Hayashi Tsutomu, Yoshikawa Takaki, Sakamaki Kentaro, Nishikawa Kazuhiro, Fujitani Kazumasa, Tanabe Kazuaki, Misawa Kazunari, Matsui Takanori, Miki Akira, Nemoto Hiroshi, Fukunaga Tetsu, Kimura Yutaka, Hihara Jun
Gastric Surgery National Cancer Center Hospital Chuo-ku Japan.
Center for Data Science Yokohama City University Yokohama Japan.
Ann Gastroenterol Surg. 2020 Jul 16;4(5):540-548. doi: 10.1002/ags3.12352. eCollection 2020 Sep.
Neoadjuvant chemotherapy (NAC) is promising to improve the survival of resectable gastric cancer. However, suitable regimen and treatment duration for NAC have not yet been established.
We conducted a randomized phase II trial to compare two and four courses of neoadjuvant S-1/cisplatin (SC) and S-1/cisplatin/docetaxel(DCS) using a two-by-two factorial design for locally resectable advanced gastric cancer. Patients with M0 and either T4 or T3 in case of junctional cancer or scirrhous-type cancer received two or four courses of SC or DCS. Then, patients underwent D2 gastrectomy and adjuvant S-1 chemotherapy for 1 year. The primary endpoint was 3-year overall survival. The planned sample size was 120 eligible patients.
Between October 2011 and September 2014, 132 patients were assigned to CS (n = 66; 33 in 2-courses and 33 in 4-courses) and DCS (n = 66; 33 in 2-courses and 33 in 4-courses). The 3-year OS was 58.1% in CS and 60.0% in DCS with hazard ratio of 0.80 (95% CI, 0.48-1.34), while it was 53.1% in the two courses and 65.0% in the four courses with hazard ratio of 0.72 (95% CI, 0.43-1.22). In the survival analysis by duration in each regimen, the 3-year OS was 58.1% for both two and four courses in CS, while it was 48.5% for two courses of DCS and 71.9% for four courses of DCS.
Considering high 3-year OS, four courses DCS has a value to be tested in a future phase III study to confirm superiority of neoadjuvant chemotherapy for locally advanced gastric cancer.
新辅助化疗（NAC）有望提高可切除胃癌患者的生存率。然而，NAC的合适方案和治疗疗程尚未确定。
我们进行了一项随机II期试验，采用二乘二析因设计，比较新辅助S-1/顺铂（SC）和S-1/顺铂/多西他赛（DCS）两个疗程和四个疗程用于局部可切除进展期胃癌的疗效。M0且肿瘤为交界性癌或硬癌类型时T4或T3的患者接受两个或四个疗程的SC或DCS治疗。然后，患者接受D2胃切除术及辅助S-1化疗1年。主要终点为3年总生存率。计划样本量为120例符合条件的患者。
2011年10月至2014年9月期间，132例患者被分配至CS组（n = 66；2个疗程33例，4个疗程33例）和DCS组（n = 66；2个疗程33例，4个疗程33例）。CS组3年总生存率为58.1%，DCS组为60.0%，风险比为0.80（95%CI，0.48 - 1.34）；两个疗程组为53.1%，四个疗程组为65.0%，风险比为0.72（95%CI，0.43 - 1.22）。在各方案按疗程进行的生存分析中，CS组两个疗程和四个疗程的3年总生存率均为58.1%，而DCS组两个疗程为48.5%，四个疗程为71.9%。
鉴于较高的3年总生存率，四个疗程的DCS有必要在未来的III期研究中进行验证，以确认其对局部进展期胃癌新辅助化疗的优越性。
