The Journal of Urology · 1999 · 226 citations · 12 references
MedicineOncologyPharmacotherapyCancer Drug Toxicity ManagementChemotherapyGenitourinary OncologyChemotherapy Drug AdministrationChemotherapy Toxicity ManagementCombination ChemotherapyCytotoxic ChemotherapyPenile CancerToxicity ManagementBleomycin InjectionBolus Chemotherapy AdministrationBolus Intravenous DosingChemotherapy For Penile CancerIntravenous Bolus InjectionIntravenous Chemotherapy DosingMetastatic Penile Cancer
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.
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One-Sample Multiple Testing Procedure for Phase II Clinical Trials
Thomas R. Fleming · Biometrics · 1982 · 997 citations
Bleomycin, an Antitumor Antibiotic
Alan Yagoda · Annals of Internal Medicine · 1972 · 292 citations
Medicine, Oncology, Pharmacology +14