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The New England Journal of MedicinePreoperative Treatment of Locally Advanced Rectal Cancer

FOLFOX vs. Chemoradiotherapy: A Comparative Study in Locally Advanced Rectal Cancer Treatment


A recent study has shed light on the efficacy of neoadjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) as an alternative to chemoradiotherapy in treating locally advanced rectal cancer. The findings suggest a potential shift in the standard care approach.

  • The study was a multicenter, unblinded, noninferiority, randomized trial comparing neoadjuvant FOLFOX to chemoradiotherapy in locally advanced rectal cancer.
  • Participants were adults with clinically staged T2 node-positive, T3 node-negative, or T3 node-positive rectal cancer, eligible for sphincter-sparing surgery.
  • The primary end point was disease-free survival, with noninferiority claimed if the hazard ratio for disease recurrence or death did not exceed 1.29.
  • From 2012 to 2018, 1,194 patients were randomized, and 1,128 started treatment; 585 in the FOLFOX group and 543 in the chemoradiotherapy group.
  • At a median follow-up of 58 months, FOLFOX was found to be noninferior to chemoradiotherapy for disease-free survival (hazard ratio, 0.92; P=0.005 for noninferiority).
  • Five-year disease-free survival was 80.8% in the FOLFOX group and 78.6% in the chemoradiotherapy group.
  • Overall survival and local recurrence rates were similar between the two groups.

“In patients with locally advanced rectal cancer who were eligible for sphincter-sparing surgery, preoperative FOLFOX was noninferior to preoperative chemoradiotherapy with respect to disease-free survival.”

PROSPECT ClinicalTrials.gov number, NCT01515787
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