Background
Randomized phase 2 trial of 73 patients with advanced HIV-associated Kaposi sarcoma (73% on HAART, 32% with undetectable viral load <400 copies/mL), comparing paclitaxel with pegylated liposomal doxorubicin.
Interventions and follow up
Arm A: Paclitaxel 100 mg/m2 IV q2wk
Arm B: Pegylated liposomal doxorubicin (PLD) 20 mg/m2 IV q3wk
Primary endpoint: Quality of life (KS FAHI instrument)
Secondary endpoints: ORR, PFS, OS, symptom (pain/swelling) improvement
Arm B: Pegylated liposomal doxorubicin (PLD) 20 mg/m2 IV q3wk
Primary endpoint: Quality of life (KS FAHI instrument)
Secondary endpoints: ORR, PFS, OS, symptom (pain/swelling) improvement
Results
ORR: 56% vs 46%; P=.49
mPFS: 17.5 mo vs 12.2 mo; P=.66
2-yr OS: 79% vs 78%; P=.75
Pain improvement: 69% of patients, P=.02
Swelling improvement: 93% of patients, P<.001
mPFS: 17.5 mo vs 12.2 mo; P=.66
2-yr OS: 79% vs 78%; P=.75
Pain improvement: 69% of patients, P=.02
Swelling improvement: 93% of patients, P<.001
Adverse events
Overall grade 3-5: 84% (paclitaxel) vs 66%; P=.08
Hematologic: neutropenia 58% vs 41%, P=.18
Non-hematologic: grade 1-2 alopecia 57.8% vs 11%, P<.001; sensory neuropathy 26% vs 9%, P=.05
Hematologic: neutropenia 58% vs 41%, P=.18
Non-hematologic: grade 1-2 alopecia 57.8% vs 11%, P<.001; sensory neuropathy 26% vs 9%, P=.05
Conclusions
Paclitaxel and pegylated liposomal doxorubicin produced similar response, survival, and significant improvements in pain and swelling in advanced symptomatic HIV-associated Kaposi sarcoma, establishing both as effective options with differing toxicity profiles.
Key Limitations
Small sample (n=73) underpowered for efficacy comparisons; primary endpoint was quality of life rather than survival. Open-label design and heterogeneous antiretroviral use.
Clinical Context
Supports paclitaxel as an effective alternative to pegylated liposomal doxorubicin for advanced HIV-associated Kaposi sarcoma; both are recognized systemic options alongside optimized antiretroviral therapy per ESMO/expert consensus.