RANDOMIZED PHASE-III TRIAL OF LIPOSOMAL DAUNORUBICIN VERSUS DOXORUBICIN, BLEOMYCIN, AND VINCRISTINE IN AIDS-RELATED KAPOSIS-SARCOMA

Purpose: To compare the safety and efficacy of liposomal daunorubicin (DaunoXome; NeXstar Pharmaceuticals, Inc, Boulder, CO) with a referenc e regimen of doxorubicin, bleomycin, and vincristine (ABV) in advanced AIDS-related Kaposi's sarcoma (KS), Patients and Methods: In a prospe ctive randomized phase III trial, 232 patients were randomized to rece ive DaunoXome 40 mg/m(2) or a combination regimen of doxorubicin 10 mg /m(2), bleomycin 15 U, and vincristine 1 mg, administered intravenousl y every 2 weeks, Treatment was continued until complete response ICR), disease progression, or unacceptable toxicity. Results: Of 232 patien ts randomized, 227 were treated: 116 with DaunoXome and 111 with ABV. The overall response rate (CR or partial response [PR]) was 25% (three CRs and 26 PRs) for DaunoXome and 28% (one CR and 30 PRs) for ABV. Th e difference in response rates was not statistically significant. The median survival time was 369 days for DaunoXome patients and 342 days for ABV patients (P=.19). The median time to treatment failure was 115 days for DaunoXome and 99 days for ABV (P=.13). ABV patients experien ced significantly more alopecia and neuropathy (P <.0001). DaunoXome p atients experienced more grade 4 neutropenia (P=.021). Cardiac functio n remained stable, with no instances of congestive heart failure on ei ther treatment arm. Conclusion: In this large phase III trial, the eff icacy of DaunoXome comparable to that of ABV. Response rates, time to treatment failure, and overall survival were similar on both treatment arms. DaunoXome is a safe and effective primary therapy for advanced AIDS-related KS. (C) 1996 by American Society of Clinical Oncology.