Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer
Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer
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DOI：
10.1056/nejm199812313392704
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发表时间：
1998-12-31
影响因子：
158.5
通讯作者：
Roth, JA
中科院分区：
文献类型：
--
作者：
Kelsen, DP;Ginsberg, R;Roth, JA
背景：我们进行了一项多机构随机试验，比较术前化疗，然后手术与单纯手术的患者与当地和可手术的食管cancer.Methods术前化疗的患者随机分配到化疗组包括三个周期的顺铂和氟尿嘧啶。手术在第三个周期完成后两到四周进行;患者在手术后还接受了另外两个周期的化疗。随机分配到即刻手术组的患者接受相同的手术程序。结果440例有充分资料的患者中，213例接受术前化疗，227例接受即刻手术。经过55.4个月的中位可能研究时间后，两组之间的中位生存期没有显著差异：接受术前化疗的患者为14.9个月，接受即刻手术的患者为16.1个月（P=0.53）。一年后，接受化疗的患者的生存率为59%，仅接受手术的患者为60%;两年后，生存率分别为35%和37%。化疗的毒性作用是可以耐受的，并且化疗的添加似乎没有增加与手术相关的发病率或死亡率。鳞状细胞癌和腺癌患者的生存率没有差异。体重减轻是不良结局的重要预测因素（P=0.03）。随着化疗的增加，局部或远处的复发率没有变化。结论术前联合顺铂和氟尿嘧啶化疗并不能提高食管表皮样癌或腺癌患者的总生存率。（N Engl J Med 1998;339：1979-84.）(C)1998年，马萨诸塞州医学会。
Background We performed a multi-institutional randomized trial comparing preoperative chemotherapy followed by surgery with surgery alone for patients with local and operable esophageal cancer.Methods Preoperative chemotherapy for patients randomly assigned to the chemotherapy group included three cycles of cisplatin and fluorouracil. Surgery was performed two to four weeks after the completion of the third cycle; patients also received two additional cycles of chemotherapy after the operation. Patients randomly assigned to the immediate-surgery group underwent the same surgical procedure. The main end point was overall survival.Results Of the 440 eligible patients with adequate data, 213 were assigned to receive preoperative chemotherapy and 227 to undergo immediate surgery. After a median possible study time of 55.4 months, there were no significant differences between the two groups in median survival: 14.9 months for the patients who received preoperative chemotherapy and 16.1 months for those who underwent immediate surgery (P=0.53). At one year, the survival rate was 59 percent for those who received chemotherapy and 60 percent for those who had surgery alone; at two years, survival was 35 percent and 37 percent, respectively. The toxic effects of chemotherapy were tolerable, and the addition of chemotherapy did not appear to increase the morbidity or mortality associated with surgery. There were no differences in survival between patients with squamous-cell carcinoma and those with adenocarcinoma. Weight loss was a significant predictor of poor outcome (P=0.03). With the addition of chemotherapy, there was no change in the rate of recurrence at locoregional or distant sites.Conclusions Preoperative chemotherapy with a combination of cisplatin and fluorouracil did not improve overall survival among patients with epidermoid cancer or adenocarcinoma of the esophagus. (N Engl J Med 1998;339:1979-84.) (C) 1998, Massachusetts Medical Society.