Capecitabine should be considered a standard of care in the pre-operative rectal cancer setting, a recent study published online ahead of print in the Journal of the National Cancer Institute has shown.1

Researchers from various institutions across the United States designed the National Surgical Adjuvant Breast and Bowel Project R-04 to evaluate whether capecitabine, an oral fluoropyrimidine, could be substituted for continuous infusion fluorouracil (5-FU) for the treatment of patients with stage 2 or 3 rectal cancer with curative intent during neoadjuvant radiotherapy.

Researchers also sought to determine whether the addition of oxaliplatin could further improve the activity of fluoropyrimidine-sensitized radiation.

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For the phase 3 trial, researchers enrolled 1,608 patients with clinical stage 2 or 3 rectal cancer undergoing preoperative radiotherapy. Participants were randomly assigned to receive continuous infusion 5-FU or capecitabine with or without oxaliplatin.

Results showed no statistically significant differences in 5-year disease-free survival, 3-year local-regional tumor event rates, or 5-year overall survival between regimens comparing 5-FU with capecitabine.

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Researchers also found no statistically significant differences between regimens with oxaliplatin and those without oxaliplatin. Oxaliplatin was significantly associated with increased overall and grade 3 to 4 diarrhea.

The findings suggest that oxaliplatin does not improve efficacy and increases toxicity in this patient population, and capecitabine combined with radiotherapy produces similar outcomes to those achieved with continuous infusion 5-FU.


  1. Allegra CJ, Yothers G, O’Connell MJ, et al. Neoadjuvant 5-FU or capecitabine plus radiation with or without oxaliplatin in rectal cancer patients: a phase III randomized clinical trial [published online ahead of print September 14, 2015]. J Natl Cancer Inst. doi: 10.1093/jnci/djv248.