title: Phase II study of gemcitabine and bexarotene (GEMBEX) in the treatment of cutaneous T-cell lymphoma.
abstract: BACKGROUND
  Both gemcitabine and bexarotene are established single agents for the treatment of cutaneous T-cell lymphoma (CTCL). We investigated the feasibility and efficacy of combining these drugs in a single-arm phase II study.
  
  
  METHODS
  Cutaneous T-cell lymphoma patients who had failed standard skin-directed therapy and at least one prior systemic therapy were given four cycles of gemcitabine and concurrent bexarotene for 12 weeks. Responders were continued on bexarotene maintenance until disease progression or unacceptable toxicity.
  
  
  RESULTS
  The median age was 65 years, stage IB (n=5), stage IIA (n=2), stage IIB (n=8), stage III (n=8) and stage IVA (n=12), 17 patients were erythrodermic, 17 patients were B1, and 10 patients were both erythrodermic and B1. Thirty (86%) patients completed four cycles of gemcitabine. In all, 80.0% of patients demonstrated a reduction in modified Severity-Weighted Assessment Tool (mSWAT) score although the objective disease response rate at 12 weeks was 31% (partial response (PR) 31%) and at 24 weeks 14% (PR 14%, stable disease (SD) 23%, progressive disease (PD) 54%, not evaluable 9%). Median progression-free survival was 5.3 months and median overall survival was 21.2 months.
  
  
  CONCLUSIONS
  The overall response rate of the combination did not reach the specified target to proceed further and is lower than that previously reported for gemcitabine as a single agent.
authors.affiliation: Manchester Academic Health Science Centre, Institute of Cancer Sciences, University of Manchester, The Christie, Wilmslow Road, Manchester, M20 4BX, UK.
authors.forename: T
authors.initials: T
authors.lastname: Illidge
authors.forename: C
authors.initials: C
authors.lastname: Chan
authors.forename: N
authors.initials: N
authors.lastname: Counsell
authors.forename: S
authors.initials: S
authors.lastname: Morris
authors.forename: J
authors.initials: J
authors.lastname: Scarisbrick
authors.forename: D
authors.initials: D
authors.lastname: Gilson
authors.forename: B
authors.initials: B
authors.lastname: Popova
authors.forename: P
authors.initials: P
authors.lastname: Patrick
authors.forename: P
authors.initials: P
authors.lastname: Smith
authors.forename: S
authors.initials: S
authors.lastname: Whittaker
authors.forename: R
authors.initials: R
authors.lastname: Cowan
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000077610:Bexarotene; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D006113:United Kingdom / Q000453:epidemiology; D000093542:Gemcitabine
chemical_list: D013764:Tetrahydronaphthalenes; D003841:Deoxycytidine; D000077610:Bexarotene; D000093542:Gemcitabine