Phase I-II evaluation of Panretin (ALRT1057; LGD1057; AGN192013; 9-cis-retinoic acid) topical gel for AIDS-related cutaneous Kaposi's sarcoma (Meeting abstract).

Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

Phase I-II evaluation of Panretin (ALRT1057; LGD1057; AGN192013; 9-cis-retinoic acid) topical gel for AIDS-related cutaneous Kaposi's sarcoma (Meeting abstract).

Proc Annu Meet Am Soc Clin Oncol; 16:A160 1997. Unique Identifier : AIDSLINE MED/97622151
uvic M; Friedman-Kien AE; Miles SA; Looney DJ; Stevens V; Truglia J; Yocum R; University of Texas, Houston, TX

Abstract: PANRETIN topical gel applied to Kaposi's sarcoma (KS) index lesions 1-4 times daily was evaluated for safety and efficacy in controlled Phase I-II studies. 115 AIDS patients with biopsy-proven KS were enrolled at nine centers. 752 treated index and 264 intrapatient control cutaneous KS lesions were evaluated. The control lesions were selected for similar characteristics and monitored untreated for 8 to 16 weeks. Patient responses were assessed using Aids Clinical Trial Group criteria applied to topical therapy. PANRETIN Topical was well-tolerated with some application site erythema but no measurable systemic absorption. In the intent-to-treat analysis, a PRH (partial response by complete flattening of 50% of lesions) or PRA (partial response by 50% decrease in the sum of lesion areas) was achieved in 27% 31/115) of patients for the group of treated index lesions versus 15% (17/115) for the control lesion group (p=0.016, matched pairs analysis). Eighty-seven percent of treatment responses were PRH. In the evaluable patient analysis (89 patients treated long enough to determine a response), a PRH or PRA was achieved in 35% (31/89) of patients for the group of treated index lesions versus 19% (17/89) for the control lesions p=0.016, matched pairs analysis). Control lesion responses were attributed in part to evidence that some patients applied PANRETIN Topical to control lesions in violation of the protocol. Eleven (35%) of the patient responders for the treated index lesions had response despite CD4 counts below 50/mm3. Median follow-up from the onset of response was 16+ weeks, with 74% 23/31) of patient responders for treated index lesions remaining in response. In contrast, the median time in response for the 8 patients who relapsed was 8 weeks. PANRETIN Topical Gel appears safe, well-tolerated and produces durable responses even with low- CD4 counts, lending itself to noninvasive, patient-controlled, outpatient-management of cutaneous KS. (C) American Society of Clinical Oncology 1997

Keywords: *AIDS-Related Opportunistic Infections/DRUG THERAPY *Retinoids/PHARMACOLOGY *Sarcoma, Kaposi/DRUG THERAPY *Skin Neoplasms/DRUG THERAPY
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