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Phase II Trial of Gefitinib in Recurrent Glioblastoma

Al Musella's Comments: (This is his personal views and are not necessarily the views of the Musella Foundation!)


Posted on: 01/02/2004

Phase II Trial of Gefitinib in Recurrent Glioblastoma

Originally published as JCO Early Release 10.1200/JCO.2004.08.110 on November 24 2003
Journal of Clinical Oncology, Vol 22, No 1 (January 1), 2004: pp. 133-142 (Abstract)

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

From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD Address reprint requests to Jeremy N. Rich, MD, Duke University Medical Center, Box 2900, Durham, NC 27710; e-mail:

Purpose. To evaluate the efficacy and tolerability of gefitinib (ZD1839, Iressa; AstraZeneca, Wilmington, DE), a novel epidermal growth factor receptor tyrosine kinase inhibitor, in patients with recurrent glioblastoma.

Patients and Methods. This was an open-label, single-center phase II trial. Fifty-seven patients with first recurrence of a glioblastoma who were previously treated with surgical resection, radiation, and usually chemotherapy underwent an open biopsy or resection at evaluation for confirmation of tumor recurrence. Each patient initially received 500 mg of gefitinib orally once daily; dose escalation to 750 mg then 1,000 mg, if a patient received enzyme-inducing antiepileptic drugs or dexamethasone, was allowed within each patient.

Results. Although no objective tumor responses were seen among the 53 assessable patients, only 21% of patients (11 of 53 patients) had measurable disease at treatment initiation. Seventeen percent of patients (nine of 53 patients) underwent at least six 4-week cycles, and the 6-month event-free survival (EFS) was 13% (seven of 53 patients). The median EFS time was 8.1 weeks, and the median overall survival (OS) time from treatment initiation was 39.4 weeks. Adverse events were generally mild (grade 1 or 2) and consisted mainly of skin reactions and diarrhea. Drug-related toxicities were more frequent at higher doses. Withdrawal caused by drug-related adverse events occurred in 6% of patients (three of 53 patients). Although the presence of diarrhea positively predicted favorable OS from treatment initiation, epidermal growth factor receptor expression did not correlate with either EFS or OS.

Conclusion. Gefitinib is well tolerated and has activity in patients with recurrent glioblastoma. Further study of this agent at higher doses is warranted.

Supported by Federal funds from the National Cancer Institute, National Institutes of Health, Bethesda, MD (grant No. R21 CA91548), and foundation funds from Accelerate Brain Cancer Cure. Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, May 31–June 3, 2003, Chicago, IL. © 2004 American Society for Clinical Oncology Source:

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