P-0046 - Five-year outcomes of a phase II study of adjuvant chemotherapy with S-1 plus docetaxel for Stage III gastric cancer after curative D2 gastrectomy

Date 28 June 2014
Event World GI 2014
Session Poster Session
Presenter Shigeyuki Tamura
Citation Annals of Oncology (2014) 25 (suppl_2): ii14-ii104. 10.1093/annonc/mdu165
Authors K. Fujitani1, T. Tsuji2, K. Inoue3, K. Kobayashi4
  • 1Department of Surgery, Osaka Prefectural General Medical Center, Osaka/JP
  • 2Wakayama Rosai Hispital, Wakayama/JP
  • 3Kansai Medical University, Hirakata/JP
  • 4Kinki Central Hospital, Itami/JP



We have already reported the superior feasibility and safety and 3-year outcomes of adjuvant S-1 plus docetaxel in patients with stage III gastric cancer as a prospective phase II study. We report 5-year follow-up data on patients enrolled onto this study.


Fifty-three patients with histologically confirmed stage III gastric cancer who underwent gastrectomy with D2 lymph-node dissection were enrolled into this study. They received oral S-1 (80 mg/m2/day) administration for 2 weeks and intravenous docetaxel (40 mg/m2) on day 1, repeated every 3 weeks (1 cycle). This treatment was started within 45 days after surgery and repeated for 4 cycles, followed by S-1 monotherapy (4 weeks on, 2 weeks off) until 1 year after surgery. Five-year overall survival (OS) and disease-free survival (DFS) were evaluated.


The OS rate at 5 years was 68.3% (95%CI, 54.2% to 85.6%) and the DFS rate at 5 years was 62.4% (95% CI, 50.4% to 77.3%). Subgroup analyses according to the stage showed 5-year OS and DFS of 73.9% (95%CI, 60.4% to 90.1%) and 68.1% (95%CI, 54.2% to 85.6%) for stage IIIA, and 56.2% (95% CI, 36.5% to 86.7%) and 50.0% (95% CI, 30.6% to 81.6%) for stage IIIB.


On the basis of 5-year follow up data, postoperative adjuvant therapy with S-1 plus docetaxel yielded promising OS and DFS in stage III gastric cancer patients who underwent gastrectomy with D2 lymph-node dissection. We believe that this regimen will be a candidate for future phase III trials seeking the optimal adjuvant chemotherapy for stage III gastric cancer.