Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer

被引:5110
作者
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
机构
[1] Royal Marsden Hosp, Dept Med, Sutton SM2 5PT, Surrey, England
[2] Royal Marsden Hosp, Dept Surg, Sutton SM2 5PT, Surrey, England
[3] Royal Marsden Hosp, Dept Med, London SW3 6JJ, England
[4] Royal Marsden Hosp, Dept Surg, London SW3 6JJ, England
[5] MRC, Clin Trials Unit, Canc Grp, London, England
[6] Aberdeen Royal Infirm, Aberdeen, Scotland
[7] Christie Hosp, Dept Med Oncol, Manchester, Lancs, England
[8] St George Hosp, Dept Med Oncol, London, England
[9] Bristol Haematol & Oncol Ctr, Dept Oncol, Bristol, Avon, England
[10] Southampton Gen Hosp, Med Oncol Unit, Southampton SO9 4XY, Hants, England
[11] Clatterbridge Ctr Oncol, Liverpool, Merseyside, England
[12] Leiden Univ, Med Ctr, Dept Surg, Leiden, Netherlands
基金
英国医学研究理事会;
关键词
D O I
10.1056/NEJMoa055531
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background 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. Methods 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. Results 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). Conclusions 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.
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页码:11 / 20
页数:10
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