The authors report the results of Phase I and Phase II evaluation of intravenous bleomycin (BLM) in 176 patients. During the trial different doses and schedules were employed. The less toxic regimen was that of 15 mg/m2 × 2/week per 4 weeks. Irrespective of the schedules, the side effects are represented by sclerotic changes of the skin of hands (88%), skin hyperpigmentation (78%), fever (70%), loss of hair (68%), stomatitis (47%) pulmonary toxicity (42%), gastro-intestinal symptoms (20%). No significant myelo-suppression was observed. Pulmonary toxicity occurred after 4-10 weeks from starting therapy and was detected on clinical bases (fine crepitations at the base), radiologically (reticulonodularity mostly at the lower lung zones) and histologically (edema of alveoli, hyaline membranes formation, collagen deposition). Upon prompt discontinuation of BLM, the signs of pulmonary damage remained unchanged or regressed in the majority of cases. Lower total doses of BLM produced a lesser incidence of lung toxicity. However, in about 5% of cases the presumptive cause of death could be related to extensive pulmonary drug-induced lesions. The incidence of lung toxicity was not found to be significantly related to the age of patients, to the total dose of BLM or to the presence of chronic pulmonary disease. BLM produced significant regression in all types of malignant lymphomas (40%), in epidermoid carcinomas of the head and neck (57%) and of the esophagus (60%). No significant responses were observed in epidermoid carcinomas of the lung. Regressions were prompt but usually short-lived with or without maintenance therapy. Because of its toxic and therapeutic properties BLM appears suitable for therapeutic trials either in short courses alone in or in combination with myelosuppressive agents.
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