Wang Lin, Li Shijie, Zhang Xiaoyan, Sun Tingting, Du Changzheng, Chen Nan, Peng Yifan, Yao Yunfeng, Zhan Tiancheng, Zhao Jun, Cai Yong, Li Yongheng, Wang Weihu, Li Zhongwu, Sun Yingshi, Ji Jiafu, Wu Aiwen
Department 3 of Gastrointestinal Surgery, Key Laboratory of Carcinogenesis and Translational Research, Peking University Cancer Hospital and Institute, Beijing 100142, China.
Endoscopy Center, Key Laboratory of Carcinogenesis and Translational Research, Peking University Cancer Hospital and Institute, Beijing 100142, China.
Zhonghua Wei Chang Wai Ke Za Zhi. 2018 Nov 25;21(11):1240-1248.
OBJECTIVE: To investigate the long-term outcome of organ preservation with local excision or "watch and wait" strategy for mid-low rectal cancer patients evaluated as clinical complete remission (cCR) or near-cCR following neoadjuvant chemoradiotherapy (NCRT). METHODS: Clinical data of 62 mid-low rectal cancer patients evaluated as cCR/near-cCR after NCRT undergoing organ preservation surgery with local excision or receiving "watch and wait" strategy at Department of Gastrointestinal Surgery, Peking University Cancer Hospital and Institute from March 2011 to August 2017 were retrospectively analyzed. According to the approximate 1:2 pairing, 123 patients who underwent radical resection with complete pathological remission(ypCR) after neoadjuvant chemotherapy during the same period were selected for prognosis comparison. The primary endpoint of the study was 3-year non-regrowth disease-free survival (NR-DFS) and tumor specific survival (CSS). Survival analysis was performed using the Kaplan-Meier curve (Log-rank method). The secondary endpoint of the study was 3-year organ preservation and sphincter preservation. RESULTS: The retrospective study included 38 male and 24 female patients. The median age was 60 (31-79) years and the median distance from tumor to anal verge was 4(1-8) cm. The ratio of cCR and near-cCR was 79.0%(49/62) and 21.0%(13/62) respectively. Local regrowth rate was 24.2%(15/62). Of 15 with tumor regrowth, 9 patients received salvage radical rectal resection and no local recurrence was found during follow-up; 4 patients received salvage local excision among whom one patient had a local recurrence occurred patient; 2 patients refused further surgery. The overall metastasis rate was 8.1%(5/62), including resectable metastasis(4.8%,3/62) and unresectable metastasis (3.2%,2/62). The valid 3-year organ preservation rate and sphincter preservation rate were 85.5%(53/62) and 95.2%(59/62) respectively. The median follow-up was 36.2(8.6-89.0) months. The 3-year NR-DFS of patients with cCR and near-cCR was 88.6% and 83.1% respectively, which was not significantly different to that of patients with ypCR (94.7%, P=0.217). The 3-year CSS of patients with cCR and near-cCR was both 100%, which was not significantly different to that of patients with ypCR(93.4%, P=0.186). CONCLUSIONS: Mid-low rectal cancer patients with cCR or near-cCR after NCRT undergoing organ preservation with local excision or receiving "watch and wait" strategy have good long-term prognosis with low rates of local tumor regrowth and distant metastasis, which is similar to those with ypCR after radical surgery. This treatment mode may be used as an option for organ preservation in mid-low rectal cancer patients with good tumor remission after NCRT.
目的:探讨新辅助放化疗(NCRT)后评估为临床完全缓解(cCR)或接近cCR的中低位直肠癌患者采用局部切除或“观察等待”策略进行器官保留的长期结局。 方法:回顾性分析2011年3月至2017年8月在北京大学肿瘤医院暨北京市肿瘤防治研究所胃肠外科接受局部切除器官保留手术或采用“观察等待”策略的62例NCRT后评估为cCR/接近cCR的中低位直肠癌患者的临床资料。按照约1:2配对,选取同期接受新辅助化疗后达到完全病理缓解(ypCR)并接受根治性切除的123例患者进行预后比较。研究的主要终点为3年无瘤再生长无病生存率(NR-DFS)和肿瘤特异性生存率(CSS)。采用Kaplan-Meier曲线(对数秩检验)进行生存分析。研究的次要终点为3年器官保留率和括约肌保留率。 结果:该回顾性研究纳入38例男性和24例女性患者。中位年龄为60(31-79)岁,肿瘤距肛缘的中位距离为4(1-8)cm。cCR和接近cCR的比例分别为79.0%(49/62)和21.0%(13/62)。局部再生长率为24.2%(15/62)。在15例肿瘤再生长的患者中,9例接受挽救性根治性直肠切除术,随访期间未发现局部复发;4例接受挽救性局部切除术,其中1例患者发生局部复发;2例患者拒绝进一步手术。总转移率为8.1%(5/62),包括可切除转移(4.8%,3/62)和不可切除转移(3.2%,2/62)。有效的3年器官保留率和括约肌保留率分别为85.5%(53/62)和95.2%(59/62)。中位随访时间为
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