Capecitabine Established as Standard of Care in Pre-Op Rectal Cancer Setting

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.

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.

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.

Reference

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.