Leoung GS, Aboulafla D, Millikan L, Duvic M, MacGregor RR, Gill G, Truglia J, Yocum R; International Conference on AIDS.
Int Conf AIDS. 1996 Jul 7-12; 11: 98 (abstract no. We.B.3241).
St. Francis Memorial Hosp, San Francisco, CA. Fax: (415) 353-6594.
Objective: To assess the safety and efficacy of a new topical retinoid gel, Targretin (LGD1069) on KS lesions. Methods: Fifty-nine patients with biopsy proven KS were randomized at 5 study sites in an unblinded fashion to either 0.5% vs. 1.0% gel, BID and increasing to 1.0% QID or the maximum dose tolerated. Patients who had an adverse event could be dropped down to 0.1% if necessary; then advanced again as tolerated. Patients' lesions were divided into control and treatment lesions, and were evaluated q2 weeks for 16 weeks then q4 weeks thereafter. After 8 weeks (later amended to 16 weeks), control lesions could be converted to treatment lesions and new (supplemental) lesions could also be treated. Response (by ACTG criteria) was defined as complete flattening of greater than or equal50% of raised lesions or greater than or equal 50% decrease of the total area of lesions. Adverse events were graded as mild, moderate, or severe. Results: Of 46 patients evaluable for response (on study greater than or equal 12 weeks of therapy), 7 (15.2%) had a partial response (PR) using ACTG criteria (reported at dose at which response first noted): 1 at 0.1% BID, 1 at 0.5% QD, 1 at 1.0% BID, 1 at 1.0% TID and 3 at 1.0% QID. Of the 7 PR patients, 3 had flattening of lesions, 4 had total lesion area decrease. The median time to PR was 10 weeks (range 4-22); the median duration of response was 18 weeks (range 6-28). Eight patients (17.4%) had progression with either a 25% increase in total area of treated lesions (6 patients) or flat lesions becoming raised (2 patients). All 59 patients were assessed for safety. No patient developed ADE's at 0.1%. Eleven of 33 patients (33%), while at 0.5% QD/BID experienced possibly/probably/definitely related adverse drug events (ADE) of rash, exfoliative dermatitis, maculopapular rash, eczema, or pain; none on TID/QID dosing. Twelve of 45 patients (26%) on 1.0% QD/BID experienced poss/prob/def related ADE; 7 patients (15%) on TID/QID dosing. Two patients randomized to 0.5% required dose reduction to 0.1%; no non-dermatologic ADE's were found at any strength. ADE's were classified as mild in 18 patients, moderate in 11 patients and severe in 1 patient. Conclusions: Targretin appears to have some efficacy for KS lesions and is accompanied by cutaneous irritation and the need for multiple applications. It may be most suitable for those patients who have limited early disease.
Publication Types:
Keywords:
- Disease Progression
- Drug Carriers
- Gels
- Humans
- Remission Induction
- Retinoids
- Sarcoma, Kaposi
- Tetrahydronaphthalenes
- Tretinoin
- bexarotene
- drug therapy
- therapy
Other ID:
UI: 102219492
From Meeting Abstracts