Clinical and Translational Oncology

, Volume 14, Issue 9, pp 689–697

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


    • Gastrointestinal Cancer Unit, Medical Oncology DivisionDoce de Octubre University Hospital
    • Gastrointestinal Cancer Clinical Research Unit, Clinical Research ProgrammeSpanish National Câncer Research Centre (CNIO), Fuenlabrada University Hospital
  • Antonio Sánchez
    • Oncology DepartmentPuerta de Hierro University Hospital
  • Antonio Irigoyen
    • Oncology DepartmentVirgen de las Nieves Hospital
  • Beatriz Llorente
    • Medical Oncology DepartmentGeneral Yagüe Hospital
  • Begoña Pérez
    • Oncology DepartmentVirgen del Rocío Hospital
  • Raquel Serrano
    • Oncology DepartmentReina Sofía Hospital
  • Mª José Safont
    • Oncology DepartmentGeneral Hospital of Valencia
  • Esther Falcó
    • Oncology DepartmentSon Llatzer Hospital
  • Adelaida Lacasta
    • Oncology DepartmentDonostia Hospital
  • Margarita Reboredo
    • Oncology DepartmentJuan Canalejo Hospital
  • Jorge Aparicio
    • Oncology DepartmentLa Fé Hospital
  • Rosario Dueñas
    • Oncology DepartmentHospital of Jaen
  • Marta Llanos Muñoz
    • Oncology DepartmentUniversity Hospital of Canarias
  • Pilar Regueiro
    • Medical DepartmentRoche Farma
  • Elena Sanchez-Viñes
    • Medical DepartmentRoche Farma
  • Rafael López López
    • Oncology DepartmentComplejo Hospitalario Universitario of Santiago
Research Article

DOI: 10.1007/s12094-012-0858-3

Cite this article as:
Gómez-Martin, C., Sánchez, A., Irigoyen, A. et al. Clin Transl Oncol (2012) 14: 689. doi:10.1007/s12094-012-0858-3



Hand–foot syndrome (HFS) is a limiting toxicity of capecitabine, which is not life-threatening but could compromise capecitabine efficacy.

Materials and 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.


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 %).


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.


Capecitabine stomach neoplasmsNeoplasm metastasisFluorouracilFoot dermatoses/chemically inducedHand dermatoses/chemically induced

Copyright information

© Federación de Sociedades Españolas de Oncología (FESEO) 2012