Three vs 6 months of oxaliplatin-based adjuvant chemotherapy for patients with stage III colon cancer: Disease-free survival results from a randomized, open-label, International Duration Evaluation of Adjuvant Chemotherapy (IDEA) France, phase III trial
Journal of Clinical Oncology Apr 11, 2018
Andre T, et al. - Researchers report the disease-free survival (DFS) results with respect to reduced adjuvant treatment duration in stage III colon cancer in International Duration Evaluation of Adjuvant Chemotherapy (IDEA) France, a phase III trial, wherein colon cancer patients were randomly assigned to 3 and 6 months of modified FOLFOX6 (mFOLFOX6: infusional fluorouracil, leucovorin, and oxaliplatin) or capecitabine plus oxaliplatin (CAPOX) by physician choice. mFOLFOX6 was given to 90% of patients. Six vs 3 months of adjuvant chemotherapy was shown to be superior, especially in the T4 and/or N2 subgroups. These results should be considered alongside the international IDEA collaboration data.
Methods- By physician choice, randomization of colon cancer patients to 3 and 6 months of modified FOLFOX6 (mFOLFOX6: infusional fluorouracil, leucovorin, and oxaliplatin) or capecitabine plus oxaliplatin (CAPOX) was carried out in International Duration Evaluation of Adjuvant Chemotherapy (IDEA) France, as part of the IDEA international collaboration.
- Disease-free survival (DFS) was the primary end point, and analyses were descriptive.
- Either 3 or 6 months of chemotherapy was received by 2,010 eligible patients (modified intention-to-treat population); 2,000 (99%) had stage III colon cancer (N1: 75%, N2: 25%); 1,809 (90%) received mFOLFOX6, and 201 (10%) received CAPOX.
- Data showed that the median age was 64 years, and the median follow-up time was 4.3 years.
- Treatment was completed (fluoropyrimidines ± oxaliplatin) by 94% (3 months) and 78% (6 months) of patients.
- As per findings, maximal grade 2 and 3 neuropathy rates were 28% and 8% in the 3-month arm and 41% and 25% in the 6-month arm (P < .001).
- In the 3-month arm and in the 6-month arm (P < .001), final rates of residual neuropathy greater than grade 1 were 3% and 7%, respectively.
- A total of 578 DFS events were reported: 314 and 264 in the 3- and 6-month arms, respectively.
- Researchers noted that the 3-year DFS rates were 72% and 76% in the 3- and 6-month arms, respectively (hazard ratio [HR], 1.24; 95% CI, 1.05 to 1.46; P=.0112).
- They also observed that in the 3 and 6-month arms, respectively, for patients who received mFOLFOX6, the 3-year DFS rates were 72% and 76% (HR, 1.27; 95% CI, 1.07 to 1.51); for the T4 and/or N2 population, they were 58% and 66% (HR, 1.44; 95% CI, 1.14 to 1.82); and for the T1-3N1 population, they were 81% and 83% (HR, 1.15; 95% CI, 0.89 to 1.49).
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