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Alitretinoin.

S M Cheer1, R H Foster

  • 1Adis International Limited, Auckland, New Zealand. demail@adis.co.nz

American Journal of Clinical Dermatology
|November 13, 2001
PubMed
Summary
This summary is machine-generated.

Alitretinoin gel significantly improved treatment responses in patients with AIDS-related Kaposi's sarcoma (KS). This retinoid receptor pan-agonist demonstrated efficacy in both topical and oral formulations, with manageable side effects.

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Area of Science:

  • Oncology
  • Dermatology
  • Pharmacology

Background:

  • Kaposi's sarcoma (KS) is an AIDS-related malignancy.
  • Retinoid receptors play a role in KS cell regulation.
  • Alitretinoin is a novel retinoid receptor pan-agonist.

Purpose of the Study:

  • To evaluate the efficacy and safety of alitretinoin in treating AIDS-related Kaposi's sarcoma.
  • To assess topical alitretinoin gel and oral alitretinoin capsules.

Main Methods:

  • Two phase III, randomized, double-blind, vehicle-controlled trials of alitretinoin 0.1% gel in patients with AIDS-related KS.
  • One phase II trial of oral alitretinoin capsules (60-100 mg/m²/day) in patients with AIDS-related KS.
  • Response evaluation based on AIDS Clinical Trials Group (ACTG) criteria.

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Main Results:

  • Alitretinoin gel showed significantly higher complete or partial response rates (35% vs 18%, p=0.002; 37% vs 7%, p=0.00003) compared to vehicle.
  • Oral alitretinoin capsules achieved a 37% response rate in an intent-to-treat analysis.
  • Responses were observed even in patients refractory to prior therapies.
  • Most adverse events for the gel were mild/moderate, application-site reactions, and reversible.
  • Common adverse events for capsules included headache, dry skin, rash, alopecia, exfoliative dermatitis, and hyperlipidemia.

Conclusions:

  • Alitretinoin gel is an effective topical treatment for AIDS-related Kaposi's sarcoma.
  • Oral alitretinoin also demonstrates therapeutic potential for this condition.
  • Alitretinoin offers a new treatment option for patients with AIDS-related KS, including those with refractory disease.