A phase II study of neoadjuvant chemotherapy with S-1 and XXXX for stage III gastric cancer: KUGC03.

@entity1 @entity900 @entity356 @entity260
OBJECTIVES: A multi-center phase II study was conducted to evaluate the safety and efficacy of neoadjuvant chemotherapy (NAC) with S-1 plus @entity900 for advanced @entity356 . METHODS: The eligibility criteria were clinical T3/T4 or N2, not Stage IV. @entity1 received two 35-day cycles of S-1 plus @entity900 , and then underwent D2 gastrectomy. The primary endpoint was 3-year progression free survival (PFS). Secondary endpoints were ratio of R0 resection, response rate, adverse events, and overall survival. A sample size of 49 was determined to have 80% power for detecting 15% improvement in the 3-year PFS over 55% at a one-sided alpha of 0.1. RESULTS: Among 53 @entity1 enrolled, 44 @entity1 completed two cycles of NAC (83%), and 48 @entity1 underwent R0 resection (91%). @entity260 occurred in 13 @entity1 (26%). A pathological response was confirmed in 24 @entity1 (45%), including four complete responses. The 3-year PFS was 50.7%, while the 3-year OS was 74.9%. CONCLUSIONS: Although the observed 3-year PFS rate was worse than expected, NAC with S1 plus @entity900 was safe and led to a high rate of R0 resection. A randomized controlled trial is needed to make conclusions about the effectiveness of NAC in Japanese @entity1 undergoing D2 resection. J. Surg. Oncol.    2015 Wiley Periodicals, Inc.
