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

被引:16
作者
Okabe, Hiroshi [1 ]
Hata, Hiroaki [2 ]
Ueda, Shugo [3 ]
Zaima, Masazumi [4 ]
Tokuka, Atsuo [5 ]
Yoshimura, Tsunehiro [6 ]
Ota, Shuichi [7 ]
Kinjo, Yousuke [1 ]
Yoshimura, Kenichi [8 ]
Sakai, Yoshiharu [1 ]
机构
[1] Kyoto Univ, Dept Surg, Grad Sch Med, Kyoto, Japan
[2] Kyoto Med Ctr, Dept Surg, Kyoto, Japan
[3] Kitano Hosp, Dept Surg Gastroenterol, Osaka, Japan
[4] Shiga Med Ctr Adults, Dept Surg, Shiga, Japan
[5] Shimane Prefectural Cent Hosp, Dept Surg, Shimane, Japan
[6] Tenri Hosp, Dept Abdominal Surg, Nara, Japan
[7] Saiseikai Noe Hosp, Dept Surg, Osaka, Japan
[8] Kanazawa Univ Hosp, Innovat Clin Res Ctr, Ishikawa, Japan
关键词
gastric cancer; neoadjuvant chemotherapy; phase II; clinical stage III; PLUS CISPLATIN; ADJUVANT CHEMOTHERAPY; PERIOPERATIVE CHEMOTHERAPY; PREOPERATIVE CHEMOTHERAPY; D2; GASTRECTOMY; SURGERY; TRIAL; ADENOCARCINOMA; MULTICENTER; GUIDELINES;
D O I
10.1002/jso.24096
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
ObjectivesA multi-center phase II study was conducted to evaluate the safety and efficacy of neoadjuvant chemotherapy (NAC) with S-1 plus cisplatin for advanced gastric cancer. MethodsThe eligibility criteria were clinical T3/T4 or N2, not Stage IV. Patients received two 35-day cycles of S-1 plus cisplatin, 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. ResultsAmong 53 patients enrolled, 44 patients completed two cycles of NAC (83%), and 48 patients underwent R0 resection (91%). Postoperative complications occurred in 13 patients (26%). A pathological response was confirmed in 24 patients (45%), including four complete responses. The 3-year PFS was 50.7%, while the 3-year OS was 74.9%. ConclusionsAlthough the observed 3-year PFS rate was worse than expected, NAC with S1 plus cisplatin 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 patients undergoing D2 resection. J. Surg. Oncol. 2016;113:36-41. (c) 2015 Wiley Periodicals, Inc.
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页码:36 / 41
页数:6
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