Efficacy of low-dose interferon with antiretroviral therapy in Kaposi's sarcoma: A randomized phase II AIDS clinical trials group study Journal Article
| Authors: | Krown, S. E.; Li, P.; Von Roenn, J. H.; Paredes, J.; Huang, J.; Testa, M. A. |
| Article Title: | Efficacy of low-dose interferon with antiretroviral therapy in Kaposi's sarcoma: A randomized phase II AIDS clinical trials group study |
| Abstract: | We wished to evaluate the efficacy and safety of a low and an intermediate daily dose of interferon-α2b (IFN-α2b) with didanosine in patients with acquired immunodeficiency syndrome (AIDS)-associated Kaposi's sarcoma (KS). HIV-seropositive subjects with biopsy-confirmed cutaneous KS were randomized to receive either a low (1 million IU) or an intermediate (10 million IU) dose of IFN-α2b once daily with twice daily doses of didanosine. Treatment assignment was stratified by CD4 count. Response, toxicity, changes in CD4 counts, and survival were evaluated. Sixty-eight eligible subjects were accrued, 35 to low-dose and 33 to intermediate-dose IFN-α2b. The response rate was 40% in the low-dose group (95% CI, 24-58) and 55% in the intermediate-dose group (95% CI, 36-72) (p = 0.338). The median response duration was approximately 110 weeks in both groups. Intermediate-dose IFN induced grade 3/4 neutropenia more often (21% vs. 3%, p = 0.048) and grade 3/4 toxicity faster (p = 0.0231) and necessitated treatment discontinuation earlier for drug-related toxicities (p = 0.0416) than low-dose IFN. There were no significant differences in survival between the treatment groups. Baseline CD4 count was the only significant factor predicting response. Once-daily low-dose and intermediate-dose IFN-α2b induced similar response rates, which were achieved without optimal antiretroviral therapy. The slightly higher response rate in the intermediate-dose group was offset by its significantly poorer tolerance. These findings justify the use of lower, well-tolerated IFN doses for treatment of KS with currently used antiretroviral regimens. |
| Keywords: | survival; adult; controlled study; treatment outcome; middle aged; survival analysis; survival rate; major clinical study; clinical trial; mortality; neutropenia; interferon; dose response; drug efficacy; drug safety; alpha interferon; human immunodeficiency virus infection; antineoplastic agent; controlled clinical trial; nephrotoxicity; phase 2 clinical trial; skin biopsy; randomized controlled trial; stomatitis; thrombocytopenia; antineoplastic combined chemotherapy protocols; peripheral neuropathy; pathology; dose-response relationship, drug; biopsy; statistical significance; multicenter study; chemically induced disorder; cardiotoxicity; acquired immune deficiency syndrome; acquired immunodeficiency syndrome; cd4 lymphocyte count; highly active antiretroviral therapy; kaposi sarcoma; sarcoma, kaposi; cd4 antigen; drug tolerance; anti-hiv agents; interferon-alpha; middle age; recombinant alpha2b interferon; dose time effect relation; alpha2 interferon; hiv seropositivity; anti human immunodeficiency virus agent; brain toxicity; didanosine; humans; human; male; female; priority journal; article; support, u.s. gov't, p.h.s.; interferon-alpha 2 |
| Journal Title: | Journal of Interferon and Cytokine Research |
| Volume: | 22 |
| Issue: | 3 |
| ISSN: | 1079-9907 |
| Publisher: | Mary Ann Liebert, Inc |
| Date Published: | 2002-03-01 |
| Start Page: | 295 |
| End Page: | 303 |
| Language: | English |
| DOI: | 10.1089/107999002753675712 |
| PUBMED: | 12034036 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Export Date: 14 November 2014 -- Source: Scopus |
