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).
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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).
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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.
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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.
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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
Organ Preservation and Survival by Clinical Response Grade in Patients With Rectal Cancer Treated With Total Neoadjuvant Therapy: A Secondary Analysis of the OPRA Randomized Clinical Trial | Oncology | JAMA Network Open | JAMA Network
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