FRIDAY, June 9, 2023 (HealthDay News) -- Neoadjuvant chemotherapy with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) is noninferior to preoperative chemoradiotherapy with respect to overall survival for patients with locally advanced rectal cancer who are eligible for sphincter-sparing surgery, according to a study published online June 4 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Clinical Oncology, held from June 2 to 6 in Chicago.
Deborah Schrag, M.D., M.P.H., from the Memorial Sloan Kettering Cancer Center in New York, and colleagues conducted a multicenter noninferiority trial of neoadjuvant FOLFOX as compared to chemoradiotherapy among patients with rectal cancer that had been clinically staged as T2 node-positive, T3 node-negative, or T3 node-positive who were candidates for sphincter-sparing surgery. Disease-free survival was assessed as the primary end point.
Data were analyzed for 1,128 patients who started treatment: 585 and 543 in the FOLFOX and chemoradiotherapy groups, respectively. The researchers found that FOLFOX was noninferior to chemoradiotherapy for disease-free survival at a median follow-up of 58 months (hazard ratio for recurrence of death, 0.92; 90.2 percent confidence interval, 0.74 to 1.14; P = 0.005 for noninferiority). Five-year disease-free survival was 80.8 and 78.6 percent in the FOLFOX and chemoradiotherapy groups, respectively. With respect to overall survival and local recurrence, the groups were similar.
"The findings in this trial have extended the therapeutic options by showing the noninferiority of neoadjuvant FOLFOX with selective use of chemoradiotherapy to the prevailing standard of neoadjuvant chemoradiotherapy," the authors write.
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