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Cancer. 2002 Dec 15;95(12):2555-61.

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

Author information

1
Department of Medicine, Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, New York 14263, USA. zale.bernstein@roswellpark.org

Abstract

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.

PMID:
12467070
DOI:
10.1002/cncr.11009
[Indexed for MEDLINE]
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