Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
A randomized trial of 2 doses of alpha interferon (IFN) added to AZT for the treatment of epidemic Kaposi's sarcoma (KS) (Meeting abstract).
Proc Annu Meet Am Soc Clin Oncol; 13:A1 1994. Unique Identifier : AIDSLINE ICDB/94699997 Shepherd F; Beaulieu R; Murphy K; Gelmon K; Thuot C; Sawka C; Singer J; Canadian HIV Trials Network, Vancouver, BC Canada
Abstract:
Moderate to high-dose IFN induces clinical response in up to 40% of patients (pts) with KS, but, pts require frequent dose reduction or discontinuation of treatment for toxicity, and high dose IFN may not be given concurrently with AZT. This study was undertaken to compare the efficacy and toxicity of IFN 8 MU sc/day or 1 MU sc/day added to AZT 100 mg po q 4 hr while awake (500 mg/day). Pts had to be HIV+ with bx-proven or unequivocal clinical KS and free from active opportunistic infection (OI). They had to have adequate hematology (Hgb greater than or equal to 90 g/L, granulocytes greater than or equal to 10(9)/L, platelets greater than or equal to 130 x 10(9)/L) and adequate hepatic function (transaminases less than or equal to 2x normal). In the absence of drug toxicity, OI or KS progression, pts were to remain on study for 4 cycles (16 wk). They were assessed monthly while on IFN and every 3 mo post-therapy. Response was judged on lesion number +/- size +/- flattening. Between October 1990 and February 1993, 118 pts (117 male) were randomized as shown in a table. The overall response rate (CR + PR) was higher in the 8MU than the 1MU group (29% vs 15%; p=0.07) with a shorter mean time to onset of response (2.94 mo vs 5.9 mo; p=0.004) and longer response duration (7.13 mo vs 2.86 mo; p=0.03). More pts on 8MU required interruption or reduction of IFN for adverse events (hematologic 17 vs 2; liver dysfunction 4 vs 2; flulike symptoms 13 vs 4). Only 10 pts completed 4 mo of IFN 8MU/d without needing dose reduction. In summary IFN 8MU/day may be combined safely with AZT 500 mg/day, and results in a higher rate of response of more rapid onset, and longer duration than low dose IFN.
Keywords: Administration, Oral *Adult Combined Modality Therapy *Disease Outbreaks Dose-Response Relationship, Drug Drug Administration Schedule Human HIV Seropositivity/*THERAPY Injections, Subcutaneous Interferon-alpha/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS Sarcoma, Kaposi's/*THERAPY Skin Neoplasms/*THERAPY Zidovudine/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS ABSTRACT CLINICAL TRIAL RANDOMIZED CONTROLLED TRIAL 940830
M9480778
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Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
