641P - Phase II multi-institutional prospective randomized trial comparing S-1 + paclitaxel with paclitaxel alone as second-line chemotherapy in patients...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Gastric Cancer
Biological Therapy
Presenter Kouki Nakanishi
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors K. Nakanishi1, D. Kobayashi2, Y. Mochizuki3, K. Ishigure4, S. Ito5, H. Kojima6, A. Ishiyama7, S. Fujitake8, T. Shikano9, Y. Kodera10
  • 1Surgery, Komaki Municipal Hospital, 4858520 - Komaki/JP
  • 2Gastroenterological Surgery, Nagoya University Graduate School of Medicine, 4668550 - Nagoya/JP
  • 3Surgery, Komaki Municipal Hospital, Komaki/JP
  • 4Department Of Surgery, Konan Kosei Hospital, Konan/JP
  • 5Gastroenterological Surgery, Aichi Cancer Center, 4648681 - Nagoya Aichi/JP
  • 6Gastroenterological Surgery, Aichi Cancer Center Aichi Hospital, Okazaki Aichi/JP
  • 7Department Of Surgery, Okazaki City Hospital, Okazaki/JP
  • 8Surgery, Nishio Municipal Hospital, Nishio/JP
  • 9Surgery, Yokkaichi Municipal Hospital, Yokkaichi/JP
  • 10Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya/JP



In Japan, S-1 has been the key drug in the first-line treatment for gastric cancer. However, there has been no evidence in support of continuation of S-1 in combination with another anticancer drug in the second-line setting. A multicenter randomized phase II trial was conducted to explore whether continuation of S-1 in addition to paclitaxel, a drug often used alone in the second-line setting, offers any benefit to the patients.


Gastric cancer patients who showed progression during the S-1-based first-line chemotherapy or has recurrence during the postoperative adjuvant treatment by S-1 were randomly assigned to the second-line treatment either by weekly administration of paclitaxel (PTX) at 80 mg/m2 three times every 4 weeks or daily oral S-1 (80 mg/m2) for 2 weeks plus paclitaxel (50 mg/m2) given on days 1 and 8, every 3 weeks (S-1 + PTX). Primary end points were the progression-free survival (PFS) at 4 months and the incidence of adverse effects. Secondary end points included response rate and overall survival (OS).


A total of 79 patients were eligible for efficacy analyses, 38 of whom were randomized to the S-1 + PTX group and 41 to the PTX group. PFS at 4 months was similar between the groups (45% for S-1 + PTX vs 49% for PTX, P = 0.71). The incidences of grade 3 or more haematological and non-haematological toxicities were also equivalent between the groups (21% vs 22% and 24% vs 27%, respectively). Although there were no statistically significant differences, the median OS was longer in the S-1 + PTX group (463 days vs 312 days, P = 0.46). Response rate was similar between the groups (22% for S-1 + PTX vs 29% for PTX, P = 0.75). The proportion of patients who remain progression-free for more than 300 days was higher among the S-1 + PTX group in a subset of patients who had relapse during the postoperative adjuvant chemotherapy (31% vs 7%).


Neither benefit nor shortcomings of S-1 administration beyond progression was proven when paclitaxel was selected as a second-line chemotherapy. S-1 + paclitaxel could be considered for patients who relapsed during postoperative adjuvant therapy by S-1.


All authors have declared no conflicts of interest.