THURSDAY, March 29, 2018 (HealthDay News) -- For patients with stage III colon cancer, three months of capecitabine and oxaliplatin (CAPOX) therapy is not noninferior to six months of therapy overall, according to a study published in the March 20 issue the New England Journal of Medicine.
Axel Grothey, M.D., from the Mayo Clinic in Rochester, Minn., 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 six 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.
The researchers identified 3,263 events of disease recurrence or death in 12,834 patients; in the overall study population, the noninferiority of three months versus six months of treatment was not confirmed (hazard ratio, 1.07; 95 percent confidence interval, 1 to 1.15). Noninferiority was seen for CAPOX (hazard ratio, 0.95; 95 percent confidence interval, 0.85 to 1.06) but not for FOLFOX (hazard ratio, 1.16; 95 percent 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, three months of therapy was as effective as six months, particularly in the lower-risk subgroup," the authors write.
Several authors disclosed financial ties to the pharmaceutical industry.
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