Tazarotene: randomized, double-blind, vehicle-controlled, and open-label concurrent trials for basal cell carcinoma prevention and therapy in patients with basal cell nevus syndrome.
Sporadic human basal cell carcinomas (BCC) are generally well managed with current surgical modalities. However, in the subset of high-risk patients predisposed to developing large numbers of BCCs, there is an unmet need for effective, low-morbidity chemoprevention. This population includes fair-skinned patients with extensive sun exposure and those with genodermatoses such as the basal cell nevus (Gorlin) syndrome (BCNS). Tazarotene (Tazorac, Allergan) is a topical retinoid with relative specificity for RAR-β and RAR-γ receptors. We previously demonstrated tazarotene's robust anti-BCC efficacy in Ptch1(+/-) mice, a murine equivalent of BCNS, and others have found it to have some efficacy against sporadic human BCCs. We report here results of a randomized, double-blind, vehicle-controlled study in patients with BCNS evaluating the efficacy of topically applied tazarotene for BCC chemoprevention (N = 34 subjects), along with an open-label trial evaluating tazarotene's efficacy for chemotherapy of BCC lesions (N = 36 subjects) for a maximum follow-up period of 3 years. We found that only 6% of patients had a chemopreventive response and that only 6% of treated BCC target lesions were clinically cured. Our studies provide no evidence for either chemopreventive or chemotherapeutic effect of tazarotene against BCCs in patients with BCNS.
Children's Hospital of Oakland Research Institute, 5700 Martin Luther King Jr. Way, Oakland, CA 94609. eepstein@chori.org.
Jean Y
JY
Tang
Albert S
AS
Chiou
Julian M
JM
Mackay-Wiggan
Michelle
M
Aszterbaum
Anita M
AM
Chanana
Wayne
W
Lee
Joselyn A
JA
Lindgren
Maria Acosta
MA
Raphael
Bobbye J
BJ
Thompson
David R
DR
Bickers
Ervin H
EH
Epstein
D000328:Adult; D001478:Basal Cell Nevus Syndrome / Q000188:drug therapy*; D002280:Basal Cell Carcinoma / Q000188:drug therapy* / Q000517:prevention & control*; D018592:Cross-Over Studies; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009539:Nicotinic Acids / Q000627:therapeutic use*; D014677:Pharmaceutical Vehicles; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000517:prevention & control*; D016896:Treatment Outcome; D012176:Retinoids
D003879:Dermatologic Agents; D009539:Nicotinic Acids; D014677:Pharmaceutical Vehicles; C086827:tazarotene; D012176:Retinoids