A Multicenter Phase II Study of the Intravenous Administration of Liposomal Tretinoin in Patients With Acquired Immunodeficiency Syndrome-Associated Kaposi's Sarcoma

Cancer. 2002 Dec 15;95(12):2555-61. doi: 10.1002/cncr.11009.

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acquired Immunodeficiency Syndrome / complications
  • Adolescent
  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects
  • Drug Carriers
  • Female
  • Gastrointestinal Diseases / chemically induced
  • Humans
  • Infusions, Intravenous
  • Liposomes
  • Male
  • Middle Aged
  • Quality of Life
  • Sarcoma, Kaposi / drug therapy*
  • Sarcoma, Kaposi / etiology
  • Treatment Outcome
  • Tretinoin / administration & dosage*
  • Tretinoin / adverse effects

Substances

  • Antineoplastic Agents
  • Drug Carriers
  • Liposomes
  • Tretinoin