CapeOx “sandwich” TNT (fluoropyrimidine/oxaliplatin + RT) drives 46.9%cCR and 46.4%pCR in low-risk distal LARC

CapeOx (capecitabine + oxaliplatin) is a fluoropyrimidine/platinum doublet used here as a “sandwich” total neoadjuvant therapy (TNT) backbone, delivered as 2 cycles before, during, and after long-course radiotherapy, followed by surgery or watch-and-wait, plus 2 cycles of adjuvant capecitabine in the Phase II, multicenter, single-arm TESS trial (NCT03840239) in relatively low-risk distal locally advanced rectal cancer (n=98). In the intention-to-treat population, clinical complete response (cCR) was 46.9% (near-cCR 7.1%); in the observed population, complete response (clinical + pathologic) was 61.2% with a pathological complete response (pCR) of 46.4% and sphincter preservation of 79.6%, alongside reported local regrowth–free survival 89.5%, local recurrence–free survival 100%, distant metastasis–free survival 92.9%, and overall survival 96.9%. Versus common TNT benchmarks, the pCR here sits above the ~20%–30% range reported in large Phase III TNT programs like RAPIDO/PRODIGE 23 (with mandatory TME), while organ-preservation-focused TNT programs (e.g., OPRA) more often report organ preservation in the ~50% range rather than pCR as the defining endpoint—making TESS notable mainly for the high cCR/pCR in a selected “low-risk distal” population rather than proving superiority across unselected LARC.