Continuous infusion bleomycin in AIDS-related Kaposi's sarcoma.

Abstract

PURPOSE To determine the toxicity, response, and survival rate of 72-hour continuous infusion bleomycin administered to patients with AIDS-related Kaposi's sarcoma. PATIENTS AND METHODS Seventeen patients with biopsy-proven and measurable-disease AIDS-related Kaposi's sarcoma were treated with a continuous infusion of bleomycin at a dose of 20 mg/m2/d for 3 days every 3 weeks. All patients were evaluated for toxicity, response, and survival using the National Cancer Institute common toxicity criteria, and both the Eastern Cooperative Oncology Group (ECOG) and AIDS Clinical Trials Group (ACTG) response criteria. Fourteen of 17 patients (82%) enrolled had at least two on-study poor-risk factors by ACTG staging criteria. RESULTS A total of 59 cycles of therapy were administered. Only one cycle (2%) was complicated by an absolute neutrophil count less than 500, and there were no episodes of febrile neutropenia. Fifty-four percent of cycles were associated with fever during the infusion, and five cycles (8%) were complicated by grade 3 rash. There were no other clinically significant (> or = grade 3) toxicities. There were seven partial remissions (41%) by ECOG criteria (95% confidence interval, 18% to 64%) and 11 partial remissions (65%) by ACTG criteria (95% confidence interval, 42% to 88%). Three of five (60%) previously treated patients had a partial remission with this schedule of bleomycin. The median survival duration was 7 months, with a range of 2.5 to 25 months. CONCLUSION This continuous infusion schedule of bleomycin is active in patients with advanced-stage AIDS-related Kaposi's sarcoma and has acceptable toxicity. This regimen should be further evaluated in patients with earlier stage Kaposi's sarcoma and as salvage therapy.