Cisplatin, methotrexate and bleomycin for the treatment of carcinoma of the penis: A Southwest Oncology Group study

Purpose: We ascertained whether combined cisplatin, methotrexate and bleomy cin have efficacy for treating locally advanced or metastatic carcinoma of the penis, and evaluate the toxicity resulting from this regimen. Materials and Methods: Patients had biopsy proved locally advanced or metas tatic epidermoid carcinoma of the penis. Chemotherapy consisted of 75 mg./m .(2) cisplatin infused intravenously on day 1, 25 mg./m.(2) intravenous bol us of methotrexate on days 1 and 8, and 10 unit per m.(2) intravenous bolus of bleomycin on days 1 and 8 with a cycle length of 21 days. Our study was performed as a standard phase II evaluation with 2 stages of accrual. Results: Enrolled in this study were 45 patients, including 40 who were eva luable for a response. There were 5 complete and 8 partial responses for a 32.5% response rate. Five treatment related deaths occurred and 6 of the 36 remaining patients evaluable for toxicity had 1 or more life threatening t oxic episodes. Conclusions: A regimen of cisplatin, methotrexate and bleomycin appears to have promising results. However, toxicity was prodigious, and an emphasis o f future research should be to decrease toxicity.