Topical treatment of cutaneous lesions of acquired immunodeficiency syndrome-related Kaposi sarcoma using alitretinoin gel: Results of phase 1 and 2 trials

M. Duvic, A. E. Friedman-Kien, D. J. Looney, S. A. Miles, P. L. Myskowski, D. T. Scadden, J. Von Roenn, J. E. Galpin, J. Groopman, G. Loewen, V. Stevens, J. A. Truglia, R. C. Yocum

Research output: Contribution to journalArticle

55 Scopus citations

Abstract

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 indexlesions 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.

Original languageEnglish (US)
Pages (from-to)1461-1469
Number of pages9
JournalArchives of dermatology
Volume136
Issue number12
StatePublished - Dec 1 2000

ASJC Scopus subject areas

  • Dermatology

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    Duvic, M., Friedman-Kien, A. E., Looney, D. J., Miles, S. A., Myskowski, P. L., Scadden, D. T., Von Roenn, J., Galpin, J. E., Groopman, J., Loewen, G., Stevens, V., Truglia, J. A., & Yocum, R. C. (2000). Topical treatment of cutaneous lesions of acquired immunodeficiency syndrome-related Kaposi sarcoma using alitretinoin gel: Results of phase 1 and 2 trials. Archives of dermatology, 136(12), 1461-1469.