Morbidity and Mortality of Patients Who Underwent Minimally Invasive Esophagectomy After Neoadjuvant Chemoradiotherapy vs Neoadjuvant Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Randomized Clinical Trial.
Morbidity and Mortality of Patients Who Underwent Minimally Invasive Esophagectomy After Neoadjuvant Chemoradiotherapy vs Neoadjuvant Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Randomized Clinical Trial.
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DOI：
10.1001/jamasurg.2021.0133
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发表时间：
2021-05-01
期刊：
影响因子：
16.9
通讯作者：
Chen KN
中科院分区：
文献类型：
--
作者：
Wang H;Tang H;Fang Y;Tan L;Yin J;Shen Y;Zeng Z;Zhu J;Hou Y;Du M;Jiao J;Jiang H;Gong L;Li Z;Liu J;Xie D;Li W;Lian C;Zhao Q;Chen C;Zheng B;Liao Y;Li K;Li H;Wu H;Dai L;Chen KN
对于局部晚期食管鳞状细胞癌（ESCC），新辅助放化疗（nCRT）联合微创食管切除术（MIE）与新辅助化疗（nCT）联合微创食管切除术的安全性有何差异？在这项264例ESCC患者的多中心随机临床试验中，nCRT组和nCT组的总发病率分别为47%和43%，差异无统计学意义。本试验表明，nCRT加MIE治疗局部晚期ESCC的安全性与nCT相似。由于缺乏高水平的临床证据，新辅助放化疗（nCRT）与新辅助化疗（nCT）治疗局部晚期食管鳞状细胞癌（ESCC）的安全性和有效性仍不确定。比较局部晚期ESCC患者nCRT联合微创食管切除术（MIE）与nCT联合微创食管切除术（MIE）的安全性和长期生存率。一项前瞻性、多中心、开放标签、随机临床试验，比较了nCRT与nCT联合MIE治疗局部晚期ESCC患者的安全性和有效性。2017年1月1日至2018年12月31日，共纳入264例临床分期为cT3 ~ T4aN0 ~ 1M0的ESCC患者。从2017年1月1日至2020年8月30日，以意向治疗为基础进行分析。通过计算机生成的随机系统将符合条件的患者随机分为nCRT组（n = 132）和nCT组（n = 132）。两组均以紫杉醇+顺铂为主化疗，nCRT组同时放疗40 Gy。新辅助治疗后约6周，两组患者均行胸腔镜、腹腔镜下MIE治疗。主要终点是3年总生存期。次要结局包括术后并发症、死亡率、术后病理结局、无复发生存时间和生活质量。264例患者（226例男性，85.6%；平均[SD]年龄，61.4[6.8]岁）中，nCRT组术后发病率为47.4%（114例中54例），nCT组术后发病率为42.6%（108例中46例），两组间无显著差异（差异为4.8%;95% CI, - 8.2% ~ 17.5%; P = 0.48）。根据Clavien-Dindo分类，两组患者并发症严重程度分布相似。nCRT组90天围手术期死亡率为3.5%（114例中有4例），nCT组为2.8%（108例中有3例）（P = 0.94）。两组R0切除率相似（112例中109例[97.3%]vs 104例中100例[96.2%];P = 0.92）。然而，nCRT组患者的病理完全缓解（残余肿瘤，0%）率更高(112例中40例[35.7%]vs 104例中4例[3.8%];P <。P = 0.001)，淋巴结阴性率更高(ypN0, 112例中74例[66.1%]vs 104例中48例[46.2%]；(3)比nCT组高。使用意向治疗分析，nCRT组的1年总生存率为87.1%（132例中115例），nCT组为82.6%（132例中109例）（P = 0.30）。此外，nCRT组因肿瘤进展或复发引起的死亡明显少于nCT组（132例中9例[6.8%]vs 132例中19例[14.4%];P = 0.046）；然而，非肿瘤原因导致的死亡相似（132例中8例[6.1%]vs 132例中4例[3.0%];P = 0.24）。试验的初步结果表明，在治疗局部晚期ESCC时，nCRT + MIE与nCT + MIE具有相似的安全性和更好的组织病理学结果。本随机临床试验比较了局部晚期食管鳞状细胞癌（ESCC）患者新辅助放化疗联合微创食管切除术（MIE）与新辅助化疗联合微创食管切除术的安全性和长期生存率。
Is there any difference in the safety of neoadjuvant chemoradiotherapy (nCRT) followed by minimally invasive esophagectomy (MIE) for locally advanced esophageal squamous cell carcinoma (ESCC) compared with that of neoadjuvant chemotherapy (nCT) followed by MIE? In this multicenter randomized clinical trial of 264 patients with ESCC, overall morbidity rates were 47% in the nCRT group and 43% in nCT group, which was not significantly different. This trial shows that the safety of nCRT followed by MIE is similar to that of nCT for the treatment of locally advanced ESCC. Safety and efficacy of neoadjuvant chemoradiotherapy (nCRT) vs neoadjuvant chemotherapy (nCT) for treatment of locally advanced esophageal squamous cell carcinoma (ESCC) remain uncertain given lack of high-level clinical evidence. To compare safety and long-term survival of nCRT followed by minimally invasive esophagectomy (MIE) with that of nCT followed by MIE for patients with locally advanced ESCC. A prospective, multicenter, open-label, randomized clinical trial that compared safety and efficacy of nCRT vs nCT followed by MIE for patients with locally advanced ESCC. From January 1, 2017, to December 31, 2018, 264 patients with ESCC of clinical stages from cT3 to T4aN0 to 1M0 were enrolled. Analysis was performed on an intention-to-treat basis from January 1, 2017, to August 30, 2020. Eligible patients were randomized to the nCRT group (n = 132) or the nCT group (n = 132) by a computer-generated random system. The chemotherapy, based on paclitaxel and cisplatin, was administered to both groups, while 40 Gy of concurrent radiotherapy was added for the nCRT group. At about 6 weeks after neoadjuvant therapy, MIE via thoracoscopy and laparoscopy was performed for the patients in both groups. The primary outcome was 3-year overall survival. Secondary outcomes included postoperative complications, mortality, postoperative pathologic outcome, recurrence-free survival time, and quality of life. Among 264 patients (226 men [85.6%]; mean [SD] age, 61.4 [6.8] years), postoperative morbidity was 47.4% in the nCRT group (54 of 114) and 42.6% in the nCT group (46 of 108), with no significant difference between groups (difference, 4.8%; 95% CI, −8.2% to 17.5%; P = .48). Distribution of the severity of complications was similar between the 2 groups based on Clavien-Dindo classification. The 90-day perioperative mortality rate was 3.5% for the nCRT group (4 of 114) and 2.8% for the nCT group (3 of 108) (P = .94). The R0 resection rates were similar between groups (109 of 112 [97.3%] vs 100 of 104 [96.2%]; P = .92). However, patients in the nCRT group had a higher pathologic complete response (residual tumor, 0%) rate (40 of 112 [35.7%] vs 4 of 104 [3.8%]; P < .001) and a higher rate of negative lymph nodes (ypN0, 74 of 112 [66.1%] vs 48 of 104 [46.2%]; P = .03) than those in the nCT group. One-year overall survival using intention-to-treat analysis was 87.1% in the nCRT group (115 of 132) and 82.6% in the nCT group (109 of 132) (P = .30). Furthermore, deaths caused by tumor progression or recurrence were significantly less in the nCRT group than in the nCT group (9 of 132 [6.8%] vs 19 of 132 [14.4%]; P = .046); however, deaths from nontumor causes were similar (8 of 132 [6.1%] vs 4 of 132 [3.0%]; P = .24). Initial results of the trial showed that nCRT followed by MIE has similar safety to and better histopathologic outcome than nCT followed by MIE for treatment of locally advanced ESCC. ClinicalTrials.gov Identifier: NCT03001596 This randomized clinical trial compares the safety and long-term survival of neoadjuvant chemoradiotherapy followed by minimally invasive esophagectomy (MIE) with that of neoadjuvant chemotherapy followed by minimally invasive esophagectomy for patients with locally advanced esophageal squamous cell carcinoma (ESCC).
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影响因子：
28.4
作者：
Dueck AC;Mendoza TR;Mitchell SA;Reeve BB;Castro KM;Rogak LJ;Atkinson TM;Bennett AV;Denicoff AM;O'Mara AM;Li Y;Clauser SB;Bryant DM;Bearden JD 3rd;Gillis TA;Harness JK;Siegel RD;Paul DB;Cleeland CS;Schrag D;Sloan JA;Abernethy AP;Bruner DW;Minasian LM;Basch E;National Cancer Institute PRO-CTCAE Study Group
通讯作者：
National Cancer Institute PRO-CTCAE Study Group
影响因子：
2.5
作者：
Tang, Han;Zheng, Hao;Wang, Qun
通讯作者：
Wang, Qun
影响因子：
3.7
作者：
Ando, Nobutoshi;Kato, Hoichi;Fukuda, Haruhiko
通讯作者：
Fukuda, Haruhiko
影响因子：
9
作者：
Straatman, Jennifer;van der Wielen, Nicole;van der Peet, Donald L.
通讯作者：
van der Peet, Donald L.
DOI：
10.1200/jco.2018.79.1483
发表时间：
2018-09-20
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
Yang H;Liu H;Chen Y;Zhu C;Fang W;Yu Z;Mao W;Xiang J;Han Y;Chen Z;Yang H;Wang J;Pang Q;Zheng X;Yang H;Li T;Lordick F;D'Journo XB;Cerfolio RJ;Korst RJ;Novoa NM;Swanson SJ;Brunelli A;Ismail M;Fernando HC;Zhang X;Li Q;Wang G;Chen B;Mao T;Kong M;Guo X;Lin T;Liu M;Fu J;AME Thoracic Surgery Collaborative Group
通讯作者：
AME Thoracic Surgery Collaborative Group