A new treatment strategy for mid-low rectal cancer patients exhibiting a clinical complete or near-complete response to neoadjuvant chemoradiotherapy: Transanal endoscopic microsurgery --A multicenter prospective case-control clinical trial by MONT-R.

[BACKGROUND] Total mesorectal excision is the standard surgery for locally advanced rectal cancer (LARC) after neoadjuvant chemoradiotherapy (nCRT), but it may lead to high complication rates and poor quality of life. This study evaluates whether transanal endoscopic microsurgery (TEM), as a partial resection procedure, can enhance quality of life for clinical complete response (cCR) or near-cCR patients without compromising survival.

[METHODS] Between May 2017 to September 2021, 80 patients with T3-4N0M0 or TanyN+M0 mid-low rectal cancer achieving cCR or near-cCR post-nCRT were prospectively included at 6 Chinese centers. Patients underwent either TEM (Group A, n = 38) or radical surgery (Group B, n = 41). Clinicopathological, oncological, and functional outcomes were analyzed.

[RESULTS] Postoperative histology revealed 22 ypT0 (57.9 %), 5 ypT1 (13.2 %), 10 ypT2 (26.3 %), and 1 ypT3 (2.6 %) cases in group A and 20 pCR (48.8 %), 1 T0N1 (2.4 %), 5 T1N0 (12.2 %), 12 T2-3N0 (29.3 %), 3 T2-3N1 (7.3 %) cases in group B. After a 60-month median follow-up, local recurrence occurred in 2 patients (5.26 %) in Group A and none in Group B. Distant metastases occurred in 8 patients (21.05 %) in group A and 7 (17.07 %) in group B. There was no significant difference between the two groups in 5-year disease-free survival (P = 0.658) or 5-year overall survival (P = 0.465). Group A showed significantly faster recovery (P < 0.001) and better sphincter function per Wexner (1 vs. 4, P = 0.001) and LARS (0 vs. 17, P < 0.001) scores than Group B.

[CONCLUSION] TEM may be an effective approach for assessing residual tumors in LARC patients with cCR or near-cCR. This approach offers an option for those requiring sphincter preservation, with no significant compromise in long-term oncological outcomes observed in our study.