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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

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Abstract

Introduction

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.

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.

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Acknowledgments

This study was supported by Roche Farma S. A. Other institutions and principal investigators who participated in the study are as follows: Alberto Abad. Oncology service. Germans Trias i Pujol Hospital. Barcelona, Spain; Alberto Arizcun. Oncology service. Palencia Hospital. Palencia, Spain; Emilio Fonseca, Oncology service. Clínico de Salamanca Hospital. Salamanca, Spain; María Gómez–Reina. Oncology service. Puerta del Mar Hospital. Cadiz, Spain; Raquel Guardeño. Oncology service. ICO Gerona (Josep Trueta) Hospital. Gerona, Spain; Purificación Martínez. Basurto Hospital. Bilbao, Spain; Miguel Méndez, Oncology service. Móstoles Hospital. Madrid, Spain; Jesús García-Foncillas López. Oncology service. Clínical University of Navarra (CUN). Navarra, Spain; Luis López-Gómez. Oncology service. Complejo Virgen de la Salud Hospital. Toledo, Spain; Jose L. García López. Oncology service. Ramón y Cajal Hospital. Madrid, Spain; Rodrigo Lastra del Prado. Oncology service. San Jorge Hospital. Huesca, Spain; Amparo Oltra. Oncology service. Virgen de los Lirios Hospital. Alicante, Spain; Pedro Salinas Hernández. Oncology service. Grupo Hospitalario Quirón. Madrid, Spain; Mª Antonieta Salud. Oncology service. Universitari Arnau de Vilanova Hospital. Lleida, Spain; Marina Alonso. Oncology service. San Pedro Hospital. Logroño, Spain.; Isabel Busquier. Oncology service. Provincial de Castellón Hospital,. Castellón, Spain; Nuria Cárdenas. Oncology service. San Cecilio Hospital. Granada, Spain; Javier Castellanos. “Xeral Cíes” University Hospital. Vigo, Spain; Teresa García García. Oncology service. Morales Meseguer H. Murcia, Spain; Alicia Hurtado. Oncology service. Fundación Alcorcón Hospital. Madrid, Spain; Antonio Lorenzo Peñuelas. Oncology service. Puerto Real Hospital. Cadiz, Spain; Jose Ramón Mel Lorenzo. Oncology service. Xeral Calde de Lugo Hospital. Lugo, Spain; Manuel Ramos Vazquez. Oncology service. Oncologic Centre of de Galicia “José Antonio Quiroga y Piñeyro”. La Coruña, Spain; Ruth Vera. Oncology service. Navarra Hospital. Pamplona, Spain.

Conflict of interest

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Authors and Affiliations

  1. Gastrointestinal Cancer Unit, Medical Oncology Division, Doce de Octubre University Hospital, Avda de Córdoba s/n, 28041, Madrid, Spain

    Carlos Gómez-Martin

  2. Oncology Department, Puerta de Hierro University Hospital, c\ Joaquin Rodrigo, Majadahonda, 28222, Madrid, Spain

    Antonio Sánchez

  3. Oncology Department, Virgen de las Nieves Hospital, Avda. de las Fuerzas Armadas, 2, 18012, Granada, Spain

    Antonio Irigoyen

  4. Medical Oncology Department, General Yagüe Hospital, Avda. del Cid s/n, 09005, Burgos, Spain

    Beatriz Llorente

  5. Oncology Department, Virgen del Rocío Hospital, Avda. Manuel Siurot, s/n, 41013, Sevilla, Spain

    Begoña Pérez

  6. Oncology Department, Reina Sofía Hospital, Avda. Menéndez Pidal, s/n, 14004, Córdoba, Spain

    Raquel Serrano

  7. Oncology Department, General Hospital of Valencia, Avda. Tres Cruces, s/n, 46014, Valencia, Spain

    Mª José Safont

  8. Oncology Department, Son Llatzer Hospital, Palma de Mallorca. Ctra. Manacor, km 4, 07198, Palma de Mallorca, Spain

    Esther Falcó

  9. Oncology Department, Donostia Hospital, Paseo Doctor Beguiristain s/n, 20014, Donostia, Spain

    Adelaida Lacasta

  10. Oncology Department, Juan Canalejo Hospital, c/Xubias de Arriba, 84, 15006, A Coruña, Spain

    Margarita Reboredo

  11. Oncology Department, La Fé Hospital, Avda. Campanar, 21, 46009, Valencia, Spain

    Jorge Aparicio

  12. Oncology Department, Hospital of Jaen, Avda. del Ejército Español, 10, 23007, Jaen, Spain

    Rosario Dueñas

  13. Oncology Department, University Hospital of Canarias, c/Ofra, s/n. La Cuesta- La Laguna, 38320, Santa Cruz de Tenerife, Spain

    Marta Llanos Muñoz

  14. Medical Department, Roche Farma, S.A. c/Eucalipto, 33, 28016, Madrid, Spain

    Pilar Regueiro & Elena Sanchez-Viñes

  15. Oncology Department, Complejo Hospitalario Universitario of Santiago, c/Travesía da Choupana, s/n, 15706, Santiago de Compostela, Spain

    Rafael López López

  16. Gastrointestinal Cancer Clinical Research Unit, Clinical Research Programme, Spanish National Câncer Research Centre (CNIO), Fuenlabrada University Hospital, Camino Del Molino 2, 28942, Madrid, Spain

    Carlos Gómez-Martin

Authors
  1. Carlos Gómez-Martin
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  2. Antonio Sánchez
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  3. Antonio Irigoyen
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  4. Beatriz Llorente
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  6. Raquel Serrano
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  7. Mª José Safont
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  8. Esther Falcó
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  9. Adelaida Lacasta
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  10. Margarita Reboredo
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  11. Jorge Aparicio
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  13. Marta Llanos Muñoz
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  14. Pilar Regueiro
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  15. Elena Sanchez-Viñes
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  16. Rafael López López
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Corresponding author

Correspondence to Carlos Gómez-Martin.

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Gómez-Martin, C., Sánchez, A., Irigoyen, A. et al. 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. Clin Transl Oncol 14, 689–697 (2012). https://doi.org/10.1007/s12094-012-0858-3

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