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Three-year outcomes of a phase II study of adjuvant chemotherapy with S-1 plus docetaxel for stage III gastric cancer after curative D2 gastrectomy

2013; Springer Science+Business Media; Volume: 17; Issue: 2 Linguagem: Inglês

10.1007/s10120-013-0273-7

1436-3305

Kazumasa Fujitani, Shigeyuki Tamura, Yutaka Kimura, Takeshi Tsuji, Jin Matsuyama, Shöhei Iijima, Hiroshi Imamura, Kentaro Inoue, Kenji Kobayashi, Yukinori Kurokawa, Toshio Shimokawa, Toshimasa Tsujinaka, Hiroshi Furukawa,

Gastrointestinal Tumor Research and Treatment

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/m2/day) for 2 consecutive weeks and intravenous docetaxel (40 mg/m2) 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.