title: Phase 1 and 2 trial of bexarotene gel for skin-directed treatment of patients with cutaneous T-cell lymphoma.
abstract: OBJECTIVE
  To evaluate the safety, dose tolerance, and efficacy of topical bexarotene gel in patients with early-stage cutaneous T-cell lymphoma (CTCL).
  
  
  METHODS
  Phase 1 and 2, open-label, dose-escalation clinical trial of bexarotene gel.
  
  
  METHODS
  Three university-based clinics.
  
  
  METHODS
  Sixty-seven adults with early-stage (TNM stages IA-IIA) CTCL.
  
  
  METHODS
  Bexarotene gel, 0.1%, 0.5%, and 1.0%, applied in incremental dose adjustments from 0.1% gel every day to 1.0% gel 4 times daily or the maximal tolerated dose.
  
  
  METHODS
  Patients were followed for efficacy and safety, and treatment continued as long as they benefited. Response (> or =50% improvement) was evaluated by the Physician's Global Assessment of cutaneous disease and by an overall severity assessment of cutaneous disease, including signs of CTCL and area involved.
  
  
  RESULTS
  Most patients tolerated topical bexarotene at 1% gel twice daily for routine use. Adverse events were generally mild to moderate in severity and were confined to treatment sites. Treatment-limiting toxic effects were associated with skin irritation and increased with gel exposure. Patients achieved an overall response rate of 63% and a clinical complete response rate of 21%. Median projected time to onset of response was 20.1 weeks (range, 4.0-86.0 weeks), and the estimated median response duration from the start of therapy was 99 weeks. Patients with no previous therapy for mycosis fungoides responded at a higher rate (75%) than those who previously underwent topical therapies (67%).
  
  
  CONCLUSIONS
  Bexarotene gel was well tolerated, was easily self-applied, and had a substantial response rate in treating patients with early-stage CTCL.
authors.affiliation: Department of Dermatology, University of Cincinnati, OH, USA.
authors.forename: Debra
authors.initials: D
authors.lastname: Breneman
authors.forename: Madeleine
authors.initials: M
authors.lastname: Duvic
authors.forename: Timothy
authors.initials: T
authors.lastname: Kuzel
authors.forename: Richard
authors.initials: R
authors.lastname: Yocum
authors.forename: Joseph
authors.initials: J
authors.lastname: Truglia
authors.forename: Victor J
authors.initials: VJ
authors.lastname: Stevens
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016588:Anticarcinogenic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000077610:Bexarotene; D005260:Female; D005782:Gels; D006801:Humans; D016399:Lymphoma, T-Cell / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D012449:Safety; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D016588:Anticarcinogenic Agents; D005782:Gels; D013764:Tetrahydronaphthalenes; D000077610:Bexarotene