Xie B W, Zang L, Ma J J, Sun J, Yang X, Wang M L, Lu A G, Hu W G, Zheng M H
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Department of GeneralSurgery, Shanghai Minimally Invasive Surgical Center, Shanghai 200025, China.
Zhonghua Wei Chang Wai Ke Za Zhi. 2021 Feb 25;24(2):138-144. doi: 10.3760/cma.j.cn.441530-20200721-00433.
To explore the safety and efficacy of oxaliplatin plus capecitabine (CapeOX) or oxaliplatin plus S-1 (SOX) regimen neoadjuvant chemotherapy in the treatment of advanced gastric cancer. A retrospective cohort study was performed. Clinical data of patients diagnosed as advanced gastric cancer undergoing CapeOX/SOX neoadjuvant chemotherapy and standard laparoscopic radical operation for gastric cancer in Ruijin Hospital of Shanghai Jiaotong University School of Medicine from April 2016 to April 2019 were retrospectively collected. Inclusion criteria were as follows: (1) age≥18 years; (2) gastric adenocarcinoma was confirmed by histopathology and the clinical stage was T3-4aN+M0; (3) tumor could be resectable; (4) preoperative neoadjuvant chemotherapy was CapeOX or SOX regimen without radiotherapy or other regimen chemotherapy; (5) no other concurrent malignant tumor; (6) the Eastern Cooperative Oncology Group (ECOG) score ≤ 1; (7) no bone marrow suppression; (8) normal liver and kidney function. Exclusion criteria were as follows: (1) patients with recurrent gastric cancer; (2) patients receiving emergency surgery due to tumor perforation, bleeding, obstruction, etc.; (3) allergy to oxaliplatin, S-1, capecitabine or any drug excipients; (4) diagnosed with coronary heart disease, cardiomyopathy, or the New York Heart Association class III or IV; (5) pregnant or lactating women. A total of 118 patients were enrolled as the neoadjuvant chemotherapy group, and 379 patients with locally advanced gastric cancer who received surgery combined with postoperative adjuvant chemotherapy over the same period simultaneously were included as the adjuvant chemotherapy group. After propensity score matching was performed including gender, age, ECOG score, tumor site, clinical stage, chemotherapy regimen and other factors by 1:1 ratio, there were 40 cases in each group. The differences between the two groups in general conditions, efficacy of neoadjuvant chemotherapy, intraoperative conditions, postoperative conditions, histopathological results, chemotherapy-related adverse events, and survival status were compared and analyzed. Comparison of baseline demographics between the two groups showed no statistically significant difference (all >0.05). In the neoadjuvant chemotherapy group, 5.0% (2/40) of patients achieved clinical complete response, 57.5% (23/40) achieved partial response, 32.5% (13/40) remained stable disease, and 5.0% (2/40) had disease progression before surgery. Objective response rate was 62.5% (25/40), and disease control rate was 95.0% (38/40). There were no statistically significant differences between neoadjuvant chemotherapy group and adjuvant chemotherapy group in terms of operation time, intraoperative blood loss, number of lymph node harvested, length of postoperative hospital stay, and postoperative mortality and morbidity (all >0.05). Postoperative complications were well managed with conservative treatment. No Clavien-Dindo IV or V complications were observed in both groups. Pathological results showed that the proportion of patients with pathological stage T1 in the neoadjuvant chemotherapy group was significantly higher than that in the adjuvant chemotherapy group [27.5% (11/40) vs. 5.0% (2/40)], while the proportion of patients with pathological stage T3 was significantly lower than that in the adjuvant chemotherapy group [20.0% (8/40) vs. 45.0% (18/40)], with statistically significant difference (χ(2)=15.432, =0.001). In the neoadjuvant chemotherapy group, there were 4 cases of tumor regression grade 0, 8 cases of grade 1, 16 cases of grade 2, and 12 cases of grade 3. The pathological complete response rate was 10% (4/40), the overall pathological response rate was 70.0% (28/40). There was no statistically significant difference in the incidence of chemotherapy-related adverse events between neoadjuvant chemotherapy group and adjuvant chemotherapy group [40% (16/40) vs. 37.5% (15/40), 0.05). There were no statistically significant differences in OS (43 months vs. 40 months) and 3-year OS rate (66.1% vs. 59.8%) between neoadjuvant chemotherapy group and adjuvant chemotherapy group (=0.428). The disease-free survival (DFS) and 3-year DFS rates of the neoadjuvant chemotherapy group were significantly superior to those of the adjuvant chemotherapy group (36 months vs. 28 months, 51.4% vs. 35.8%, =0.048). CapeOX or SOX regimen neoadjuvant chemotherapy is a safe, effective and feasible treatment mode for advanced gastric cancer without increasing surgical risk and can improve the DFS of patients.
探讨奥沙利铂联合卡培他滨(CapeOX)或奥沙利铂联合S-1(SOX)方案新辅助化疗在晚期胃癌治疗中的安全性和疗效。进行了一项回顾性队列研究。回顾性收集了2016年4月至2019年4月在上海交通大学医学院附属瑞金医院被诊断为晚期胃癌并接受CapeOX/SOX新辅助化疗及标准腹腔镜胃癌根治术患者的临床资料。纳入标准如下:(1)年龄≥18岁;(2)经组织病理学确诊为胃腺癌且临床分期为T3-4aN+M0;(3)肿瘤可切除;(4)术前新辅助化疗为CapeOX或SOX方案,未接受放疗或其他方案化疗;(5)无其他并发恶性肿瘤;(6)东部肿瘤协作组(ECOG)评分≤1;(7)无骨髓抑制;(8)肝肾功能正常。排除标准如下:(1)复发性胃癌患者;(2)因肿瘤穿孔、出血、梗阻等接受急诊手术的患者;(3)对奥沙利铂、S-1、卡培他滨或任何药物辅料过敏者;(4)诊断为冠心病、心肌病或纽约心脏协会III或IV级者;(5)孕妇或哺乳期妇女。共纳入118例患者作为新辅助化疗组,同时将同期接受手术联合术后辅助化疗的379例局部晚期胃癌患者纳入辅助化疗组。按性别、年龄、ECOG评分、肿瘤部位、临床分期、化疗方案等因素进行1:1倾向评分匹配后,每组各40例。比较分析两组在一般情况、新辅助化疗疗效、术中情况、术后情况、组织病理学结果、化疗相关不良事件及生存状况等方面的差异。两组基线人口统计学比较差异无统计学意义(均>0.05)。新辅助化疗组中,5.0%(2/40)的患者达到临床完全缓解,57.5%(23/40)达到部分缓解,32.5%(13/40)病情稳定,5.0%(2/40)在手术前病情进展。客观缓解率为62.5%(25/40),疾病控制率为95.0%(38/40)。新辅助化疗组与辅助化疗组在手术时间、术中出血量、清扫淋巴结数目、术后住院时间及术后死亡率和发病率方面比较差异均无统计学意义(均>0.05)。术后并发症经保守治疗处理良好。两组均未观察到Clavien-Dindo IV或V级并发症。病理结果显示,新辅助化疗组病理分期为T1的患者比例显著高于辅助化疗组[27.5%(11/40)对5.0%(2/40)],而病理分期为T3的患者比例显著低于辅助化疗组[20.0%(8/40)对45.0%(18/40)],差异有统计学意义(χ(2)=15.432,=0.001)。新辅助化疗组中,肿瘤退缩分级0级4例,1级8例,2级16例,3级12例。病理完全缓解率为10%(4/40),总体病理缓解率为70.0%(28/40)。新辅助化疗组与辅助化疗组化疗相关不良事件发生率比较差异无统计学意义[40%(16/40)对37.5%(15/40),0.《05》。新辅助化疗组与辅助化疗组的总生存期(OS)(43个月对40个月)及3年OS率(66.1%对59.8%)比较差异无统计学意义(=0.428)。新辅助化疗组的无病生存期(DFS)及3年DFS率显著优于辅助化疗组(36个月对28个月,51.4%对35.8%,=0.048)。CapeOX或SOX方案新辅助化疗是晚期胃癌安全、有效且可行的治疗方式,不增加手术风险且可提高患者的DFS。