HealthDay News — For patients with stage III colon cancer, 3 months of capecitabine and oxaliplatin (CAPOX) therapy is not noninferior to 6 months of therapy overall, according to a study published in the March 20 issue the New England Journal of Medicine.

Axel Grothey, MD, from the Mayo Clinic in Rochester, Minnesota, and colleagues performed a prospective pooled analysis of six randomized, phase 3 trials conducted to assess the noninferiority of adjuvant therapy with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) or CAPOX administered for three versus 6 months. Noninferiority could be claimed if the upper limit of the two-sided 95 percent confidence interval of the hazard ratio did not exceed 1.12. 

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The researchers identified 3,263 events of disease recurrence or death in 12,834 patients; in the overall study population, the noninferiority of 3 months versus 6 months of treatment was not confirmed (hazard ratio, 1.07; 95% confidence interval, 1 to 1.15). Noninferiority was seen for CAPOX (hazard ratio, 0.95; 95% confidence interval, 0.85 to 1.06) but not for FOLFOX (hazard ratio, 1.16; 95% confidence interval, 1.06 to 1.26). For FOLFOX, a therapy duration of three months was inferior to a duration of six months when all stages and risk groups were combined.

“In patients treated with CAPOX, 3 months of therapy was as effective as 6 months, particularly in the lower-risk subgroup,” the authors write.

Several authors disclosed financial ties to the pharmaceutical industry.

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