We found three small uncontrolled phase II trials of bleomycin as single-agent therapy in the treatment of AIDS-related KS and one small non-randomised study comparing singleagent bleomycin with combination ABV chemotherapy.42-45 In one non-randomised phase
11 study of single-agent bleomycin, 30 patients received intramuscular bleomycin, 5 mg/day for
3 days every 14-21 days, and another 30 patients received bleomycin by infusion, 6 mg/m2/day for
4 days every 28 days.42 The overall partial response rate for the combined groups was 48% (29/60), and the response rates in the intramuscular group and the continuous infusion groups were similar (although the groups were not randomly assigned).42 Mean duration of bleomycin therapy was 5 months. Nineteen patients died during the treatment and four patients after withdrawal of bleomycin. Opportunistic infections were the cause of death in 18 of the 23 patients who died.42 In another small uncontrolled study, 17 patients with AIDS-related KS were treated with infusional bleomycin at 20 mg/m2/day for 3 days every 21 days and the partial response rate by ACTG criteria (see Table 29.2) was 65%.43 Three of five previously treated patients also had a partial response. Median survival was 7 months.43 In a third uncontrolled phase II study, 70 patients with AIDS-related mucocutaneous KS were given intramuscular bleomycin 5 mg/day for 3 days every 2 weeks. Two patients had a complete response and 50 patients had a partial response, giving an overall response rate of 74%.44 The median time to relapse was 10 weeks.
In a small non-randomised study comparing bleomycin with ABV combination chemotherapy in 24 patients with extensive AIDS-related KS, there were no complete or partial responses in
12 patients who received bleomycin alone. Four of 12 patients who received ABV chemotherapy had a partial response.45
What are the effects of systemic chemotherapy in KS and do liposomal anthracyclines produce higher response rates (by ACTG criteria), with less toxicity, than conventional combination chemotherapy in advanced AIDS-related Kaposi's sarcoma?
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