SCOT.

Same song different verse. Over 6000 patients with high risk stage II (T4, high grade, obstruction, LVSI, PNI, or <10 nodes examined) or stage III colorectal cancer were randomized to 3 or 6 months of investigator’s choice FOLFOX (33%) or CAPOX (67%). Again, this was a noninferiority design with a primary endpoint of disease free survival (DFS). Just over 6000 of a planned 9500 patients were randomized, meaning this study was really underpowered with only about half the number of events needed. Nevertheless, 3 year DFS was so close between arms (76.7% versus 77.1%) that it met noninferiority criteria. Yet again this didn’t hold true for FOLFOX, nor with N2 disease. As expected, neuropathy significantly decreased with 3 versus 6 months of chemo (58→25%). TBL: SCOT did demonstrate noninferiority of 3 versus 6 months of chemo, with subset analyses consistent with the pooled analysis. | Iverson, Lancet Oncol 2018