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CLINICAL TRIAL
JOURNAL ARTICLE
RESEARCH SUPPORT, U.S. GOV'T, P.H.S.
Cisplatin, methotrexate and bleomycin for the treatment of carcinoma of the penis: a Southwest Oncology Group study.
Journal of Urology 1999 June
PURPOSE: We ascertained whether combined cisplatin, methotrexate and bleomycin 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 metastatic epidermoid carcinoma of the penis. Chemotherapy consisted of 75 mg./m.2 cisplatin infused intravenously on day 1, 25 mg./m.2 intravenous bolus 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 evaluable 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 toxic episodes.
CONCLUSIONS: A regimen of cisplatin, methotrexate and bleomycin appears to have promising results. However, toxicity was prodigious, and an emphasis of future research should be to decrease toxicity.
MATERIALS AND METHODS: Patients had biopsy proved locally advanced or metastatic epidermoid carcinoma of the penis. Chemotherapy consisted of 75 mg./m.2 cisplatin infused intravenously on day 1, 25 mg./m.2 intravenous bolus 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 evaluable 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 toxic episodes.
CONCLUSIONS: A regimen of cisplatin, methotrexate and bleomycin appears to have promising results. However, toxicity was prodigious, and an emphasis of future research should be to decrease toxicity.
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