A PHASE-II STUDY OF RECOMBINANT HUMAN INTERFERON-(ALPHA-2A) AND ZIDOVUDINE IN PATIENTS WITH AIDS-RELATED KAPOSIS-SARCOMA

To assess safety, antitumor response, and immunological and virologica l activity of interferon-alpha(2a) and zidovudine combination therapy in patients with AIDS-related Kaposi's sarcoma, we conducted an open-l abel, Phase II, multicenter study. Sixty-three patients with biopsy-pr oven Kaposi's sarcoma and no previous interferon-alpha therapy receive d 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%) o r partial (15%) antitumor response. Eight of 30 patients (27%) with <1 00 CD4 cells/mm(3) and 17 of 32 patients (53%) with greater than or eq ual to 100 CD4 cells/mm(3) had a response. The median time to response was 36 weeks. Of the 25 patients with a response, four developed tumo r progression. The median duration of response was 22.4 weeks. Eight p atients (13%) developed another AIDS-defining event and 13 (21%) died. The major toxicities included anemia (16%), neutropenia (27%), elevat ed serum transaminases (16%), weight loss (16%), malaise (14%), fatigu e (14%), fever (10%), and headache (6%). Therapy with intermediate-dos e interferon-alpha(2a) and zidovudine resulted in tumor regression in patients with AIDS-related Kaposi's sarcoma who had a wide range of CD 4 cell counts; this therapy was relatively well tolerated.