Phase III comparative evaluation of PCNU and carmustine combined with radiation therapy for high-grade glioma

• Published in: Journal of clinical oncology Vol. 11; no. 7; p. 1316
• Main Authors: Dinapoli, R P, Brown, L D, Arusell, R M, Earle, J D, O'Fallon, J R, Buckner, J C, Scheithauer, B W, Krook, J E, Tschetter, L K, Maier, J A
• Format: Journal Article
• Language: English
• Published: United States 01-07-1993
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Brain Neoplasms - drug therapy; Brain Neoplasms - radiotherapy; Brain Neoplasms - therapy; Carmustine - administration & dosage; Combined Modality Therapy; Female; Glioma - drug therapy; Glioma - radiotherapy; Glioma - therapy; Humans; Male; Middle Aged; Multivariate Analysis; Nitrosourea Compounds - administration & dosage; Survival Analysis; Treatment Outcome
• ISSN: 0732-183X
• DOI: 10.1200/JCO.1993.11.7.1316

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.
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.
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.
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.