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Gefitinib in Recurrent Glioblastoma

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 al¹ 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

1. Rich JN, Reardon DA, Peery T, et al: Phase II trial of gefitinib in recurrent glioblastoma. J Clin Oncol 22:133-142, 2004[Abstract/Free Full Text]

Related Reply

• In Reply:
  Jeremy N. Rich, Henry S. Friedman, James B. Powell, Jr, and Janet E. Dancey
  JCO 2004 22: 2755-2756 [Full Text]

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• Phase II Trial of Gefitinib in Recurrent Glioblastoma
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  JCO 2004 22: 133-142 [Abstract] [Full Text]

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