Important secondary analysis of the OPRA trial with a median f/u of 4 years. This provides important details from a landmark study, and can help guide patient counseling. Of note, it's not broken down to compare induction TNT to consolidation TNT. My analysis is long-winded, and the target audience is surgeons who offer organ preservation to patients with rectal cancer: Patients with a cCR at restaging: 98% offered organ preservation/watch-and-wait (WW), of which 22% experienced local regrowth. Patients with a sustained cCR had a 5% rate of distant metastases. Of the local regrowths, 93% underwent salvage TME and 7% underwent salvage local excision. For these patients, 33% developed recurrence (4% local, 22% distant, and 7% local+distant). _______________________________________ Patients with a near-complete CR at restaging: 20 (17.5%) went straight to surgery, of which only 3 (16%) had a pathologic CR (pCR). Recurrence after upfront TME for near-cCR was 30% (15% local, 10% distant, 5% local+distant). These numbers were small (n=3 for local recurrence) and should be interpreted with caution. Of the remaining 94 patients (82.5%) who underwent WW, 48 (51%) developed local regrowth. Salvage TME was performed in 34 patients (71% compared to 93% for cCRs). 2 of 34 TMEs (6%) had a pCR. For patients with a near-cCR who developed regrowth after WW, 33% developed recurrence (4% local, 21% distant, 8% local+distant). Of the 46 patients (40%) with a near-cCR who remained in the WW program, 13% developed distant metastases (compared to 5% for cCRs). ______________________________________ Patients with an incomplete response at restaging: 88% were offered upfront TME, of which 4/51 (8%) had a pCR. For ICR and upfront TME, recurrence rate was 35% (3.5% local, 21% distant, 10.5% local+distant). 8 patients with incomplete response were still enrolled in WW for different reasons, of which 5/8 (63%) developed local regrowth. All 5 underwent TME, and the local recurrence was 20% (1/5). Of the 3/8 that remained in WW without regrowth, 2/3 (66%) developed lung metastases. _______________________________________ Overall, the 3-year organ preservation rate was 77% for cCRs and 40% for near-cCRs. The median time to TME for near-cCRs was 1 year. 3-year DFS was 88% for cCR, 69% for near-cCR, and 56% for incomplete response. _____________________________ For patient counseling purposes: Of the 123 patients with a cCR who were offered WW, the local recurrence rate was 22% (0f which 93% underwent salvage TME) and the rate of distant metastasis was 10.5%. Of the 94 patients with a near-cCR who were offered WW, local recurrence rate was 51% (of which 71% underwent salvage TME) and the rate of distant metastasis was 15%. Of the 57 patients with incomplete response who were offered upfront TME, local recurrence was 14% and the rate of distant metastasis was 32%. @JohnRTMonsonMD @R_Perez_MD @ianmpaquette @JonVogel7 @jendavidsmd @KyleCologne @debby_keller @juliomayol @Neil_J_Smart @FergaljFleming @ScottRSteeleMD @JISBMD

"Hartmann’s procedure no longer has a role in colorectal surgery" is way too strong of a hypothesis. All retrospective data on HP vs protected anastomosis suffers from selection bias. RCTs never worked due to low accrual, which is ALSO selection bias, although appropriate, ie decisions at 2am that "this one is too sick for the trial."