611O - A phase III clinical trial of neoadjuvant chemoradiotherapy followed by surgery versus surgery alone for locally advanced squamous cell carcinoma o...

Date 08 October 2016
Event ESMO 2016 Congress
Session Gastrointestinal tumours, non-colorectal 1
Topics Anticancer agents
Therapy
Biological Therapy
Presenter Hong Yang
Citation Annals of Oncology (2016) 27 (6): 207-242. 10.1093/annonc/mdw371
Authors H. Yang1, J. Fu2, M. Liu3, Y. Chen4, Z. Chen5, C. Zhu6, H. Yang7, W. Fang8, J. Wang9, Z. Yu10, Q. Pang11, W. Mao12, X. Zheng13, J. Xiang14, H. Yang15, Y. Han16
  • 1Thoracic Oncology, Cancer Centre Sun Yat-Sen University, 510060 - Guangzhou/CN
  • 2Thoracic Oncology, Cancer Centre Sun Yat-Sen University, Guangzhou/CN
  • 3Radiation Oncology, Cancer Centre Sun Yat-Sen University, Guangzhou/CN
  • 4Thoracic Oncology, Cancer Hospital of Shantou University, Shantou/CN
  • 5Radiotherapy, Cancer Hospital of Shantou University, Shantou/CN
  • 6Thoracic Oncology, Taizhou Hospital of Zhejiang Province, Taizhou/CN
  • 7Radiotherapy, Taizhou Hospital of Zhejiang Province, Taizhou/CN
  • 8Thoracic Surgery, Shanghai Chest Hospital, Shanghai/CN
  • 9Radiotherapy, Shanghai Chest Hospital, Shanghai/CN
  • 10Thoracic Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin/CN
  • 11Radiotherapy, Tianjin Medical University Cancer Institute and Hospital, Tianjin/CN
  • 12Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou/CN
  • 13Radiotherapy, Zhejiang Cancer Hospital, Hangzhou/CN
  • 14Thoracic Oncology, Shanghai Cancer Center Fudan University, Shanghai/CN
  • 15Radiotherapy, Shanghai Cancer Center Fudan University, Shanghai/CN
  • 16Thoracic Oncology, Sichuan Cancer Hospital, Chengdu/CN

Abstract

Background

Preoperative chemoradiotherapy followed by surgery seems to hopefully improve the survival of locally advanced ESCC. Nevertheless, the results of different studies were inconsistent. We are to carry out a phased III clinical trial to investigate the effect of this multidisciplinary therapy for the overall survival of patients with locally advanced ESCC.

Methods

According to Sixth Edition AJCC Cancer Staging, patients with IIB-III staged squamous cell carcinoma of the thoracic esophagus are randomly allocated to either preoperative chemoradiotherapy followed by surgery (arm A), or surgery alone(arm B). The intended number of randomized patients will be 430, 215 per arm. In the arm A, Chemotherapy and radiotherapy are performed concurrently. Patients received two cycles of vinorelbine and cisplatin. Vinorelbine at 25 mg/m2 per day is administered in bolus infusion on d1, d8, d22 and d29. Cisplatin at 75 mg/m2 is administered by intravenously infusion on d1 and d22 (or 25 mg/m2 days 1 to 4 and 22 to 25). A total radiotherapy dose of 40 Gy is delivered in 20 daily fractions of 2.0 Gy each (given 5 d/wk for 4 weeks). McKeown esophagectomy or Ivor Lewis esophagectomy will be performed 4-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during sugery. Primary outcomes are 3 and 5 years overall survival.

Results

From July 2007 to December 2014, 451 eligible patients were randomly assigned in eight cooperative cancer centers (224 cases in arm A, and 227 cases in arm B). The median follow-up for surviving patients was 30.6 months. In arm A, 185 cases continued to undergo surgery after chemoradiotherapy. The rate of R0 resection was 98.4% (182/185) in arm A versus 91.2% (207/227) in arm B (P = 0.002). A pathological complete response was achieved in 80 of 185 patients (43.2%) who underwent resection in the arm A. The overall survivals at 3 years in arm A was significantly higher than arm B (69.6% vs 62.4%; HR 0.71 [95% CI 0.52–0.98]; log-rank P = 0.035).

Conclusions

Neoadjuvant chemoradiotherapy plus surgery improved survival among patients with locally advanced esophageal squamous cell carcinoma.

Clinical trial identification

NCT01216527

Legal entity responsible for the study

Sun Yat-Sen University

Funding

The Health Ministry of China; Sun Yat-sen University Clinical Research 5010 Program; National Science Foundation of China (NSFC); Science and technology fund for projects of Guangdong Province; Major science and technology special fund for projects of Zhejiang Province.

Disclosure

All authors have declared no conflicts of interest.