Background
Phase 3 randomized controlled trial of 258 patients with advanced AIDS-related Kaposi sarcoma (≥25 mucocutaneous lesions, or ≥10 new in the prior month, or visceral disease) and serologic evidence of HIV infection, Karnofsky >40%, normal LVEF, Hb >8 g/dL, WBC >1,200/µL, platelets >75,000/µL.
Interventions and follow up
Arm A: Pegylated liposomal doxorubicin 20 mg/m2 q2wk x6 cycles
Arm B: Doxorubicin 20 mg/m2 + bleomycin 10 mg/m2 + vincristine 1 mg (ABV) q2wk x6 cycles
Primary endpoint: Objective response rate
Secondary endpoints: Survival, toxicity, treatment completion
Arm B: Doxorubicin 20 mg/m2 + bleomycin 10 mg/m2 + vincristine 1 mg (ABV) q2wk x6 cycles
Primary endpoint: Objective response rate
Secondary endpoints: Survival, toxicity, treatment completion
Results
ORR: 45.9% vs 24.8%; P<.001
Median OS: ~5.5 mo, no significant difference between arms
Treatment completion: 68% vs 34%
Median OS: ~5.5 mo, no significant difference between arms
Treatment completion: 68% vs 34%
Adverse events
Overall severe AEs: 15.7% vs 14.9%
Hematologic/infectious: leukopenia 71.9% vs 50.8%, oral candidiasis 28.9% vs 17.5%, infection 19.8% vs 13.3%
Other: fever 15.7% vs 25%, nausea/vomiting 15.7% vs 25%
Hematologic/infectious: leukopenia 71.9% vs 50.8%, oral candidiasis 28.9% vs 17.5%, infection 19.8% vs 13.3%
Other: fever 15.7% vs 25%, nausea/vomiting 15.7% vs 25%
Conclusions
Pegylated liposomal doxorubicin produced higher response rates with comparable or lower toxicity and better treatment completion than ABV combination chemotherapy for advanced AIDS-related Kaposi sarcoma, supporting it as a preferred single-agent option.
Key Limitations
Conducted in the pre-HAART era; modern antiretroviral therapy alone induces Kaposi sarcoma regression and alters treatment context. No survival difference and short follow-up limit long-term conclusions.
Clinical Context
Supported FDA approval of pegylated liposomal doxorubicin for AIDS-related Kaposi sarcoma; remains a standard cytotoxic option alongside antiretroviral therapy per ESMO/expert consensus, with paclitaxel as an alternative.