Department of Surgery, Osaka National Hospital, 2-1-14 Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan,
Gastric Cancer. 2014 Apr;17(2):348-53. doi: 10.1007/s10120-013-0273-7. Epub 2013 Jun 5.
We have previously reported the superior feasibility and safety of adjuvant S-1 plus docetaxel in patients with stage III gastric cancer during a prospective phase II study. We report 3-year follow-up data on patients enrolled in this study.
Fifty-three patients with histologically confirmed stage III gastric cancer who underwent gastrectomy with D2 lymphadenectomy were enrolled into this study. They received oral S-1 (80 mg/m(2)/day) for 2 consecutive weeks and intravenous docetaxel (40 mg/m(2)) on day 1, repeated every 3 weeks (one cycle). Treatment was initiated within 45 days after surgery and repeated for four cycles, followed by S-1 monotherapy (4 weeks on, 2 weeks off) until 1 year after surgery. Three-year overall survival (OS) and disease-free survival (DFS) were evaluated.
The OS rate at 3 years was 78.4 % [95 % confidence interval (CI), 67.9-90.6 %] and the DFS rate at 3 years was 66.2 % (95 % CI, 54.4-80.7 %). Subgroup analyses according to disease stage showed a 3-year OS and DFS rate of 85.7 % (95 % CI, 74.9-98.1 %) and 70.8 % (95 % CI, 57.1-87.8 %) for stage IIIA, and 62.5 % (95 % CI, 42.8-91.4 %) and 56.2 % (95 % CI, 36.5-86.7 %) for stage IIIB, respectively.
On the basis of 3-year follow-up data, postoperative adjuvant therapy with S-1 plus docetaxel yielded promising OS and DFS in stage IIIA gastric cancer patients who had undergone D2 gastrectomy. We believe that this regimen is a candidate for future phase III trials studying the optimal adjuvant chemotherapy regimen for stage III gastric cancer.
我们之前曾报道过在一项前瞻性 II 期研究中，辅助 S-1 加多西他赛治疗 III 期胃癌患者的良好可行性和安全性。我们报告了这项研究中入组患者的 3 年随访数据。
53 例经组织学证实的 III 期胃癌患者接受了 D2 淋巴结清扫术的胃切除术。他们接受口服 S-1（80 mg/m2/天）连续 2 周，静脉注射多西他赛（40 mg/m2）第 1 天，每 3 周重复一次（一个周期）。治疗在手术后 45 天内开始，重复 4 个周期，然后进行 S-1 单药治疗（4 周 ON，2 周 OFF），直到手术后 1 年。评估 3 年总生存率（OS）和无病生存率（DFS）。
3 年 OS 率为 78.4%[95%置信区间（CI），67.9-90.6%]，3 年 DFS 率为 66.2%（95%CI，54.4-80.7%）。根据疾病分期的亚组分析显示，III 期 A 期的 3 年 OS 和 DFS 率分别为 85.7%（95%CI，74.9-98.1%）和 70.8%（95%CI，57.1-87.8%），而 IIIB 期的分别为 62.5%（95%CI，42.8-91.4%）和 56.2%（95%CI，36.5-86.7%）。
基于 3 年随访数据，接受 D2 胃切除术的 IIIA 期胃癌患者术后辅助 S-1 加多西他赛治疗可获得良好的 OS 和 DFS。我们认为，该方案是未来 III 期研究 III 期胃癌最佳辅助化疗方案的候选方案。
