医脉通编译，转载请务必注明出处
2015年ASCO年会将于5月29日—6月2日在美国芝加哥召开。5月29日下午的全球肿瘤研讨会专场上，将会发表一项在单一不可治愈因素晚期胃癌（ACG）换种中，胃大部切除（Gx）联合化疗（CTX）与单独CTX比较的随机对照试验，即JCOG 0705/KGCA01研究（REGATTA）。医脉通整理如下：
伴有不可治愈因素的晚期胃癌（AGC）患者预后较差。对这些病人来说，化疗是标准的治疗方案。然而，文献显示胃大部切除（Gx）可能提高患者的生存期。基于此，为研究Gx在伴有单个不可治愈因素AGC中的作用，研究人员们开展了一项国际化随机试验。这项试验在日本，韩国和新加坡进行。
研究方法：
入组标准包括组织学证实胃腺癌，cT1-3，CT扫描或腹腔镜/开腹手术明确存在局限于肝（H1），腹膜（P1），或腹主动脉旁淋巴结（16A1/B2）侵犯的单一不可治愈因素，无其他远处转移，年龄20～75岁，以及PS评分为0-1。符合条件的患者随机分配到Gx序贯CTX组或单独CTX组。推荐术式为Gx联合D1淋巴结清扫术，转移病灶不做切除。CTX方案为S-1 80mg/m2/d，d1-21；顺铂（CDDP）60mg/m2，d8，每5周重复一次。主要终点为总生存期（OS）。计划样本量每组165例，采用单侧检验，α取5%，检验效能取80%，组间2年OS差异为10%（20%[单独CTX] vs. CTX30%[Gx联合]）。
研究结果：
2008年2月至2013年8月随机入组175例（日本95例，韩国80例）。随机分组Gx联合CTX组89例，单纯CTX组86例。2013年9月进行首次中期分析，终点事件发生率为37%（110/294），整体疗效过差，JCOG DSMC建议提前终止试验。2014年12月最新分析显示，中位随访时间14.5个月，2年-OS存活率Gx联合CTX组25.1%（95%CI：16.2至34.9），而单纯CTX组31.7%（95%CI：21.7至42.2）。 然而，亚组分析显示伴有淋巴结病变或cN2/N3的病人可能从胃大部切除术中获益。
结论:
在所有随机入组患者中，Gx序贯CTX与单纯CTX相比较，对伴有单个不可治愈因素的晚期胃癌患者无生存获益。胃大部切除术在满足远端胃大部切除术患者中的价值需要重新评估。临床试验信息：UMIN000001012。
会议专题》》》2015年ASCO年会专题报道
阅读摘要原文
Randomized controlled trial of comparing gastrectomy (Gx) plus chemotherapy (CTX) with CTX alone in advanced gastric cancer (AGC) with a single non-curable factor: JCOG 0705/KGCA01 study (REGATTA).（Abstract 200）
Authors：Han-Kwang Yang, Toshimasa Tsujinaka，et al.
Session Type：Oral Abstract Session
Background：The prognosis of AGC with non-curable factors is poor. Chemotherapy is the standard-of-care for those patients. However, literatures suggest that Gx may improve patients’ survival. Based on these, we conducted an international randomized trial to test the role of Gx in AGC with a single non-curable factor. This trial was performed in Japan, Korea, and Singapore.
Methods：Eligibility criteria included histologically proven gastric adenocarcinoma, cT1-3, presence of a single non-curable factor confined to either liver (H1), peritoneum (P1), or para-aortic lymph node (16a1/b2) confirmed by both CT scan and laparoscopy/laparotomy, no other distant metastasis, aged 20-75, and PS 0-1. Eligible patients were randomized to Gx followed by CTX or CTX alone. Gx with D1 lymph node dissection was recommended without resection of metastatic lesions. CTX regimen was S-1 80 mg/m2/day on days 1-21 plus CDDP 60 mg/m2 on day 8 repeated every 5 weeks. The primary endpoint was overall survival (OS). The planned sample size was 165 cases per arm, with one-sided alpha of 5%, and an 80% power detecting a 2y-survival difference of 10% (20% with CTX alone vs. 30% with Gx and CTX).
Results：Between Feb 2008 and Aug 2013, 175 patients (95 in Japan, 80 in Korea) were randomized. 89 pts were randomized to Gx and CTX, and 86 pts were randomized to CTX alone. The first interim analysis was performed in Sep 2013, with 37% (110/294) of the planned events observed, and JCOG DSMC recommended early termination of the trial based on the overall futile effect. In the updated analysis in Dec 2014 with a median follow-up period of 14.5 months, the 2y-OS were 25.1 (95% CI: 16.2 to 34.9) % with Gx followed by CTX and 31.7 (95% CI: 21.7 to 42.2) % with CTX alone (p = 0.68). However, subgroup analyses suggested gastrectomy might be beneficial especially for patients with L lesion or cN2/N3.
Conclusions：In all randomized patients, Gx followed by CTX has no survival benefit over CTX alone for AGC patients with a single non-curable factor. There is a room to re-evaluate the additional gastrectomy confined to the patients in whom distal gastrectomy suffices for tumor resection. Clinical trial information: UMIN000001012.
