Journal of Clinical Oncology, Vol 16, 1736-1742, Copyright © 1998 by American Society of Clinical Oncology
Prospective randomized trial of two dose levels of interferon alfa with zidovudine for the treatment of Kaposi's sarcoma associated with human immunodeficiency virus infection: a Canadian HIV Clinical Trials Network study
FA Shepherd, R Beaulieu, K Gelmon, CA Thuot, C Sawka, S Read and J Singer
Department of Medicine of the Toronto Hospital, Canada. fshepherd@torhosp.toronto.on.ca
PURPOSE: Interferon alfa alone has shown antitumor activity against
Kaposi's sarcoma (KS), and phase I and II clinical trials showed that
interferon and zidovudine could be administered safely to patients with
human immunodeficiency virus (HIV)-associated KS. These observations led to
our trial of zidovudine with two dose levels of interferon alfa. METHODS:
HIV-positive patients with KS were eligible if they were older than 18
years of age, had a performance status of 0 to 2, and were free of active
infection. All patients received zidovudine 500 mg daily and were
randomized to receive-interferon alfa 1 million U or 8 million U
subcutaneously daily. RESULTS: The 108 eligible and assessable patients
were well balanced for known prognostic factors. Response was reported in
31% of high-dose therapy and 8% of low-dose therapy patients (P=.011).
Response at both dose levels was higher for patients with CD4 counts
greater than 150 x 10(9)/L. The median time to progression was longer for
patients in the 8-million U arm (18 v 13 weeks; P=.002). Both hematologic
and nonhematologic toxicities were higher in the high- dose arm; 50 of 54
patients who received 8 million U required dose alterations in the first 4
months compared with only 19 of 53 patients who received 1 million U
(P=.0002). No significant differences were reported with respect to
improvement in CD4 count, elimination of p24 antigen, or development of
opportunistic infections. CONCLUSION: Zidovudine and
moderate-dose-interferon alfa may be combined safely for the treatment of
HIV-associated KS, and both response to treatment and toxicity are dose
related.
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