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Topical Treatment of Cutaneous Lesions of Acquired Immunodeficiency Syndrome–Related Kaposi Sarcoma Using Alitretinoin Gel
Results of Phase 1 and 2 Trials
Madeleine Duvic, MD;
Alvin E. Friedman-Kien, MD;
David J. Looney, MD;
Steven A. Miles, MD;
Patricia L. Myskowski, MD;
David T. Scadden, MD;
Jamie Von Roenn, MD;
Jeffrey E. Galpin, MD;
Jerome Groopman, MD;
Gordon Loewen, PhD;
Victor Stevens, PhD;
Joseph A. Truglia, MD;
Richard C. Yocum, MD
Arch Dermatol. 2000;136:1461-1469.
Objective To evaluate the efficacy and safety of topical alitretinoin gel (9-cis-retinoic acid [LGD1057], Panretin gel; Ligand Pharmaceuticals, Inc, San Diego, Calif) in cutaneous Kaposi sarcoma (KS).
Design Open-label, within-patient, controlled, dose-escalating phase 1 and 2 clinical trials. In all patients, 1 or more cutaneous KS lesions were treated with alitretinoin gel, and at least 2 other lesions served as untreated controls for up to 16 weeks. Alitretinoin (0.05% or 0.1% gel) was applied twice daily for the first 2 weeks and up to 4 times daily thereafter, if tolerated.
Setting Nine academic clinical centers.
Patients One hundred fifteen patients with biopsy-proven acquired immunodeficiency syndrome (AIDS)–related KS.
Main Outcome Measures AIDS Clinical Trials Group response criteria.
Results Statistically significant clinical responses were observed in 31 (27%) of 115 patients for the group of treated index lesions compared with 13 (11%) for the group of untreated control lesions (P<.001). Responses occurred with low CD4+ lymphocyte counts (<200 cells/µL) and in some patients with refractory response to previous systemic anti-KS therapy. The incidence of disease progression was significantly lower for treated index lesions compared with untreated control lesions (39/115 [34%] vs 53/115 [46%]; P = .02). Alitretinoin gel generally was well tolerated, with 90% of treatment-related adverse events confined to the application site and only mild or moderate in severity.
Conclusions Alitretinoin gel has significant antitumor activity as a topical treatment for AIDS-related KS lesions, substantially reduces the incidence of disease progression in treated lesions, and is generally well tolerated.
From the Section of Dermatology, M. D. Anderson Cancer Center, and the Department of Dermatology, University of Texas Medical School, Houston (Dr Duvic); Department of Dermatology, New York University Medical Center (Dr Friedman-Kien), and Dermatology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center (Dr Myskowski), New York, NY; Divisions of Hematology and Oncology, Departments of Medicine, University of California–San Diego (Dr Looney), University of California–Los Angeles (Dr Miles), Massachusetts General Hospital (Dr Scadden) and Deaconess Hospital (Dr Groopman), Boston, and Northwestern University, Chicago, Ill (Dr Von Roenn); Shared Medical Research, Tarzana, Calif (Dr Galpin); and Ligand Pharmaceuticals Inc, San Diego (Drs Loewen, Stevens, Truglia, and Yocum). Dr Duvic is a paid consultant and primary investigator of clinical trials for Ligand Pharmaceuticals, Inc.
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