First-line cetuximab plus capecitabine in elderly patients with advanced colorectal cancer: Clinical outcome and subgroup analysis according to KRAS status from a Spanish TTD group study

Javier Sastre, Cristina Grávalos, Fernando Rivera, Bartomeu Massuti, Manuel Valladares-Ayerbes, Eugenio Marcuello, José L. Manzano, Manuel Benavides, Manuel Hidalgo, Eduardo Díaz-Rubio, Enrique Aranda

Research output: Contribution to journalArticle

Abstract

Single-agent cetuximab is safe and active in elderly patients with advanced colorectal cancer (CRC). A cetuximab-capecitabine combination has not previously been tested in elderly patients with advanced CRC. Material and Methods. Sixty-six patients with advanced CRC were treated with cetuximab as a 400 mg/m 2 i.v. infusion followed by 250 mg/m 2 i.v. weekly plus capecitabine at a dose of 1,250 mg/m 2 every 12 hours. After the inclusion of 27 patients, the protocol was amended for safety reasons, reducing the dose of capecitabine to 1,000 mg/m 2 every 12 hours. Thirty-nine additional patients were treated with the reduced dose of capecitabine. Results. The overall response rate was 31.8%. KRAS status was determined in 58 patients (88%). Fourteen of 29 patients with wild-type KRAS tumors responded (48.3%; 95% confidence interval [CI], 29.4%-67.5%), compared with six of 29 patients with mutant KRAS tumors (20.7%; 95% CI, 8.0%-39.7%). The median progression-free survival (PFS) interval was 7.1 months. The median PFS interval for patients whose tumors were wild-type KRAS was significantly longer than for those with mutant KRAS tumors (8.4 months versus 6.0 months; p = 024). The high incidence of severe paronychia (29.6%) declined (7.7%) after capecitabine dose adjustment. Conclusions. Cetuximab plus capecitabine at a dose of 1,000 mg/m 2 every 12 hours may be an alternative to more aggressive regimens in elderly patients with advanced wild-type KRAS CRC.

Original languageEnglish (US)
Pages (from-to)339-345
Number of pages7
JournalOncologist
Volume17
Issue number3
DOIs
StatePublished - Apr 10 2012

    Fingerprint

Keywords

  • Aged patients
  • Capecitabine
  • Cetuximab
  • Colorectal neoplasms

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Sastre, J., Grávalos, C., Rivera, F., Massuti, B., Valladares-Ayerbes, M., Marcuello, E., Manzano, J. L., Benavides, M., Hidalgo, M., Díaz-Rubio, E., & Aranda, E. (2012). First-line cetuximab plus capecitabine in elderly patients with advanced colorectal cancer: Clinical outcome and subgroup analysis according to KRAS status from a Spanish TTD group study. Oncologist, 17(3), 339-345. https://doi.org/10.1634/theoncologist.2011-0406