Interferon-α with zidovudine: Safety, tolerance, and clinical and virologic effects in patients with Kaposi sarcoma associated with the acquired immunodeficiency syndrome (AIDS) Journal Article

  

Authors:	Krown, S. E.; Gold, J. W. M.; Niedzwiecki, D.; Bundow, D.; Flomenberg, N.; Gansbacher, B.; Brew, B. J.
Article Title:	Interferon-α with zidovudine: Safety, tolerance, and clinical and virologic effects in patients with Kaposi sarcoma associated with the acquired immunodeficiency syndrome (AIDS)
Abstract:	Objective: To evaluate safety, tolerance, and potential efficacy of interferon-α and zidovudine combination therapy in patients with Kaposi sarcoma and the acquired immunodeficiency syndrome (AIDS). Design: Open, phase-I study with randomization between two preparations of interferon-α. Setting: Outpatient clinic of a cancer research center. Patients: Forty-three patients with Kaposi sarcoma associated with AIDS. Interventions: Patients were treated with interferon-α, 4.5, 9, or 18 million U/d, and zidovudine, 100 or 200 mg orally every 4 hours. Measurement and main results: Neutropenia was the major dose-limiting toxicity. Fatigue, liver enzyme elevation, anemia, and thrombocytopenia were dose-limiting in some patients. Maximum tolerated dosages for interferon-α2a with zidovudine, respectively, were 4.5 million U/d with 200 mg every 4 hours or 18 million U/d with 100 mg every 4 hours. An interferon-α dosage of 9 million U/d with zidovudine dosages of either 100 or 200 mg every 4 hours induced dose-limiting toxicity in most patients. Of 37 evaluable patients, 17 (46%; 95% CI, 30% to 62%) showed complete or partial tumor regression. Antitumor effects occurred more frequently in patients with baseline CD4 counts above 200 x 106 cells/L (65%) than in patients with lower baseline counts (30%, P = 0.05). Effects on CD4 cells were related to both initial CD4 count and interferon dose. Increased skin test reactivity and decreased serum human immunodeficiency virus (HIV) p24 antigen and virus recovery from blood cells were seen. Conclusions: Combined therapy with interferon-α and zidovudine can be safely administered to patients with AIDS and Kaposi sarcoma. The observed effects on tumor growth, HIV replication, and immune function support further studies of the combination in patients at various stages of HIV infection.
Keywords:	adult; clinical article; neutropenia; nonhuman; alpha interferon; t lymphocyte; human immunodeficiency virus; kaposi sarcoma; oral drug administration; zidovudine; intramuscular drug administration; recombinant alpha2a interferon; human; male; priority journal; article
Journal Title:	Annals of Internal Medicine
Volume:	112
Issue:	11
ISSN:	0003-4819
Publisher:	American College of Physicians
Date Published:	1990-06-01
Start Page:	812
End Page:	821
Language:	English
DOI:	10.7326/0003-4819-112-11-812
PUBMED:	1971504
PROVIDER:	scopus
DOI/URL:	https://www.scopus.com/inward/record.uri?eid=2-s2.0-0025341328&doi=10.7326%2f0003-4819-112-11-812&partnerID=40&md5=f8167080ca278854802068de2afd594b
Notes:	Correction issued, see DOI: 10.7326/0003-4819-113-4-334_1 -- Article -- Source: Scopus

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