Cunningham David, Allum William H, Stenning Sally P, Thompson Jeremy N, Van de Velde Cornelis J H, Nicolson Marianne, Scarffe J Howard, Lofts Fiona J, Falk Stephen J, Iveson Timothy J, Smith David B, Langley Ruth E, Verma Monica, Weeden Simon, Chua Yu Jo
Department of Medicine, Royal Marsden Hospital, Sutton , Surrey, United Kingdom.
N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.
A 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.
We 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.
ECF-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<0.001).
In patients with operable gastric or lower esophageal adenocarcinomas, a perioperative regimen of ECF decreased tumor size and stage and significantly improved progression-free and overall survival. (Current Controlled Trials number, ISRCTN93793971 [controlled-trials.com].).
表柔比星、顺铂和氟尿嘧啶持续静脉输注（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。我们评估了在手术基础上加用围手术期ECF方案是否能改善潜在可治愈的胃癌患者的预后。
我们将可切除的胃、食管胃交界或食管下段腺癌患者随机分为围手术期化疗联合手术组（250例患者）和单纯手术组（253例患者）。化疗包括术前3个周期和术后3个周期，静脉注射表柔比星（每平方米体表面积50 mg）和顺铂（每平方米60 mg），于第1天给药，氟尿嘧啶持续静脉输注（每天每平方米200 mg），共21天。主要终点为总生存期。
ECF相关不良反应与既往报道的晚期胃癌患者相似。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分期更低。中位随访4年，围手术期化疗组有149例患者死亡，手术组有170例患者死亡。与手术组相比，围手术期化疗组的总生存期（死亡风险比为0.75；95%置信区间为0.60至0.93；P = 0.009；五年生存率分别为36%和23%）和无进展生存期（进展风险比为0.66；95%置信区间为0.53至0.81；P < 0.001）更优。
对于可手术切除的胃或食管下段腺癌患者，围手术期ECF方案可减小肿瘤大小、降低分期，并显著改善无进展生存期和总生存期。（当前对照试验编号，ISRCTN93793971 [controlled-trials.com]。）
