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Phase III Study Comparing Three Cycles of Infusional Carmustine and Cisplatin Followed by Radiation Therapy With Radiation Therapy and Concurrent Carmustine in Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme: Eastern Cooperative Oncology Group Trial 2394

Stuart A. Grossman, Anne O’Neill, Margaret Grunnet, Minesh Mehta, James L. Pearlman, Henry Wagner, Mark Gilbert, Herbert B. Newton, Richard Hellman

From the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Dana-Farber Cancer Institute, Boston, MA; University of Connecticut, Farmington; Lawrence and Memorial Hospital, New London, CT; University of Wisconsin, Madison, WI; H. Lee Moffitt Cancer Center, Tampa, FL; M.D. Anderson Cancer Center, Houston, TX; Ohio State University, Columbus, OH.

Address reprint requests to Stuart A. Grossman, MD, 1650 Orleans St, Room G93, The Sydney Kimmel Cancer Center at Johns Hopkins, Baltimore, MD 21231; email: grossman{at}jhmi.edu.

Purpose: This phase III Eastern Cooperative Oncology Group-Southwest Oncology Group intergroup study was conducted to determine whether three 72-hour infusions of carmustine (BiCNU) and cisplatin administered monthly before external-beam radiotherapy would improve the survival of patients with newly diagnosed glioblastoma multiforme. The control arm consisted of radiation with standard adjuvant BiCNU.

Patients and Methods: A total of 223 patients were accrued from 1996 to 1999. Of these, 219 patients were eligible; 109 were randomly assigned to the experimental arm, and 110 were randomly assigned to the control arm. Randomization was stratified by age, performance status, and extent of resection.

Results: The median age of the patients was 55 years; 55% were male, 93% were white, 26% had a biopsy only, and 84% were ambulatory. Treatment arms were well balanced with respect to baseline characteristics. Median follow-up time of the 15 patients still alive at the time of analysis was 3.3 years (range, 2 to 5 years). Median survival times for the standard and experimental arms were 11.2 and 11.0 months (P = .33, two-sided log-rank test), and survival at 1 year was 45% versus 44%, respectively. Fifty-six percent of patients received all three cycles of BiCNU/cisplatin, 12% received two cycles, and 31% received only one cycle. Toxicity was primarily hematologic and was more common in the experimental arm (P < .01).

Conclusion: This study demonstrates that 72-hour infusions of BiCNU and cisplatin followed by radiation do not improve median survival, survival at 1 year, or time to progression. Furthermore, this treatment requires more time in the hospital and is associated with more serious toxicities than standard therapy.

This study was coordinated by the Eastern Cooperative Oncology Group and supported in part by Public Health Service grants CA16116, CA23318, CA21076, CA73590, CA04920, CA32102, CA66636, CA21115 and from the National Cancer Institute, National Institutes of Health, and the Department of Health and Human Services, Bethesda, MD.

The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

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