A phase II study of recombinant human interferon-alpha 2a and zidovudine in patients with AIDS-related Kaposi's sarcoma. AIDS Clinical Trials Group.

Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

A phase II study of recombinant human interferon-alpha 2a and zidovudine in patients with AIDS-related Kaposi's sarcoma. AIDS Clinical Trials Group.

J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Apr 1;11(4):379-84. Unique Identifier : AIDSLINE MED/96183601
Fischl MA; Finkelstein DM; He W; Powderly WG; Triozzi PL; Steigbigel RT; Department of Medicine, University of Miami School of Medicine,; Miami, Florida, USA.

Abstract: To assess safety, antitumor response, and immunological and virological activity of interferon-alpha 2a and zidovudine combination therapy in patients with AIDS-related Kaposi's sarcoma, we conducted an open-label, Phase II, multicenter study. Sixty-three patients with biopsy-proven Kaposi's sarcoma and no previous interferon-alpha therapy received zidovudine 600 mg/day and interferon-alpha 2a 18 x 10(6) U/day. The median duration of follow-up was 49 weeks. Of 62 evaluable patients, 25 (40%; 95% confidence interval, 0.28-0.52) showed a complete (26%) or partial (15%) antitumor response. Eight of 30 patients (27%) with < 100 CD4 cells/mm3 and 17 of 32 patients (53%) with > or = 100 CD4 cells/mm3 had a response. The median time to response was 36 weeks. Of the 25 patients with a response, four developed tumor progression. The median duration of response was 22.4 weeks. Eight patients (13%) developed another AIDS-defining event and 13 (21%) died. The major toxicities included anemia (16%), neutropenia (27%), elevated serum transaminases (16%), weight loss (16%), malaise (14%), fatigue (14%), fever (10%), and headache (6%). Therapy with intermediate-dose interferon-alpha 2a and zidovudine resulted in tumor regression in patients with AIDS-related Kaposi's sarcoma who had a wide range of CD4 cell counts; this therapy was relatively well tolerated.

Keywords: Acquired Immunodeficiency Syndrome/*COMPLICATIONS Adult Antineoplastic Agents/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Antiviral Agents/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ *THERAPEUTIC USE Disease Progression Drug Therapy, Combination Female Human Interferon Alfa-2a/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ *THERAPEUTIC USE Male Sarcoma, Kaposi's/COMPLICATIONS/*DRUG THERAPY/MORTALITY Support, U.S. Gov't, P.H.S. Survival Rate Zidovudine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE CLINICAL TRIAL CLINICAL TRIAL, PHASE II JOURNAL ARTICLE MULTICENTER STUDY
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M9670464

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