10.1007/s11060-009-9956-7</TIT= LE> <META http-equiv=3DContent-Type content=3D"text/html; = charset=3DISO-8859-1"><LINK=20 href=3D"http://www.springerlink.com/config/css/A++_common.css" = type=3Dtext/css=20 rel=3DstyleSheet><LINK=20 href=3D"http://www.springerlink.com/config/css/content_A++_SpringerLink.c= ss"=20 type=3Dtext/css rel=3DstyleSheet> <META content=3D"MSHTML 6.00.6000.16890" name=3DGENERATOR></HEAD> <BODY class=3Dfor-print> <TABLE cellPadding=3D2 border=3D1> <TBODY> <TR class=3Dheader> <TD>Journal of Neuro-Oncology</TD></TR> <TR> <TD>=A9 The Author(s) 2009</TD></TR> <TR> <TD>10.1007/s11060-009-9956-7</TD></TR></TBODY></TABLE> <H2 class=3Drubric>Clinical Study - Patient Study</H2> <DIV class=3DHeading1><A name=3Dtitle></A>Effectiveness of temozolomide = for primary=20 glioblastoma multiforme in routine clinical practice </DIV> <P = class=3DAuthorGroup>J. A. B. van Genugten<SUP>1</SUP>= ,=20 P. Leffers<SUP>2</SUP>, B. G. Baumert<SUP>3</SUP>,=20 H. Tjon-a-Fat<SUP>1</SUP> and A. Twijnstra<SUP>1 <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#ContactOfAuthor5"><IMG=20 alt=3D"Contact Information"=20 src=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/contact.gif" = border=3D0></A></SUP></P> <TABLE> <TBODY> <TR vAlign=3Dtop> <TD><SPAN class=3DAffiliation><A = name=3DAff1></A>(1) </SPAN></TD> <TD><SPAN class=3DAffiliation>Department of Neurology, Maastricht = University=20 Medical Centre, P.O. Box 5800, Maastricht, 6202 AZ, The=20 Netherlands</SPAN></TD></TR></TBODY></TABLE> <TABLE> <TBODY> <TR vAlign=3Dtop> <TD><SPAN class=3DAffiliation><A = name=3DAff2></A>(2) </SPAN></TD> <TD><SPAN class=3DAffiliation>Department of Epidemiology, Faculty of = Health,=20 Medicine and Life Sciences, University of Maastricht, P.O. Box = 616,=20 Maastricht, 6200 MD, The = Netherlands</SPAN></TD></TR></TBODY></TABLE> <TABLE> <TBODY> <TR vAlign=3Dtop> <TD><SPAN class=3DAffiliation><A = name=3DAff3></A>(3) </SPAN></TD> <TD><SPAN class=3DAffiliation>Department of Radiation Oncology = (MAASTRO),=20 GROW (Research Institute Growth and Development), Maastricht = University=20 Medical Centre, Maastricht, The = Netherlands</SPAN></TD></TR></TBODY></TABLE> <P><A name=3DContactOfAuthor5></A></P> <TABLE class=3DContact> <TBODY> <TR> <TD vAlign=3Dtop><IMG alt=3D"Contact Information"=20 = src=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/contact.gif" = border=3D0></TD> = <TD><STRONG>A. </STRONG><STRONG>Twijnstra</STRONG><STRONG></STRONG><= BR><STRONG>Email:=20 </STRONG><A=20 = href=3D"mailto:jessie_van_genugten@hotmail.com">jessie_van_genugten@hotma= il.com</A></TD></TR></TBODY></TABLE> <P class=3DAffiliation><STRONG>Received:=20 </STRONG>1 April 2009 <STRONG>Accepted:=20 </STRONG>22 June 2009 <STRONG>Published online:=20 </STRONG>7 July 2009 </P> <DIV class=3DAbstract><A name=3DAbs1></A><SPAN=20 class=3DAbstractHeading>Abstract </SPAN>Temozolomide has been = used as a=20 standard therapy for the treatment of newly diagnosed glioblastoma = multiforme=20 since 2005. To assess the effectiveness of temozolomide in routine = clinical=20 practice, we conducted an observational study at Maastricht University = Medical=20 Centre (MUMC). Data of patients receiving radiotherapy and temozolomide = between=20 January 2005 and January 2008 were retrieved from a clinical database=20 (radiochemotherapy group), as were data of patients in a historical = control=20 group from the period before 2005 treated with radiotherapy only = (radiotherapy=20 group). The primary endpoint was overall survival. A total of 125 = patients with=20 GBM were selected to form the study cohort. Median survival benefit was=20 4 months: the median overall survival was 12 months (95% CI, = 9.7=9614.3)=20 in the group with radiochemotherapy with temozolomide, versus = 8 months (95%=20 CI, 5.3=9610.7) in the group with only radiotherapy. Progression-free = survival was=20 7 months (95% CI, 5.5=968.5) in the radiochemotherapy group and = 4 months=20 (95% CI, 2.9-5.1) in the group with only radiotherapy. The two-year = survival=20 rate was 18% with radiochemotherapy with temozolomide against 4% with=20 radiotherapy alone. Concomitant treatment with radiotherapy and = temozolomide=20 followed by adjuvant temozolomide resulted in grade III or IV = haematological=20 toxic effects in 9% of patients. The addition of temozolomide to = radiotherapy in=20 routine clinical practice for newly diagnosed glioblastoma resulted in a = clinically meaningful survival benefit with minimal haematological = toxicity,=20 which confirms the experience of previous trials and justifies the = continued use=20 of temozolomide in routine clinical practice. </DIV> <P class=3DKeyword><SPAN=20 class=3DKeywordHeading>Keywords </SPAN>Temozolomide -&nbs= p;Glioblastoma=20 multiforme - Survival - Routine clinical=20 practice - Radiotherapy </P> <DIV class=3D""><A name=3DSec1></A> <HR> <DIV class=3Dheading2>Introduction</DIV> <P class=3D"">Gliomas represent about half of all histologically = verified primary=20 CNS cancers among adults [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR1">1</A></CITE>].=20 Glioblastoma multiforme (GBM), grade IV glioma, is the most frequent and = most=20 aggressive type of malignant brain tumour. The most characteristic = features of=20 GBM are necrosis and endothelial proliferation [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR2">2</A></CITE>].=20 Despite the best available treatment, the clinical course is fatal, with = a=20 median survival of less than one year [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR3">3</A></CITE>].=20 Factors that are prognostic for survival, apart from treatment = modalities, are=20 patient age, performance status and degree of surgical resection = [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR1">1</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR3">3</A></CITE>=96<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR13">13</A></CITE>].=20 When a high grade glioma is suspected, maximal resection of the tumour = is aimed=20 for, on condition that neurological functions are spared. Such = cytoreductive=20 surgery is of limited value without adjuvant therapy. Until 2005, = standard=20 therapy consisted of surgical resection, followed by radiotherapy, which = has=20 been shown to prolong survival [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR14">14</A></CITE>].=20 Unfortunately, the addition of various chemotherapeutics only resulted = in=20 marginal survival benefits [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR15">15</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR16">16</A></CITE>].=20 Therefore, chemotherapy was not part of standard therapy for GBM in = Europe and=20 was only administered in the context of clinical trials. This changed = after the=20 publication of an EORTC/NCIC study in 2005, in which Stupp et al.=20 demonstrated improved survival in patients with a histological diagnosis = of=20 glioblastoma multiforme, when concomitant temozolomide followed by = adjuvant=20 temozolomide was added to the standard treatment [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR17">17</A></CITE>].=20 Similar results were seen in a smaller phase II trial by Athanassiou = et al=20 [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR18">18</A></CITE>].=20 Temozolomide is an oral alkylating agent, with a lower toxicity profile = than=20 most other chemotherapeutic agents [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR19">19</A></CITE>].=20 It can easily cross the blood-brain barrier, so that cerebrospinal fluid = levels=20 can reach at least 20% of those observed in the plasma [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR20">20</A></CITE>].=20 Since the publication of these studies, temozolomide has been widely = adopted as=20 the new standard of care for patients with newly diagnosed GBM. </P> <P class=3D"">The outcome of randomised controlled trials cannot be = directly=20 applied without considering differences in patient characteristics = between the=20 trial population and patient populations in routine clinical practice. = The=20 objective of the present study was to assess the effectiveness of = temozolomide=20 in addition to radiotherapy in patients with newly diagnosed GBM in = routine=20 clinical practice. For this purpose, we conducted an observational study = at=20 Maastricht University Medical Centre (MUMC) among patients receiving=20 radiotherapy and temozolomide and a historical control group of patients = who=20 were treated with radiotherapy only. </P></DIV> <DIV class=3D""><A name=3DSec2></A> <HR> <DIV class=3Dheading2>Patients and methods</DIV> <DIV class=3D""><A name=3DSec3></A> <DIV class=3DHeading3>Study objectives</DIV> <P class=3D"">The primary endpoint in this study was overall survival = (OS),=20 defined as the time from the starting date of radiotherapy to the date = of death.=20 Secondary endpoints were progression-free survival (PFS), 2-year overall = survival and toxicity. PFS was defined from the starting date of = radiotherapy to=20 the date of tumour progression or death. The exact date of death was = acquired=20 from a database held at the General Registry Office of the Dept. of = Radiation=20 Oncology (MAASTRO Clinic). The safety and tolerability of temozolomide = were=20 estimated in the radiotherapy plus temozolomide group by assessing the=20 haematological and non-haematological toxicity data from medical records = and=20 routine blood examinations. Although the National Cancer Institute has = updated=20 its Common Toxicity Criteria into version 3.0 (2006), we used version = 2.0 to=20 ensure better comparability with previous trials. </P></DIV> <DIV class=3D""><A name=3DSec4></A> <DIV class=3DHeading3>Eligibility</DIV> <P class=3D"">Since 1991, the Neuro-Oncology Department of the MUMC has = been=20 entering data on all neuro-oncological patients who are discussed in its = weekly=20 neuro-oncology meetings into a database. For the present study, we added = data on=20 patients who had not been discussed in these neuro-oncology meetings, = but who=20 had been registered in a pathology database (PALGA) with a histological = GBM=20 diagnosis. This allowed us to identify all patients aged 18 to = 70 years who=20 had a newly diagnosed and histologically confirmed supratentorial GBM = according=20 to the World Health Organization classification and who had been = referred to the=20 MUMC between January 2000 and January 2008. Data of patients who = received=20 radiotherapy and temozolomide between January 2005 and January 2008 were = collected from this database (radiochemotherapy group). Data of patients = receiving radiotherapy only were retrieved from the database for the = period=20 before 2005 (radiotherapy group). The subtypes of GBM, namely giant cell = and=20 gliosarcoma, were included. </P> <P class=3D"">Patients with a secondary glioblastoma, based on a prior=20 histopathological diagnosis of a lower grade astrocytoma, were excluded. = In=20 cases where the first histopathological diagnosis was glioblastoma, but = the=20 clinical history was longer than one year, the pathologist was asked to = do=20 further immunohistochemical examinations to confirm or exclude the = diagnosis of=20 primary glioblastoma. Patients with gliomatosis cerebri were excluded, = as well=20 as patients with prior chemotherapy. </P></DIV> <DIV class=3D""><A name=3DSec5></A> <DIV class=3DHeading3>Treatment</DIV> <P class=3D"">All patients had surgery before radiotherapy. The extent = of the=20 surgery was defined as biopsy, partial resection or macroscopically = complete=20 resection and was determined from the surgical report and postoperative = imaging,=20 if performed. In the radiochemotherapy group, patients received = radiotherapy=20 with concomitant temozolomide, followed by adjuvant temozolomide, = whereas the=20 reference group received radiotherapy only (same radiotherapy treatment = scheme=20 with 30 fractions of 2 Gy to total dose of 60 Gy as used in = the EORTC=20 study by Stupp et al. [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR17">17</A></CITE>]).=20 Chemotherapy consisted of temozolomide at a dose of = 75 mg/m<SUP>2</SUP> per=20 day, seven days a week for 42 consecutive days during radiotherapy. = After a=20 break of four weeks, patients received six cycles of adjuvant = temozolomide at a=20 dose of 150 to 200 mg/m<SUP>2</SUP>, on days 1 through 5, every=20 28 days. Prophylactic co-trimoxazol against Pneumocystis carinii = was given.=20 Antiemetics, anticonvulsants and corticosteroids were prescribed if = needed. </P> <P class=3D"">In case of disease progression, patients were assessed for = their=20 performance status and were offered =91salvage therapy=92, such as = surgery,=20 re-irradiation, second-line chemotherapy and/or supportive care. = </P></DIV> <DIV class=3D""><A name=3DSec6></A> <DIV class=3DHeading3>Statistical analysis</DIV> <P class=3D"">Overall and progression-free survival curves were plotted = using the=20 method developed by Kaplan and Meier. The Cox proportional hazards model = was=20 used to adjust the hazard ratio for confounding and to improve the = statistical=20 efficiency. The prognostic factors tested were age, sex, WHO performance = status=20 and extent of surgery, since these have been reported in the literature = as=20 prognostic factors for survival outcome [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR1">1</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR3">3</A></CITE>=96<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR13">13</A></CITE>].=20 </P> <P class=3D"">We corrected for age per decade rather than the binary = categories=20 above or below 50 years, to obtain a more accurate measure of this=20 variable. <I>P</I>-values lower than 0.05 were considered to be = statistically=20 significant. Statistical analysis was performed using the Statistical = Package=20 for the Social Sciences 15.0 (SPSS, Inc., Chicago, IL). </P></DIV></DIV> <DIV class=3D""><A name=3DSec7></A> <HR> <DIV class=3Dheading2>Results</DIV> <DIV class=3D""><A name=3DSec8></A> <DIV class=3DHeading3>Patient characteristics</DIV> <DIV class=3DPara> <DIV class=3D"">One hundred and twenty-five patients with GBM were = selected to=20 form the study cohort. Patient details are outlined in Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab1">1</A>.=20 Median age was 56 years. Male/female ratio was 1.55. The initial = complaints=20 were motor symptoms in 34% of the patients, headache in 45%, epileptic = seizures=20 in 33%, personality change in 12%, and speech disorder in 26%. The=20 radiochemotherapy group consisted of 67 patients and the radiotherapy = group of=20 58 patients. The median time from diagnosis to start of treatment was=20 5.9 weeks in the radiotherapy group and 3.9 weeks in the=20 radiochemotherapy group. The baseline characteristics of the patients = were not=20 balanced as regards sex, extent of resection, corticosteroid use, giant = cell or=20 waiting time between diagnosis and the start of treatment.<A = name=3DTab1></A> <DIV class=3DCapt><SPAN class=3DCaptNr>Table 1 </SPAN>Patient=20 characteristics </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dchar char=3D"("> <COL align=3Dchar char=3D"("></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft> <P class=3D"">Characteristic</P></TH> <TH align=3Dleft char=3D"("> <P class=3D"">Radiotherapy (<I>N</I> =3D 58) </P></TH> <TH align=3Dleft char=3D"("> <P class=3D"">Radiochemotherapy (<I>N</I> =3D 67) = </P></TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Age (year)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Median</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">56</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">57</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Range</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">33=9670</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">25=9670</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Sex=96=96no. (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Male</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">29 (50)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">47 (70)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Female</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">29 (50)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">20 (30)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">WHO performance status, no. (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> 0</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">23 (40)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">25 (37)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> 1</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">24 (41)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">30 (45)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> 2</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">8 (14)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">11 (16)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> 3</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">3 (5)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">1 (2)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Extent of surgery, no. (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Biopsy</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">33 (57)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">30 (45)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Partial</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">11 (19)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">12 (18)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Macroscopically complete=20 resection</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">14 (24)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">25 (37)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Time from diagnosis to treatment, wk</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Median</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">5.9</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">3.9</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Range</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">0.7-18</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">2-8.4</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Corticosteroid therapy, no. (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Yes</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">39 (67)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">46 (69)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> No</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">5 (9)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">20 (30)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Data missing</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">14 (24)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">1 (2)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Subtype of glioblastoma, no. (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Giant cell</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">1 (2)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">6 = (9)</P></TD></TR></TBODY></TABLE></DIV></DIV></DIV> <DIV class=3D""><A name=3DSec9></A> <DIV class=3DHeading3>Treatment</DIV> <DIV class=3DPara> <DIV class=3D"">Median received radiation dose was 60 Gy (range,=20 4=9660 Gy). Ten patients (8%) did not complete the entire = radiotherapy,=20 reasons including disease progression and death. Among the 67 patients = who=20 started radiochemotherapy, 93% completed the concomitant phase with both = radiotherapy and temozolomide. Of the 67 patients in the = radiochemotherapy=20 group, 75% started the adjuvant therapy with temozolomide after the = 4-week=20 break. Seventy percent of the radiochemotherapy group completed=20 three cycles of temozolomide, and 40% had ultimately completed=20 six cycles (see Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab2">2</A>).=20 The main reason for not completing concomitant and/or adjuvant = temozolomide=20 therapy in our study was disease progression, assessed by clinical = deterioration=20 and/or radiological assessment. Five patients (7.5%) in the = radiochemotherapy=20 group discontinued therapy because of haematological toxicity effects.<A = name=3DTab2></A> <DIV class=3DCapt><SPAN = class=3DCaptNr>Table 2 </SPAN>Temozolomide=20 compliance </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dchar char=3D"."></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft> <P class=3D"">Treatment episode</P></TH> <TH align=3Dleft char=3D"."> <P class=3D"">% Completed</P></TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Week 3 RT concomitant</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">100.0</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Week 5 RT concomitant</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">97.0</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Total concomitant period</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">92.5</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Cycle 1</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">74.6</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Cycle 2</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">73.1</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Cycle 3</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">70.1</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Cycle 4</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">44.7</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Cycle 5</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">43.2</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Cycle 6</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">40.3</P></TD></TR></TBODY></TABLE></DIV></DIV></DIV> <DIV class=3D""><A name=3DSec10></A> <DIV class=3DHeading3>Survival and progression</DIV> <DIV class=3DPara> <DIV class=3D"">The follow-up ended on 8 July 2008. The unadjusted = hazard ratio=20 for death in the radiochemotherapy group compared to the radiotherapy = group was=20 0.48 (95% CI, 0.32=960.72; <I>P</I> < 0.001). Multivariate = analysis,=20 including all considered covariates gave the same hazard ratio: 0.47 = (95% CI,=20 0.29=960.73; <I>P</I> =3D 0.001). The Kaplan=96Meier curve = showed a median=20 overall survival of 12 months (95% CI, 5.3 to 10.7) in the=20 radiochemotherapy group, versus 8 months (95% CI, 9.7=9614.3) in = the group=20 with radiotherapy only (Fig. <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Fig1">1</A>=20 and Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab3">3</A>).=20 The estimated median survival benefit was therefore 4 months.=20 <DIV class=3DFigure><A name=3DFig1></A><IMG=20 alt=3DMediaObjects/11060_2009_9956_Fig1_HTML.gif=20 src=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/MediaObjects/= 11060_2009_9956_Fig1_HTML.gif"></DIV> <DIV class=3DCapt><SPAN = class=3DCaptNr>Fig. 1 </SPAN>Kaplan=96Meier curves=20 of overall survival: radiochemotherapy versus radiotherapy only. = <I>P</I>=20 value =3D 0.000. Censored: Still alive at end of study period = 08-07-08=20 </DIV> <HR> <A name=3DTab3></A> <DIV class=3DCapt><SPAN class=3DCaptNr>Table 3 </SPAN>Overall = and=20 progression-free survival </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dchar char=3D"."> <COL align=3Dchar char=3D"."></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft rowSpan=3D2> <P class=3D"">Variable</P></TH> <TH align=3Dleft char=3D"."> <P class=3D"">Radiotherapy (<I>N</I> =3D 47) </P></TH> <TH align=3Dleft char=3D"."> <P class=3D"">Radiochemotherapy (<I>N</I> =3D 66) = </P></TH></TR> <TR class=3Dheader> <TH align=3Dleft char=3D"."> <P class=3D"">Value (95% CI)</P></TH> <TH align=3Dleft char=3D"."> <P class=3D"">Value (95% CI)</P></TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Median overall survival (months)</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">8.0 (5.3=9610.7)</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">12.0 (9.7=9614.3)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Overall survival (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> At 6 months</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">57.4</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">78.8</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> At 12 months</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">23.4</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">46.8</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> At 24 months</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">4.3</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">18.2</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Median progression-free = survival=20 (months)</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">4.0 (2.9=965.1)</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">7.0 (5.5=968.5)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Progression-free survival (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> At 6 months</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">34.0</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">56.1</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> At 12 months</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">6.4</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">26.6</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> At 24 months</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">2.1</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">9.5</P></TD></TR></TBODY></TABLE></DIV></DIV> <DIV class=3DPara> <DIV class=3D"">The unadjusted hazard ratio for PFS of radiochemotherapy = compared=20 to the radiotherapy was 0.58 (95% CI, 0.39=960.85; = <I>P</I> =3D 0.006).=20 The adjusted hazard ratio, corrected for all considered factors, was = 0.59 (95%=20 CI, 0.38=960.91; <I>P</I> =3D 0.016). The median = progression-free survival=20 was 7 months (95% CI, 5.5=968.5) with radiochemotherapy and = 4 months=20 (95% CI, 2.9=965.1) with only radiotherapy (Fig. <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Fig2">2</A>,=20 Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab3">3</A>).=20 The two-year survival rate was 18% in the radiochemotherapy group and 4% = in the=20 group with only radiotherapy.=20 <DIV class=3DFigure><A name=3DFig2></A><IMG=20 alt=3DMediaObjects/11060_2009_9956_Fig2_HTML.gif=20 src=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/MediaObjects/= 11060_2009_9956_Fig2_HTML.gif"></DIV> <DIV class=3DCapt><SPAN = class=3DCaptNr>Fig. 2 </SPAN>Kaplan=96Meier curves=20 of progression-free survival: radiochemotherapy versus radiotherapy = only.=20 <I>P</I>-value =3D 0.003. Censored: Still alive at end of = study period=20 08-07-08 </DIV> <HR> </DIV></DIV> <DIV class=3DPara> <DIV class=3D"">The waiting time (medians 5.9 for radiotherapy and = 3.9 weeks=20 for radiochemotherapy) was also added to the Cox Regression model. The = adjusted=20 hazard ratio for death of radiotherapy plus temozolomide compared to=20 radiotherapy alone, then became 0.42 (95% CI, 0.24=960.73;=20 <I>P</I> =3D 0.002). This change of the HR was caused by a = clear=20 positive association between waiting time and survival in the = radiotherapy group=20 as is shown in Fig. <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Fig3">3</A>.=20 This association is probably due to patient selection. In the = radiochemotherapy=20 period (2005=962008), there was a weak inverse association.=20 <DIV class=3DFigure><A name=3DFig3></A><IMG=20 alt=3DMediaObjects/11060_2009_9956_Fig3_HTML.gif=20 src=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/MediaObjects/= 11060_2009_9956_Fig3_HTML.gif"></DIV> <DIV class=3DCapt><SPAN = class=3DCaptNr>Fig. 3 </SPAN>Correlation between=20 waiting time and survival in radiotherapy and radiochemotherapy groups = </DIV> <HR> </DIV></DIV></DIV> <DIV class=3D""><A name=3DSec11></A> <DIV class=3DHeading3>Subgroup analysis</DIV> <P class=3D"">Survival was analysed according to the prognostic factors. = Radiochemotherapy was associated with a significant improvement in = median=20 overall survival in nearly all subgroups of patients, with the exception = of the=20 relatively large subgroup of patients who underwent biopsy only and the = patients=20 with a WHO performance status 1 (whereas those with the poorer = performance=20 status WHO 2 and 3 did show a significant improvement in median = survival).=20 </P></DIV> <DIV class=3D""><A name=3DSec12></A> <DIV class=3DHeading3>Comparison with EORTC/NCIC trial</DIV> <DIV class=3DPara> <DIV class=3D"">To achieve the best possible comparison of the effect of = this new=20 treatment in routine clinical practice and in the EORTC/NCIC trial, we=20 calculated what the effect of the treatment in our setting would have = been for=20 the patients of the EORTC/NCIC trial. To this end, we entered the mean = patient=20 characteristics of their trial population (Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab4">4</A>)=20 into our Cox regression model. The survival curve in Fig. <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Fig4">4</A>=20 shows the effect of treatment on the survival of an average patient in = the EORTC=20 trial. This patient would be expected to survive for 10.0 months = with=20 radiotherapy and 14.2 months when temozolomide was added to the = treatment.=20 An average patient in our routine clinical practice cohort survived=20 9.0 months with radiotherapy and 12.9 months with = radiochemotherapy=20 (Fig. <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Fig5">5</A>).<A=20 name=3DTab4></A> <DIV class=3DCapt><SPAN class=3DCaptNr>Table 4 </SPAN>Patient=20 characteristics=96=96comparison with EORTC/NCIC trial </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dchar char=3D"."> <COL align=3Dchar char=3D"."> <COL align=3Dchar char=3D"."> <COL align=3Dchar char=3D"."></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft rowSpan=3D2> <P class=3D"">Characteristic</P></TH> <TH align=3Dleft colSpan=3D2 char=3D"."> <P class=3D"">Present study</P></TH> <TH align=3Dleft colSpan=3D2 char=3D"."> <P class=3D"">Stupp et al.</P></TH></TR> <TR class=3Dheader> <TH align=3Dleft char=3D"."> <P class=3D"">RT</P></TH> <TH align=3Dleft char=3D"."> <P class=3D"">RT + TMZ</P></TH> <TH align=3Dleft char=3D"."> <P class=3D"">RT</P></TH> <TH align=3Dleft char=3D"."> <P class=3D"">RT + TMZ</P></TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D5> <P class=3D"">Age (year)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Median</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">56</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">57</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>57</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>56</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D5> <P class=3D"">Sex (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Male</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">50</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">70</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>61</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>64</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Female</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">50</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">30</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>39</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>36</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D5> <P class=3D"">WHO performance status (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> 0</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">40</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">37</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>38</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>39</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> 1</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">41</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">45</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>49</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>47</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> 2</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">14</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">16</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>12</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>13</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> 3</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">5</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">2</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>0</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>0</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D5> <P class=3D"">Extent of surgery (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Biopsy</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">57</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">45</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>16</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>17</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Partial</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">19</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">18</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>45</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>44</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Macroscopically complete=20 resection</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">24</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">37</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>40</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>39</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D5> <P class=3D"">Time from diagnosis to = treatment=96=96wk</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Median</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">5.9</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">3.9</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>5.0</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>5.0</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D5> <P class=3D"">Corticosteroid therapy (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Yes</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">67</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">69</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>75</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>67</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> No</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">9</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">30</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>24</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>33</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Data missing</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">24</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>2</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I><1</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>0</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D5> <P class=3D"">Subtype of glioblastoma (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Giant cell</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">2</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">9</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">?</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">?</P></TD></TR></TBODY></TABLE> <DIV class=3DFigure><A name=3DFig4></A><IMG=20 alt=3DMediaObjects/11060_2009_9956_Fig4_HTML.gif=20 src=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/MediaObjects/= 11060_2009_9956_Fig4_HTML.gif"></DIV> <DIV class=3DCapt><SPAN class=3DCaptNr>Fig. 4 </SPAN>Survival = curve of an=20 average patient of the EORTC/NCIC trial </DIV> <HR> <DIV class=3DFigure><A name=3DFig5></A><IMG=20 alt=3DMediaObjects/11060_2009_9956_Fig5_HTML.gif=20 src=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/MediaObjects/= 11060_2009_9956_Fig5_HTML.gif"></DIV> <DIV class=3DCapt><SPAN class=3DCaptNr>Fig. 5 </SPAN>Survival = curve of an=20 average patient of selected patients from clinical practice </DIV> <HR> </DIV></DIV></DIV> <DIV class=3D""><A name=3DSec13></A> <DIV class=3DHeading3>Toxicity</DIV> <P class=3D"">Detailed toxicity data were not recorded for the = radiotherapy group=20 in the neurology treatment charts, whereas temozolomide-related = haematotoxicity=20 was recorded for each patient in the radiochemotherapy group. Six = patients (9%)=20 had any type of grade III or IV haematological toxic effect. In five of = these=20 cases chemotherapy was discontinued. Anti-epileptic drugs were given to = 41% of=20 patients in the radiotherapy group and 47% of patients in the = radiochemotherapy=20 group. Only 5% received the non-enzyme inducing valproic acid. = </P></DIV> <DIV class=3D""><A name=3DSec14></A> <DIV class=3DHeading3>Treatment after disease progression</DIV> <DIV class=3DPara> <DIV class=3D"">At the moment of disease progression, four patients in = both=20 treatment groups underwent a second surgery, seven patients were = re-irradiated,=20 16 patients received additional cycles of temozolomide and four patients = received second-line chemotherapy other than temozolomide. In total, 17% = of=20 patients in the radiochemotherapy group and 18% of patients in the = radiotherapy=20 group received salvage chemotherapy (see Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab5">5</A>).=20 Salvage chemotherapy consisted of additional cycles of temozolomide in = 67% of=20 patients in the radiochemotherapy group and 100% of patients in the = radiotherapy=20 group.<A name=3DTab5></A> <DIV class=3DCapt><SPAN class=3DCaptNr>Table 5 </SPAN>Salvage = treatment=20 </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dchar char=3D"("> <COL align=3Dchar char=3D"("></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft> <P class=3D"">Type of treatment</P></TH> <TH align=3Dleft char=3D"("> <P class=3D"">Radiotherapy (<I>N</I> =3D 47) </P></TH> <TH align=3Dleft char=3D"("> <P class=3D"">Radiochemotherapy (<I>N</I> =3D 66) = </P></TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Second surgery, no. (%)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">0 (0)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">4 (6)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Re-irradiation, no. (%)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">1 (2)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">6 (9)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Chemotherapy, no. (%)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">8 (17)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">12 (18)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Temozolomide</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">8 (17)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">8 (12)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Other than = temozolomide</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">0 (0)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">4 = (6)</P></TD></TR></TBODY></TABLE></DIV></DIV></DIV></DIV> <DIV class=3D""><A name=3DSec15></A> <HR> <DIV class=3Dheading2>Discussion</DIV> <P class=3D"">Since the publication of randomised trials in which = patients with=20 newly diagnosed glioblastoma multiforme (GBM) showed a prolonged = survival when=20 treated with both radiotherapy and temozolomide, this chemotherapeutic = agent has=20 been implemented as the standard therapy. To verify the value of this=20 established treatment with temozolomide in routine clinical practice, we = conducted an observational study at the Maastricht University Medical = Centre,=20 comparing survival in a cohort of patients receiving radiochemotherapy = with that=20 in a historical control group receiving radiotherapy only. Our study = showed that=20 radiochemotherapy is indeed also effective in routine clinical practice, = although the effectiveness is somewhat different from that in the = published=20 trials. </P> <DIV class=3DPara> <DIV class=3D"">We found a median overall survival of 12.0 months = in the=20 group with radiochemotherapy and 8.0 months in the group with = radiotherapy=20 only. The median survival benefit in the present study was thus = 4 months,=20 which is lower than the 5.7 months benefit found by Athanassiou = et al.=20 but higher than the 2.5 months median survival benefit found by = Stupp=20 et al. (Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab6">6</A>).=20 [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR17">17</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR18">18</A></CITE>]=20 In the study by Athanassiou et al. the dose of temozolomide during = the=20 concomitant phase was the same, but temozolomide was given every two = instead of=20 four weeks during the adjuvant phase. It remains unclear whether that is = an=20 explanation for the higher survival benefit in their study.<A = name=3DTab6></A> <DIV class=3DCapt><SPAN class=3DCaptNr>Table 6 </SPAN>Overall = and=20 progression-free survival=96=96comparison with trials </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dchar char=3D"("> <COL align=3Dchar char=3D"("></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft rowSpan=3D2> <P class=3D"">Variable</P></TH> <TH align=3Dleft char=3D"("> <P class=3D"">Radiotherapy</P></TH> <TH align=3Dleft char=3D"("> <P class=3D"">Radiochemotherapy</P></TH></TR> <TR class=3Dheader> <TH align=3Dleft char=3D"("> <P class=3D"">Median (95% CI)</P></TH> <TH align=3Dleft char=3D"("> <P class=3D"">Median (95% CI)</P></TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Overall survival (months)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Present study</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">8.0 (5.5=9610.5)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">12.0 (9.7=9614.3)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Stupp et al.</P></TD> <TD align=3Dchar char=3D"("> <P class=3D""><I>12.1 (11.2=9613.0)</I> </P></TD> <TD align=3Dchar char=3D"("> <P class=3D""><I>14.6 (13.2=9616.8)</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Athanassiou = et al.</P></TD> <TD align=3Dchar char=3D"("> <P class=3D""><I>7.7 (5.3=969.2)</I> </P></TD> <TD align=3Dchar char=3D"("> <P class=3D""><I>13.4 (9.6=9617.1)</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Progression-free survival (months)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Present study</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">4.0 (2.9=965.1)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">7.0 (5.5=968.5)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Stupp et al.</P></TD> <TD align=3Dchar char=3D"("> <P class=3D""><I>5.0 (4.2=965.5)</I> </P></TD> <TD align=3Dchar char=3D"("> <P class=3D""><I>6.9 (5.8=968.2)</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Athanassiou et al.</P></TD> <TD align=3Dchar char=3D"("> <P class=3D""><I>5.2 (4.0=967.4)</I> </P></TD> <TD align=3Dchar char=3D"("> <P class=3D""><I>10.8 (8.1=9614.7)</I> = </P></TD></TR></TBODY></TABLE></DIV></DIV> <P class=3D"">In our study, 40% of all patients in the radiochemotherapy = group=20 completed the concomitant and total adjuvant treatments, which was = slightly=20 higher than the 36.6% in the study by Stupp et al. while 61.4% of = the=20 patients in the trial by Athanassiou et al. completed = six cycles of=20 temozolomide. The difference in compliance between the present study and = the=20 phase III trial by Stupp et al. can only partially explain the larger = median=20 survival benefit in our study. </P> <P class=3D"">The decrease in waiting time with median times of 5.9 = until 2005 and=20 3.9 in recent years is the consequence of a more time-efficient approach = to=20 patients with GBM introduced in recent years. It has been reported that = a delay=20 until the first fraction of radiotherapy after surgery or after first=20 consultation in the radiotherapy department results in a clinically = significant=20 reduction of survival for patients with glioblastoma [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR21">21</A></CITE>=96<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR24">24</A></CITE>].=20 We investigated the correlation between waiting time and survival and = found a=20 positive association in the radiotherapy group, which seems to be = responsible=20 for the stronger therapeutic effect (lower hazard ratio) after = correction for=20 waiting time. This association is probably caused by selection: patients = assessed as =91better=92 in terms of performance status had to wait = longer for=20 treatment. Recently Blumenthal et al. also showed that delaying = initiation=20 of radiotherapy did not show reduction in survival, but a superior = outcome=20 instead [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR25">25</A></CITE>].=20 These comparable results may be based on the same kind of patient = selection for=20 early treatment as was mentioned before. The difference in waiting time = between=20 the two cohorts could not explain the larger survival benefit in the = present=20 study compared to the EORTC/NCIC trial (median waiting time being = 5 weeks=20 in both groups). </P> <P class=3D"">The fact that the median overall survival was shorter in = both groups=20 in the present study than in the EORTC/NCIC trial can at least partly be = explained by a larger number of patients being surgically treated with = biopsy=20 only. In our study, 57% and 45% of the radiotherapy and = radiochemotherapy=20 groups, respectively, had a biopsy only, versus 16% and 17% in the = EORTC/NCIC=20 trial. Most studies have shown a significant survival advantage for = patients=20 undergoing a more extensive degree of resection [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR3">3</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR5">5</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR10">10</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR12">12</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR13">13</A></CITE>].=20 Also one has to keep in mind that both our study and EORTC/NCIC trial = did not=20 show a clear survival advantage in the subgroup with patients undergoing = biopsy=20 [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR17">17</A></CITE>].=20 </P> <P class=3D"">Although we have corrected for the possible confounding = factors, the=20 slightly worse results in our MUMC cohort can also be the consequence of = the=20 well-known phenomenon of selection bias from patient selection for = clinical=20 trials. </P> <P class=3D"">Since a primary goal of therapy for patients with GBM is = improvement=20 or maintenance of quality of life, delaying disease progression by = extending the=20 progression-free survival is very important. The present study = demonstrated that=20 the addition of temozolomide to radiotherapy achieved a prolongation of = the=20 median progression-free survival from 4 months in the radiotherapy = group to=20 7 months in the radiochemotherapy group (Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab6">6</A>).=20 </P> <P class=3D"">Survival from progression, that is, the difference between = OS and=20 PFS, was shorter in our study (4.0 and 5.0 months in the = radiotherapy and=20 radiochemotherapy groups, respectively) than in the EORTC/NCIC trial = (7.1 and=20 7.7 months). This may be caused by less salvage treatment. In our = study,=20 only 17% of the radiotherapy group and 18% of the radiochemotherapy = group=20 received salvage chemotherapy, whereas in the EORTC/NCIC trial, 72% and = 58%,=20 respectively, received salvage chemotherapy after progression. In the = EORTC/NCIC=20 trial, 23% of patients in both treatment groups underwent repeat = surgery,=20 compared to only 4% in our study. Re-irradiation was given to 6% of = patients in=20 the present study (3% before 2005 and 9% since 2005). The number of = patients=20 receiving re-irradiation in the EORTC/NCIC trial was not reported = [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR17">17</A></CITE>].=20 </P> <P class=3D"">Apart from biopsy and waiting time, reported patient = characteristics=20 of the randomised EORTC trial and our study were quite similar = (Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab4">4</A>).=20 By estimating the treatment effect of the EORTC/NCIC trial population in = our=20 setting from our Cox regression model (Fig. <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Fig4">4</A>),=20 we showed that a quite similar survival benefit would have been = accomplished as=20 what was achieved in our study population (4.2 instead of = 3.9 months) and a=20 higher survival of 10 months with radiotherapy and 14.2 months = with=20 radiochemotherapy. </P> <P class=3D"">Among the 125 cases of glioblastoma multiforme included in = this=20 study, only seven patients (5.6%) had giant cell glioblastoma = multiforme.=20 Normally, giant cell GBM (GC-GBM) constitutes approximately 5% of the = cases of=20 glioblastoma multiforme, and GC-GBM is recognised as a distinct=20 clinicopathologic entity in the WHO 2007 classification [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR2">2</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR26">26</A></CITE>].=20 The difference in the prevalence of the giant cell subtype between the = two=20 groups in our study (Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab1">1</A>)=20 is remarkable: one patient in the radiotherapy group and six in the=20 radiochemotherapy group. This might be a coincidence but it is more = probable due=20 to a change in pathological analysis. Patients with giant cell GBM were = on=20 average 16.5 years younger than those with non giant cell GBM and=20 macroscopically complete resection was possible in 71% patients versus = 29% in=20 non giant cell, probably contributing to a better survival [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR27">27</A></CITE>].=20 Unfortunately, the Stupp trial did not mention the number of patients = with giant=20 cell subtype. </P> <P class=3D"">Our results demonstrate that temozolomide combined with = radiotherapy=20 is an effective chemotherapeutic agent for patients with primary = glioblastoma=20 multiforme in clinical practice. </P></DIV> <DIV class=3DAcknowledgments><SPAN class=3DAcknowledgmentsHeading>Open=20 Access </SPAN><SPAN class=3D"">This article is distributed = under the=20 terms of the Creative Commons Attribution Noncommercial License which = permits=20 any noncommercial use, distribution, and reproduction in any medium, = provided=20 the original author(s) and source are credited.</SPAN></DIV> <P></P> <HR> <H2><A name=3DBib1></A>References </H2> <TABLE> <TBODY class=3DCitation> <TR vAlign=3Dtop> <TD>1.</TD> <TD><A name=3DCR1></A>Ohgaki H, Kleihues P (2005) Epidemiology and = etiology=20 of gliomas. 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From: Subject: 10.1007/s11060-009-9956-7 Date: Sun, 2 Aug 2009 12:17:03 +0200 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01CA136B.24AD5C50" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.5579 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01CA136B.24AD5C50 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.html 10.1007/s11060-009-9956-7</TIT= LE> <META http-equiv=3DContent-Type content=3D"text/html; = charset=3DISO-8859-1"><LINK=20 href=3D"http://www.springerlink.com/config/css/A++_common.css" = type=3Dtext/css=20 rel=3DstyleSheet><LINK=20 href=3D"http://www.springerlink.com/config/css/content_A++_SpringerLink.c= ss"=20 type=3Dtext/css rel=3DstyleSheet> <META content=3D"MSHTML 6.00.6000.16890" name=3DGENERATOR></HEAD> <BODY class=3Dfor-print> <TABLE cellPadding=3D2 border=3D1> <TBODY> <TR class=3Dheader> <TD>Journal of Neuro-Oncology</TD></TR> <TR> <TD>=A9 The Author(s) 2009</TD></TR> <TR> <TD>10.1007/s11060-009-9956-7</TD></TR></TBODY></TABLE> <H2 class=3Drubric>Clinical Study - Patient Study</H2> <DIV class=3DHeading1><A name=3Dtitle></A>Effectiveness of temozolomide = for primary=20 glioblastoma multiforme in routine clinical practice </DIV> <P = class=3DAuthorGroup>J. A. B. van Genugten<SUP>1</SUP>= ,=20 P. Leffers<SUP>2</SUP>, B. G. Baumert<SUP>3</SUP>,=20 H. Tjon-a-Fat<SUP>1</SUP> and A. Twijnstra<SUP>1 <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#ContactOfAuthor5"><IMG=20 alt=3D"Contact Information"=20 src=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/contact.gif" = border=3D0></A></SUP></P> <TABLE> <TBODY> <TR vAlign=3Dtop> <TD><SPAN class=3DAffiliation><A = name=3DAff1></A>(1) </SPAN></TD> <TD><SPAN class=3DAffiliation>Department of Neurology, Maastricht = University=20 Medical Centre, P.O. Box 5800, Maastricht, 6202 AZ, The=20 Netherlands</SPAN></TD></TR></TBODY></TABLE> <TABLE> <TBODY> <TR vAlign=3Dtop> <TD><SPAN class=3DAffiliation><A = name=3DAff2></A>(2) </SPAN></TD> <TD><SPAN class=3DAffiliation>Department of Epidemiology, Faculty of = Health,=20 Medicine and Life Sciences, University of Maastricht, P.O. Box = 616,=20 Maastricht, 6200 MD, The = Netherlands</SPAN></TD></TR></TBODY></TABLE> <TABLE> <TBODY> <TR vAlign=3Dtop> <TD><SPAN class=3DAffiliation><A = name=3DAff3></A>(3) </SPAN></TD> <TD><SPAN class=3DAffiliation>Department of Radiation Oncology = (MAASTRO),=20 GROW (Research Institute Growth and Development), Maastricht = University=20 Medical Centre, Maastricht, The = Netherlands</SPAN></TD></TR></TBODY></TABLE> <P><A name=3DContactOfAuthor5></A></P> <TABLE class=3DContact> <TBODY> <TR> <TD vAlign=3Dtop><IMG alt=3D"Contact Information"=20 = src=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/contact.gif" = border=3D0></TD> = <TD><STRONG>A. </STRONG><STRONG>Twijnstra</STRONG><STRONG></STRONG><= BR><STRONG>Email:=20 </STRONG><A=20 = href=3D"mailto:jessie_van_genugten@hotmail.com">jessie_van_genugten@hotma= il.com</A></TD></TR></TBODY></TABLE> <P class=3DAffiliation><STRONG>Received:=20 </STRONG>1 April 2009 <STRONG>Accepted:=20 </STRONG>22 June 2009 <STRONG>Published online:=20 </STRONG>7 July 2009 </P> <DIV class=3DAbstract><A name=3DAbs1></A><SPAN=20 class=3DAbstractHeading>Abstract </SPAN>Temozolomide has been = used as a=20 standard therapy for the treatment of newly diagnosed glioblastoma = multiforme=20 since 2005. To assess the effectiveness of temozolomide in routine = clinical=20 practice, we conducted an observational study at Maastricht University = Medical=20 Centre (MUMC). Data of patients receiving radiotherapy and temozolomide = between=20 January 2005 and January 2008 were retrieved from a clinical database=20 (radiochemotherapy group), as were data of patients in a historical = control=20 group from the period before 2005 treated with radiotherapy only = (radiotherapy=20 group). The primary endpoint was overall survival. A total of 125 = patients with=20 GBM were selected to form the study cohort. Median survival benefit was=20 4 months: the median overall survival was 12 months (95% CI, = 9.7=9614.3)=20 in the group with radiochemotherapy with temozolomide, versus = 8 months (95%=20 CI, 5.3=9610.7) in the group with only radiotherapy. Progression-free = survival was=20 7 months (95% CI, 5.5=968.5) in the radiochemotherapy group and = 4 months=20 (95% CI, 2.9-5.1) in the group with only radiotherapy. The two-year = survival=20 rate was 18% with radiochemotherapy with temozolomide against 4% with=20 radiotherapy alone. Concomitant treatment with radiotherapy and = temozolomide=20 followed by adjuvant temozolomide resulted in grade III or IV = haematological=20 toxic effects in 9% of patients. The addition of temozolomide to = radiotherapy in=20 routine clinical practice for newly diagnosed glioblastoma resulted in a = clinically meaningful survival benefit with minimal haematological = toxicity,=20 which confirms the experience of previous trials and justifies the = continued use=20 of temozolomide in routine clinical practice. </DIV> <P class=3DKeyword><SPAN=20 class=3DKeywordHeading>Keywords </SPAN>Temozolomide -&nbs= p;Glioblastoma=20 multiforme - Survival - Routine clinical=20 practice - Radiotherapy </P> <DIV class=3D""><A name=3DSec1></A> <HR> <DIV class=3Dheading2>Introduction</DIV> <P class=3D"">Gliomas represent about half of all histologically = verified primary=20 CNS cancers among adults [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR1">1</A></CITE>].=20 Glioblastoma multiforme (GBM), grade IV glioma, is the most frequent and = most=20 aggressive type of malignant brain tumour. The most characteristic = features of=20 GBM are necrosis and endothelial proliferation [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR2">2</A></CITE>].=20 Despite the best available treatment, the clinical course is fatal, with = a=20 median survival of less than one year [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR3">3</A></CITE>].=20 Factors that are prognostic for survival, apart from treatment = modalities, are=20 patient age, performance status and degree of surgical resection = [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR1">1</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR3">3</A></CITE>=96<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR13">13</A></CITE>].=20 When a high grade glioma is suspected, maximal resection of the tumour = is aimed=20 for, on condition that neurological functions are spared. Such = cytoreductive=20 surgery is of limited value without adjuvant therapy. Until 2005, = standard=20 therapy consisted of surgical resection, followed by radiotherapy, which = has=20 been shown to prolong survival [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR14">14</A></CITE>].=20 Unfortunately, the addition of various chemotherapeutics only resulted = in=20 marginal survival benefits [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR15">15</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR16">16</A></CITE>].=20 Therefore, chemotherapy was not part of standard therapy for GBM in = Europe and=20 was only administered in the context of clinical trials. This changed = after the=20 publication of an EORTC/NCIC study in 2005, in which Stupp et al.=20 demonstrated improved survival in patients with a histological diagnosis = of=20 glioblastoma multiforme, when concomitant temozolomide followed by = adjuvant=20 temozolomide was added to the standard treatment [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR17">17</A></CITE>].=20 Similar results were seen in a smaller phase II trial by Athanassiou = et al=20 [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR18">18</A></CITE>].=20 Temozolomide is an oral alkylating agent, with a lower toxicity profile = than=20 most other chemotherapeutic agents [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR19">19</A></CITE>].=20 It can easily cross the blood-brain barrier, so that cerebrospinal fluid = levels=20 can reach at least 20% of those observed in the plasma [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR20">20</A></CITE>].=20 Since the publication of these studies, temozolomide has been widely = adopted as=20 the new standard of care for patients with newly diagnosed GBM. </P> <P class=3D"">The outcome of randomised controlled trials cannot be = directly=20 applied without considering differences in patient characteristics = between the=20 trial population and patient populations in routine clinical practice. = The=20 objective of the present study was to assess the effectiveness of = temozolomide=20 in addition to radiotherapy in patients with newly diagnosed GBM in = routine=20 clinical practice. For this purpose, we conducted an observational study = at=20 Maastricht University Medical Centre (MUMC) among patients receiving=20 radiotherapy and temozolomide and a historical control group of patients = who=20 were treated with radiotherapy only. </P></DIV> <DIV class=3D""><A name=3DSec2></A> <HR> <DIV class=3Dheading2>Patients and methods</DIV> <DIV class=3D""><A name=3DSec3></A> <DIV class=3DHeading3>Study objectives</DIV> <P class=3D"">The primary endpoint in this study was overall survival = (OS),=20 defined as the time from the starting date of radiotherapy to the date = of death.=20 Secondary endpoints were progression-free survival (PFS), 2-year overall = survival and toxicity. PFS was defined from the starting date of = radiotherapy to=20 the date of tumour progression or death. The exact date of death was = acquired=20 from a database held at the General Registry Office of the Dept. of = Radiation=20 Oncology (MAASTRO Clinic). The safety and tolerability of temozolomide = were=20 estimated in the radiotherapy plus temozolomide group by assessing the=20 haematological and non-haematological toxicity data from medical records = and=20 routine blood examinations. Although the National Cancer Institute has = updated=20 its Common Toxicity Criteria into version 3.0 (2006), we used version = 2.0 to=20 ensure better comparability with previous trials. </P></DIV> <DIV class=3D""><A name=3DSec4></A> <DIV class=3DHeading3>Eligibility</DIV> <P class=3D"">Since 1991, the Neuro-Oncology Department of the MUMC has = been=20 entering data on all neuro-oncological patients who are discussed in its = weekly=20 neuro-oncology meetings into a database. For the present study, we added = data on=20 patients who had not been discussed in these neuro-oncology meetings, = but who=20 had been registered in a pathology database (PALGA) with a histological = GBM=20 diagnosis. This allowed us to identify all patients aged 18 to = 70 years who=20 had a newly diagnosed and histologically confirmed supratentorial GBM = according=20 to the World Health Organization classification and who had been = referred to the=20 MUMC between January 2000 and January 2008. Data of patients who = received=20 radiotherapy and temozolomide between January 2005 and January 2008 were = collected from this database (radiochemotherapy group). Data of patients = receiving radiotherapy only were retrieved from the database for the = period=20 before 2005 (radiotherapy group). The subtypes of GBM, namely giant cell = and=20 gliosarcoma, were included. </P> <P class=3D"">Patients with a secondary glioblastoma, based on a prior=20 histopathological diagnosis of a lower grade astrocytoma, were excluded. = In=20 cases where the first histopathological diagnosis was glioblastoma, but = the=20 clinical history was longer than one year, the pathologist was asked to = do=20 further immunohistochemical examinations to confirm or exclude the = diagnosis of=20 primary glioblastoma. Patients with gliomatosis cerebri were excluded, = as well=20 as patients with prior chemotherapy. </P></DIV> <DIV class=3D""><A name=3DSec5></A> <DIV class=3DHeading3>Treatment</DIV> <P class=3D"">All patients had surgery before radiotherapy. The extent = of the=20 surgery was defined as biopsy, partial resection or macroscopically = complete=20 resection and was determined from the surgical report and postoperative = imaging,=20 if performed. In the radiochemotherapy group, patients received = radiotherapy=20 with concomitant temozolomide, followed by adjuvant temozolomide, = whereas the=20 reference group received radiotherapy only (same radiotherapy treatment = scheme=20 with 30 fractions of 2 Gy to total dose of 60 Gy as used in = the EORTC=20 study by Stupp et al. [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR17">17</A></CITE>]).=20 Chemotherapy consisted of temozolomide at a dose of = 75 mg/m<SUP>2</SUP> per=20 day, seven days a week for 42 consecutive days during radiotherapy. = After a=20 break of four weeks, patients received six cycles of adjuvant = temozolomide at a=20 dose of 150 to 200 mg/m<SUP>2</SUP>, on days 1 through 5, every=20 28 days. Prophylactic co-trimoxazol against Pneumocystis carinii = was given.=20 Antiemetics, anticonvulsants and corticosteroids were prescribed if = needed. </P> <P class=3D"">In case of disease progression, patients were assessed for = their=20 performance status and were offered =91salvage therapy=92, such as = surgery,=20 re-irradiation, second-line chemotherapy and/or supportive care. = </P></DIV> <DIV class=3D""><A name=3DSec6></A> <DIV class=3DHeading3>Statistical analysis</DIV> <P class=3D"">Overall and progression-free survival curves were plotted = using the=20 method developed by Kaplan and Meier. The Cox proportional hazards model = was=20 used to adjust the hazard ratio for confounding and to improve the = statistical=20 efficiency. The prognostic factors tested were age, sex, WHO performance = status=20 and extent of surgery, since these have been reported in the literature = as=20 prognostic factors for survival outcome [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR1">1</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR3">3</A></CITE>=96<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR13">13</A></CITE>].=20 </P> <P class=3D"">We corrected for age per decade rather than the binary = categories=20 above or below 50 years, to obtain a more accurate measure of this=20 variable. <I>P</I>-values lower than 0.05 were considered to be = statistically=20 significant. Statistical analysis was performed using the Statistical = Package=20 for the Social Sciences 15.0 (SPSS, Inc., Chicago, IL). </P></DIV></DIV> <DIV class=3D""><A name=3DSec7></A> <HR> <DIV class=3Dheading2>Results</DIV> <DIV class=3D""><A name=3DSec8></A> <DIV class=3DHeading3>Patient characteristics</DIV> <DIV class=3DPara> <DIV class=3D"">One hundred and twenty-five patients with GBM were = selected to=20 form the study cohort. Patient details are outlined in Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab1">1</A>.=20 Median age was 56 years. Male/female ratio was 1.55. The initial = complaints=20 were motor symptoms in 34% of the patients, headache in 45%, epileptic = seizures=20 in 33%, personality change in 12%, and speech disorder in 26%. The=20 radiochemotherapy group consisted of 67 patients and the radiotherapy = group of=20 58 patients. The median time from diagnosis to start of treatment was=20 5.9 weeks in the radiotherapy group and 3.9 weeks in the=20 radiochemotherapy group. The baseline characteristics of the patients = were not=20 balanced as regards sex, extent of resection, corticosteroid use, giant = cell or=20 waiting time between diagnosis and the start of treatment.<A = name=3DTab1></A> <DIV class=3DCapt><SPAN class=3DCaptNr>Table 1 </SPAN>Patient=20 characteristics </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dchar char=3D"("> <COL align=3Dchar char=3D"("></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft> <P class=3D"">Characteristic</P></TH> <TH align=3Dleft char=3D"("> <P class=3D"">Radiotherapy (<I>N</I> =3D 58) </P></TH> <TH align=3Dleft char=3D"("> <P class=3D"">Radiochemotherapy (<I>N</I> =3D 67) = </P></TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Age (year)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Median</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">56</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">57</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Range</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">33=9670</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">25=9670</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Sex=96=96no. (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Male</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">29 (50)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">47 (70)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Female</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">29 (50)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">20 (30)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">WHO performance status, no. (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> 0</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">23 (40)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">25 (37)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> 1</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">24 (41)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">30 (45)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> 2</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">8 (14)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">11 (16)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> 3</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">3 (5)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">1 (2)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Extent of surgery, no. (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Biopsy</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">33 (57)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">30 (45)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Partial</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">11 (19)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">12 (18)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Macroscopically complete=20 resection</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">14 (24)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">25 (37)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Time from diagnosis to treatment, wk</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Median</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">5.9</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">3.9</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Range</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">0.7-18</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">2-8.4</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Corticosteroid therapy, no. (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Yes</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">39 (67)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">46 (69)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> No</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">5 (9)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">20 (30)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Data missing</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">14 (24)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">1 (2)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Subtype of glioblastoma, no. (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Giant cell</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">1 (2)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">6 = (9)</P></TD></TR></TBODY></TABLE></DIV></DIV></DIV> <DIV class=3D""><A name=3DSec9></A> <DIV class=3DHeading3>Treatment</DIV> <DIV class=3DPara> <DIV class=3D"">Median received radiation dose was 60 Gy (range,=20 4=9660 Gy). Ten patients (8%) did not complete the entire = radiotherapy,=20 reasons including disease progression and death. Among the 67 patients = who=20 started radiochemotherapy, 93% completed the concomitant phase with both = radiotherapy and temozolomide. Of the 67 patients in the = radiochemotherapy=20 group, 75% started the adjuvant therapy with temozolomide after the = 4-week=20 break. Seventy percent of the radiochemotherapy group completed=20 three cycles of temozolomide, and 40% had ultimately completed=20 six cycles (see Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab2">2</A>).=20 The main reason for not completing concomitant and/or adjuvant = temozolomide=20 therapy in our study was disease progression, assessed by clinical = deterioration=20 and/or radiological assessment. Five patients (7.5%) in the = radiochemotherapy=20 group discontinued therapy because of haematological toxicity effects.<A = name=3DTab2></A> <DIV class=3DCapt><SPAN = class=3DCaptNr>Table 2 </SPAN>Temozolomide=20 compliance </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dchar char=3D"."></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft> <P class=3D"">Treatment episode</P></TH> <TH align=3Dleft char=3D"."> <P class=3D"">% Completed</P></TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Week 3 RT concomitant</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">100.0</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Week 5 RT concomitant</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">97.0</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Total concomitant period</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">92.5</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Cycle 1</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">74.6</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Cycle 2</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">73.1</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Cycle 3</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">70.1</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Cycle 4</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">44.7</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Cycle 5</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">43.2</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Cycle 6</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">40.3</P></TD></TR></TBODY></TABLE></DIV></DIV></DIV> <DIV class=3D""><A name=3DSec10></A> <DIV class=3DHeading3>Survival and progression</DIV> <DIV class=3DPara> <DIV class=3D"">The follow-up ended on 8 July 2008. The unadjusted = hazard ratio=20 for death in the radiochemotherapy group compared to the radiotherapy = group was=20 0.48 (95% CI, 0.32=960.72; <I>P</I> < 0.001). Multivariate = analysis,=20 including all considered covariates gave the same hazard ratio: 0.47 = (95% CI,=20 0.29=960.73; <I>P</I> =3D 0.001). The Kaplan=96Meier curve = showed a median=20 overall survival of 12 months (95% CI, 5.3 to 10.7) in the=20 radiochemotherapy group, versus 8 months (95% CI, 9.7=9614.3) in = the group=20 with radiotherapy only (Fig. <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Fig1">1</A>=20 and Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab3">3</A>).=20 The estimated median survival benefit was therefore 4 months.=20 <DIV class=3DFigure><A name=3DFig1></A><IMG=20 alt=3DMediaObjects/11060_2009_9956_Fig1_HTML.gif=20 src=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/MediaObjects/= 11060_2009_9956_Fig1_HTML.gif"></DIV> <DIV class=3DCapt><SPAN = class=3DCaptNr>Fig. 1 </SPAN>Kaplan=96Meier curves=20 of overall survival: radiochemotherapy versus radiotherapy only. = <I>P</I>=20 value =3D 0.000. Censored: Still alive at end of study period = 08-07-08=20 </DIV> <HR> <A name=3DTab3></A> <DIV class=3DCapt><SPAN class=3DCaptNr>Table 3 </SPAN>Overall = and=20 progression-free survival </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dchar char=3D"."> <COL align=3Dchar char=3D"."></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft rowSpan=3D2> <P class=3D"">Variable</P></TH> <TH align=3Dleft char=3D"."> <P class=3D"">Radiotherapy (<I>N</I> =3D 47) </P></TH> <TH align=3Dleft char=3D"."> <P class=3D"">Radiochemotherapy (<I>N</I> =3D 66) = </P></TH></TR> <TR class=3Dheader> <TH align=3Dleft char=3D"."> <P class=3D"">Value (95% CI)</P></TH> <TH align=3Dleft char=3D"."> <P class=3D"">Value (95% CI)</P></TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Median overall survival (months)</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">8.0 (5.3=9610.7)</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">12.0 (9.7=9614.3)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Overall survival (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> At 6 months</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">57.4</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">78.8</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> At 12 months</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">23.4</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">46.8</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> At 24 months</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">4.3</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">18.2</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Median progression-free = survival=20 (months)</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">4.0 (2.9=965.1)</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">7.0 (5.5=968.5)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Progression-free survival (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> At 6 months</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">34.0</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">56.1</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> At 12 months</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">6.4</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">26.6</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> At 24 months</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">2.1</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">9.5</P></TD></TR></TBODY></TABLE></DIV></DIV> <DIV class=3DPara> <DIV class=3D"">The unadjusted hazard ratio for PFS of radiochemotherapy = compared=20 to the radiotherapy was 0.58 (95% CI, 0.39=960.85; = <I>P</I> =3D 0.006).=20 The adjusted hazard ratio, corrected for all considered factors, was = 0.59 (95%=20 CI, 0.38=960.91; <I>P</I> =3D 0.016). The median = progression-free survival=20 was 7 months (95% CI, 5.5=968.5) with radiochemotherapy and = 4 months=20 (95% CI, 2.9=965.1) with only radiotherapy (Fig. <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Fig2">2</A>,=20 Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab3">3</A>).=20 The two-year survival rate was 18% in the radiochemotherapy group and 4% = in the=20 group with only radiotherapy.=20 <DIV class=3DFigure><A name=3DFig2></A><IMG=20 alt=3DMediaObjects/11060_2009_9956_Fig2_HTML.gif=20 src=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/MediaObjects/= 11060_2009_9956_Fig2_HTML.gif"></DIV> <DIV class=3DCapt><SPAN = class=3DCaptNr>Fig. 2 </SPAN>Kaplan=96Meier curves=20 of progression-free survival: radiochemotherapy versus radiotherapy = only.=20 <I>P</I>-value =3D 0.003. Censored: Still alive at end of = study period=20 08-07-08 </DIV> <HR> </DIV></DIV> <DIV class=3DPara> <DIV class=3D"">The waiting time (medians 5.9 for radiotherapy and = 3.9 weeks=20 for radiochemotherapy) was also added to the Cox Regression model. The = adjusted=20 hazard ratio for death of radiotherapy plus temozolomide compared to=20 radiotherapy alone, then became 0.42 (95% CI, 0.24=960.73;=20 <I>P</I> =3D 0.002). This change of the HR was caused by a = clear=20 positive association between waiting time and survival in the = radiotherapy group=20 as is shown in Fig. <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Fig3">3</A>.=20 This association is probably due to patient selection. In the = radiochemotherapy=20 period (2005=962008), there was a weak inverse association.=20 <DIV class=3DFigure><A name=3DFig3></A><IMG=20 alt=3DMediaObjects/11060_2009_9956_Fig3_HTML.gif=20 src=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/MediaObjects/= 11060_2009_9956_Fig3_HTML.gif"></DIV> <DIV class=3DCapt><SPAN = class=3DCaptNr>Fig. 3 </SPAN>Correlation between=20 waiting time and survival in radiotherapy and radiochemotherapy groups = </DIV> <HR> </DIV></DIV></DIV> <DIV class=3D""><A name=3DSec11></A> <DIV class=3DHeading3>Subgroup analysis</DIV> <P class=3D"">Survival was analysed according to the prognostic factors. = Radiochemotherapy was associated with a significant improvement in = median=20 overall survival in nearly all subgroups of patients, with the exception = of the=20 relatively large subgroup of patients who underwent biopsy only and the = patients=20 with a WHO performance status 1 (whereas those with the poorer = performance=20 status WHO 2 and 3 did show a significant improvement in median = survival).=20 </P></DIV> <DIV class=3D""><A name=3DSec12></A> <DIV class=3DHeading3>Comparison with EORTC/NCIC trial</DIV> <DIV class=3DPara> <DIV class=3D"">To achieve the best possible comparison of the effect of = this new=20 treatment in routine clinical practice and in the EORTC/NCIC trial, we=20 calculated what the effect of the treatment in our setting would have = been for=20 the patients of the EORTC/NCIC trial. To this end, we entered the mean = patient=20 characteristics of their trial population (Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab4">4</A>)=20 into our Cox regression model. The survival curve in Fig. <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Fig4">4</A>=20 shows the effect of treatment on the survival of an average patient in = the EORTC=20 trial. This patient would be expected to survive for 10.0 months = with=20 radiotherapy and 14.2 months when temozolomide was added to the = treatment.=20 An average patient in our routine clinical practice cohort survived=20 9.0 months with radiotherapy and 12.9 months with = radiochemotherapy=20 (Fig. <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Fig5">5</A>).<A=20 name=3DTab4></A> <DIV class=3DCapt><SPAN class=3DCaptNr>Table 4 </SPAN>Patient=20 characteristics=96=96comparison with EORTC/NCIC trial </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dchar char=3D"."> <COL align=3Dchar char=3D"."> <COL align=3Dchar char=3D"."> <COL align=3Dchar char=3D"."></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft rowSpan=3D2> <P class=3D"">Characteristic</P></TH> <TH align=3Dleft colSpan=3D2 char=3D"."> <P class=3D"">Present study</P></TH> <TH align=3Dleft colSpan=3D2 char=3D"."> <P class=3D"">Stupp et al.</P></TH></TR> <TR class=3Dheader> <TH align=3Dleft char=3D"."> <P class=3D"">RT</P></TH> <TH align=3Dleft char=3D"."> <P class=3D"">RT + TMZ</P></TH> <TH align=3Dleft char=3D"."> <P class=3D"">RT</P></TH> <TH align=3Dleft char=3D"."> <P class=3D"">RT + TMZ</P></TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D5> <P class=3D"">Age (year)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Median</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">56</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">57</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>57</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>56</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D5> <P class=3D"">Sex (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Male</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">50</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">70</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>61</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>64</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Female</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">50</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">30</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>39</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>36</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D5> <P class=3D"">WHO performance status (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> 0</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">40</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">37</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>38</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>39</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> 1</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">41</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">45</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>49</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>47</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> 2</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">14</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">16</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>12</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>13</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> 3</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">5</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">2</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>0</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>0</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D5> <P class=3D"">Extent of surgery (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Biopsy</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">57</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">45</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>16</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>17</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Partial</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">19</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">18</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>45</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>44</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Macroscopically complete=20 resection</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">24</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">37</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>40</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>39</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D5> <P class=3D"">Time from diagnosis to = treatment=96=96wk</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Median</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">5.9</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">3.9</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>5.0</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>5.0</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D5> <P class=3D"">Corticosteroid therapy (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Yes</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">67</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">69</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>75</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>67</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> No</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">9</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">30</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>24</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>33</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Data missing</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">24</P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>2</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I><1</I> </P></TD> <TD align=3Dchar char=3D"."> <P class=3D""><I>0</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D5> <P class=3D"">Subtype of glioblastoma (%)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Giant cell</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">2</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">9</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">?</P></TD> <TD align=3Dchar char=3D"."> <P class=3D"">?</P></TD></TR></TBODY></TABLE> <DIV class=3DFigure><A name=3DFig4></A><IMG=20 alt=3DMediaObjects/11060_2009_9956_Fig4_HTML.gif=20 src=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/MediaObjects/= 11060_2009_9956_Fig4_HTML.gif"></DIV> <DIV class=3DCapt><SPAN class=3DCaptNr>Fig. 4 </SPAN>Survival = curve of an=20 average patient of the EORTC/NCIC trial </DIV> <HR> <DIV class=3DFigure><A name=3DFig5></A><IMG=20 alt=3DMediaObjects/11060_2009_9956_Fig5_HTML.gif=20 src=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/MediaObjects/= 11060_2009_9956_Fig5_HTML.gif"></DIV> <DIV class=3DCapt><SPAN class=3DCaptNr>Fig. 5 </SPAN>Survival = curve of an=20 average patient of selected patients from clinical practice </DIV> <HR> </DIV></DIV></DIV> <DIV class=3D""><A name=3DSec13></A> <DIV class=3DHeading3>Toxicity</DIV> <P class=3D"">Detailed toxicity data were not recorded for the = radiotherapy group=20 in the neurology treatment charts, whereas temozolomide-related = haematotoxicity=20 was recorded for each patient in the radiochemotherapy group. Six = patients (9%)=20 had any type of grade III or IV haematological toxic effect. In five of = these=20 cases chemotherapy was discontinued. Anti-epileptic drugs were given to = 41% of=20 patients in the radiotherapy group and 47% of patients in the = radiochemotherapy=20 group. Only 5% received the non-enzyme inducing valproic acid. = </P></DIV> <DIV class=3D""><A name=3DSec14></A> <DIV class=3DHeading3>Treatment after disease progression</DIV> <DIV class=3DPara> <DIV class=3D"">At the moment of disease progression, four patients in = both=20 treatment groups underwent a second surgery, seven patients were = re-irradiated,=20 16 patients received additional cycles of temozolomide and four patients = received second-line chemotherapy other than temozolomide. In total, 17% = of=20 patients in the radiochemotherapy group and 18% of patients in the = radiotherapy=20 group received salvage chemotherapy (see Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab5">5</A>).=20 Salvage chemotherapy consisted of additional cycles of temozolomide in = 67% of=20 patients in the radiochemotherapy group and 100% of patients in the = radiotherapy=20 group.<A name=3DTab5></A> <DIV class=3DCapt><SPAN class=3DCaptNr>Table 5 </SPAN>Salvage = treatment=20 </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dchar char=3D"("> <COL align=3Dchar char=3D"("></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft> <P class=3D"">Type of treatment</P></TH> <TH align=3Dleft char=3D"("> <P class=3D"">Radiotherapy (<I>N</I> =3D 47) </P></TH> <TH align=3Dleft char=3D"("> <P class=3D"">Radiochemotherapy (<I>N</I> =3D 66) = </P></TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Second surgery, no. (%)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">0 (0)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">4 (6)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Re-irradiation, no. (%)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">1 (2)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">6 (9)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D"">Chemotherapy, no. (%)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">8 (17)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">12 (18)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Temozolomide</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">8 (17)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">8 (12)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Other than = temozolomide</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">0 (0)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">4 = (6)</P></TD></TR></TBODY></TABLE></DIV></DIV></DIV></DIV> <DIV class=3D""><A name=3DSec15></A> <HR> <DIV class=3Dheading2>Discussion</DIV> <P class=3D"">Since the publication of randomised trials in which = patients with=20 newly diagnosed glioblastoma multiforme (GBM) showed a prolonged = survival when=20 treated with both radiotherapy and temozolomide, this chemotherapeutic = agent has=20 been implemented as the standard therapy. To verify the value of this=20 established treatment with temozolomide in routine clinical practice, we = conducted an observational study at the Maastricht University Medical = Centre,=20 comparing survival in a cohort of patients receiving radiochemotherapy = with that=20 in a historical control group receiving radiotherapy only. Our study = showed that=20 radiochemotherapy is indeed also effective in routine clinical practice, = although the effectiveness is somewhat different from that in the = published=20 trials. </P> <DIV class=3DPara> <DIV class=3D"">We found a median overall survival of 12.0 months = in the=20 group with radiochemotherapy and 8.0 months in the group with = radiotherapy=20 only. The median survival benefit in the present study was thus = 4 months,=20 which is lower than the 5.7 months benefit found by Athanassiou = et al.=20 but higher than the 2.5 months median survival benefit found by = Stupp=20 et al. (Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab6">6</A>).=20 [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR17">17</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR18">18</A></CITE>]=20 In the study by Athanassiou et al. the dose of temozolomide during = the=20 concomitant phase was the same, but temozolomide was given every two = instead of=20 four weeks during the adjuvant phase. It remains unclear whether that is = an=20 explanation for the higher survival benefit in their study.<A = name=3DTab6></A> <DIV class=3DCapt><SPAN class=3DCaptNr>Table 6 </SPAN>Overall = and=20 progression-free survival=96=96comparison with trials </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dchar char=3D"("> <COL align=3Dchar char=3D"("></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft rowSpan=3D2> <P class=3D"">Variable</P></TH> <TH align=3Dleft char=3D"("> <P class=3D"">Radiotherapy</P></TH> <TH align=3Dleft char=3D"("> <P class=3D"">Radiochemotherapy</P></TH></TR> <TR class=3Dheader> <TH align=3Dleft char=3D"("> <P class=3D"">Median (95% CI)</P></TH> <TH align=3Dleft char=3D"("> <P class=3D"">Median (95% CI)</P></TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Overall survival (months)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Present study</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">8.0 (5.5=9610.5)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">12.0 (9.7=9614.3)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Stupp et al.</P></TD> <TD align=3Dchar char=3D"("> <P class=3D""><I>12.1 (11.2=9613.0)</I> </P></TD> <TD align=3Dchar char=3D"("> <P class=3D""><I>14.6 (13.2=9616.8)</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Athanassiou = et al.</P></TD> <TD align=3Dchar char=3D"("> <P class=3D""><I>7.7 (5.3=969.2)</I> </P></TD> <TD align=3Dchar char=3D"("> <P class=3D""><I>13.4 (9.6=9617.1)</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft colSpan=3D3> <P class=3D"">Progression-free survival (months)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Present study</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">4.0 (2.9=965.1)</P></TD> <TD align=3Dchar char=3D"("> <P class=3D"">7.0 (5.5=968.5)</P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Stupp et al.</P></TD> <TD align=3Dchar char=3D"("> <P class=3D""><I>5.0 (4.2=965.5)</I> </P></TD> <TD align=3Dchar char=3D"("> <P class=3D""><I>6.9 (5.8=968.2)</I> </P></TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> <P class=3D""> Athanassiou et al.</P></TD> <TD align=3Dchar char=3D"("> <P class=3D""><I>5.2 (4.0=967.4)</I> </P></TD> <TD align=3Dchar char=3D"("> <P class=3D""><I>10.8 (8.1=9614.7)</I> = </P></TD></TR></TBODY></TABLE></DIV></DIV> <P class=3D"">In our study, 40% of all patients in the radiochemotherapy = group=20 completed the concomitant and total adjuvant treatments, which was = slightly=20 higher than the 36.6% in the study by Stupp et al. while 61.4% of = the=20 patients in the trial by Athanassiou et al. completed = six cycles of=20 temozolomide. The difference in compliance between the present study and = the=20 phase III trial by Stupp et al. can only partially explain the larger = median=20 survival benefit in our study. </P> <P class=3D"">The decrease in waiting time with median times of 5.9 = until 2005 and=20 3.9 in recent years is the consequence of a more time-efficient approach = to=20 patients with GBM introduced in recent years. It has been reported that = a delay=20 until the first fraction of radiotherapy after surgery or after first=20 consultation in the radiotherapy department results in a clinically = significant=20 reduction of survival for patients with glioblastoma [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR21">21</A></CITE>=96<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR24">24</A></CITE>].=20 We investigated the correlation between waiting time and survival and = found a=20 positive association in the radiotherapy group, which seems to be = responsible=20 for the stronger therapeutic effect (lower hazard ratio) after = correction for=20 waiting time. This association is probably caused by selection: patients = assessed as =91better=92 in terms of performance status had to wait = longer for=20 treatment. Recently Blumenthal et al. also showed that delaying = initiation=20 of radiotherapy did not show reduction in survival, but a superior = outcome=20 instead [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR25">25</A></CITE>].=20 These comparable results may be based on the same kind of patient = selection for=20 early treatment as was mentioned before. The difference in waiting time = between=20 the two cohorts could not explain the larger survival benefit in the = present=20 study compared to the EORTC/NCIC trial (median waiting time being = 5 weeks=20 in both groups). </P> <P class=3D"">The fact that the median overall survival was shorter in = both groups=20 in the present study than in the EORTC/NCIC trial can at least partly be = explained by a larger number of patients being surgically treated with = biopsy=20 only. In our study, 57% and 45% of the radiotherapy and = radiochemotherapy=20 groups, respectively, had a biopsy only, versus 16% and 17% in the = EORTC/NCIC=20 trial. Most studies have shown a significant survival advantage for = patients=20 undergoing a more extensive degree of resection [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR3">3</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR5">5</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR10">10</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR12">12</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR13">13</A></CITE>].=20 Also one has to keep in mind that both our study and EORTC/NCIC trial = did not=20 show a clear survival advantage in the subgroup with patients undergoing = biopsy=20 [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR17">17</A></CITE>].=20 </P> <P class=3D"">Although we have corrected for the possible confounding = factors, the=20 slightly worse results in our MUMC cohort can also be the consequence of = the=20 well-known phenomenon of selection bias from patient selection for = clinical=20 trials. </P> <P class=3D"">Since a primary goal of therapy for patients with GBM is = improvement=20 or maintenance of quality of life, delaying disease progression by = extending the=20 progression-free survival is very important. The present study = demonstrated that=20 the addition of temozolomide to radiotherapy achieved a prolongation of = the=20 median progression-free survival from 4 months in the radiotherapy = group to=20 7 months in the radiochemotherapy group (Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab6">6</A>).=20 </P> <P class=3D"">Survival from progression, that is, the difference between = OS and=20 PFS, was shorter in our study (4.0 and 5.0 months in the = radiotherapy and=20 radiochemotherapy groups, respectively) than in the EORTC/NCIC trial = (7.1 and=20 7.7 months). This may be caused by less salvage treatment. In our = study,=20 only 17% of the radiotherapy group and 18% of the radiochemotherapy = group=20 received salvage chemotherapy, whereas in the EORTC/NCIC trial, 72% and = 58%,=20 respectively, received salvage chemotherapy after progression. In the = EORTC/NCIC=20 trial, 23% of patients in both treatment groups underwent repeat = surgery,=20 compared to only 4% in our study. Re-irradiation was given to 6% of = patients in=20 the present study (3% before 2005 and 9% since 2005). The number of = patients=20 receiving re-irradiation in the EORTC/NCIC trial was not reported = [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR17">17</A></CITE>].=20 </P> <P class=3D"">Apart from biopsy and waiting time, reported patient = characteristics=20 of the randomised EORTC trial and our study were quite similar = (Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab4">4</A>).=20 By estimating the treatment effect of the EORTC/NCIC trial population in = our=20 setting from our Cox regression model (Fig. <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Fig4">4</A>),=20 we showed that a quite similar survival benefit would have been = accomplished as=20 what was achieved in our study population (4.2 instead of = 3.9 months) and a=20 higher survival of 10 months with radiotherapy and 14.2 months = with=20 radiochemotherapy. </P> <P class=3D"">Among the 125 cases of glioblastoma multiforme included in = this=20 study, only seven patients (5.6%) had giant cell glioblastoma = multiforme.=20 Normally, giant cell GBM (GC-GBM) constitutes approximately 5% of the = cases of=20 glioblastoma multiforme, and GC-GBM is recognised as a distinct=20 clinicopathologic entity in the WHO 2007 classification [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR2">2</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR26">26</A></CITE>].=20 The difference in the prevalence of the giant cell subtype between the = two=20 groups in our study (Table <A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#Tab1">1</A>)=20 is remarkable: one patient in the radiotherapy group and six in the=20 radiochemotherapy group. This might be a coincidence but it is more = probable due=20 to a change in pathological analysis. Patients with giant cell GBM were = on=20 average 16.5 years younger than those with non giant cell GBM and=20 macroscopically complete resection was possible in 71% patients versus = 29% in=20 non giant cell, probably contributing to a better survival [<CITE><A=20 href=3D"http://www.springerlink.com/content/y1t3q3jp586848v3/fulltext.htm= l#CR27">27</A></CITE>].=20 Unfortunately, the Stupp trial did not mention the number of patients = with giant=20 cell subtype. </P> <P class=3D"">Our results demonstrate that temozolomide combined with = radiotherapy=20 is an effective chemotherapeutic agent for patients with primary = glioblastoma=20 multiforme in clinical practice. </P></DIV> <DIV class=3DAcknowledgments><SPAN class=3DAcknowledgmentsHeading>Open=20 Access </SPAN><SPAN class=3D"">This article is distributed = under the=20 terms of the Creative Commons Attribution Noncommercial License which = permits=20 any noncommercial use, distribution, and reproduction in any medium, = provided=20 the original author(s) and source are credited.</SPAN></DIV> <P></P> <HR> <H2><A name=3DBib1></A>References </H2> <TABLE> <TBODY class=3DCitation> <TR vAlign=3Dtop> <TD>1.</TD> <TD><A name=3DCR1></A>Ohgaki H, Kleihues P (2005) Epidemiology and = etiology=20 of gliomas. 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