- In clinical high-risk, stage II colorectal cancer (CRC), 6 months of FOLFOX (fluorouracil, leucovorin, and oxaliplatin) led to better 5-year relapse-free survival (RFS) than 3 months, but 3 months of CAPOX (capecitabine plus oxaliplatin) was noninferior to 6 months.
Why this matters
- 3 months of CAPOX and 6 months of FOLFOX are viable options.
- Preplanned subgroup analysis of patients with stage II CRC in a phase 3, randomized, controlled trial (TOSCA, n=1254) that compared treatment with FOLFOX or CAPOX for 3 or 6 months.
- Funding: Italian Group for the Study of Digestive Tract Cancers Foundation; Agenzia Italiana del Farmaco.
- Median follow-up, 62 months; 24.0% pT4N0M0 tumors, 76.0% high-risk pT3N0M0 tumors.
- 61.9% received FOLFOX, 38.1% CAPOX.
- Among those who underwent 3 months of treatment, 5-year RFS was 82.2% vs 88.2% for 6 months (HR, 1.41; P=.02 for superiority).
- In the CAPOX regimen, 3 months was noninferior to 6 months with respect to 5-year RFS (HR, 1.13; 95% CI, 0.70-1.84).
- In the FOLFOX regimen, 6 months was associated with better RFS (HR, 1.58; 95% CI, 1.09-2.28).
- The 6-month group had a greater frequency of grade 3-4 neuropathy (8.4% vs 1.3%; P<.001>
- Secondary analysis.