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Phase II Study of Carboplatin in Children With Progressive Low-Grade Gliomas

From the Duke University Medical Center, Durham, NC; Primary Children’s Medical Center, Salt Lake City, UT; Hospital Sainte-Justine, Montreal, Canada; and Royal Melbourne Children’s Hospital, Melbourne, Australia.

Address reprint requests to Sridharan Gururangan, MRCP, The Brain Tumor Center at Duke, Duke University Medical Center, Box 3624, DUMC, Durham, NC 27710; email: gurur002{at}mc.duke.edu

PURPOSE: To assess the rate of tumor response and activity of carboplatin in stabilizing the growth of progressive low-grade gliomas.

PATIENTS AND METHODS: Eligible patients received carboplatin 560 mg/m² intravenously every 4 weeks for 1 year after maximum tumor response or until disease progression or unacceptable toxicity.

RESULTS: Between October 1993 and October 2000, 81 children (median age, 79 months; range, 6 to 204) were enrolled onto this study. Patients received a median of 11 cycles of carboplatin (range, one to 29). Median follow-up from the time of enrollment was 55 months (range, 10 to 93). The overall objective response (complete response [CR] + partial response [PR] + minor response [MR]) and disease stabilization (CR + PR + stable disease + MR) rates to carboplatin treatment were 28% (95% confidence interval [CI], 18% to 38%) and 85% (95% CI, 74% to 93%), respectively. Eleven and 14 patients suffered progressive disease on study and after stopping therapy, respectively. Toxicity was predominantly myelosuppression and included grade 3/4 neutropenia in 56 patients and grade 3/4 thrombocytopenia in 40 patients. The 3-year failure-free survival (FFS) and overall survival (OS) for all patients were 64% (95% CI, 54% to 76%) and 84% (95% CI, 76% to 93%), respectively. Patients with diencephalic tumors had inferior FFS and OS compared with those with tumor at other sites (38% v 74% for FFS, P = .011; 54% v 91% for OS, P = .004). Neurofibromatosis type 1 patients with progressive low-grade glioma had a significantly better OS (95% v 80%; P = .052).

CONCLUSION: Carboplatin, in the schedule used in this study, produced disease stabilization or improvement in a majority of children with progressive low-grade glioma, with manageable toxicity. Improved treatment strategies are particularly required for patients with diencephalic tumors.

Presented in part at the Thirty-Seventh Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, May 12-15, 2001.

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