681P - Long-term follow up of a feasibility study of the factorial phase III SAMIT trial: adjuvant paclitaxel followed by S-1 for gastric cancer

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anti-Cancer Agents & Biologic Therapy
Gastric Cancer
Presenter Shigefumi Yoshino
Authors S. Yoshino1, A. Tsuburaya2, M. Kobayashi3, N. Hirabayashi4, N. Nagata5, Y. Miyashita6, S. Morita7, J. Sakamoto8
  • 1Department Of Digestive Surgery And Surgical Oncol, Yamaguchi University Graduate School of Medicine, 755-8505 - Ube/JP
  • 2Department Of Surgery, Kanagawa Cancer Center, Yokohama/JP
  • 3Department Of Surgery, Kochi Medical School, Nankoku/JP
  • 4Department Of Surgery, Hiroshima City Asa Hospital, Hiroshima/JP
  • 5Surgery, Kitakyushu General Hospital, JP-803-0814 - Kitakyushu/JP
  • 6Department Of Epidemiological And Clinical Research, NPO Epidemiological and Clinical Research Information Network, Okazaki/JP
  • 7Biostatistics And Epidemiology, Yokohama City University Medical Center, Yokohama/JP
  • 8Young Leaders Program, Nagoya University, 466-8550 - Nagoya/JP

Abstract

Background

SAMIT is a randomized, multicenter phase III study of FP (S1 or UFT) vs. paclitaxel (PTX) followed by FP in patients (pts) with gastric adenocarcinoma. Between August 2004 and October 2007, 1,495 pts were randomized to Arms A, B, C, or D, and the final efficacy results will be formally assessed in the end of 2012. In SAMIT, the treatment arms with sequential PTX and FP for GC were safe and the compliance of the FP part was high. In this analysis, the long-term survival of the preceding phase II feasibility study of SAMIT was performed. The primary endpoints was met with compliance of 86% (95%CI >73%) and grade 4 hematological toxicity and grade 3 non-hematological toxicities were 2% and 4%, respectively; which were similar to those of SAMIT.

Methods

Eligibility criteria included histologically proven GC; sT4a-4b; sN0-2; M0 (except peritoneal cytology: CY); post D2-3 gastrectomy and R0-1; ECOG PS 0-1; and 20-80 years old. On postoperative day 14 to 56, pts received 3 courses of weekly PTX (80mg/m2 on day 1, 8 for the 1st course and on day 1, 8, 15 for the 2nd and 3rd course, repeated every 3 or 4 weeks) followed by 4 courses of S1 (80mg/m2 daily for 2 weeks, repeated every 3 weeks). Final follow up was performed in March 2012.

Results

Fifty pts were accrued between May 2003 to March 2004, the median age was 63 (range 34-74); male/female: 34/16; pT2-3/T4a/T4b: 1/44/5; CY0/CY1: 4/46; pN0/1/2/3a/3b/ unknown: 8/7/9/12/20/ 4. The median OS was 2876 days (95%CI: 2572-3175 days), and 5 year OS was 60.6% (95%CI: 47.1-74.1%). Half of the pts with CY1, and median survival with pts with pN2 and pN3 were 1862 days and 1305 days, respectively.

Conclusions

Adjuvant PTX/S1 is safe and may be active for gastric cancer pts especially who are at high risk for peritoneal spread. This promising result would be confirmed by the final results of SAMIT.

Disclosure

All authors have declared no conflicts of interest.