[Phase I clinical study of a new anticancer drug boanmycin]

From August 1993 to March 1994, 36 patients were enrolled for a phase I study of Boanmycin (Bleomycin A6) a new anticancer drug to determine it toxicity and maximal dose. Of the 36 cases, 16 were male and 20 female, age 20-62. Dose escalation was performed if a minimum of threed patients were fully evaluable for toxicity (2 weeks following drug administration) and if severe or life-threatening toxicity had not occurred. Dose of Boanmycin were escalated from 1 mg (0.5-0.7 mg/m2) to 12 mg(6.7-7.5 mg/m2) i. m. three times every week for two weeks. Surveillance of serum concentration of Boanmycin was conducted in six cases by microbiological analysis, and the pharmacokinetics parameters were obtained. Phase I study of Boanmycin showed that Boanmycin had no myelosuppression and cardiac toxicity, and its major adverse reactions were fever, gastrointestinal reactions and hardening at injection (by i. m. route). Rather than dose-related, fever was individual-related. There were mild myalgia, alopecia, skin rash, pigmentation in some patients. All adverse reactions resolved after discontinuation of therapy. There was no Boanmycin-related lethal complication, and the maximum tolerated dose was not obtainable. If patients have renal or lung disease, Boanmycin aggravate their renal and lung functions. Therefore we recommend that dose of Boanmycin for phase I clinical trial should be is 8-10 mg(5-6 mg/m2) i m or iv (iv can decrease local side effect) two-three times per week.