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Gefitinib
in Recurrent Glioblastoma
M. Raphael Pfeffer, Mark L. Levitt, Dan Aderka
Chaim
Sheba Medical Center, Tel Hashomer, Israel
To
the Editor:
We received the American
Society of Clinical Oncology e-mail alert referring to the early
release of a paper by Rich et al [1] on
the use of gefitinib (Iressa; AstraZeneca, Wilmington, DE) for
recurrent glioblastoma multiforme with great excitement, because this
is a group of patients for whom no effective therapy currently exists.
Our interest
was further spiked by the conclusion of the abstract, which states
that gefitinib has activity in patients with recurrent glioblastoma.
The results
presented do not justify this conclusion.
The paper states that the
primary end point of the study was 6-month progression-free survival
(PFS), and the study was designed to differentiate between a 6-month
PFS rate of 15% and 30% with type I and type II error rates of
0.091.
In fact, none
of the patients on the study responded to therapy, and the actual PFS
was 13.2%.
The authors
noted that this is better than the results from a phase II randomized
study where another ineffective agent (procarbazine) was compared
with temozolamide, and had a 6-month PFS of 8%.
The authors
carried out subgroup analyses of this phase II study and showed that
the most significant factor for event-free survival was extent of
surgical resection.
Historical
controls in studies of glioblastoma multiforme are problematic because
of the effect of new surgical techniques, including navigation and
intraoperative mapping, which have increased the neurosurgeon's
ability to resect recurrent tumors.
The abstract's conclusion
that gefitinib has activity in glioblastoma multiforme is likely to
cause unjustified demand for this drug from patients and their
advocates, who are not capable of analyzing the actual results of the
study, particularly when the American Society of Clinical Oncology
considers the paper to be important enough to warrant early
publication and an e-mail alert.
Authors'
Disclosures of Potential Conflicts of Interest.
The
authors indicated no potential conflicts of interest.
Reference.
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1. |
Jeremy N. Rich, David
A. Reardon, Terry Peery, Jeannette M. Dowell,
Jennifer A. Quinn, Kara L. Penne, Carol J.
Wikstrand, Lauren B. Van Duyn, Janet E. Dancey,
Roger E. McLendon, James C. Kao, Timothy
T. Stenzel, B.K. Ahmed Rasheed, Sandra E.
Tourt-Uhlig, James E. Herndon, II, James J.
Vredenburgh, John H. Sampson, Allan H. Friedman,
Darell D. Bigner, Henry S. Friedman
Phase II Trial of Gefitinib in Recurrent
Glioblastoma
Journal of Clinical Oncology, Vol 22, No 1 (January 1), 2004: pp. 133-142 (Clinical
Study, Abstract & PDF Full Text)
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© 2004
American
Society for Clinical Oncology
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