Department of Surgery, Graduate School of Medicine Kyoto University, Kyoto, Japan.
Department of Surgery, Kyoto Medical Center, Kyoto, Japan.
J Surg Oncol. 2016 Jan;113(1):36-41. doi: 10.1002/jso.24096. Epub 2015 Nov 25.
A multi-center phase II study was conducted to evaluate the safety and efficacy of neoadjuvant chemotherapy (NAC) with S-1 plus cisplatin for advanced gastric cancer.
The eligibility criteria were clinical T3/T4 or N2, not Stage IV. Patients received two 35-day cycles of S-1 plus cisplatin, and then underwent D2 gastrectomy. The primary endpoint was 3-year progression free survival (PFS). Secondary endpoints were ratio of R0 resection, response rate, adverse events, and overall survival. A sample size of 49 was determined to have 80% power for detecting 15% improvement in the 3-year PFS over 55% at a one-sided alpha of 0.1.
Among 53 patients enrolled, 44 patients completed two cycles of NAC (83%), and 48 patients underwent R0 resection (91%). Postoperative complications occurred in 13 patients (26%). A pathological response was confirmed in 24 patients (45%), including four complete responses. The 3-year PFS was 50.7%, while the 3-year OS was 74.9%.
Although the observed 3-year PFS rate was worse than expected, NAC with S1 plus cisplatin was safe and led to a high rate of R0 resection. A randomized controlled trial is needed to make conclusions about the effectiveness of NAC in Japanese patients undergoing D2 resection.
进行了一项多中心 II 期研究，以评估 S-1 联合顺铂新辅助化疗治疗晚期胃癌的安全性和有效性。
入选标准为临床 T3/T4 或 N2，非 IV 期。患者接受两个 35 天周期的 S-1 联合顺铂治疗，然后行 D2 胃切除术。主要终点为 3 年无进展生存期（PFS）。次要终点为 R0 切除率、缓解率、不良事件和总生存期。确定了 49 例样本量，以单侧 α 值为 0.1 时，80%的效能检测到 3 年 PFS 提高 15%，而非 55%。
53 例患者中，44 例完成了两个周期的 NAC（83%），48 例患者行 R0 切除术（91%）。13 例患者（26%）发生术后并发症。24 例患者（45%）确认有病理缓解，包括 4 例完全缓解。3 年 PFS 为 50.7%，3 年 OS 为 74.9%。
尽管观察到的 3 年 PFS 率低于预期，但 S1 联合顺铂的 NAC 是安全的，并导致 R0 切除率较高。需要进行随机对照试验来确定 NAC 在接受 D2 切除术的日本患者中的有效性。
