Treatment > Carmustine

Meeting Abstract

A phase II trial of pre-irradiation chemotherapy with BCNU, cisplatin and oral etoposide combined with radiation therapy in the treatment of glioblastoma (GBM)

Timothy J Moynihan, Judith R O'Fallon, J. E Krook, Paula Schomberg, Robert P Dinapoli, I. Kazem, Bernd Scheithauer, Jan C Buckner

NCCTG, Rochester, MN

Prognosis for patients with GBM remains poor, with median survival of 10-12 months and less than 10% 2-year survival.
Pre-irradiation chemotherapy has been shown to be safe and produce some tumor response and offers the theoretical advantage of radiosensitization and determining chemosensitivity of the tumor.
We therefore conducted a phase II trial of pre-irradiation BCNU, cisplatin and etoposide in patients with newly diagnosed GBM.
Patients > 18 yo with EC0G PS = 0-2 were eligible.
Treatment: BCNU 40 mg/m2/d IV over one hour on days 1-3, VP-16 50 mg/d PO days 1-21 and 29-49, and cisplatin 20 mg/m2/d IV days 1-3 and 29-31.
At week 8, a second cycle was administered concomitantly with cerebral radiation to a total of 6000 cGy.
At week 16, patients went on to receive 4 cycles of BCNU 200mg/m2 IV over one hour repeated every 8 weeks.
Scans were obtained after each cycle, and patients who progressed were monitored.
The 93 patients enrolled on study (57 men, 36 women) ranged in age from 19 to 79 years (median = 56).
88% had PS of 0-1, 12% had PS 2.
15% had a biopsy only, 50% had subtotal resection, and 32% had gross total resection.
One canceled, and one died of progressive disease before receiving any therapy.

Results. The primary efficacy endpoint is percent survival at 365 days.
Currently, with 54 deaths and follow-up on those still alive ranging from 26 to 130 weeks, median and one-year survival are estimated to be 267 days (8.9 mos) and 24%, respectively.
Of  74 patients evaluable for tumor response, 17% (2 CR, 10 PR) have responded.
Significant hematologic and other toxicities were encountered.

Conclusion. This regimen shows no benefit in survival or response rate to other, less toxic regimens.
Innovative treatment regimens for GBM are needed.

© Copyright 2002 American Society of Clinical Oncology