Department of Surgery, Tokyo Dental College Ichikawa General Hospital, Ichikawa, Japan.
Ann Surg Oncol. 2012 Jan;19(1):68-74. doi: 10.1245/s10434-011-2049-9. Epub 2011 Aug 31.
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.
日本癌症化疗组（JCOG9204）试验表明，接受术后化疗的食管癌患者无疾病生存率优于单独接受手术的患者。本研究旨在评估局部晚期食管鳞状细胞癌患者接受化疗的最佳围手术期时机，即手术前或手术后。
符合临床 II 期或 III 期（不包括 T4 期）、鳞状细胞癌的患者被随机分为手术组（第 1 组）或手术前化疗组（第 2 组），化疗方案为顺铂联合氟尿嘧啶两周期。主要终点为无进展生存期。
我们于 2000 年 5 月至 2006 年 5 月期间随机分配了 330 例患者，其中 166 例分配到第 1 组，164 例分配到第 2 组。计划的中期分析在患者入组完成后进行。无进展生存期未达到终止边界，但第 2 组的总生存期优于第 1 组（P=0.01）。因此，数据和安全监测委员会建议提前发表。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），截止时接受censored 分析的患者的中位随访时间为 61.6 个月。关于手术并发症，第 2 组手术后肾功能不全略高于第 1 组。
顺铂联合氟尿嘧啶术前化疗可作为 II/III 期鳞状细胞癌患者的标准治疗方法。
