Perioperative versus adjuvant S-1 plus oxaliplatin chemotherapy for stage II/III resectable gastric cancer (RESONANCE): a randomized, open-label, phase 3 trial

被引：17

作者：

Wang, Xinxin ^{[1
]}

Lu, Canrong ^{[1
]}

Wei, Bo ^{[1
]}

Li, Shuo ^{[1
]}

Li, Ziyu ^{[2
]}

Xue, Yingwei ^{[3
]}

Ye, Yingjiang ^{[4
]}

Zhang, Zhongtao ^{[5
]}

Sun, Yihong ^{[6
]}

Liang, Han ^{[7
]}

Li, Kai ^{[8
]}

Zhu, Linghua ^{[9
]}

Zheng, Zhichao ^{[10
]}

Zhou, Yanbing ^{[11
]}

He, Yulong ^{[12
]}

Li, Fei ^{[13
]}

Wang, Xin ^{[14
]}

Liang, Pin ^{[15
]}

Huang, Hua ^{[16
]}

Li, Guoli ^{[17
]}

Shen, Xian ^{[18
]}

Ji, Jiafu ^{[2
]}

Tang, Yun ^{[1
]}

Xu, Zekuan ^{[19
]}

Chen, Lin ^{[1
,20
]}

机构：

[1] Chinese Peoples Liberat Army Gen Hosp, Dept Gen Surg, 28 Fuxing Rd, Beijing 100853, Peoples R China

[2] Peking Univ Canc Hosp, Dept Gastrointestinal Surg, 52 Fucheng Rd, Beijing 100142, Peoples R China

[3] Harbin Med Univ Canc Hosp, Dept Gastroenterol Surg, 150 Haping Rd, Harbin 150081, Heilongjiang, Peoples R China

[4] Peking Univ Peoples Hosp, Dept Gastroenterol Surg, 11 Xizhimen South St, Beijing 100044, Peoples R China

[5] Capital Med Univ, Beijing Friendship Hosp, Dept Gen Surg, 95 Yongan Rd, Beijing 100050, Peoples R China

[6] Fudan Univ, Zhongshan Hosp, Dept Gen Surg, 180 Fenglin Rd, Shanghai 200032, Peoples R China

[7] Tianjin Med Univ Canc Hosp, Dept Gastr Canc Surg, West Huan Hu Rd, Tianjin 300060, Peoples R China

[8] China Med Univ, Hosp 1, Dept Surg Oncol, 155 Nanjing St North, Shenyang 110002, Liaoning, Peoples R China

[9] Zhejiang Univ, Sir Run Run Shaw Hosp, Sch Med, Dept Gen Surg, 3 East Qingchun Rd, Hangzhou 310016, Zhejiang, Peoples R China

[10] Liaoning Canc Hosp & Inst, Dept Gastr Surg, 44 Xiaoheyan Rd, Shenyang 110042, Liaoning, Peoples R China

[11] Qingdao Univ, Affiliated Hosp, Dept Gen Surg, 16 Jiangsu Rd, Qingdao 266000, Shandong, Peoples R China

[12] Sun Yat Sen Univ, Affiliated Hosp 1, Dept Gastrointestinal Surg, 58 Zhongshaner Rd, Guangzhou 510080, Guangdong, Peoples R China

[13] Capital Med Univ, Xuanwu Hosp, Dept Gen Surg, 45 Changchun St, Beijing 100053, Peoples R China

[14] Peking Univ First Hosp, Dept Gen Surg, 8 Xishiku St, Beijing 100034, Peoples R China

[15] Dalian Med Univ, Affiliated Hosp 1, Dept Gastrointestinal Surg, 222 Zhongshan Rd, Dalian 116011, Liaoning, Peoples R China

[16] Fudan Univ, Shanghai Canc Ctr, Dept Gastr Surg, 270 Dongan Rd, Shanghai 200032, Peoples R China

[17] Gen Hosp Eastern Theater Command Chinese PLA, Inst Gen Surg, 305 East Zhongshan Rd, Nanjing 210002, Jiangsu, Peoples R China

[18] Wenzhou Med Univ, Affiliated Hosp 2, Div Gastrointestinal Surg, 109 West Xueyuan Rd, Wenzhou 325027, Zhejiang, Peoples R China

[19] Jiangsu Prov Hosp, Dept Gen Surg, 300 Guangzhou Rd, Nanjing 210029, Jiangsu, Peoples R China

[20] Peking Univ Int Hosp, Dept Gastrointestinal Surg, 1 Life Garden Rd,Zhongguancun Life Sci Pk, Beijing 102206, Peoples R China

来源：

JOURNAL OF HEMATOLOGY & ONCOLOGY | 2024年 / 17卷 / 01期

关键词：

Gastric cancer; Perioperative; Adjuvant; Chemotherapy; S-1; Oxaliplatin; SURGERY; ADENOCARCINOMA; CAPECITABINE;

D O I：

10.1186/s13045-024-01536-7

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Evidence from Europe shows that perioperative chemotherapy may be beneficial for the treatment of locally advanced gastric cancer, but reliable and robust data is lacking. To rectify this, the phase 3 RESONANCE trial investigated the efficacy and safety of S-1 plus oxaliplatin (SOX) as a perioperative chemotherapy regimen for gastric cancer. This randomized, open-label trial enrolled patients from 19 medical centers with stage II/III resectable gastric cancer who were centrally randomly assigned to either perioperative chemotherapy (PC) arm or adjuvant chemotherapy (AC) arm. Patients in the PC arm received two to four cycles of SOX followed by surgery and four to six cycles of SOX. Patients in the AC arm received upfront surgery and eight cycles of SOX. 386 patients in each group were enrolled and 756 (382 in PC and 374 in AC) were included in the mITT population. The three-year DFS rate was 61.7% in the PC arm and 53.8% in the AC arm (log-rank p = 0.019). The R0 resection rate in the PC arm was significantly higher than that in the AC arm (94.9% vs. 83.7%, p < 0.0001). There was no difference between two arms in surgical outcomes or postoperative complications. Safety-related data were like the known safety profile. In conclusion, from a clinical perspective, this trial indicated a trend towards higher three-year disease-free survival rate with perioperative SOX in stage II/III resectable gastric cancer with well-tolerated toxicity compared to adjuvant SOX, which might provide a theoretical basis for applying perioperative SOX in advanced gastric cancer patients. (ClinicalTrials.gov NCT01583361)

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