本研究进行了一项第III期临床试验，比较了S-1与单独应用S-1作为Gastric Stage III恶性肿瘤术后化疗的docetaxel，并以3年无复发生存率作为主要终点，明确了双剂在此方面的优越性（分别为67.7%与57.4%，风险比[HR]为0.715，95%置信区间[CI]为0.587-0.871；p = 0.0008）。本最终报告分析了5年生存结果以及晚期复发的发生率和模式。病理确诊为Gastric Stage III的患者，在胃切除术后进行D2淋巴结切除，随机分配为接受S-1与docetaxel或仅接受S-1辅助化疗。与前一报告中评估了3年生存结果的同一912名患者进行了分析。S-1与docetaxel组的5年总生存率（67.91%）显著优于S-1组（60.27%；HR为0.752，95% CI为0.613-0.922；p = 0.0059）。随机分组后3年以上复发的晚期复发发生率在两组中相似（分别为7.3%与7.2%）。腹膜播散是晚期复发的最常见方式。在整个5年的随访期间，docetaxel的添加显著抑制了淋巴途径（分别为6.8% [95% CI 4.52-9.17]与15% [95% CI 11.76-18.30]；p < 0.0001）和血液途径（分别为10.2% [95% CI 7.37-12.94]与15.7% [95% CI 12.36-19.01]；p < 0.0137）的复发。对于病理Stage III的Gastric癌症患者，S-1与docetaxel术后化疗在5年总生存率方面的生存益处得到了确认，尽管晚期复发并未被阻止。© 2023. 作者.

A phase III trial comparing S-1 and docetaxel with S-1 alone as postoperative chemotherapy for pathologically Stage III gastric cancer was conducted and clarified the superiority of the doublet in terms of 3-year relapse-free survival as the primary endpoint (67.7% versus 57.4%, hazard ratio [HR] 0.715, 95% confidence interval [CI] 0.587-0.871; p = 0.0008). This final report analyzed 5-year survival outcomes along with the incidence and pattern of late recurrences.Patients with histologically confirmed Stage III gastric cancer who underwent gastrectomy with D2 lymphadenectomy were randomly assigned to receive adjuvant chemotherapy with either S-1 plus docetaxel or S-1 alone. The same 912 patients who were evaluated for 3-year survival outcomes in the previous report were analyzed.Five-year overall survival rate of the S-1 plus docetaxel group (67.91%) was significantly superior to that in the S-1 group (60.27%; HR 0.752, 95% CI 0.613-0.922; p = 0.0059). The incidence of late recurrence at > 3 years after randomization was similar in both groups (7.3% versus 7.2%). Peritoneal dissemination was the most common pattern of late recurrence. Addition of docetaxel significantly suppressed relapse through the lymphatic (6.8% [95% CI 4.52-9.17] versus 15% [95% CI 11.76-18.30]; p < 0.0001) and hematogenous (10.2% [95% CI 7.37-12.94] versus 15.7% [95% CI 12.36-19.01]; p < 0.0137) pathways throughout the 5 years of follow-up.The survival benefit of postoperative chemotherapy with S-1 and docetaxel in terms of 5-year overall survival rate was confirmed for patients with pathologically Stage III gastric cancer, although late recurrences were not prevented.© 2023. The Author(s).