局部晚期胃癌术前同步放化疗与新辅助化疗的比较：II期随机研究
Preoperative Concurrent Chemoradiotherapy Versus Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer: Phase II Randomized Study.
作者信息
Wang Xin, Zhao Dong-Bing, Yang Lin, Chi Yihebali, Zhao Hong, Jiang Li-Ming, Jiang Jun, Tang Yuan, Li Ning, Liu Wen-Yang, Dou Li-Zhou, Zou Shuang-Mei, Xue Li-Yan, Ren Jian-Song, Tian Yan-Tao, Che Xu, Guo Chun-Guang, Bai Xiao-Feng, Sun Yue-Min, Wang Shu-Lian, Song Yong-Wen, Liu Yue-Ping, Fang Hui, Li Ye-Xiong, Jin Jing
机构信息
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Pancrea-gastric Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
出版信息
Front Oncol. 2022 Apr 29;12:870741. doi: 10.3389/fonc.2022.870741. eCollection 2022.
OBJECTIVE
We evaluated and compared the efficacy and safety of neoadjuvant chemoradiotherapy (NACRT) versus neoadjuvant chemotherapy (NACT) for locally advanced gastric cancer (LAGC) in a single-center randomized phase II trial.
METHODS
Patients with LAGC were enrolled and received either NACT or NACRT, followed by gastrectomy and adjuvant chemotherapy. The primary endpoint was an R0 resection rate.
RESULTS
We enrolled 75 patients: 75.7% (NACT, 28/37 patients) and 76.3% (NACRT, 29/38 patients) underwent surgery; R0 resection rates were 73.0% (27/37) and 73.7% (28/38), respectively. The NACRT group had significantly better major pathological response than the NACT group (37.9% vs 17.9%, p = 0.019). Between-group postoperative complications were not significantly different. The median follow-up was 59.6 months; 5-year overall survival (OS) rate was 50.1% (NACT) and 61.9% (NACRT); neither group reached the median OS; median progression-free survival was 37.3 and 63.4 months, respectively.
CONCLUSIONS
S-1-based NACRT did not improve the R0 resection rate, although it presented better tumor regression with similar safety to NACT.
TRIAL REGISTRATION
ClinicalTrial.gov NCT02301481.
目的
在一项单中心随机II期试验中，我们评估并比较了新辅助放化疗（NACRT）与新辅助化疗（NACT）治疗局部晚期胃癌（LAGC）的疗效和安全性。
方法
纳入LAGC患者，给予NACT或NACRT治疗，随后进行胃切除术和辅助化疗。主要终点为R0切除率。
结果
我们纳入了75例患者：75.7%（NACT组，28/37例患者）和76.3%（NACRT组，29/38例患者）接受了手术；R0切除率分别为73.0%（27/37）和73.7%（28/38）。NACRT组的主要病理反应明显优于NACT组（37.9%对17.9%，p = 0.019）。组间术后并发症无显著差异。中位随访时间为59.6个月；5年总生存率（OS）分别为50.1%（NACT组）和61.9%（NACRT组）；两组均未达到OS中位数；无进展生存期中位数分别为37.3个月和63.4个月。
结论
基于S-1的NACRT虽与NACT安全性相似，但肿瘤退缩更佳，却未提高R0切除率。
试验注册
ClinicalTrial.gov NCT02301481。
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