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A multicenter phase II study of the intravenous administration of liposomal tretinoin in patients with acquired immunodeficiency syndrome-associated Kaposi's sarcoma.

Author(s): Bernstein ZP, Chanan-Khan A, Miller KC, Northfelt DW, Lopez-Berestein G, Gill PS

Affiliation(s): Department of Medicine, Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, New York 14263, USA. zale.bernstein@roswellpark.org

Publication date & source: 2002-12-15, Cancer., 95(12):2555-61.

Publication type: Clinical Trial; Clinical Trial, Phase II; Multicenter Study; Randomized Controlled Trial

BACKGROUND: A multicenter trial was conducted to determine the efficacy and toxicity of escalating dosages of liposomal tretinoin (all-trans-retinoic acid) administered once or three times weekly in patients with acquired immunodeficiency syndrome (AIDS)-associated Kaposi sarcoma. METHODS: Seventy-six patients with acquired immunodeficiency syndrome (AIDS)-associated Kaposi sarcoma were randomized to receive the study drug either once (n = 30) or 3 times weekly (n = 46). The starting dosage was 60 mg/m(2), which was escalated to 90 mg/m(2) and then 120 mg/m(2) if the drug was well tolerated (<or= Grade 2 toxicities [according to the Southwest Oncology Group toxicity scale]). Four weeks of therapy constituted 1 cycle; patients could receive up to 8 cycles and those who completed 8 cycles were given the option of receiving extended therapy. Clinical response was defined as complete response (CR), partial response (PR), or stable disease (SD). RESULTS: Efficacy was assessed after the completion of 3 treatment cycles; 28.9% of patients (22 of 76 patients) responded (no CRs, 1 PR, and 21 SDs). Among the patients receiving treatment 3 times weekly, 16 of 49 patients (32.7%) achieved a clinical response at the end of the third treatment cycle (no CRs, 1 PR, and 15 SDs). Concomitant or prior use of protease inhibitors did not appear to affect the patient's response to treatment (P = 0.183). CONCLUSIONS: Liposomal tretinoin is a new therapeutic agent that has been reported to have some clinical activity in patients with AIDS-associated Kaposi sarcoma. A three-times-per-week dosing schedule was noted to be more effective compared with a once-a-week schedule without any significant difference in toxicity reported. Copyright 2002 American Cancer Society.DOI 10.1002/cncr.11009

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