Topical treatment of cutaneous lesions of acquired immunodeficiency syndrome-related Kaposi sarcoma using alitretinoin gel: results of phase 1 and 2 trials
| Autor: | S. A. Miles, J. E. Galpin, David Looney, Gordon Loewen, David T. Scadden, Jerome E. Groopman, Richard C. Yocum, Joseph Truglia, P. L. Myskowski, Victor Stevens, J H Von Roenn, Madeleine Duvic, A. Friedman-Kien |
|---|---|
| Rok vydání: | 2000 |
| Předmět: |
Adult
Male medicine.medical_specialty Skin Neoplasms medicine.medical_treatment Antineoplastic Agents Tretinoin Dermatology Administration Cutaneous Drug Administration Schedule law.invention Alitretinoin Randomized controlled trial law Immunopathology medicine Humans Adverse effect Kaposi's sarcoma Sarcoma Kaposi Chemotherapy AIDS-Related Opportunistic Infections Dose-Response Relationship Drug business.industry General Medicine Middle Aged medicine.disease United States Surgery Clinical trial Treatment Outcome Complication business Gels medicine.drug |
| Zdroj: | Archives of dermatology. 136(12) |
| ISSN: | 0003-987X |
| Popis: | 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).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.Nine academic clinical centers.One hundred fifteen patients with biopsy-proven acquired immunodeficiency syndrome (AIDS)-related KS.AIDS Clinical Trials Group response criteria.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/microL) 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.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. |
| Databáze: | OpenAIRE |
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