Wang L, Zhao Y M, Sun T T, Xu Y L, Li S J, Zhang X Y, Cai Y, Li Y H, Li Z W, Chen P J, Peng Y F, Wang W H, Wu A W
Department of Gastrointestinal Cancer, Unit III, Peking University Cancer Hospital & Institute, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Bejing 100142, China.
Endoscopy Center, Peking University Cancer Hospital & Institute, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Bejing 100142, China.
Zhonghua Wei Chang Wai Ke Za Zhi. 2020 Mar 25;23(3):258-265. doi: 10.3760/cma.j.cn.441530-20200222-00070.
To explore the safety and efficacy of watch and wait strategy and organ preservation surgery after total neoadjuvant treatment for MRI stratified low-risk rectal cancer. A prospective single arm phase Ⅱ trial developed at Department of Gastrointestinal Cancer, Peking University Cancer Hospital & Institute was preliminarily analyzed. Subjects were enrolled from August 2016 to January 2019. Low-risk rectal cancer with following MRI features were recruited: mid-low tumor, mrT2-3b, MRF (-), EMVI (-), CRM (-), differentiation grade 1-3. Patients received intensity-modulated radiotherapy (IMRT) 50.6 Gy/22f with concurrent capecitabine and 4 cycles of consolidation CAPEOX. Patients with cCR/near-cCR confirmed by physical examination, rectal MRI, endoscopy, and serum CEA were recommended for watch & wait approach or local excision (LE). The main study outcomes were 2-year organ preservation rate (OPR) and sphincter preservation rate (SPR). Thirty-eight patients were eligible for analysis, including 24 males and 14 females with median age of 56 years; 9 cases of mrT2 (23.7%), 14 cases of mrT3a (36.8%) and 15 cases of mrT3b (39.5%); 5 cases of well differentiated adenocarcinoma (13.2%), 32 cases of moderately differentiated adenocarcinoma (84.2%) and 1 case of mucinous adenocarcinoma (2.6%). Carcinoemobryonic antigen (CEA) was elevated before treatment in 1 case. One case (2.6%) of grade 3 radiation dermatitis occurred during IMRT; 18 cases (47.4%) occurred grade 3 to 4 adverse events during consolidation chemotherapy. After total neoadjuvant treatment, the cCR and near-cCR rates were 42.1% (16/38) and 23.7% (9/38), respectively, while non-cCR rate was 34.2% (13/38). Twenty patients (20/38, 52.6%) of cCR or near-cCR underwent watch & wait approach, with a local regrowth rate of 20% (4/20). Four patients received LE, including one salvage LE. Thirteen patients (4 were ypCR) received radical resection, including 10 cases of initial low anterior resections (LAR), 1 cases of initial abdominal perineal resection (APR) and 2 cases of salvage LAR, four patients refused operation. The median follow-up time was 23.5 (8.5-38.3) months. At the last interview of follow-up, the OPR and SPR were 52.6% (20/38) and 84.2% (32/38), respectively. Only one patient developed lung metastasis and no local recurrence occurred after radical resection or LE. Total neoadjuvant treatment for low-risk rectal cancer achieves high cCR/near-cCR rate, with increased probability of receiving watch and wait approach and organ preservation in this subgroup.
探讨全新辅助治疗后，针对MRI分层的低危直肠癌采用观察等待策略及器官保留手术的安全性和有效性。对北京大学肿瘤医院暨研究所胃肠癌科开展的一项前瞻性单臂Ⅱ期试验进行了初步分析。研究对象于2016年8月至2019年1月入组。招募具有以下MRI特征的低危直肠癌患者：肿瘤中低位、mrT2 - 3b、MRF（-）、EMVI（-）、CRM（-）、分化程度1 - 3级。患者接受调强放疗（IMRT）50.6 Gy/22次分割，同时使用卡培他滨，并进行4周期巩固性CAPEOX化疗。经体格检查、直肠MRI、内镜检查及血清癌胚抗原（CEA）确认达到临床完全缓解（cCR）/接近临床完全缓解（near - cCR）的患者，建议采用观察等待策略或局部切除（LE）。主要研究结局为2年器官保留率（OPR）和括约肌保留率（SPR）。38例患者符合分析条件，其中男性24例，女性14例，中位年龄56岁；mrT2 9例（23.7%），mrT3a 14例（36.8%），mrT3b 15例（39.5%）；高分化腺癌5例（13.2%），中分化腺癌32例（84.2%），黏液腺癌1例（2.6%）。治疗前1例患者癌胚抗原（CEA）升高。IMRT期间发生1例3级放射性皮炎（2.6%）；巩固化疗期间发生18例3 - 4级不良事件（47.4%）。全新辅助治疗后，cCR率和near - cCR率分别为42.1%（16/38）和23.7%（9/38），非cCR率为34.2%（13/38）。20例（20/38，52.6%）cCR或near - cCR患者采用观察等待策略，局部复发率为20%（4/20）。4例患者接受LE，其中1例为挽救性LE。13例患者（4例为ypCR）接受根治性切除，包括10例初次低位前切除术（LAR）、1例初次腹会阴联合切除术（APR）和2例挽救性LAR，4例患者拒绝手术。中位随访时间为23.5（8.5 - 38.3）个月。在末次随访访谈时，OPR和SPR分别为52.6%（20/38）和84.2%（32/38）。仅1例患者发生肺转移，根治性切除或LE后未发生局部复发。低危直肠癌的全新辅助治疗可实现较高的cCR/near - cCR率，该亚组患者采用观察等待策略及器官保留的可能性增加。
