OBJECTIVES: We sought to determine the safety and efficacy of topical bexarotene (Targretin; Ligand Pharmaceuticals, La Jolla, Calif) gel 1% in patients with refractory or persistent early-stage cutaneous T-cell lymphoma. METHODS: We conducted a multinational, open-label, phase III study of 50 patients with stage IA to IIA cutaneous T-cell lymphoma. The primary end point classification was the overall complete and partial response rate by the higher of 2 measures: the Physician's Global Assessment of Clinical Condition or the Composite Assessment of Index Lesion Disease Severity. RESULTS: The overall response rates for the Physician's Global Assessment of Clinical Condition, Composite Assessment of Index Lesion Disease Severity, and primary end point classification were 44%, 46%, and 54%, respectively. The most common adverse events possibly related to study medication were mild to moderate irritant dermatitis, pruritus, pain (ie, primarily burning at application site), and skin disorder (eg, skin inflammation, excoriation, and new lesions). There were no serious treatment-related adverse events. CONCLUSIONS: Topical bexarotene gel was generally well tolerated and demonstrated substantial efficacy in patients with refractory or persistent early-stage cutaneous T-cell lymphoma.
OBJECTIVES: We sought to determine the safety and efficacy of topical bexarotene (Targretin; Ligand Pharmaceuticals, La Jolla, Calif) gel 1% in patients with refractory or persistent early-stage cutaneous T-cell lymphoma. METHODS: We conducted a multinational, open-label, phase III study of 50 patients with stage IA to IIA cutaneous T-cell lymphoma. The primary end point classification was the overall complete and partial response rate by the higher of 2 measures: the Physician's Global Assessment of Clinical Condition or the Composite Assessment of Index Lesion Disease Severity. RESULTS: The overall response rates for the Physician's Global Assessment of Clinical Condition, Composite Assessment of Index Lesion Disease Severity, and primary end point classification were 44%, 46%, and 54%, respectively. The most common adverse events possibly related to study medication were mild to moderate irritant dermatitis, pruritus, pain (ie, primarily burning at application site), and skin disorder (eg, skin inflammation, excoriation, and new lesions). There were no serious treatment-related adverse events. CONCLUSIONS: Topical bexarotene gel was generally well tolerated and demonstrated substantial efficacy in patients with refractory or persistent early-stage cutaneous T-cell lymphoma.
Authors: Joselin D Tacastacas; Derek V Chan; Sean Carlson; Stanton L Gerson; Afshin Dowlati; Pingfu Fu; Kurt Lu; Sarah Groft; Julie Rosenjack; Kord Honda; Thomas S McCormick; Kevin D Cooper Journal: JAMA Dermatol Date: 2017-05-01 Impact factor: 10.282
Authors: C O Anyanwu; D F Fiorentino; L Chung; C Dzuong; Y Wang; J Okawa; K Carr; K J Propert; V P Werth Journal: Br J Dermatol Date: 2015-08-11 Impact factor: 9.302
Authors: Stuart R Lessin; Madeleine Duvic; Joan Guitart; Amit G Pandya; Bruce E Strober; Elise A Olsen; Christopher M Hull; Elizabeth H Knobler; Alain H Rook; Ellen J Kim; Mark F Naylor; David M Adelson; Alexa B Kimball; Gary S Wood; Uma Sundram; Hong Wu; Youn H Kim Journal: JAMA Dermatol Date: 2013-01 Impact factor: 10.282
Authors: Misha Rosenbach; Dedee F Murrell; Jean-Claude Bystryn; Sam Dulay; Sarah Dick; Steve Fakharzadeh; Russell Hall; Neil J Korman; Julie Lin; Joyce Okawa; Amit G Pandya; Aimee S Payne; Mathew Rose; David Rubenstein; David Woodley; Carmela Vittorio; Benjamin B Werth; Erik A Williams; Lynne Taylor; Andrea B Troxel; Victoria P Werth Journal: J Invest Dermatol Date: 2009-04-09 Impact factor: 8.551