Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer
Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer
复制标题
DOI：
10.1056/nejmoa055531
复制
发表时间：
2006-07-06
影响因子：
158.5
通讯作者：
Chua, Yu Jo
中科院分区：
文献类型：
--
作者：
Cunningham, David;Allum, William H.;Chua, Yu Jo
背景表柔比星、顺铂和输注氟尿嘧啶 (ECF) 方案可提高无法治愈的局部晚期或转移性胃腺癌患者的生存率。我们评估了在手术中加入 ECF 围手术期治疗方案是否可以改善可能治愈的胃癌患者的预后。方法我们将可切除的胃、食管胃结合部或下食管腺癌患者随机分配至围手术期化疗和手术（250 名患者）或单独手术（253 名患者）。化疗包括三个术前和术后三个周期，第1天静脉注射表柔比星（50 mg/平方米体表面积）和顺铂（60 mg/平方米），以及连续静脉输注氟尿嘧啶（200 mg/平方米/天），持续21天。主要终点是总生存率。结果ECF 相关的不良反应与之前报道的晚期胃癌患者的不良反应相似。围手术期化疗组和手术组的术后并发症发生率相似（分别为 46% 和 45%），术后 30 天内的死亡人数也相似。围手术期化疗组切除的肿瘤明显更小且进展程度较低。中位随访四年后，围手术期化疗组有 149 名患者死亡，手术组有 170 名患者死亡。与手术组相比，围手术期化疗组的总生存率（死亡风险比，0.75；95%置信区间，0.60至0.93；P=0.009；五年生存率，36%对23%）和无进展生存率（进展风险比，0.66；95%置信区间，0.53至0.93）更高。 0.81；
BackgroundA regimen of epirubicin, cisplatin, and infused fluorouracil (ECF) improves survival among patients with incurable locally advanced or metastatic gastric adenocarcinoma. We assessed whether the addition of a perioperative regimen of ECF to surgery improves outcomes among patients with potentially curable gastric cancer.MethodsWe randomly assigned patients with resectable adenocarcinoma of the stomach, esophagogastric junction, or lower esophagus to either perioperative chemotherapy and surgery (250 patients) or surgery alone (253 patients). Chemotherapy consisted of three preoperative and three postoperative cycles of intravenous epirubicin (50 mg per square meter of body-surface area) and cisplatin (60 mg per square meter) on day 1, and a continuous intravenous infusion of fluorouracil (200 mg per square meter per day) for 21 days. The primary end point was overall survival.ResultsECF-related adverse effects were similar to those previously reported among patients with advanced gastric cancer. Rates of postoperative complications were similar in the perioperative-chemotherapy group and the surgery group (46 percent and 45 percent, respectively), as were the numbers of deaths within 30 days after surgery. The resected tumors were significantly smaller and less advanced in the perioperative-chemotherapy group. With a median follow-up of four years, 149 patients in the perioperative-chemotherapy group and 170 in the surgery group had died. As compared with the surgery group, the perioperative-chemotherapy group had a higher likelihood of overall survival (hazard ratio for death, 0.75; 95 percent confidence interval, 0.60 to 0.93; P=0.009; five-year survival rate, 36 percent vs. 23 percent) and of progression-free survival (hazard ratio for progression, 0.66; 95 percent confidence interval, 0.53 to 0.81; P