表 2.新辅助治疗后评估为临床完全缓解（cCR）或近临床完全缓解（near-cCR）患者的随访计划 围手术期治疗模式的改变对于等待观察策略有哪些影响？ 近年来，免疫治疗的加入改写了局部进展期直肠癌的围手术期治疗模式。经典的新辅助治疗模式主要为放化疗。如今，对于错配修复完整/微卫星稳定（pMMR/MSS）的直肠癌，新辅助治疗方案除部分采用单纯化疗外，多以放疗为主；对于错配修复缺失/微卫星高度不稳定（dMMR/MSI-H）直肠癌可考虑免疫检查点抑制剂单药治疗，进一步显著提高 cCR 率。 无论采用何种新辅助治疗方案，通常初次评估时间宜在治疗后 12 周内完成。建议传统长程放疗结束后 8~12 周、短程放疗联合巩固治疗或单纯药物治疗结束后 4 周作为初次评估时间。若达到 cCR 可考虑等待观察策略，如退缩明显或达 near-cCR，可巩固治疗或观察到 12~16 周再行评估。通常不建议新辅助治疗时间超过 24 周。超过 24 周仍考虑肿瘤残留者，建议病理活检，确认肿瘤残留后应及早行全直肠系膜切除术；如果病理活检阴性，可与患者及家属充分沟通协商决定是否采取等待观察策略[12]。 等待观察策略目前已成为局部进展期直肠癌新辅助治疗后的重要治疗选择之一，目前多项研究证实等待观察策略安全可行，但仍缺乏高级别循证医学证据支持；同时其远期肿瘤学疗效、风险获益、适用人群、cCR 的评估标准、随访策略以及补救方法等均需要进一步明确。在临床实践中，等待观察策略不仅需要经验丰富的医疗中心多学科参与，更需要的是患者依从性较好、能积极密切随访。 参考文献[1] van Gijn W, Marijnen CA, Nagtegaal ID, et al. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 12-year follow-up of the multicentre, randomised controlled TME trial[J]. Lancet Oncol, 2011,12(6):575-582.[2] Rödel C, Liersch T, Becker H, et al. Preoperative chemoradiotherapy and postoperative chemotherapy with fluorouracil and oxaliplatin versus fluorouracil alone in locally advanced rectal cancer: initial results of the German CAO/ARO/AIO-04 randomised phase 3 trial[J]. Lancet Oncol, 2012, 13(7):679-687.[3] Paun BC, Cassie S, MacLean AR, et al. Postoperative complications following surgery for rectal cancer[J]. Ann Surg, 2010,251(5):807-818.[4] Lange MM, Maas CP, Marijnen CA, et al. Urinary dysfunction after rectal cancer treatment is mainly caused by surgery[J]. Br J Surg, 2008,95(8):1020-1028.[5] Hendren SK, O'Connor BI, Liu M, et al. Prevalence of male and female sexual dysfunction is high following surgery for rectal cancer[J]. Ann Surg, 2005,242(2):212-223.[6] Juul T, Ahlberg M, Biondo S, et al. Low anterior resection syndrome and quality of life: an international multicenter study[J]. Dis Colon Rectum, 2014,57(5):585-591.[7] Verheij FS, Omer DM, Williams H, et al. Long-term results of organ preservation in patients with rectal adenocarcinoma treated with total neoadjuvant therapy: the randomized phase II OPRA trial[J]. J Clin Oncol, 2023, JCO2301208.[8] Wang L, Zhang XY, Zhao YM, et al. Intentional watch and wait or organ preservation surgery following neoadjuvant chemoradiotherapy plus consolidation CAPEOX for MRI-defined low-risk rectal cancer: findings from a prospective phase 2 Trial (PKUCH-R01 tTrial, NCT02860234) [J]. Ann Surg, 2023, 277(4):647-654. [9] Appelt AL, Pløen J, Harling H, et al. High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study[J]. Lancet Oncol, 2015,16(8):919-927.[10] Habr-Gama A, Perez RO, Nadalin W, et al. Operative versus nonoperative treatment for stage 0 distal rectal cancer following chemoradiation therapy: long-term results[J]. Ann Surg, 2004,240(4):711-718.[11] Van der Valk MJM, Hilling DE, Bastiaannet E, et al. Long-term outcomes of clinical complete responders after neoadjuvant treatment for rectal cancer in the International Watch & Wait Database (IWWD): an international multicentre registry study[J].Lancet, 2018,391(10139):2537-2545.[12] 中国直肠癌新辅助治疗后等待观察数据库研究协作组, 中华医学会外科学分会结直肠外科学组, 中国医师协会结直肠肿瘤医师专业委员会, 等. 直肠癌新辅助治疗后等待观察策略中国专家共识（2024版）[J]. 中华胃肠外科杂志, 2024, 27(4): 301-315.[13] Dattani M, HR, Heald RJ, Goussous G, et al. Oncological and survival outcomes in watch and wait patients with a clinical complete response after neoadjuvant chemoradiotherapy for rectal cancer: a systematic review and pooled analysis[J]. Ann Surg, 2018,268(6):955-967. 转载自：丁香园肿瘤时间作者：黄玉庭；编辑：Bree 投稿：tangshixuan@dxy.cn
