Journal of Clinical Oncology, Vol 16, 2445-2451, Copyright © 1998 by American Society of Clinical Oncology
Pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi's sarcoma: results of a randomized phase III clinical trial
DW Northfelt, BJ Dezube, JA Thommes, BJ Miller, MA Fischl, A Friedman-Kien, LD Kaplan, C Du Mond, RD Mamelok and DH Henry
University of California, San Francisco, USA. dnorthfelt@pol.net
PURPOSE: Kaposi's sarcoma (KS), the most common neoplasm in patients with
AIDS, is a significant clinical problem for which current therapies are
frequently unsatisfactory. We conducted a randomized phase III clinical
trial to compare the efficacy and toxicities of a new form of therapy,
pegylated-liposomal doxorubicin, with standard combination chemotherapy in
patients with advanced AIDS-related KS (AIDS-KS). PATIENTS AND METHODS: Two
hundred fifty-eight patients with advanced AIDS-KS were randomly assigned
to receive either pegylated- liposomal doxorubicin (20 mg/m2) or the
combination of doxorubicin (20 mg/m2), bleomycin (10 mg/m2) and vincristine
(1 mg) (ABV) every 14 days for six cycles. Standard response criteria,
toxicity criteria, and predefined indicators of clinical benefit were
examined to evaluate outcomes. RESULTS: Among 133 patients randomized to
receive pegylated- liposomal doxorubicin, one achieved a complete clinical
response and 60 achieved a partial response for an overall response rate of
45.9% (95% confidence interval [CI], 37% to 54%). Among 125 patients
randomized to receive ABV, 31 achieved a partial response (24.8%; 95%
confidence interval [CI], 17% to 32%). This difference was statistically
significant (P < .001). In addition to objective responses,
prospectively defined clinical benefits and toxicity outcomes also favored
pegylated-liposomal doxorubicin. CONCLUSION: Pegylated- liposomal
doxorubicin is more effective and less toxic than the standard combination
chemotherapy regimen ABV for treatment of AIDS-KS.

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