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Clinical Trial
. 2012;17(3):339-45.
doi: 10.1634/theoncologist.2011-0406. Epub 2012 Feb 23.

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  1 , Cristina Grávalos, Fernando Rivera, Bartomeu Massuti, Manuel Valladares-Ayerbes, Eugenio Marcuello, José L Manzano, Manuel Benavides, Manuel Hidalgo, Eduardo Díaz-Rubio, Enrique Aranda
Affiliations
Clinical Trial

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 et al. Oncologist. 2012.

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/m2 i.v. infusion followed by 250 mg/m2 i.v. weekly plus capecitabine at a dose of 1,250 mg/m2 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/m2 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/m2 every 12 hours may be an alternative to more aggressive regimens in elderly patients with advanced wild-type KRAS CRC.

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Conflict of interest statement

Disclosures: Javier Sastre: Roche (RF); Cristina Gràvalos: None; Fernando Rivera: Merck-Serono (RF); Bartomeu Massuti: Roche, Merck (C/A); Manuel Valladares-Ayerbes: Roche, Merck-Serono (H, RF); Eugenio Marcuello: None; José L. Manzano: None; Manuel Benavides: Roche (C/A); Manuel Hidalgo: None; Eduardo Díaz-Rubio: Merck-Serono, Roche (C/A, RF); Enrique Aranda: Roche, Merck-Serono (C/A).

Figures

Figure 1.
Figure 1.
Overall survival and progression-free survival times for the whole population by the Kaplan–Meier method. Abbreviations: CI, confidence interval; PFS, progression-free survival.
Figure 2.
Figure 2.
Progression-free survival (PFS) time according to KRAS status by the Kaplan–Meier method.
Figure 3.
Figure 3.
Overall survival time according to KRAS status by the Kaplan–Meier method.
See this image and copyright information in PMC

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