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针对新辅助放化疗后出现临床完全缓解或接近完全缓解的中低位直肠癌患者的一种新治疗策略:经肛门内镜显微手术——MONT-R多中心前瞻性病例对照临床试验

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.

作者信息

Qiu Xiaoyuan, Zhou Jiaolin, Qiu Huizhong, Shen Zhanlong, Wu Bin, Jia Wenzhuo, Niu Beizhan, Li Fei, Yao Hongwei, Wu Aiwen, Hu Ke, Xue Huadan, Zhong Guangxi, Zhou Weixun, Chen Weijie, Li Ganbin, Lin Guole

机构信息

Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuai Fu Yuan, Dong Cheng District, Beijing 100730, China.

Department of Gastroenterological Surgery, Peking University People's Hospital, No.11 Xizhimen South Street, Xicheng District, Beijing 100044, China.

出版信息

Eur J Cancer. 2025 Feb 5;216:115156. doi: 10.1016/j.ejca.2024.115156. Epub 2024 Nov 29.

Abstract

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.

摘要

背景

全直肠系膜切除术是局部晚期直肠癌(LARC)新辅助放化疗(nCRT)后的标准手术,但可能导致高并发症发生率和生活质量差。本研究评估经肛门内镜显微手术(TEM)作为一种局部切除手术,是否能在不影响生存的情况下提高临床完全缓解(cCR)或接近cCR患者的生活质量。

方法

2017年5月至2021年9月期间,6个中国中心前瞻性纳入了80例nCRT后达到cCR或接近cCR的T3-4N0M0或任何N+M0的中低位直肠癌患者。患者接受了TEM(A组,n = 38)或根治性手术(B组,n = 41)。分析了临床病理、肿瘤学和功能结局。

结果

术后组织学检查显示,A组有22例ypT0(57.9%)、5例ypT1(13.2%)、10例ypT2(26.3%)和1例ypT3(2.6%),B组有20例pCR(48.8%)、1例T0N1(2.4%)、5例T1N0(12.2%)、12例T2-3N0(29.3%)、3例T2-3N1(7.3%)。中位随访60个月后,A组有2例患者(5.26%)发生局部复发,B组无局部复发。A组有8例患者(21.05%)发生远处转移,B组有7例(17.07%)。两组在5年无病生存率(P = 0.658)或5年总生存率(P = 0.465)方面无显著差异。A组的恢复明显更快(P < 0.001),根据韦克斯纳评分(1比4,P = 0.001)和低位前切除综合征(LARS)评分(0比17,P < 0.001),其括约肌功能也优于B组。

结论

TEM可能是评估cCR或接近cCR的LARC患者残留肿瘤的有效方法。这种方法为那些需要保留括约肌的患者提供了一种选择,在我们的研究中未观察到长期肿瘤学结局有显著损害。

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