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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).