Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Surgical Oncology, Changzhi Medical College Affiliated Peace Hospital, Changzhi, Shanxi, China.
Cancer Med. 2020 Aug;9(16):5731-5745. doi: 10.1002/cam4.3224. Epub 2020 Jun 24.
Exploring the efficacy and safety of perioperative chemotherapy on patients with AGC at different clinical and pathological stages.
A phase III randomized, multicenter, trial comparing adjuvant (arm A) or perioperative S-1 plus oxaliplatin (SOX, arm B), and perioperative capecitabine plus oxaliplatin (XELOX, arm C) was initiated in T3/4, node + gastric cancer patients (unclear). Each patient received an 8-cycle chemotherapy (3 weeks for one cycle). Group arms B and C received two cycles preoperatively, and six cycles postoperatively. Primary endpoints were R0 resection rate and DFS, and secondary endpoints included OS, ORR, DCR, and safety. This study was registered on Clinicaltrials.gov. NCT01516944.
A total of 749 patients were randomly assigned into groups A, B, and C. Group A received 1460 circles chemotherapy and group B received 1177 circles while group C received 1200 circles. R0 resection rates in the three groups were 81.7%, 88.7%, and 83.1%, respectively. The difference between groups A and B was considered to be statistically significant (P = .018), and no significant difference between groups B and C (P = .051). Hazard ratio were compared between groups B and C and DFS showed 0.72 (0.67-0.77 with 95% CI), P < .0001, P = .064). The CI top limit actually lower than the estimated value of 1.38, which indicated noninferiority of SOX to XELOX.
Compared with PAC, perioperative chemotherapy showed a significant improvement in R0 resection rates and prognosis in AGC patients with higher safety rates. This study was powered to show superiority of perioperative over adjuvant SOX, and noninferiority of SOX to XELOX. Volume measurement, repeated laparoscopic exploration combined with exfoliative cytology can be used as a supplementary method in the clinical staging and efficacy evaluation of AGC.
探讨不同临床病理分期的 AGC 患者围手术期化疗的疗效和安全性。
一项比较辅助（A 组）或围手术期 S-1 联合奥沙利铂（SOX，B 组）和围手术期卡培他滨联合奥沙利铂（XELOX，C 组）的 III 期随机、多中心试验，在 T3/4、淋巴结阳性+胃癌患者中启动（不明确）。每位患者接受 8 个周期的化疗（1 个周期 3 周）。组 B 和 C 术前接受 2 个周期，术后接受 6 个周期。主要终点为 R0 切除率和无病生存期（DFS），次要终点包括总生存期（OS）、客观缓解率（ORR）、疾病控制率（DCR）和安全性。该研究在 Clinicaltrials.gov 上注册。NCT01516944。
共有 749 例患者被随机分为 A、B 和 C 组。A 组接受 1460 个周期化疗，B 组接受 1177 个周期，C 组接受 1200 个周期。三组的 R0 切除率分别为 81.7%、88.7%和 83.1%。组 A 和 B 之间的差异被认为具有统计学意义（P=0.018），而组 B 和 C 之间没有显著差异（P=0.051）。组 B 和 C 之间的风险比与 DFS 进行了比较，DFS 显示 0.72（95%CI 为 0.67-0.77），P<0.0001，P=0.064）。CI 上限实际上低于估计值 1.38，表明 SOX 不劣于 XELOX。
与 PAC 相比，围手术期化疗在安全性更高的情况下，显著提高了 AGC 患者的 R0 切除率和预后。本研究旨在显示围手术期 SOX 优于辅助 SOX，SOX 不劣于 XELOX。体积测量、重复腹腔镜探查结合脱落细胞学检查可作为 AGC 临床分期和疗效评价的补充方法。
