Neoadjuvant Chemotherapy Compared With Surgery Alone for Locally Advanced Cancer of the Stomach and Cardia: European Organisation for Research and Treatment of Cancer Randomized Trial 40954
Neoadjuvant Chemotherapy Compared With Surgery Alone for Locally Advanced Cancer of the Stomach and Cardia: European Organisation for Research and Treatment of Cancer Randomized Trial 40954
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DOI：
10.1200/jco.2009.26.6114
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发表时间：
2010-12-10
影响因子：
45.3
通讯作者：
Schlag, Peter M.
中科院分区：
文献类型：
--
作者：
Schuhmacher, Christoph;Gretschel, Stephan;Schlag, Peter M.
目的局部进展期胃癌患者术前术后联合化疗可使其获益，但术后化疗率不足50%。我们研究的价值，纯粹的术前化疗的III期临床试验，严格的术前分期和手术切除guidelines.Patients和方法局部晚期腺癌的胃或食管胃交界处（AEG II和III）患者被随机分配到术前化疗，然后手术或单独手术。检测80%的权力，从17个月的中位生存期的改善与手术单独到24个月的新辅助治疗，282事件是required.Results本试验停止后，144例患者随机分配（72：72）不良收益率; 52.8%的患者肿瘤位于近端三分之一的胃，包括AEG II型和III型。新辅助化疗后国际抗癌联盟RO切除率为81.9%，而单纯手术切除率为66.7%（P = 0.036）。单纯手术组的淋巴结转移多于新辅助治疗组（76.5% v61.4%; P = 0.018）。新辅助治疗组的术后并发症发生率更高（27.1% vs 16.2%; P = 0.09）。中位随访4.4年，67例死亡，未显示生存获益（风险比，0.84; 95%CI，0.52至1.35; P = 0.466）。结论本试验显示RO切除率显著增加，但未能显示生存获益。可能的解释是统计功效低、近端胃癌（包括AEG）发生率高和/或单纯根治性手术后的结局优于预期，这是由于手术质量高，切除了胃周区域外的局部淋巴结（腹腔干、肝韧带、a. lienalis; D2）。
Purpose Patients with locally advanced gastric cancer benefit from combined pre- and postoperative chemotherapy, although fewer than 50% could receive postoperative chemotherapy. We examined the value of purely preoperative chemotherapy in a phase III trial with strict preoperative staging and surgical resection guidelines.Patients and Methods Patients with locally advanced adenocarcinoma of the stomach or esophagogastric junction (AEG II and III) were randomly assigned to preoperative chemotherapy followed by surgery or to surgery alone. To detect with 80% power an improvement in median survival from 17 months with surgery alone to 24 months with neoadjuvant, 282 events were required.Results This trial was stopped for poor accrual after 144 patients were randomly assigned (72: 72); 52.8% patients had tumors located in the proximal third of the stomach, including AEG type II and III. The International Union Against Cancer RO resection rate was 81.9% after neoadjuvant chemotherapy as compared with 66.7% with surgery alone (P = .036). The surgery-only group had more lymph node metastases than the neoadjuvant group (76.5% v 61.4%; P = .018). Postoperative complications were more frequent in the neoadjuvant arm (27.1% v 16.2%; P = .09). After a median follow-up of 4.4 years and 67 deaths, a survival benefit could not be shown (hazard ratio, 0.84; 95% CI, 0.52 to 1.35; P = .466).Conclusion This trial showed a significantly increased RO resection rate but failed to demonstrate a survival benefit. Possible explanations are low statistical power, a high rate of proximal gastric cancer including AEG and/or a better outcome than expected after radical surgery alone due to the high quality of surgery with resections of regional lymph nodes outside the perigastic area (celiac trunc, hepatic ligament, lymph node at a. lienalis; D2).