Canadian Association of General Surgeons and American College of Surgeons Evidence-Based Reviews in Surgery. 25.

摘要

>Question: Does perioperative adjuvant therapy improve the outcome of operable gastric cancer? >Design: Multicentre randomized controlled trial. >Setting: Forty-five centres in the United Kingdom as well as centres in the Netherlands, Germany, Brazil, Singapore and New Zealand. >Patients: Five hundred and three patients with histologically proven adenocarcinoma of the stomach, esophogastric junction or lower esophagus were randomized to perioperative chemotherapy plus surgery (n = 250 patients) or surgery alone (n = 253 patients). >Interventions: Patients who were assigned to the perioperative chemotherapy and surgery group received 3 doses of chemotherapy (epirubicin, cisplatin and fluorouracil) preoperatively, followed by surgery 3–6 weeks after the third dose, and then 3 doses of postoperative chemotherapy beginning 6–12 weeks after surgery. Patients assigned to surgery alone were scheduled to have surgery within 6 weeks of randomization. The main outcome measure was overall survival. Secondary outcomes were progression-free survival, assessments of downstaging, the surgeon's assessment of whether the surgery was curative and quality of life. >Results: Rates of postoperative complications were similar in both groups (46% v. 45%, respectively), as were the numbers of deaths within 30 days of surgery. The resected tumours were significantly smaller and less advanced in the group that received perioperative chemotherapy. With a mean follow-up of 4 years, 144 (60%) of the patients in the perioperative chemotherapy group and 170 (67%) of the patients in the surgery group died. The likelihood of overall survival was higher in the perioperative chemotherapy group (hazard ratio [HR] for death 0.75, 95% confidence interval [CI] 0.60–0.93; p = 0.009; 5-year survival rate 36% v. 23%), as was the likelihood of progression-free survival (HR for progression 0.66; 95% CI 0.53–0.81; p < 0.001). >Conclusion: Compared with the group receiving surgery alone, overall survival improved in the group receiving perioperative chemotherapy, as did progression-free survival among patients with resectable adenocarcinoma of the stomach, esophogastric junction or lower esophagus.