多中心随机 II 期研究比较顺铂和氟尿嘧啶加多西他赛（DCF）与顺铂和氟尿嘧啶加阿霉素（ACF）作为可切除食管鳞癌（OGSG1003）术前化疗。

Multicenter randomized phase II study of cisplatin and fluorouracil plus docetaxel (DCF) compared with cisplatin and fluorouracil plus Adriamycin (ACF) as preoperative chemotherapy for resectable esophageal squamous cell carcinoma (OGSG1003).

机构信息

Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka.

Department of Surgery, Kinki University School of Medicine, Osaka Sayama, Osaka.

出版信息

Ann Oncol. 2017 Jan 1;28(1):116-120. doi: 10.1093/annonc/mdw439.

DOI:10.1093/annonc/mdw439

PMID:27687307

Abstract

BACKGROUND

This phase II trial evaluated the efficacy of cisplatin and fluorouracil (CF)-based combination neoadjuvant chemotherapy on the outcome of patients with resectable locally advanced esophageal squamous cell carcinoma (ESCC). We compared the recurrence-free survival (RFS) associated with CF plus Adriamycin (ACF) with that associated with CF plus docetaxel (DCF) to select an alternative regimen in a new phase III trial investigating the optimal neoadjuvant treatment of patients with ESCC.

PATIENTS AND METHODS

Patients with resectable advanced ESCC were randomly assigned to either ACF (Adriamycin 35 mg/m2, cisplatin 70 mg/m2 i.v. on day 1, fluorouracil 700 mg/m2 continuous infusion for 7 days) every 4 weeks or DCF (docetaxel 70 mg/m2, cisplatin 70 mg/m2 i.v. on day 1, fluorouracil 700 mg/m2 continuous infusion for 5 days) every 3 weeks. Surgery was scheduled after completion of two cycles of chemotherapy. The primary end point was RFS, analyzed by the intention-to-treat.

RESULTS

Between October 2011 and October 2013, 162 patients at 10 institutions were enrolled in the study, all of whom were eligible and randomly assigned to the two groups (81 to the ACF group and 81 to the DCF group). The R0 resection rates for the ACF and DCF groups were equivalent (95.9% versus 96.2%, P = 0.93). The 2-year RFS and overall survival rates for DCF versus ACF were 64.1% versus 42.9% (hazard ratio 0.53, 95% confidence interval 0.33-0.83, P = 0.0057) and 78.6% versus 65.4% (P = 0.08), respectively.

CONCLUSION

Compared with ACF, DCF chemotherapy was associated with prolonged RFS for patients with resectable advanced ESCC. Thus, DCF chemotherapy has potential as a standard neoadjuvant therapy for resectable ESCC.

CLINICAL TRIAL REGISTRATION

University Hospital Medical Information Network Clinical Trials Registry of Japan (identification number UMIN000004555/000004616).

摘要

背景

本 II 期临床试验评估了顺铂和氟尿嘧啶（CF）为基础的新辅助化疗联合方案对可切除局部晚期食管鳞癌（ESCC）患者结局的疗效。我们比较了 CF 联合阿霉素（ACF）与 CF 联合多西他赛（DCF）方案的无复发生存（RFS），以便在一项新的 III 期临床试验中选择一种新的治疗方案，该试验旨在研究 ESCC 患者最佳的新辅助治疗。

患者和方法

可切除的晚期 ESCC 患者被随机分配到 ACF（阿霉素 35mg/m2，顺铂 70mg/m2 静脉注射第 1 天，氟尿嘧啶 700mg/m2 连续输注 7 天）每 4 周或 DCF（多西他赛 70mg/m2，顺铂 70mg/m2 静脉注射第 1 天，氟尿嘧啶 700mg/m2 连续输注 5 天）每 3 周。手术在完成两个周期的化疗后安排。主要终点是 RFS，通过意向治疗进行分析。

结果

2011 年 10 月至 2013 年 10 月，10 个机构的 162 名患者入组研究，所有患者均符合条件并被随机分配到两组（81 名患者分配到 ACF 组，81 名患者分配到 DCF 组）。ACF 和 DCF 两组的 R0 切除率相当（95.9%比 96.2%，P=0.93）。与 ACF 相比，DCF 组的 2 年 RFS 和总生存率分别为 64.1%比 42.9%（风险比 0.53，95%置信区间 0.33-0.83，P=0.0057）和 78.6%比 65.4%（P=0.08）。