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Preradiation Chemotherapy in Primary High-Risk Brainstem Tumors: Phase II Study CCG-9941 of the Children’s Cancer Group

From the Vanderbilt Cancer Center, Nashville, and Saint Jude’s Children’s Research Hospital, Memphis, TN; Children’s Cancer Group, Arcadia, University of California San Francisco, San Francisco, and Children’s Hospital of Orange County, Orange, CA; Children’s National Medical Center, Washington, DC; Primary Children’s Hospital, Salt Lake City, UT; University of Texas, M.D. Anderson Cancer Center, Houston, TX; University of Minnesota Medical Center, Minneapolis, and United Hospital, St Paul, MN; Saint Peter’s University Hospital and University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick, NJ; Children’s Hospital of Pittsburgh, Pittsburgh, PA; Trinity Lutheran Hospital, Kansas City, MO; Boulder Community Hospital, Boulder CO; and Babies Hospital, Lincoln Hospital, Columbia University, New York, NY.

Address reprint requests to Mark T. Jennings, MD, Children’s Oncology Group, PO Box 60012, Arcadia, CA 91066-6012; email: mark.jennings@ mcmail.vanderbilt.edu; cc: smason{at}childrensoncologygroup.org

PURPOSE: This Children’s Cancer Group group-wide phase II trial evaluated the efficacy and toxicity of two chemotherapy arms administered before hyperfractionated external-beam radiotherapy (HFEBRT).

PATIENTS AND METHODS: Thirty-two patients with newly diagnosed brainstem gliomas were randomly assigned to regimen A and 31 to regimen B. Regimen A comprised three courses of carboplatin, etoposide, and vincristine; regimen B comprised cisplatin, etoposide, cyclophosphamide, and vincristine. Both arms included granulocyte colony-stimulating factor. Patients were evaluated by magnetic resonance imaging after induction chemotherapy and HFEBRT at a dose of 72 Gy.

RESULTS: Ten percent ± 5% of regimen A patients objectively responded to chemotherapy. For combined induction and radiotherapy, 27% ± 9% of patients improved. The neuroradiographic response rate for regimen B was 19% ± 8% for chemotherapy and 23% ± 9% after HFEBRT. Response rates were not statistically significant between regimens after induction or chemotherapy/HFEBRT. Event-free survival was 17% ± 5% (estimate ± SE) at 1 year and 6% ± 3% at 2 years. Survival was significantly longer among patients who responded to chemotherapy (P < .05). Among patients who received regimen A induction, grades 3 and 4 leukopenia were observed in 50% to 65%, with one toxicity-related death. For regimen B, severe leukopenia occurred in 86% to 100%, with febrile neutropenia in 48% to 60% per course.

CONCLUSION: Neither chemotherapy regimen meaningfully improved response rate, event-free survival, or overall survival relative to previous series of patients with brainstem gliomas who received radiotherapy with or without chemotherapy.

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