Adjuvant chemotherapy with adriamycin, cytoxan, and cis-platinum in high-grade carcinoma of the prostate treated with definitive radiotherapy (RTOG pilot 81-12).

Abstract

In a phase I-II trial, a regimen of Adriamycin, Cytoxan, and cis-Platinum has been tested as an adjuvant to definitive radiotherapy in patients with high-grade (Gleason score 8-10) locally advanced carcinoma of the prostate limited to the pelvis. The patients had no evidence of distant disease, were in good general condition, and had satisfactory cardiac, hepatic, and renal function. Radiation therapy consisted of 4,320-4,500 rad in 23-25 fractions to the pelvis followed by a boost to the prostate to a total of 6,480-7,020 rad in 36-39 treatments. Chemotherapy was scheduled to start 4 weeks after completion of radiotherapy and consisted of 300 mg/m2 of Cyclophosphamide, 30 mg/m2 of Adriamycin, and 50 mg/m2 of cis-Platinum cycles given at 4-week intervals. The primary aim of the study was evaluation of toxicity of the combined regimen. Nine patients were evaluable. No adverse effects of chemotherapy on the incidence and severity of radiation-related toxicity in the pelvis have been observed. Myelosuppression has been significant and has prevented delivery of full doses of chemotherapy. Although planned, no dose escalation was possible. Further reduction of dosage was necessitated in 67% of the patients. Delays in the delivery of chemotherapy were necessary in four patients; the delays ranged from 1 to 14 weeks. Although the regimen had been reported to produce a high rate of response in disseminated disease and has not been associated with an increased incidence of radiation-chemotherapy toxicity in the irradiated pelvis, it does not appear suitable for further testing in an adjuvant setup in patients treated with definitive radiotherapy.