一项诱导性表柔比星、奥沙利铂和氟尿嘧啶，随后手术和术后顺铂和氟尿嘧啶同期放化疗治疗局部晚期食管和胃食管交界处腺癌患者的 II 期临床试验。

A phase II trial of induction epirubicin, oxaliplatin, and fluorouracil, followed by surgery and postoperative concurrent cisplatin and fluorouracil chemoradiotherapy in patients with locoregionally advanced adenocarcinoma of the esophagus and gastroesophageal junction.

机构信息

*Cleveland Clinic, Taussig Cancer Institute, Solid Tumor Oncology, Cleveland, OH; †Cleveland Clinic, Taussig Cancer Institute, Radiation Oncology, Cleveland, OH; ‡Cleveland Clinic, Heart and Vascular Institute, Thoracic and Cardiovascular Surgery, Cleveland, OH; §Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA; and ‖Cleveland Clinic, Quantitative Health Sciences, Cleveland, OH.

出版信息

J Thorac Oncol. 2014 Oct;9(10):1561-7. doi: 10.1097/JTO.0000000000000312.

DOI:10.1097/JTO.0000000000000312

PMID:25170643

Abstract

INTRODUCTION

Preoperative chemoradiotherapy improves local control in patients with locoregionally advanced adenocarcinoma of the esophagus and gastroesophageal junction (GEJ). Distant failure remains common, however, suggesting potential benefit from additional chemotherapy. This phase II study investigated the addition of induction chemotherapy to surgery and adjuvant chemoradiotherapy.

METHODS

Patients with cT3-4 or N1 or M1a (American Joint Committee on Cancer 6th edition) adenocarcinoma of the esophagus and GEJ were eligible. Induction chemotherapy, with epirubicin 50 mg/m/d, oxaliplatin 130 mg/m/d, and fluorouracil 200 mg/m/d continuous infusion for 3 weeks, was given every 21 days for three courses, followed by surgery. Adjuvant chemoradiotherapy consisted of 50 to 55 Gy at 1.8 to 2.0 Gy/d and two courses of cisplatin (20 mg/m/d) and fluorouracil (1000 mg/m/d) during weeks 1 and 4 of radiotherapy.

RESULTS

Between February 2008 and January 2012, 60 evaluable patients enrolled. Resection was accomplished in 54 patients (90%) and adjuvant chemoradiotherapy in 48 (80%) patients. Toxicity included unplanned hospitalization in 18% of patients during induction chemotherapy and 19% of patients during adjuvant chemoradiotherapy. There was one chemotherapy-related and two postoperative deaths. With a median follow-up of 43 months, the projected 3-year locoregional control is 88%, distant metastatic control 46%, relapse-free survival 41%, and overall survival 47%. Symptomatic response to chemotherapy and the percentage of remaining viable tumor at surgery proved the strongest predictors of survival and distant control.

CONCLUSIONS

Chemotherapy, surgery, and adjuvant chemoradiotherapy are feasible and produce outcomes similar to other multimodality treatment schedules in locoregionally advanced adenocarcinoma of the esophagus and GEJ. Symptomatic response and less residual tumor at surgery were associated with improved outcomes.

摘要

引言

术前放化疗可提高局部区域晚期食管和胃食管交界处腺癌（GEJ）患者的局部控制率。然而，远处转移仍然很常见，这表明额外化疗可能有益。这项 II 期研究调查了在手术和辅助放化疗中加入诱导化疗。

方法

符合条件的患者为 cT3-4 或 N1 或 M1a（美国癌症联合委员会第 6 版）食管和 GEJ 腺癌。诱导化疗采用表柔比星 50mg/m/d、奥沙利铂 130mg/m/d 和氟尿嘧啶 200mg/m/d 持续输注 3 周，每 21 天 1 个疗程，共 3 个疗程，然后手术。辅助放化疗包括 50 至 55Gy，1.8 至 2.0Gy/d 和放疗第 1 周和第 4 周的顺铂（20mg/m/d）和氟尿嘧啶（1000mg/m/d）2 个疗程。

结果

2008 年 2 月至 2012 年 1 月，共纳入 60 例可评估患者。54 例（90%）患者行切除术，48 例（80%）患者行辅助放化疗。诱导化疗期间 18%的患者和辅助放化疗期间 19%的患者需要非计划住院。有 1 例化疗相关死亡和 2 例术后死亡。中位随访 43 个月，预计 3 年局部区域控制率为 88%，远处转移控制率为 46%，无复发生存率为 41%，总生存率为 47%。化疗的症状反应和手术时残留的活肿瘤百分比是生存和远处控制的最强预测因素。