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 (JCOG9907)
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 (JCOG9907)
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DOI：
10.1245/s10434-011-2049-9
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发表时间：
2012-01-01
影响因子：
3.7
通讯作者：
Fukuda, Haruhiko
中科院分区：
文献类型：
--
作者：
Ando, Nobutoshi;Kato, Hoichi;Fukuda, Haruhiko
在日本临床肿瘤组试验（JCOG 9204）中，接受术后化疗的食管癌患者的无病生存率上级单纯接受手术的患者。本研究的目的是评估最佳的围手术期时间，即手术前或手术后，为局部晚期食管鳞状细胞癌患者提供化疗。符合条件的患者临床分期II或III期，不包括T4，鳞状细胞癌随机接受手术后（组1）或化疗前（组2），化疗包括两个疗程的顺铂加5-氟尿嘧啶。研究的主要终点是无进展生存期，我们在2000年5月至2006年5月间随机分配了330例患者，其中166例分配到第1组，164例分配到第2组。计划的中期分析在完成患者招募后进行。无进展生存期未达到停止边界，但组2的总生存期上级组1（P = 0.01）。因此，数据和安全监测委员会建议尽早发表。更新的分析显示，第1组的5年总生存率为43%，第2组为55%（风险比0.73，95%置信区间0.54-0.99，P = 0.04），其中删失患者的中位随访时间为61.6个月。术前顺铂联合5-氟尿嘧啶化疗可作为Ⅱ/Ⅲ期鳞癌的标准治疗方案。
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 was to evaluate optimal perioperative timing-that is, before or after surgery-for providing chemotherapy in patients with locally advanced esophageal squamous cell carcinoma.Eligible patients with clinical stage II or III, excluding T4, squamous cell carcinoma were randomized to undergo surgery followed (group 1) or preceded (group 2) by chemotherapy consisting of two courses of cisplatin plus 5-fluorouracil. The primary end point was progression-free survival.We randomized 330 patients, with 166 assigned to group 1 and 164 to group 2, 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 group 2 was superior to that of group 1 (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 group 1 and 55% in group 2 (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 group 2 was slightly higher than in group 1.Preoperative chemotherapy with cisplatin plus 5-fluorouracil can be regarded as standard treatment for patients with stage II/III squamous cell carcinoma.