AimThe optimal management of patients with clinical complete response after neoadjuvant treatment for rectal cancer is controversial. The aim of this study is to compare the morbidity between patients with locally advanced rectal cancer who have had a pathological complete response (pCR) or not after neoadjuvant chemoradiotherapy (NCRT) and total mesorectal excision (TME). The study hypothesis was that pCR may impact the surgical complication rate.MethodA retrospective cohort study was conducted of a prospectively maintained database in Australia and New Zealand, the Binational Colorectal Cancer Audit, that identified patients with locally advanced rectal cancer (<15 cm from anal verge) from 1 January 2007 to 31 December 2019. Patients were included if they had locally advanced rectal cancer and had undergone NCRT and proceeded to surgical resection.ResultsThere were 4584 patients who satisfied the inclusion criteria, 65% being male. The mean age was 63 years and 11% had a pCR (ypT0N0). TME with anastomosis was performed in 67.8% of patients, and the majority of the cohort received long‐course radiotherapy (81.7%). Both major and minor complications were higher in the TME without anastomosis group (17.3% vs. 14.7% and 30.6% vs. 20.8%, respectively), and the 30‐day mortality was 1.31%. In the TME with anastomosis group, pCR did not contribute to higher rates of surgical complications, but male gender (p < 0.0012), age (p < 0.0001), preoperative N stage (p = 0.0092) and American Society of Anesthesologists (ASA) score ≥3 (p < 0.0002) did. In addition, pCR had no significant effect (p = 0.44) but male gender (p = 0.0047) and interval to surgery (p = 0.015) contributed to higher rates of anastomotic leak. In the TME without anastomosis cohort, the only variable that contributed to higher rates of complications was ASA score ≥3 (p = 0.033).ConclusionPatients undergoing TME dissection for rectal cancer following NCRT showed no difference in complications whether they had achieved pCR or not.

中文翻译：

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完全病理缓解是否会增加直肠癌围手术期发病风险？

目的直肠癌新辅助治疗后临床完全缓解的患者的最佳管理存在争议。本研究的目的是比较新辅助放化疗 (NCRT) 和全直肠系膜切除 (TME) 后获得病理完全缓解 (pCR) 或未获得病理完全缓解 (pCR) 的局部晚期直肠癌患者的发病率。研究假设 pCR 可能会影响手术并发症发生率。 方法 对澳大利亚和新西兰的一个前瞻性维护的数据库——两国结直肠癌审计进行了一项回顾性队列研究，该研究确定了患有局部晚期直肠癌（距肛门 <15 厘米）的患者。边缘）从2007年1月1日至2019年12月31日。如果患有局部晚期直肠癌并接受NCRT并进行手术切除的患者被纳入。结果有4584名患者满足纳入标准，其中65%是男性。平均年龄为 63 岁，11% 获得 pCR (ypT0N0)。67.8% 的患者接受了吻合术 TME，大多数患者接受了长程放疗 (81.7%)。无吻合组的主要和次要并发症均较高（分别为 17.3% vs. 14.7% 和 30.6% vs. 20.8%），30 天死亡率为 1.31%。在吻合术组的 TME 中，pCR 并未导致手术并发症发生率较高，但男性（p< 0.0012), 年龄 (p< 0.0001), 术前 N 分期 (p= 0.0092) 且美国麻醉医师协会 (ASA) 评分 ≥3 (p< 0.0002) 做到了。此外，pCR没有显着影响（p= 0.44) 但男性 (p= 0.0047) 和手术间隔 (p= 0.015）导致吻合口漏率较高。在无吻合术的 TME 队列中，导致并发症发生率较高的唯一变量是 ASA 评分≥3（p= 0.033）。结论 NCRT 后接受 TME 直肠癌切除术的患者无论是否达到 pCR，并发症均无差异。