Journal of Clinical Oncology, Vol 14, 2353-2364, Copyright © 1996 by American Society of Clinical Oncology
Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma
PS Gill, J Wernz, DT Scadden, P Cohen, GM Mukwaya, JH von Roenn, M Jacobs, S Kempin, I Silverberg, G Gonzales, MU Rarick, AM Myers, F Shepherd, C Sawka, MC Pike and ME Ross
Kenneth Norris Jr Comprehensive Cancer Center and Hospital, University of Southern California, School of Medicine, Los Angeles, USA. parkashg@hsc.usc.edu
PURPOSE: To compare the safety and efficacy of liposomal daunorubicin
(DaunoXome; NeXstar Pharmaceuticals, Inc, Boulder, CO) with a reference
regimen of doxorubicin, bleomycin, and vincristine (ABV) in advanced
AIDS-related Kaposi's sarcoma (KS). PATIENTS AND METHODS: In a prospective
randomized phase III trial, 232 patients were randomized to receive
DaunoXome 40 mg/m2 or a combination regimen of doxorubicin 10 mg/m2,
bleomycin 15 U, and vincristine 1 mg, administered intravenously every 2
weeks. Treatment was continued until complete response (CR), disease
progression, or unacceptable toxicity. RESULTS: Of 232 patients 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. The 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 experienced significantly more alopecia and
neuropathy (P < .0001). DaunoXome patients experienced more grade 4
neutropenia (P = .021). Cardiac function remained stable, with no instances
of congestive heart failure on either treatment arm. CONCLUSION: In this
large phase III trial, the efficacy of DaunoXome was 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.
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