An appraisal of the efficacy of bleomycin in epidermoid carcinoma of the penis.

Since 1975 ten patients with advanced bidimensionally measurable epidermoid carcinoma of the penis were treated prospectively with bleomycin as a single agent. In addition, data of four patients with penile cancer treated at Memorial Hospital in 1971-72 as part of a drug-oriented prospective Phase I-II trial of bleomycin are included. Each patient had a complete evaluation including measurement of all measurable lesions by two independent observers. Standard response criteria were used. Bleomycin was given in doses of 3-20 mg/m2/day in a continuous infusion to 8 men and as a daily or weekly bolus in doses of 10-30 mg/m2 to six men. The median age of the patients was 54 years and median KPS 50%. Six patients had previously received two or more chemotherapeutic agents. All patients had Stage III-IV disease. Three (21%) of 14 patients responded including one patient who achieved a complete remission in the primary penile lesion and in malignant inguinal lymphadenopathy. Tumor regression was noted to start rapidly, i.e. within 2 weeks of starting protocol, but the duration of remission was short - median 3 months. The most frequent toxicity was mucositis which occurred in 8 cases. Three patients had a drug-related fever, two a drug rash and 2 had evidence of pulmonary toxicity. There was one instance each of an elevation of tests of liver function, and of alopecia. Within the context of this study, bleomycin has modest activity and moderately severe toxicity in patients with advanced penile carcinoma.