title: Efficacy and safety of capecitabine in heavily pretreated recurrent/metastatic head and neck squamous cell carcinoma.
abstract: The objective of this study was to evaluate the efficacy and tolerability of capecitabine as a single agent in the treatment of recurrent/metastatic head and neck squamous cell carcinoma. Patients were treated with oral capecitabine according to good clinical practice. Efficacy and safety outcomes were analyzed retrospectively. The response and adverse events rates and their exact confidence intervals (CIs) were calculated. Survival distributions were estimated using the Kaplan-Meier method. Twenty-nine patients were included in the study. Twenty-five patients (86%) had received at least three previous lines of chemotherapy. The disease control rate was 48% (95% CI: 29-67%). The median progression-free survival was 2.0 months (95% CI: 0.1-3.9 months) and the median overall survival was 7.0 months (95% CI: 4.1-9.9 months). Hand-foot syndrome, fatigue, and mucositis were the most frequent severe side effects. No patient died, and only three patients discontinued treatment because of side effects. Capecitabine seems to be an active and well-tolerated regimen, even in heavily pretreated, frail patients.
  
  
  METHODS
  2C 'Outcomes Research'.
authors.affiliation: Department of Medical Oncology, Centre Léon Bérard, University of Lyon, Lyon, France.
authors.forename: Julien
authors.initials: J
authors.lastname: Péron
authors.forename: Marc
authors.initials: M
authors.lastname: Poupart
authors.forename: Philippe
authors.initials: P
authors.lastname: Ceruse
authors.forename: Antoine
authors.initials: A
authors.lastname: Ramade
authors.forename: Didier
authors.initials: D
authors.lastname: Girodet
authors.forename: Philippe
authors.initials: P
authors.lastname: Zrounba
authors.forename: Jérôme
authors.initials: J
authors.lastname: Fayette
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000069287:Capecitabine; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D012189:Retrospective Studies; D000077195:Squamous Cell Carcinoma of Head and Neck; D015996:Survival Rate
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil