Authors: Bodsworth N.J.¹; Bloch M.²; Bower M.³; Donnell D.⁴; Yocum R.⁵

Source: American Journal of Clinical Dermatology, Volume 2, Number 2, 1 February 2001 , pp. 77-87(11)

Publisher: Adis International

Abstract:

Objective: This randomized, double-blind and vehicle-controlled phase III study was conducted to evaluate the efficacy and safety of alitretinoin gel 0.1% for the topical treatment of the cutaneous lesions of AIDS-related Kaposi's sarcoma (KS).

Methods: Patients received treatment with alitretinoin gel (n = 62) or vehicle gel (n = 72) twice daily for 12 weeks. The primary efficacy endpoint was the cutaneous KS tumor response rate according to AIDS Clinical Trials Group (ACTG) objective criteria applied to topical therapy, with the patient as the unit of analysis.

Results: Treatment of patients with alitretinoin gel resulted in a significant antitumor effect. The overall patient response rate (complete plus partial response) was 37% (23 of 62) for the alitretinoin-treated patients and 7% (5 of 72) for the vehicle-treated patients (p = 0.00003). The difference in response rates for the 2 treatment groups remained significant even after taking into consideration numerous variables, including age (p = 0.00001), Eastern Cooperative Oncology Group (ECOG) status (p = 0.00002), CD4+ cell count (p = 0.00002), history of opportunistic infection (p = 0.00002), aggregate area of indicator lesions (p = 0.00005), number of raised indicator lesions (p = 0.00002), prior therapy for KS (p = 0.00003), and number of drugs (p = 0.00002) used in concomitant antiretroviral therapy. Generally, treatment with alitretinoin gel was well tolerated. The overall incidence of adverse events was similar for the 2 treatment groups. Adverse events related to treatment with alitretinoin gel tended to be mild to moderate in severity and limited to the site of application. The most frequent adverse event occurring at the application site following alitretinoin gel treatment was irritation coded as rash (32%).

Conclusions: The results of this study provide convincing evidence of the superiority of alitretinoin gel over vehicle gel for the treatment of the cutaneous lesions of AIDS-related KS.

Keywords: Alitretinoin, therapeutic use; Antineoplastics, therapeutic use; Kaposi's sarcoma; Research and development; Retinoids, therapeutic use; Skin eruptions, treatment

Document Type: Original article

Affiliations: 1: Taylor Square Private Clinic, Darlinghurst, New South Wales, Australia 2: Holdsworth House General Practice, Darlinghurst, New South Wales, Australia 3: Chelsea & Westminster Hospital, London, England 4: Nelson-Tebedo Clinic, Dallas, Texas, USA 5: Ligand Pharmaceuticals Inc., San Diego, California, USA

Publication date: 2001-02-01

Related content

• In this: publication
• By this: publisher
• In this Subject: Dermatology
• By this author: Bodsworth N.J. ;  Bloch M. ;  Bower M. ;  Donnell D. ;  Yocum R.

Website © Publishing Technology. Article copyright remains with the publisher, society or author(s) as specified within the article.

• Terms and conditions
• Privacy policy
• Information for advertisers