title: Incidence of hand-foot syndrome with capecitabine in combination with chemotherapy as first-line treatment in patients with advanced and/or metastatic gastric cancer suitable for treatment with a fluoropyrimidine-based regimen.
abstract: BACKGROUND
  Hand-foot syndrome (HFS) is a limiting toxicity of capecitabine, which is not life-threatening but could compromise capecitabine efficacy.
  
  
  METHODS
  This phase II, multicenter, non-controlled study assessed the safety, particularly grade three HFS incidence, and efficacy of four capecitabine-based chemotherapy regimens [cisplatin/capecitabine (CX), epirubicin/cisplatin/capecitabine (ECX), epirubicin/oxaliplatin/capecitabine (EOX) and docetaxel/cisplatin/capecitabine (DCX)] as first-line treatment for advanced and/or metastatic gastric cancer.
  
  
  RESULTS
  One hundred and eight patients were assigned to one of the four treatment groups, according to investigator's criteria, and grouped together for both safety and efficacy primary analyses. HFS was reported in 31 patients (19.6%) and its first presentation occurred at a median of 72 days (range 19-209 days). Grade 3 HFS developed in 6.3, 5.2, 3.7 and 2.4%, of patients receiving ECX, DCX, EOX or CX chemotherapy regimen, respectively. Capecitabine dose reduction/discontinuation due to HFS was required in 5.7% of patients (9/158). The most common (> 10%) grade 3-4 treatment-related AEs were neutropenia (15.2%), asthenia (12.0%) and diarrhoea (11.4%).
  
  
  CONCLUSIONS
  A moderate incidence of HFS was reported in patients treated with capecitabine, which generally presented late and required dose reduction in < 1/3 of patients. The results suggest that capecitabine may be useful in combination with standard fluorouracil-based regimens in patients with advanced and/or metastatic gastric cancer with favourable safety profile.
authors.affiliation: Gastrointestinal Cancer Unit, Medical Oncology Division, Doce de Octubre University Hospital, Avda de Córdoba s/n, 28041, Madrid, Spain. cgomezm@cnio.es
authors.forename: Carlos
authors.initials: C
authors.lastname: Gómez-Martin
authors.forename: Antonio
authors.initials: A
authors.lastname: Sánchez
authors.forename: Antonio
authors.initials: A
authors.lastname: Irigoyen
authors.forename: Beatriz
authors.initials: B
authors.lastname: Llorente
authors.forename: Begoña
authors.initials: B
authors.lastname: Pérez
authors.forename: Raquel
authors.initials: R
authors.lastname: Serrano
authors.forename: M José
authors.initials: MJ
authors.lastname: Safont
authors.forename: Esther
authors.initials: E
authors.lastname: Falcó
authors.forename: Adelaida
authors.initials: A
authors.lastname: Lacasta
authors.forename: Margarita
authors.initials: M
authors.lastname: Reboredo
authors.forename: Jorge
authors.initials: J
authors.lastname: Aparicio
authors.forename: Rosario
authors.initials: R
authors.lastname: Dueñas
authors.forename: Marta Llanos
authors.initials: ML
authors.lastname: Muñoz
authors.forename: Pilar
authors.initials: P
authors.lastname: Regueiro
authors.forename: Elena
authors.initials: E
authors.lastname: Sanchez-Viñes
authors.forename: Rafael López
authors.initials: RL
authors.lastname: López
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D060831:Hand-Foot Syndrome / Q000453:epidemiology* / Q000473:pathology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D015251:Epirubicin; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil