Journal of Clinical Oncology, Vol 11, 1316-1321, Copyright © 1993 by American Society of Clinical Oncology
Phase III comparative evaluation of PCNU and carmustine combined with radiation therapy for high-grade glioma
RP Dinapoli, LD Brown, RM Arusell, JD Earle, JR O'Fallon, JC Buckner, BW Scheithauer, JE Krook, LK Tschetter and JA Maier
North Central Cancer Treatment Group, Rochester, MN.
PURPOSE: We performed a randomized trial to compare survival distributions
and toxicity of radiation therapy (RT) and PCNU with those of RT and
carmustine (BCNU) in patients with malignant glioma. PATIENTS AND METHODS:
A total of 346 patients with histologically verified supratentorial grade 3
and grade 4 astrocytoma were studied. After surgery, patients were randomly
assigned to receive RT 60 Gy in 30 fractions and either PCNU 100 mg/m2 or
BCNU 200 mg/m2 every 7 weeks for 1 year and every 10 weeks for the second
year. RT and chemotherapy were started within 72 hours of randomization and
usually on the same day. Of 334 assessable patients, 72% had partial or
radical resection and 71% had grade 4 tumors. Median age was 59 years, and
85% had performance scores of 0 to 2 (Eastern Cooperative Oncology Group
[ECOG]). The follow-up duration of 51 living patients ranged from 10.3 to
63.2 months, with a median of 36.2 months. RESULTS: The median survival
duration in each group was 47 weeks, and median time to progression was 28
weeks. PCNU produced significantly more leukopenia and thrombocytopenia,
whereas BCNU produced significantly more nausea, vomiting, and irritation.
CONCLUSION: PCNU has no therapeutic advantage at this dose and schedule and
does not warrant further study as a single agent for patients with
high-grade glioma.
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