Incidence of hand–foot syndrome with capecitabine in combination with chemotherapy as first-line treatment in patients with advanced and/or metastatic gastric ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2012-07-19

AUTHORS

Carlos Gómez-Martin, Antonio Sánchez, Antonio Irigoyen, Beatriz Llorente, Begoña Pérez, Raquel Serrano, Mª José Safont, Esther Falcó, Adelaida Lacasta, Margarita Reboredo, Jorge Aparicio, Rosario Dueñas, Marta Llanos Muñoz, Pilar Regueiro, Elena Sanchez-Viñes, Rafael López López

ABSTRACT

IntroductionHand–foot syndrome (HFS) is a limiting toxicity of capecitabine, which is not life-threatening but could compromise capecitabine efficacy.Materials and methodsThis 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.ResultsOne 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 %).ConclusionsA 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. More... »

PAGES

689-697

Journal

TITLE

Clinical and Translational Oncology

ISSUE

9

VOLUME

14

Author Affiliations

  • Gastrointestinal Cancer Clinical Research Unit, Clinical Research Programme, Spanish National Câncer Research Centre (CNIO), Fuenlabrada University Hospital, Camino Del Molino 2, 28942, Madrid, Spain
  • Oncology Department, Puerta de Hierro University Hospital, c\ Joaquin Rodrigo, Majadahonda, 28222, Madrid, Spain
  • Oncology Department, Virgen de las Nieves Hospital, Avda. de las Fuerzas Armadas, 2, 18012, Granada, Spain
  • Medical Oncology Department, General Yagüe Hospital, Avda. del Cid s/n, 09005, Burgos, Spain
  • Oncology Department, Virgen del Rocío Hospital, Avda. Manuel Siurot, s/n, 41013, Sevilla, Spain
  • Oncology Department, Reina Sofía Hospital, Avda. Menéndez Pidal, s/n, 14004, Córdoba, Spain
  • Oncology Department, General Hospital of Valencia, Avda. Tres Cruces, s/n, 46014, Valencia, Spain
  • Oncology Department, Son Llatzer Hospital, Palma de Mallorca. Ctra. Manacor, km 4, 07198, Palma de Mallorca, Spain
  • Oncology Department, Donostia Hospital, Paseo Doctor Beguiristain s/n, 20014, Donostia, Spain
  • Oncology Department, Juan Canalejo Hospital, c/Xubias de Arriba, 84, 15006, A Coruña, Spain
  • Oncology Department, La Fé Hospital, Avda. Campanar, 21, 46009, Valencia, Spain
  • Oncology Department, Hospital of Jaen, Avda. del Ejército Español, 10, 23007, Jaen, Spain
  • Oncology Department, University Hospital of Canarias, c/Ofra, s/n. La Cuesta- La Laguna, 38320, Santa Cruz de Tenerife, Spain
  • Medical Department, Roche Farma, S.A. c/Eucalipto, 33, 28016, Madrid, Spain
  • Oncology Department, Complejo Hospitalario Universitario of Santiago, c/Travesía da Choupana, s/n, 15706, Santiago de Compostela, Spain
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s12094-012-0858-3

    DOI

    http://dx.doi.org/10.1007/s12094-012-0858-3

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1036087970

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/22855151


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        "description": "IntroductionHand\u2013foot syndrome (HFS) is a limiting toxicity of capecitabine, which is not life-threatening but could compromise capecitabine efficacy.Materials and methodsThis 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.ResultsOne hundred and eight patients were assigned to one of the four treatment groups, according to investigator\u2019s criteria, and grouped together for both safety and efficacy primary analyses. HFS was reported in 31 patients (19.6\u00a0%) and its first presentation occurred at a median of 72\u00a0days (range 19\u2013209\u00a0days). Grade 3 HFS developed in 6.3, 5.2, 3.7 and 2.4\u00a0%, of patients receiving ECX, DCX, EOX or CX chemotherapy regimen, respectively. Capecitabine dose reduction/discontinuation due to HFS was required in 5.7\u00a0% of patients (9/158). The most common (>10\u00a0%) grade 3\u20134 treatment-related AEs were neutropenia (15.2\u00a0%), asthenia (12.0\u00a0%) and diarrhoea (11.4\u00a0%).ConclusionsA 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.", 
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