Document 2990 DOCN M94A2990 TI Interferon alpha-2a+zidovudine vs. bleomycin+zidovudine for HIV-associated Kaposi's sarcoma. The Swiss Group for Clinical Studies on AIDS. DT 9412 AU Opravil M; Hodapp K; Luthy R; Div. of Infectious Diseases, University Hospital, Zurich,; Switzerland. SO Int Conf AIDS. 1994 Aug 7-12;10(1):179 (abstract no. PB0141). Unique Identifier : AIDSLINE ICA10/94369585 AB OBJECTIVE: To compare the efficacy and tolerability of two combination treatments for HIV-associated Kaposi's sarcoma (KS) in a prospective randomized multicenter study. METHODS: Patient with progressive cutaneous KS were randomized to receive zidovudine (2 x 250 mg/d) with either interferon alpha-2a (IFN: 9 Mio U/d) or bleomycin (BLEO: 15 mg every 2 weeks). KS, clinical and laboratory data were documented monthly. Partial remission (PR) was defined as > 50% reduction in size (area) or number of lesions lasting > or = 4 weeks, progression (PD) as > 25% increase. Stable disease (SD) did not meet the criteria for PR or PD. Mortality was assessed until 2/15/94 (intent-to-treat). RESULTS: 26 men entered the trial and were evaluable for toxicity and mortality; 22 (12 IFN, 10 BLEO) were evaluable for efficacy (> or = 1 month of treatment). Despite stratification, CD4 counts were median 154/microliters in IFN and 90/microliters in BLEO (p = 0.38). Mean duration on assigned treatment was 4.3 months in both arms. A trend toward reduction in p24 antigen was observed in IFN vs. BLEO (p = 0.07). After a mean follow-up of 15.9 months in IFN and 11.7 in BLEO, a trend toward lower mortality in IFN arm (p = 0.11) was explained by imbalance in predictive factors at base-line (multivariate Cox regression). TABULAR DATA, SEE ABSTRACT VOLUME. CONCLUSION: IFN and BLEO had similar efficacy and tolerability for treatment of KS. However, patients randomized to IFN might benefit from a concurrent anti-HIV effect. DE Bleomycins/*ADMINISTRATION & DOSAGE Combined Modality Therapy Comparative Study Dose-Response Relationship, Drug Drug Administration Schedule Follow-Up Studies Human HIV Infections/MORTALITY/*THERAPY Interferon Alfa-2a/*ADMINISTRATION & DOSAGE Male Prospective Studies Sarcoma, Kaposi's/MORTALITY/*THERAPY Skin Neoplasms/MORTALITY/*THERAPY Survival Rate Treatment Outcome Zidovudine/*ADMINISTRATION & DOSAGE CLINICAL TRIAL MEETING ABSTRACT MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL SOURCE: National Library of Medicine. NOTICE: This material may be protected by Copyright Law (Title 17, U.S.Code).