUP> </SUP>safe when administered to heavily =
pretreated=20
      cancer patients<SUP> </SUP>as an adjunct to WBRT. The main AE was=20
      primarily reversible<SUP> </SUP>hypoxemia. On the basis of the =
study=20
      results, a confirmatory<SUP> </SUP>trial of WBRT with or without=20
      efaproxiral (the Enhancing Whole<SUP> </SUP>Brain Radiation in =
Patients=20
      With Breast Cancer and Hypoxic Brain<SUP> </SUP>Metastases =
[ENRICH] trial)=20
      has been initiated in patients with<SUP> </SUP>brain metastases =
from=20
      breast cancer.<SUP> </SUP>
      <P><A name=3DSEC5><!-- null --></A><BR clear=3Dright>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"100%" =
bgColor=3D#e1e1e1>
        <TBODY>
        <TR>
          <TD vAlign=3Dcenter align=3Dleft width=3D"5%" =
bgColor=3D#ffffff><IMG=20
            height=3D21 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/rarrow.gif" =
width=3D10></TD>
          <TH vAlign=3Dcenter align=3Dleft width=3D"95%"><FONT =
size=3D+2>&nbsp;&nbsp;=20
            Appendix </FONT></TH></TR></TBODY></TABLE>
      <TABLE cellPadding=3D5 align=3Dright border=3D1>
        <TBODY>
        <TR>
          <TH align=3Dleft><FONT size=3D-1><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#top"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>TOP<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#ABS"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>ABSTRACT<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC1"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>INTRODUCTION<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC2"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>PATIENTS AND METHODS<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC3"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>RESULTS<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC4"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>DISCUSSION<BR></A><IMG height=3D9 alt=3D" " =
hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/dot.gif" width=3D11 =
border=3D0><FONT=20
            color=3D#464c53>Appendix</FONT><BR><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC6"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Authors' Disclosures of...<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC7"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Author Contributions<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#BIBL"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            =
border=3D0>REFERENCES<BR></A></FONT></TH></TR></TBODY></TABLE>&nbsp;<BR><=
I>The=20
      following investigators participated in the RT-009 (REACH)<SUP>=20
      </SUP>Study</I>: L. Rogers, Foundation for Cancer Research and=20
      Education,<SUP> </SUP>Phoenix, AZ; T. Pinter, Petz Alald=E1r =
Hospital of=20
      Gyor,<SUP> </SUP>Gyor, Hungary; W. Demas, SUMMA Health System =
Hospitals,=20
      Akron,<SUP> </SUP>OH; W. Roa, Cross Cancer Institute, Edmonton, =
Alberta,=20
      Canada;<SUP> </SUP>F. Yunus, Boston Baskin Cancer Group, Memphis, =
TN; J.P.=20
      Bahary,<SUP> </SUP>Centre Hospitalier de l=92Universit=E9 de=20
      Montr=E9al-Campus<SUP> </SUP>Notre Dame, Montr=E9al, Qu=E9bec, =
Canada; L.=20
      Mechtler,<SUP> </SUP>Dent Neurologic Institute, Buffalo, NY; A. =
Monnier,=20
      H=F4pital<SUP> </SUP>de Montb=E9liard, Montb=E9liard, France; Y. =
Hammoud,<SUP>=20
      </SUP>H=F4pital de Montb=E9liard, Montb=E9liard, France;<SUP> =
</SUP>K. Sultanem,=20
      McGill University, Montreal, Qu=E9bec, Canada;<SUP> </SUP>S. =
Kadish, Lahey=20
      Medical Center, Burlington, MA; T. Lo, Lahey<SUP> </SUP>Medical =
Center,=20
      Burlington, MA; M. Henke, Abteilung Strahlentherapie,<SUP> =
</SUP>Freiburg,=20
      Germany; S. Husain, Tom Baker Cancer Centre, Calgary,<SUP> =
</SUP>Alberta,=20
      Canada; P.K. Ganguly, Newfoundland Cancer Centre, St<SUP> =
</SUP>John,=20
      Newfoundland, Canada; M. Jahanzeb, Boca Raton Community<SUP>=20
      </SUP>Hospital, Boca Raton, FL; M. Kasper, Boca Raton Community=20
      Hospital,<SUP> </SUP>Boca Raton, FL; J. Menten, University of =
Hospital=20
      Gasthuisberg,<SUP> </SUP>Leuven, Belgium; N. Laperriere, Princess =
Margaret=20
      Hospital,<SUP> </SUP>Toronto, Ontario, Canada; F. Mornex, Centre=20
      Hospitalier Lyon<SUP> </SUP>Sud, Lyon Pierre Benite, France; M. =
Stuschke,=20
      Univeritaetskilinikum<SUP> </SUP>GHS Essen, Essen, Germany; R. =
Rampling,=20
      Beatson Oncology Centre,<SUP> </SUP>Glasgow, Scotland; M. Sobczak, =

      Lexington Clinic Cancer Center,<SUP> </SUP>Lexington, KY; A. =
Gregor,=20
      Western General Hospital, Eidenburgh,<SUP> </SUP>Scottland; S. =
Hamburg,=20
      Tower Hematology/Oncology, Los Angeles,<SUP> </SUP>CA; R. Hudes, =
St Agnes=20
      Health Care, Baltimore, MD; D. Irwin,<SUP> </SUP>Alta Bates =
Comprehensive=20
      Cancer, Berkeley, CA; M. Liu, Fraser<SUP> </SUP>Valley Cancer =
Centre,=20
      Surrey, British Colombia, Canada; L. Mulroy,<SUP> </SUP>Nova =
Scotia Cancer=20
      Centre, Halifax, Nova Scotia, Canada; L.<SUP> </SUP>Thurzo, =
University of=20
      Szeged Clinic of Oncotherapy, Szeged,<SUP> </SUP>Hungary; H. Hong, =
Harbor=20
      View Radiation Oncology, Baltimore,<SUP> </SUP>MD; G. Hyland, =
Clinical=20
      Research Services, Bismarck, ND; R.<SUP> </SUP>Orecchia, Istituto =
Europeo=20
      di Oncologia di Milano, Milano, Italy;<SUP> </SUP>P. Song, Fairfax =

      Hospital, Falls Church, VA; T. Zuk-Shiuna,<SUP> </SUP>Bat Galin =
Haifa,=20
      Haifa, Israel; M. Fromm, Akron General Hospital,<SUP> </SUP>Akron, =
OH; V.=20
      Rudat, Neurochirurgie Universit=E4tsklinikum,<SUP> </SUP>Hamburg, =
Germany;=20
      B. Kavanagh, Virginia Commonwealth University,<SUP> =
</SUP>Richmond, VA; R.=20
      Schmidt-Ulrich, Virginia Commonwealth University,<SUP> =
</SUP>Richmond, VA;=20
      M. Szilasi, University of Debrecen, Debrecen,<SUP> </SUP>Hugary; =
S.=20
      McCauley, University of Massachusetts, Worcester,<SUP> </SUP>MA; =
G. Ryan,=20
      Peter MacCallum Cancer Institute, East Melbourne,<SUP> =
</SUP>Victoria,=20
      Australia; H. Wheeler, Royal North Shore Hospital,<SUP> </SUP>St =
Leonards,=20
      Northern Territory, Australia; J. Bozzino, Newcastle<SUP> =
</SUP>General=20
      Hospital, Newcastle, United Kingdom; C. Koprowski, Cooper<SUP>=20
      </SUP>Hospital, Camden, NJ; A. Cohler, Cooper Hospital, Camden, =
NJ;<SUP>=20
      </SUP>I. Cokgor, California Cancer Care, Greenbrae, CA; A. de la=20
      Torre<SUP> </SUP>Tomas, Hospital Puerta de Hierro, Madrid, Spain; =
M. de=20
      las Heras<SUP> </SUP>Gonzales, Hospital Virgen de la Arrixaca, =
Murcia,=20
      Spain; W.<SUP> </SUP>DeNeve, Ghent University Hospital, Gent, =
Belgium; L.=20
      Gaspar,<SUP> </SUP>University of Colorado Health, Aurora, CO; H. =
Keys,=20
      Albany Medical<SUP> </SUP>Center, Albany, NY; P. Leider, The =
Center for=20
      Radiation Oncology,<SUP> </SUP>Danville, VA; R. Ma, Vancouver =
Cancer=20
      Centre, Vancouver, British<SUP> </SUP>Columbia, Canada; P. =
Maingon, Centre=20
      Georges-Francois Leclerc,<SUP> </SUP>Dijon, France; R. Pfeffer, =
Sheba=20
      Medical Centre, Tel-Hashomer,<SUP> </SUP>Israel; T. Scroggins, =
Ochsner=20
      Clinic, New Orleans, LA; J. Szanto,<SUP> </SUP>Miskolc County =
Hospital,=20
      Miskolc, Hungary; A. Pearlman, North<SUP> </SUP>Shore University =
Hospital,=20
      East Setauket, NY; S. Turner, North<SUP> </SUP>Shore University =
Hospital,=20
      East Setauket, NY; P. Van Houtte,<SUP> </SUP>Institut Jules =
Bordet,=20
      Brussels, Belgium; J.C. Bennett, The<SUP> </SUP>Florida Wellcare =
Alliance,=20
      Inverness, FL; R. Byhardt, Zablocki<SUP> </SUP>Veterans Affairs =
Medical=20
      Center, Milwaukee, WI; L. Cher, Austin<SUP> </SUP>and Repatriation =

      Medical, Heidelberg, Victoria, Australia; L.<SUP> </SUP>Cionini,=20
      University of Pisa, Pisa, Italy; G. Cotter, University<SUP> =
</SUP>of South=20
      Alabama, Mobile, AL; I. Dayes, Juravinski Cancer Centre,<SUP>=20
      </SUP>Hamilton, Ontario, Canada; G. Hruby, Rolay Prince Alfred=20
      Hospital,<SUP> </SUP>Camperdown, Northern Territory, Australia; F. =
Kovner,=20
      Tel-Aviv<SUP> </SUP>Medical Centre, Tel-Aviv, Israel; D. Stewart, =
Ottawa=20
      Regional<SUP> </SUP>Cancer Centre, Ottawa, Ontario, Canada; J. =
Meng,=20
      Ottawa Regional<SUP> </SUP>Cancer Centre, Ottawa, Ontario, Canada; =
A.=20
      Peddada, Penrose<SUP> </SUP>Hospital Cancer Center, Colorado =
Springs, CO;=20
      R. Warnick, University<SUP> </SUP>of Cincinnati, Cincinnati, OH; =
A. Sills,=20
      Memphis Regional Brain<SUP> </SUP>Tumor, Memphis, TN; and P. Tai, =
Allan=20
      Blair Cancer Centre, Regina,<SUP> </SUP>Saskatchewan, Canada.<SUP> =
</SUP>
      <P><A name=3DSEC6><!-- null --></A><BR clear=3Dright>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"100%" =
bgColor=3D#e1e1e1>
        <TBODY>
        <TR>
          <TD vAlign=3Dcenter align=3Dleft width=3D"5%" =
bgColor=3D#ffffff><IMG=20
            height=3D21 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/rarrow.gif" =
width=3D10></TD>
          <TH vAlign=3Dcenter align=3Dleft width=3D"95%"><FONT =
size=3D+2>&nbsp;&nbsp;=20
            Authors' Disclosures of Potential Conflicts of Interest=20
        </FONT></TH></TR></TBODY></TABLE>
      <TABLE cellPadding=3D5 align=3Dright border=3D1>
        <TBODY>
        <TR>
          <TH align=3Dleft><FONT size=3D-1><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#top"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>TOP<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#ABS"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>ABSTRACT<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC1"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>INTRODUCTION<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC2"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>PATIENTS AND METHODS<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC3"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>RESULTS<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC4"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>DISCUSSION<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC5"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>Appendix<BR></A><IMG height=3D9 alt=3D" " =
hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/dot.gif" width=3D11 =
border=3D0><FONT=20
            color=3D#464c53>Authors' Disclosures of...</FONT><BR><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC7"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            border=3D0>Author Contributions<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#BIBL"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            =
border=3D0>REFERENCES<BR></A></FONT></TH></TR></TBODY></TABLE>&nbsp;<BR>A=
lthough=20
      all authors completed the disclosure declaration, the<SUP> =
</SUP>following=20
      authors or their immediate family members indicated<SUP> </SUP>a =
financial=20
      interest. No conflict exists for drugs or devices<SUP> </SUP>used =
in a=20
      study if they are not being evaluated as part of the<SUP>=20
      </SUP>investigation. For a detailed description of the =
disclosure<SUP>=20
      </SUP>categories, or for more information about ASCO's conflict =
of<SUP>=20
      </SUP>interest policy, please refer to the Author Disclosure=20
      Declaration<SUP> </SUP>and the Disclosures of Potential Conflicts =
of=20
      Interest section<SUP> </SUP>in Information for Contributors. <BR=20
clear=3Dall>
      <TABLE width=3D"100%" border=3D1>
        <TBODY>
        <TR>
          <TD>
            <TABLE cellSpacing=3D10 cellPadding=3D0 width=3D"100%">
              <TBODY>
              <TR>
                <TD vAlign=3Dbottom align=3Dmiddle>Authors</TD>
                <TD vAlign=3Dbottom align=3Dmiddle>Employment</TD>
                <TD vAlign=3Dbottom align=3Dmiddle>Leadership</TD>
                <TD vAlign=3Dbottom align=3Dmiddle>Consultant</TD>
                <TD vAlign=3Dbottom align=3Dmiddle>Stock</TD>
                <TD vAlign=3Dbottom align=3Dmiddle>Honoraria</TD>
                <TD vAlign=3Dbottom align=3Dmiddle>Research<SUP> =
</SUP>Funds</TD>
                <TD vAlign=3Dbottom align=3Dmiddle>Testimony</TD>
                <TD vAlign=3Dbottom align=3Dmiddle>Other</TD></TR>
              <TR>
                <TD colSpan=3D9>
                  <HR>
                </TD></TR>
              <TR>
                <TD vAlign=3Dtop align=3Dleft>John H. Suh</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle>Allos Therapeutics, =
Inc.<SUP>=20
                  </SUP>(A)</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle>Allos Therapeutics, Inc. =
(B)</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD></TR>
              <TR>
                <TD vAlign=3Dtop align=3Dleft>Baldassarre Stea</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle>Allos<SUP> =
</SUP>Therapeutics,=20
                  Inc. (A)</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle>Allos Therapeutics, Inc. =
(A) Allos=20
                  Therapeutics,<SUP> </SUP>Inc. (B)</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD></TR>
              <TR>
                <TD vAlign=3Dtop align=3Dleft>Abdenour Nabid</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle>Allos Therapeutics, Inc. =
(B)</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD></TR>
              <TR>
                <TD vAlign=3Dtop align=3Dleft>John<SUP> </SUP>J. =
Kresl</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle>Allos Therapeutics, Inc. =
(B)</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD></TR>
              <TR>
                <TD vAlign=3Dtop align=3Dleft>Jean-Philippe<SUP> =
</SUP>Mercier</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle>Allos Therapeutics, Inc. =
(B)</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD></TR>
              <TR>
                <TD vAlign=3Dtop align=3Dleft>Eric L. Chang</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle>Allos<SUP> =
</SUP>Therapeutics,=20
                  Inc. (A)</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD></TR>
              <TR>
                <TD vAlign=3Dtop align=3Dleft>Adam P. Boyd</TD>
                <TD vAlign=3Dtop align=3Dmiddle>Allos Therapeutics,<SUP> =

                  </SUP>Inc. (N/R)</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle>Allos Therapeutics, Inc. =
(A)</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD></TR>
              <TR>
                <TD vAlign=3Dtop align=3Dleft>Pablo J. Cagnoni</TD>
                <TD vAlign=3Dtop align=3Dmiddle>Allos<SUP> =
</SUP>Therapeutics,=20
                  Inc. (N/R)</TD>
                <TD vAlign=3Dtop align=3Dmiddle>Allos Therapeutics, Inc. =
(A)</TD>
                <TD vAlign=3Dtop align=3Dmiddle>Allos<SUP> =
</SUP>Therapeutics,=20
                  Inc. (A)</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD></TR>
              <TR>
                <TD vAlign=3Dtop align=3Dleft>Edward Shaw</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop align=3Dmiddle>Allos Therapeutics,<SUP> =

                  </SUP>Inc. (A)</TD>
                <TD vAlign=3Dtop align=3Dmiddle></TD>
                <TD vAlign=3Dtop=20
      =
align=3Dmiddle></TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE>
      <P><!-- tblfn --><B>Dollar Amount Codes</B> (A) &lt; $10,000 (B)=20
      $10,000-99,999<SUP> </SUP>(C) <IMG alt=3D&#8805;=20
      src=3D"http://www.jco.org/math/ge.gif" border=3D0> $100,000 (N/R) =
Not Required
      <P><SUP></SUP>
      <P><A name=3DSEC7><!-- null --></A><BR clear=3Dright>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"100%" =
bgColor=3D#e1e1e1>
        <TBODY>
        <TR>
          <TD vAlign=3Dcenter align=3Dleft width=3D"5%" =
bgColor=3D#ffffff><IMG=20
            height=3D21 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/rarrow.gif" =
width=3D10></TD>
          <TH vAlign=3Dcenter align=3Dleft width=3D"95%"><FONT =
size=3D+2>&nbsp;&nbsp;=20
            Author Contributions </FONT></TH></TR></TBODY></TABLE>
      <TABLE cellPadding=3D5 align=3Dright border=3D1>
        <TBODY>
        <TR>
          <TH align=3Dleft><FONT size=3D-1><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#top"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>TOP<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#ABS"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>ABSTRACT<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC1"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>INTRODUCTION<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC2"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>PATIENTS AND METHODS<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC3"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>RESULTS<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC4"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>DISCUSSION<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC5"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>Appendix<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC6"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>Authors' Disclosures of...<BR></A><IMG height=3D9 =
alt=3D" "=20
            hspace=3D5 src=3D"http://www.jco.org/icons/toc/dot.gif" =
width=3D11=20
            border=3D0><FONT color=3D#464c53>Author =
Contributions</FONT><BR><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#BIBL"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/darrow.gif" width=3D11=20
            =
border=3D0>REFERENCES<BR></A></FONT></TH></TR></TBODY></TABLE>&nbsp;<BR><=
BR=20
      clear=3Dall>
      <TABLE cellPadding=3D10 border=3D1>
        <TBODY>
        <TR bgColor=3D#e1e1e1>
          <TD><B>Conception and design:</B> John H. Suh, Adam P. Boyd, =
Pablo=20
            J. Cagnoni,<SUP> </SUP>Edward Shaw
            <P><B>Provision of study materials or patients:</B> =
John<SUP>=20
            </SUP>H. Suh, Baldassarre Stea, Abdenour Nabid, John J. =
Kresl,=20
            Andr=E9<SUP> </SUP>Fortin, Jean-Philippe Mercier, Neil =
Senzer, Eric L.=20
            Chang, Edward<SUP> </SUP>Shaw
            <P><B>Collection and assembly of data:</B> John H. Suh, Adam =
P.<SUP>=20
            </SUP>Boyd, Pablo J. Cagnoni
            <P><B>Data analysis and inerpretation:</B> John<SUP> =
</SUP>H. Suh,=20
            Adam P. Boyd, Pablo J. Cagnoni
            <P><B>Manuscript writing:</B><SUP> </SUP>John H. Suh, =
Baldassarre=20
            Stea, Abdenour Nabid, John J. Kresl,<SUP> </SUP>Andr=E9 =
Fortin,=20
            Jean-Philippe Mercier, Neil Senzer, Eric<SUP> </SUP>L. =
Chang, Adam=20
            P. Boyd, Pablo J. Cagnoni, Edward Shaw
            <P><B>Final<SUP> </SUP>approval of manuscript:</B> John H. =
Suh,=20
            Baldassarre Stea, Abdenour<SUP> </SUP>Nabid, John J. Kresl, =
Andr=E9=20
            Fortin, Jean-Philippe Mercier,<SUP> </SUP>Neil Senzer, Eric =
L.=20
            Chang, Adam P. Boyd, Pablo J. Cagnoni,<SUP> </SUP>Edward =
Shaw
            <P></P></TD></TR></TBODY></TABLE>&nbsp;<BR><SUP></SUP>
      <P><SUP></SUP>
      <P><A name=3DACK><!-- null --></A><BR clear=3Dright>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"100%" =
bgColor=3D#e1e1e1>
        <TBODY>
        <TR>
          <TD vAlign=3Dcenter align=3Dleft width=3D"5%" =
bgColor=3D#ffffff><IMG=20
            height=3D21 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/rarrow.gif" =
width=3D10></TD>
          <TH vAlign=3Dcenter align=3Dleft width=3D"95%"><FONT =
size=3D+2>&nbsp;&nbsp;=20
            Acknowledgment </FONT></TH></TR></TBODY></TABLE>&nbsp;<BR>We =
thank Rebecca=20
      Spence, PhD, for her expert assistance with<SUP> </SUP>writing =
this=20
      article.<SUP> </SUP>
      <P><A name=3DFN><!-- null --></A><BR clear=3Dright>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"100%" =
bgColor=3D#e1e1e1>
        <TBODY>
        <TR>
          <TD vAlign=3Dcenter align=3Dleft width=3D"5%" =
bgColor=3D#ffffff><IMG=20
            height=3D21 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/rarrow.gif" =
width=3D10></TD>
          <TH vAlign=3Dcenter align=3Dleft width=3D"95%"><FONT =
size=3D+2>&nbsp;&nbsp;=20
            NOTES </FONT></TH></TR></TBODY></TABLE>&nbsp;<BR><A=20
      name=3D""><!-- null --></A>Supported by Allos Therapeutics Inc, =
Westminster,=20
      CO.<SUP> </SUP>
      <P>Presented in part at the 40th Annual Meeting of the =
American<SUP>=20
      </SUP>Society of Clinical Oncology, New Orleans, LA, June 5-8, =
2004;<SUP>=20
      </SUP>26th Annual San Antonio Breast Cancer Symposium, San =
Antonio,<SUP>=20
      </SUP>TX, December 3-6, 2003; and Eighth Annual Scientific =
Meeting<SUP>=20
      </SUP>of the Society for Neuro-Oncology, Keystone, CO, November=20
      13-16,<SUP> </SUP>2003.<SUP> </SUP>
      <P>Authors' disclosures of potential conflicts of interest =
and<SUP>=20
      </SUP>author contributions are found at the end of this =
article.<SUP>=20
      </SUP>
      <P><A name=3DBIBL><!-- null --></A><BR clear=3Dright>
      <TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"100%" =
bgColor=3D#e1e1e1>
        <TBODY>
        <TR>
          <TD vAlign=3Dcenter align=3Dleft width=3D"5%" =
bgColor=3D#ffffff><IMG=20
            height=3D21 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/rarrow.gif" =
width=3D10></TD>
          <TH vAlign=3Dcenter align=3Dleft width=3D"95%"><FONT =
size=3D+2>&nbsp;&nbsp;=20
            REFERENCES </FONT></TH></TR></TBODY></TABLE>
      <TABLE cellPadding=3D5 align=3Dright border=3D1>
        <TBODY>
        <TR>
          <TH align=3Dleft><FONT size=3D-1><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#top"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>TOP<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#ABS"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>ABSTRACT<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC1"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>INTRODUCTION<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC2"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>PATIENTS AND METHODS<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC3"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>RESULTS<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC4"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>DISCUSSION<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC5"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>Appendix<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC6"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>Authors' Disclosures of...<BR></A><A=20
            =
href=3D"http://www.jco.org/cgi/content/full/24/1/106?ijkey=3D767b17959819=
7f9cfc7c97d9060a13a966ed1468#SEC7"><IMG=20
            height=3D9 alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/uarrow.gif" width=3D11=20
            border=3D0>Author Contributions<BR></A><IMG height=3D9 =
alt=3D" " hspace=3D5=20
            src=3D"http://www.jco.org/icons/toc/dot.gif" width=3D11 =
border=3D0><FONT=20
            =
color=3D#464c53>REFERENCES</FONT><BR></FONT></TH></TR></TBODY></TABLE>&nb=
sp;<BR>
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      October 1, 2004; accepted August 5, 2005.
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Not Fully Supported in Opera=0A=
----------------------------=0A=
* async requests=0A=
* abort()=0A=
* getAllResponseHeaders(), getAllResponseHeader(header)=0A=
=0A=
*/=0A=
// IE support=0A=
if (window.ActiveXObject && !window.XMLHttpRequest) {=0A=
  window.XMLHttpRequest =3D function() {=0A=
    var msxmls =3D new Array(=0A=
      'Msxml2.XMLHTTP.5.0',=0A=
      'Msxml2.XMLHTTP.4.0',=0A=
      'Msxml2.XMLHTTP.3.0',=0A=
      'Msxml2.XMLHTTP',=0A=
      'Microsoft.XMLHTTP');=0A=
    for (var i =3D 0; i < msxmls.length; i++) {=0A=
      try {=0A=
        return new ActiveXObject(msxmls[i]);=0A=
      } catch (e) {=0A=
      }=0A=
    }=0A=
    return null;=0A=
  };=0A=
}=0A=
// Gecko support=0A=
/* ;-) */=0A=
// Opera support=0A=
if (window.opera && !window.XMLHttpRequest) {=0A=
  window.XMLHttpRequest =3D function() {=0A=
    this.readyState =3D 0; // =
0=3Duninitialized,1=3Dloading,2=3Dloaded,3=3Dinteractive,4=3Dcomplete=0A=
    this.status =3D 0; // HTTP status codes=0A=
    this.statusText =3D '';=0A=
    this._headers =3D [];=0A=
    this._aborted =3D false;=0A=
    this._async =3D true;=0A=
    this._defaultCharset =3D 'ISO-8859-1';=0A=
    this._getCharset =3D function() {=0A=
      var charset =3D _defaultCharset;=0A=
      var contentType =3D =
this.getResponseHeader('Content-type').toUpperCase();=0A=
      val =3D contentType.indexOf('CHARSET=3D');=0A=
      if (val !=3D -1) {=0A=
        charset =3D contentType.substring(val);=0A=
      }=0A=
      val =3D charset.indexOf(';');=0A=
      if (val !=3D -1) {=0A=
        charset =3D charset.substring(0, val);=0A=
      }=0A=
      val =3D charset.indexOf(',');=0A=
      if (val !=3D -1) {=0A=
        charset =3D charset.substring(0, val);=0A=
      }=0A=
      return charset;=0A=
    };=0A=
    this.abort =3D function() {=0A=
      this._aborted =3D true;=0A=
    };=0A=
    this.getAllResponseHeaders =3D function() {=0A=
      return this.getAllResponseHeader('*');=0A=
    };=0A=
    this.getAllResponseHeader =3D function(header) {=0A=
      var ret =3D '';=0A=
      for (var i =3D 0; i < this._headers.length; i++) {=0A=
        if (header =3D=3D '*' || this._headers[i].h =3D=3D header) {=0A=
          ret +=3D this._headers[i].h + ': ' + this._headers[i].v + '\n';=0A=
        }=0A=
      }=0A=
      return ret;=0A=
    };=0A=
    this.getResponseHeader =3D function(header) {=0A=
      var ret =3D getAllResponseHeader(header);=0A=
      var i =3D ret.indexOf('\n');=0A=
      if (i !=3D -1) {=0A=
        ret =3D ret.substring(0, i);=0A=
      }=0A=
      return ret;=0A=
    };=0A=
    this.setRequestHeader =3D function(header, value) {=0A=
      this._headers[this._headers.length] =3D {h:header, v:value};=0A=
    };=0A=
    this.open =3D function(method, url, async, user, password) {=0A=
      this.method =3D method;=0A=
      this.url =3D url;=0A=
      this._async =3D true;=0A=
      this._aborted =3D false;=0A=
      this._headers =3D [];=0A=
      if (arguments.length >=3D 3) {=0A=
        this._async =3D async;=0A=
      }=0A=
      if (arguments.length > 3) {=0A=
        opera.postError('XMLHttpRequest.open() - user/password not =
supported');=0A=
      }=0A=
      this.readyState =3D 1;=0A=
      if (this.onreadystatechange) {=0A=
        this.onreadystatechange();=0A=
      }=0A=
    };=0A=
    this.send =3D function(data) {=0A=
      if (!navigator.javaEnabled()) {=0A=
        alert("XMLHttpRequest.send() - Java must be installed and =
enabled.");=0A=
        return;=0A=
      }=0A=
      if (this._async) {=0A=
        setTimeout(this._sendasync, 0, this, data);=0A=
        // this is not really asynchronous and won't execute until the =
current=0A=
        // execution context ends=0A=
      } else {=0A=
        this._sendsync(data);=0A=
      }=0A=
    }=0A=
    this._sendasync =3D function(req, data) {=0A=
      if (!req._aborted) {=0A=
        req._sendsync(data);=0A=
      }=0A=
    };=0A=
    this._sendsync =3D function(data) {=0A=
      this.readyState =3D 2;=0A=
      if (this.onreadystatechange) {=0A=
        this.onreadystatechange();=0A=
      }=0A=
      // open connection=0A=
      var url =3D new java.net.URL(new =
java.net.URL(window.location.href), this.url);=0A=
      var conn =3D url.openConnection();=0A=
      for (var i =3D 0; i < this._headers.length; i++) {=0A=
        conn.setRequestProperty(this._headers[i].h, this._headers[i].v);=0A=
      }=0A=
      this._headers =3D [];=0A=
      if (this.method =3D=3D 'POST') {=0A=
        // POST data=0A=
        conn.setDoOutput(true);=0A=
        var wr =3D new =
java.io.OutputStreamWriter(conn.getOutputStream(), this._getCharset());=0A=
        wr.write(data);=0A=
        wr.flush();=0A=
        wr.close();=0A=
      }=0A=
      // read response headers=0A=
      // NOTE: the getHeaderField() methods always return nulls for me :(=0A=
      var gotContentEncoding =3D false;=0A=
      var gotContentLength =3D false;=0A=
      var gotContentType =3D false;=0A=
      var gotDate =3D false;=0A=
      var gotExpiration =3D false;=0A=
      var gotLastModified =3D false;=0A=
      for (var i =3D 0; ; i++) {=0A=
        var hdrName =3D conn.getHeaderFieldKey(i);=0A=
        var hdrValue =3D conn.getHeaderField(i);=0A=
        if (hdrName =3D=3D null && hdrValue =3D=3D null) {=0A=
          break;=0A=
        }=0A=
        if (hdrName !=3D null) {=0A=
          this._headers[this._headers.length] =3D {h:hdrName, =
v:hdrValue};=0A=
          switch (hdrName.toLowerCase()) {=0A=
            case 'content-encoding': gotContentEncoding =3D true; break;=0A=
            case 'content-length'  : gotContentLength   =3D true; break;=0A=
            case 'content-type'    : gotContentType     =3D true; break;=0A=
            case 'date'            : gotDate            =3D true; break;=0A=
            case 'expires'         : gotExpiration      =3D true; break;=0A=
            case 'last-modified'   : gotLastModified    =3D true; break;=0A=
          }=0A=
        }=0A=
      }=0A=
      // try to fill in any missing header information=0A=
      var val;=0A=
      val =3D conn.getContentEncoding();=0A=
      if (val !=3D null && !gotContentEncoding) =
this._headers[this._headers.length] =3D {h:'Content-encoding', v:val};=0A=
      val =3D conn.getContentLength();=0A=
      if (val !=3D -1 && !gotContentLength) =
this._headers[this._headers.length] =3D {h:'Content-length', v:val};=0A=
      val =3D conn.getContentType();=0A=
      if (val !=3D null && !gotContentType) =
this._headers[this._headers.length] =3D {h:'Content-type', v:val};=0A=
      val =3D conn.getDate();=0A=
      if (val !=3D 0 && !gotDate) this._headers[this._headers.length] =
=3D {h:'Date', v:(new Date(val)).toUTCString()};=0A=
      val =3D conn.getExpiration();=0A=
      if (val !=3D 0 && !gotExpiration) =
this._headers[this._headers.length] =3D {h:'Expires', v:(new =
Date(val)).toUTCString()};=0A=
      val =3D conn.getLastModified();=0A=
      if (val !=3D 0 && !gotLastModified) =
this._headers[this._headers.length] =3D {h:'Last-modified', v:(new =
Date(val)).toUTCString()};=0A=
      // read response data=0A=
      var reqdata =3D '';=0A=
      var stream =3D conn.getInputStream();=0A=
      if (stream) {=0A=
        var reader =3D new java.io.BufferedReader(new =
java.io.InputStreamReader(stream, this._getCharset()));=0A=
        var line;=0A=
        while ((line =3D reader.readLine()) !=3D null) {=0A=
          if (this.readyState =3D=3D 2) {=0A=
            this.readyState =3D 3;=0A=
            if (this.onreadystatechange) {=0A=
              this.onreadystatechange();=0A=
            }=0A=
          }=0A=
          reqdata +=3D line + '\n';=0A=
        }=0A=
        reader.close();=0A=
        this.status =3D 200;=0A=
        this.statusText =3D 'OK';=0A=
        this.responseText =3D reqdata;=0A=
        this.readyState =3D 4;=0A=
        if (this.onreadystatechange) {=0A=
          this.onreadystatechange();=0A=
        }=0A=
        if (this.onload) {=0A=
          this.onload();=0A=
        }=0A=
      } else {=0A=
        // error=0A=
        this.status =3D 404;=0A=
        this.statusText =3D 'Not Found';=0A=
        this.responseText =3D '';=0A=
        this.readyState =3D 4;=0A=
        if (this.onreadystatechange) {=0A=
          this.onreadystatechange();=0A=
        }=0A=
        if (this.onerror) {=0A=
          this.onerror();=0A=
        }=0A=
      }=0A=
    };=0A=
  };=0A=
}=0A=
// ActiveXObject emulation=0A=
if (!window.ActiveXObject && window.XMLHttpRequest) {=0A=
  window.ActiveXObject =3D function(type) {=0A=
    switch (type.toLowerCase()) {=0A=
      case 'microsoft.xmlhttp':=0A=
      case 'msxml2.xmlhttp':=0A=
      case 'msxml2.xmlhttp.3.0':=0A=
      case 'msxml2.xmlhttp.4.0':=0A=
      case 'msxml2.xmlhttp.5.0':=0A=
        return new XMLHttpRequest();=0A=
    }=0A=
    return null;=0A=
  };=0A=
}=0A=

------=_NextPart_000_0105_01C67843.3D5991E0
Content-Type: application/octet-stream
Content-Transfer-Encoding: quoted-printable
Content-Location: http://www.jco.org/javascript/ajax/utility.js

/************************************************************************=
*****=0A=
 * javascript/ajax/utility.js=0A=
 *=0A=
 * Utility functions for working with XMLHttpRequest data.=0A=
 *=0A=
 * Copyright 2006 Board of Trustees of the Leland Stanford Junior =
University.=0A=
 =
*************************************************************************=
***/=0A=
=0A=
/*=0A=
 * Copy XML nodes into an HTMLElement. This effectively=0A=
 * clones XML markup which uses XHTML naming conventions=0A=
 * into an HTML DOM.=0A=
 */=0A=
function copy_xml_to_html(src, dst) {=0A=
  if (src.nodeType =3D=3D 1) { /* Node.ELEMENT_NODE */=0A=
    var e =3D document.createElement(src.nodeName);=0A=
    for (var i =3D 0; i < src.childNodes.length; i++) {=0A=
	  copy_xml_to_html(src.childNodes[i], e);=0A=
    }=0A=
    for (var i =3D 0; i < src.attributes.length; i++) {=0A=
      var n =3D src.attributes[i].name;=0A=
      var v =3D unescape_xml_string(src.attributes[i].value);      =0A=
      e.setAttribute(n, v);=0A=
      if (n =3D=3D "class") {=0A=
        e.className =3D v;=0A=
      }=0A=
      else if (n =3D=3D "style") {=0A=
        set_css_style(v, e, "");=0A=
      }=0A=
    }=0A=
    dst.appendChild(e);=0A=
  }=0A=
  else if (src.nodeType =3D=3D 3) { /* Node.TEXT_NODE */=0A=
    dst.appendChild(document.createTextNode(src.nodeValue));=0A=
  }=0A=
}=0A=
=0A=
/* =0A=
 * It is unclear that this is the right thing to be calling=0A=
 * from copy_xml_to_html, but it appears that Safari decides=0A=
 * to convert &amp; to the NCR &#35;, and then encodes that=0A=
 * NCR to &%26%2338;.  So, I'm going to treat the DOM Attr=0A=
 * value as a plain string, and run our XML string input=0A=
 * through the decoding routine below.=0A=
 */=0A=
function unescape_xml_string(s) {=0A=
  return s.replace(/&apos;/g, "'")=0A=
          .replace(/&#39;/g,  "'")=0A=
          .replace(/&quot;/g, "\"")=0A=
          .replace(/&#34;/g,  "\"")=0A=
          .replace(/&gt;/g,   ">")=0A=
          .replace(/&#62;/g,  ">")=0A=
          .replace(/&lt;/g,   "<")=0A=
          .replace(/&#60;/g,  "<")=0A=
          .replace(/&amp;/g,  "&")=0A=
          .replace(/&#38;/g,  "&");=0A=
}=0A=
=0A=
/*=0A=
 * Parse set of CSS rules and apply them to an element.=0A=
 * This is quite horrifying, but I'm unable to determine=0A=
 * how else to handle this with IE 6.  FireFox and other=0A=
 * sane browsers let you simply set the style attribute=0A=
 * or use e.style.setProperty(rule, value, priority),=0A=
 * IE 6 appears to have neither of these capabilities..=0A=
 */=0A=
function set_css_style(css, e, priority) {=0A=
  var rules =3D css.split(";");=0A=
  for (var i =3D 0; i < rules.length; i++) {=0A=
    var nvpair =3D rules[i].split(":");=0A=
    if (nvpair.length =3D=3D 2) {=0A=
      try {=0A=
        var name  =3D nvpair[0]; /* style attribute */=0A=
        var value =3D nvpair[1]; /* attribute value */=0A=
  =0A=
        /*=0A=
         * For each possible style attribute, set the=0A=
         * appropriate style property in the element.=0A=
         */=0A=
        if (name =3D=3D "background") {=0A=
           e.style.background =3D value;=0A=
        }=0A=
        else if (name =3D=3D "background-attachment") {=0A=
          e.style.backgroundAttachment =3D value;=0A=
        }=0A=
        else if (name =3D=3D "background-color") {=0A=
          e.style.backgroundColor =3D value;=0A=
        }=0A=
        else if (name =3D=3D "background-image") {=0A=
          e.style.backgroundImage =3D value;=0A=
        }=0A=
        else if (name =3D=3D "background-position") {=0A=
          e.style.backgroundPosition =3D value;=0A=
        }=0A=
        else if (name =3D=3D "background-position-x") {=0A=
          e.style.backgroundPositionX =3D value;=0A=
        }=0A=
        else if (name =3D=3D "background-position-y") {=0A=
          e.style.backgroundPositionY =3D value;=0A=
        }=0A=
        else if (name =3D=3D "background-repeat") {=0A=
          e.style.backgroundRepeat =3D value;=0A=
        }=0A=
        else if (name =3D=3D "behavior") {=0A=
          e.style.behavior =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border") {=0A=
          e.style.border =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-bottom") {=0A=
          e.style.borderBottom =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-bottom-color") {=0A=
          e.style.borderBottomColor =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-bottom-style") {=0A=
          e.style.borderBottomStyle =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-bottom-width") {=0A=
          e.style.borderBottomWidth =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-collapse") {=0A=
          e.style.borderCollapse =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-color") {=0A=
          e.style.borderColor =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-left") {=0A=
          e.style.borderLeft =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-left-color") {=0A=
          e.style.borderLeftColor =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-left-style") {=0A=
          e.style.borderLeftStyle =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-left-width") {=0A=
          e.style.borderLeftWidth =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-right") {=0A=
          e.style.borderRight =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-right-color") {=0A=
          e.style.borderRightColor =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-right-style") {=0A=
          e.style.borderRightStyle =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-right-width") {=0A=
          e.style.borderRightWidth =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-style") {=0A=
          e.style.borderStyle =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-top") {=0A=
          e.style.borderTop =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-top-color") {=0A=
          e.style.borderTopColor =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-top-style") {=0A=
          e.style.borderTopStyle =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-top-width") {=0A=
          e.style.borderTopWidth =3D value;=0A=
        }=0A=
        else if (name =3D=3D "border-width") {=0A=
          e.style.borderWidth =3D value;=0A=
        }=0A=
        else if (name =3D=3D "bottom") {=0A=
          e.style.bottom =3D value;=0A=
        }=0A=
        else if (name =3D=3D "clear") {=0A=
          e.style.clear =3D value;=0A=
        }=0A=
        else if (name =3D=3D "clip") {=0A=
          e.style.clip =3D value;=0A=
        }=0A=
        else if (name =3D=3D "color") {=0A=
          e.style.color =3D value;=0A=
        }=0A=
        else if (name =3D=3D "cssText") {=0A=
          e.style.Sets =3D value;=0A=
        }=0A=
        else if (name =3D=3D "cursor") {=0A=
          e.style.cursor =3D value;=0A=
        }=0A=
        else if (name =3D=3D "direction") {=0A=
          e.style.direction =3D value;=0A=
        }=0A=
        else if (name =3D=3D "display") {=0A=
          e.style.display =3D value;=0A=
        }=0A=
        else if (name =3D=3D "font") {=0A=
          e.style.font =3D value;=0A=
        }=0A=
        else if (name =3D=3D "font-family") {=0A=
          e.style.fontFamily =3D value;=0A=
        }=0A=
        else if (name =3D=3D "font-size") {=0A=
          e.style.fontSize =3D value;=0A=
        }=0A=
        else if (name =3D=3D "font-style") {=0A=
          e.style.fontStyle =3D value;=0A=
        }=0A=
        else if (name =3D=3D "font-variant") {=0A=
          e.style.fontVariant =3D value;=0A=
        }=0A=
        else if (name =3D=3D "font-weight") {=0A=
          e.style.fontWeight =3D value;=0A=
        }=0A=
        else if (name =3D=3D "height") {=0A=
          e.style.height =3D value;=0A=
        }=0A=
        else if (name =3D=3D "ime-mode") {=0A=
          e.style.imeMode =3D value;=0A=
        }=0A=
        else if (name =3D=3D "layout-flow") {=0A=
          e.style.layoutFlow =3D value;=0A=
        }=0A=
        else if (name =3D=3D "layout-grid") {=0A=
          e.style.layoutGrid =3D value;=0A=
        }=0A=
        else if (name =3D=3D "layout-grid-char") {=0A=
          e.style.layoutGridChar =3D value;=0A=
        }=0A=
        else if (name =3D=3D "layout-grid-line") {=0A=
          e.style.layoutGridLine =3D value;=0A=
        }=0A=
        else if (name =3D=3D "layout-grid-mode") {=0A=
          e.style.layoutGridMode =3D value;=0A=
        }=0A=
        else if (name =3D=3D "layout-grid-type") {=0A=
          e.style.layoutGridType =3D value;=0A=
        }=0A=
        else if (name =3D=3D "left") {=0A=
          e.style.left =3D value;=0A=
        }=0A=
        else if (name =3D=3D "letter-spacing") {=0A=
          e.style.letterSpacing =3D value;=0A=
        }=0A=
        else if (name =3D=3D "line-break") {=0A=
          e.style.lineBreak =3D value;=0A=
        }=0A=
        else if (name =3D=3D "line-height") {=0A=
          e.style.lineHeight =3D value;=0A=
        }=0A=
        else if (name =3D=3D "list-style") {=0A=
          e.style.listStyle =3D value;=0A=
        }=0A=
        else if (name =3D=3D "list-style-image") {=0A=
          e.style.listStyleImage =3D value;=0A=
        }=0A=
        else if (name =3D=3D "list-style-position") {=0A=
          e.style.listStylePosition =3D value;=0A=
        }=0A=
        else if (name =3D=3D "list-style-type") {=0A=
          e.style.listStyleType =3D value;=0A=
        }=0A=
        else if (name =3D=3D "margin") {=0A=
          e.style.margin =3D value;=0A=
        }=0A=
        else if (name =3D=3D "margin-bottom") {=0A=
          e.style.marginBottom =3D value;=0A=
        }=0A=
        else if (name =3D=3D "margin-left") {=0A=
          e.style.marginLeft =3D value;=0A=
        }=0A=
        else if (name =3D=3D "margin-right") {=0A=
          e.style.marginRight =3D value;=0A=
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          e.style.overflowY =3D value;=0A=
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          e.style.padding =3D value;=0A=
        }=0A=
        else if (name =3D=3D "padding-bottom") {=0A=
          e.style.paddingBottom =3D value;=0A=
        }=0A=
        else if (name =3D=3D "padding-left") {=0A=
          e.style.paddingLeft =3D value;=0A=
        }=0A=
        else if (name =3D=3D "padding-right") {=0A=
          e.style.paddingRight =3D value;=0A=
        }=0A=
        else if (name =3D=3D "padding-top") {=0A=
          e.style.paddingTop =3D value;=0A=
        }=0A=
        else if (name =3D=3D "page-break-after") {=0A=
          e.style.pageBreakAfter =3D value;=0A=
        }=0A=
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          e.style.pageBreakBefore =3D value;=0A=
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        else if (name =3D=3D "pixelBottom") {=0A=
          e.style.pixelBottom =3D value;=0A=
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          e.style.pixelHeight =3D value;=0A=
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          e.style.pixelLeft =3D value;=0A=
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      }=0A=
      catch (e) {=0A=
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  }=0A=
}=0A=

------=_NextPart_000_0105_01C67843.3D5991E0
Content-Type: application/octet-stream
Content-Transfer-Encoding: quoted-printable
Content-Location: http://www.jco.org/javascript/entrez/callback.js

/************************************************************************=
*****=0A=
 * javascript/entrez/callback.js=0A=
 *=0A=
 * Entrez Linking callback to populate content box.=0A=
 *=0A=
 * Copyright 2006 Board of Trustees of the Leland Stanford Junior =
University.=0A=
 =
*************************************************************************=
***/=0A=
=0A=
/*=0A=
 * Execute callback to fill content box with Entrez Linking information.=0A=
 */=0A=
function entrez_callback(pmid, callback_url) {=0A=
  /*=0A=
   * MSIE 5.5 and below have issues with the JavaScript=0A=
   * used for Entrez Linking. For now we have to disable=0A=
   * the callback until we can track down a proper fix=0A=
   * (or everybody sanely upgrades to version 6 or 7!).=0A=
   */=0A=
  if (navigator) {=0A=
    var appname =3D navigator.appName;=0A=
    if (appname =3D=3D "Microsoft Internet Explorer") {=0A=
      var userAgent =3D navigator["userAgent"];=0A=
      var s =3D "MSIE ";=0A=
      var n =3D -1;      =0A=
      if ((n =3D userAgent.indexOf(s)) !=3D -1) {=0A=
        var v =3D parseFloat(userAgent.substring(n+s.length));=0A=
        if (v < 6) {=0A=
          return;=0A=
        }=0A=
      }=0A=
    }=0A=
  }=0A=
=0A=
  /*=0A=
   * Acquire table row element to update, initiate callback=0A=
   * to update table with Entrez Links.=0A=
   */=0A=
  var tr =3D document.getElementById('entrez_callback_'+pmid);=0A=
  if (!tr) {=0A=
    return;=0A=
  }=0A=
  var req =3D new XMLHttpRequest();=0A=
  if (!req) {=0A=
    return;=0A=
  }=0A=
  req.onreadystatechange =3D function() {=0A=
    if (req.readyState =3D=3D 4 && (req.status =3D=3D 200 || req.status =
=3D=3D 304)) {=0A=
      var src =3D req.responseXML.documentElement;=0A=
      var dst =3D document.createDocumentFragment();=0A=
      for (var i =3D 0; i < src.childNodes.length; i++) {=0A=
      	copy_xml_to_html(src.childNodes[i], dst);=0A=
      }=0A=
      var tbl =3D tr.parentNode;=0A=
      tbl.replaceChild(dst, tr);=0A=
    }=0A=
  }=0A=
  req.open('GET', callback_url, true);=0A=
  req.send(null);=0A=
}=0A=

------=_NextPart_000_0105_01C67843.3D5991E0--
