Interferon-alpha maintenance therapy after cytotoxic chemotherapy for treatment of acquired immunodeficiency syndrome-related Kaposi's sarcoma.

A prospective phase I clinical trial with recombinant interferon-alpha-2b as maintenance therapy after cytotoxic chemotherapy was conducted. Twenty-one homosexual and bisexual males with extensive mucocutaneous or visceral epidemic acquired immunodeficiency syndrome (AIDS)-Kaposi's sarcoma (KS) were studied. After a complete response (6 patients) or partial response (15 patients) from chemotherapy consisting of Adriamycin (20 mg/m2), bleomycin (10 U/m2), and vincristine (1.4 mg/m2; 2 mg maximum), patients were given interferon-alpha (IFN-alpha) in an attempt to prolong disease-free survival. Three dose levels of daily IFN-alpha were tested: 5, 10, and 15 million U. The maximum tolerated dose was 10 million units. Dose-limiting toxicities included recurrent grade 3 fatigue, diarrhea, and fever, which resulted in the termination of therapy in eight patients (38%). Hematologic toxicities were infrequent (four patients; 19%). Responses were observed in two patients on IFN-alpha, both at the 10-million-U dose level. The median duration of response on IFN-alpha therapy following chemotherapy was 8 weeks (range, 3-11). We conclude that the duration of IFN-alpha maintenance response following cytotoxic chemotherapy is short with response to residual disease observed in a minority of cases at this dose and schedule. Additional trials of maintenance therapy in patients with advanced AIDS-KS combining antiretroviral agents are in progress.
AuthorsP S Gill, M U Rarick, M Bernstein-Singer, B M Espina, B Jones, T Montgomery, D Sharma, S Rasheed, A M Levine
JournalJournal of biological response modifiers (J Biol Response Mod) Vol. 9 Issue 5 Pg. 512-6 (Oct 1990) ISSN: 0732-6580 [Print] UNITED STATES
PMID2254762 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Interferon-alpha
  • Recombinant Proteins
  • interferon alfa-2b
  • Acquired Immunodeficiency Syndrome (complications)
  • Adult
  • Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
  • Drug Evaluation
  • Humans
  • Interferon-alpha (administration & dosage, adverse effects)
  • Male
  • Middle Aged
  • Prospective Studies
  • Recombinant Proteins
  • Sarcoma, Kaposi (drug therapy, etiology)

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