Title A randomized trial comparing postoperative adjuvant chemotherapy with cisplatin and 5-fluorouracil versus preoperative chemotherapy for localized advanced squamous cell carcinoma of the thoracic esophagus ( JCOG 9907 )
Title A randomized trial comparing postoperative adjuvant chemotherapy with cisplatin and 5-fluorouracil versus preoperative chemotherapy for localized advanced squamous cell carcinoma of the thoracic esophagus ( JCOG 9907 )
复制标题
标题 比较胸段食管局部晚期鳞状细胞癌术后辅助化疗（顺铂和 5-氟尿嘧啶）与术前化疗的随机试验（JCOG 9907）
DOI：
--
复制
发表时间：
2017
期刊：
影响因子：
--
通讯作者：
H. Fukuda
中科院分区：
文献类型：
--
作者：
N. Ando;H. Kato;H. Igaki;M. Shinoda;S. Ozawa;H. Shimizu;Tsutomu Nakamura;H. Yabusaki;N. Aoyama;A. Kurita;K. Ikeda;T. Kanda;T. Tsujinaka;Kenichi Nakamura;H. Fukuda
背景：日本临床肿瘤组试验（JCOG9204）显示，食管癌术后化疗患者的无病生存期优于单纯手术患者。本研究的目的是评估局部晚期食管鳞状细胞癌患者实施化疗的最佳围手术期，即术前或术后。方法：符合条件的临床II期或III期（不包括T4期）鳞状细胞癌患者随机接受手术后（后组）或术前（前组）化疗，化疗由顺铂加5-氟尿嘧啶两个疗程组成。主要终点为无进展生存期。结果：在2000年5月至2006年5月期间，我们随机抽取了330例患者，其中166例分配到Post组，164例分配到Pre组。计划的中期分析是在患者累积完成后进行的。无进展生存期未达到停止边界，但总生存期Pre组优于Post组（p = 0.01）。因此，数据和安全监测委员会建议尽早公布。最新分析显示，术后组的5年总生存率为43%，术前组为55%（风险比0.73,95%可信区间0.54-0.99;p=0.04），其中截尾患者的中位随访时间为61.6个月。在手术发病率方面，术前组术后肾功能不全略高于术后组。结论：术前顺铂联合5-氟尿嘧啶化疗可作为II/III期鳞状细胞癌患者的标准治疗方案。
Background: Patients with esophageal carcinoma receiving postoperative chemotherapy showed superior disease-free survival than those receiving surgery alone in a Japan Clinical Oncology Group trial (JCOG9204). The purpose of this study is to evaluate optimal perioperative timing, i.e. before or after surgery, for implementing chemotherapy in patients with locally advanced esophageal squamous cell carcinoma. Methods: Eligible patients with clinical stage II or III, excluding T4, squamous cell carcinoma were randomized to undergo surgery followed (Post group) or preceded (Pre group) by chemotherapy consisting of two courses of cisplatin plus 5-fluorouracil. The primary endpoint was progression-free survival. Results: We randomized 330 patients, with 166 assigned to the Post group and 164 to the Pre group between May 2000 and May 2006. The planned interim analysis was conducted after completion of patient accrual. Progression-free survival did not reach the stopping boundary, but overall survival in the Pre group was superior to that of the Post group (p = 0.01). Therefore, the Data and Safety Monitoring Committee recommended early publication. Updated analyses showed the 5-year overall survival to be 43% in the Post group and 55% in the Pre group (hazard ratio 0.73, 95% confidence interval 0.54-0.99; p=0.04), where the median follow-up of censored patients was 61.6 months. Concerning operative morbidity, renal dysfunction after surgery in the Pre group was slightly higher than in the Post group. Conclusions: Preoperative chemotherapy with cisplatin plus 5-fluorouracil can be regarded as standard treatment for patients with stage II/III squamous cell carcinoma.
影响因子：
45.3
作者：
Kelsen, David P.;Winter, Katryn A.;Willett, Christopher G.
通讯作者：
Willett, Christopher G.
影响因子：
45.3
作者：
Tepper, Joel;Krasna, Mark J.;Mayer, Robert
通讯作者：
Mayer, Robert
影响因子：
158.5
作者：
Kelsen, DP;Ginsberg, R;Roth, JA
通讯作者：
Roth, JA