Here's the abstract on the halted International trial:
[618/22277] Topical 9-cis-Retinoic acid (PanretinT) gel as treatment of cutaneous AIDS-related Kaposis sarcoma: Interim results of an international, placebo-controlled trial (ALRT 1057-503) Neil Bodsworth On Behalf of the International Panretin KS Study Group International. Taylor Square Private Clinic, 302 Bourke Street Darlinghurst NSW 2010, Australia
Objective: To assess the efficacy and safety of Panretin 0.1% gel (9-cis-retinoic; Allergan Inc and Ligand Pharmaceuticals Inc.) as treatment of AIDS-related cutaneous Kaposis sarcoma (KS) lesions. Method: HIV-infected persons with <Picture>3 biopsy confirmed, cutaneous KS lesions and with no prior local treatment to indicator lesions nor prior systemic retinoids were eligible for this placebo-controlled, randomised (1:1 ratio), double-blind study of 0.1% 9-cis-retinoic acid gel. Gel or matching placebo vehicle was applied to lesions twice daily for 12-weeks or until lesions progressed (PD). Enrolment was at 17 sites in Australia, US and Europe. Response was assessed by measurement of lesions according to the ACTG KS criteria as applied to topical therapy for complete clinical response (CCR), partial response (PR) and progressive disease (PD) and with supportive photography. Target enrolment was 270. A single planned interim analysis was performed for the first 82 patients. Results: Accrual was ceased after the interim analysis showed a significant difference in treatment arms which met the trial's stopping rule (alpha < 0.005). Patients assigned active gel (n = 36) were significantly more likely than placebo assignees (n = 46) to respond (either CCR or PR) to treatment (41.7% vs 6.5%, p = 0.00027). Therapy was well tolerated with toxicity limited to local cutaneous irritation. Treatment arms (active vs placebo) were well matched for ethnicity, age, gender (all subjects were male), mean (ñ SE) CD4 cell count at baseline (197 ñ 29 vs 161 ñ 25), proportion receiving any antiRetroviral (ARV) therapy on study (95% vs 100%), any protease inhibitor (72% vs 87%) and any triple (or greater) ARV combination (78% vs 94%). Conclusion: In this international study, topical treatment of cutaneous KS lesions with 0.1% 9-cis-retinoic acid gel was associated with a six-fold improvement in response rate when compared to vehicle gel (42% vs 7%, p = 0.00027). Therapy was well tolerated with toxicity limited to local skin irritation.
Author-indicated categories:
Choice 1: Track B Clinical Science and Care, HIV-related Diseases, Kaposi's sarcoma
Choice 2: Track B Clinical Science and Care, Organ Systems, Dermatological
HIV-Associated Neoplasia
Presentation Date, Time, Room: 02-Jul-98, 3:00P, Hall VII |
