Source: Sun Yat-sen University Cancer Center
Written by: Sun Yat-sen University Cancer Center
Edited by: Wang Dongmei

The phase III Study of NEOCRTEC 5010 trial (neoadjuvant chemoradiotherapy followed by surgery for squamous cell esophageal cancer, NCT01216527) led by Prof. Fu Jianhua and Prof. Liu Mengzhong of Sun Yat-sen University Cancer Center and supported by grants from the Sun Yat-sen University 5010 Clinical Research Project and the Key Clinical Project from the Chinese Ministry of Health, has yielded fruitful results. The results were officially published in the Journal of Clinical Oncology (JCO) on August 9th, 2018. This is the first time that the results of a clinical research on esophageal cancer led by Chinese doctors as principal investigators are published in JCO since the launch of the magazine.

Significance of the research

Surgical resection hitherto remains the mainstay of treatment for esophageal cancer. Despite advances in treatment modalities, the 5-year survival rate for patients with locally advanced esophageal cancer ranges only from 20.64 to 34.00%, which is not satisfactory.

In order to further improve the efficacy of the treatment of esophageal cancer, medical professionals have been intensively exploring a variety of treatment modalities, and up till now the available evidence remains insufficient to favor an optimal treatment of locally advanced esophageal squamous cell carcinoma. Studies from European and American countries have investigated the efficacy of "neoadjuvant chemoradiotherapy combined with surgery for locally advanced esophageal squamous cell carcinoma", but with inconsistent final results due to a small sample size, limiting de facto the level of evidence. It is therefore of great clinical significance to further carry out such research specially targeting Asian populations in Asian countries with high incidence of esophageal squamous cell carcinoma such as China and Japan.

Remarkable research results

The study was initiated in 2007 with the participation of eight centers or hospitals within China, namely: Sun Yat-sen University Cancer Center, Shantou University Affiliated Tumor Hospital, Taizhou Hospital, Shanghai Jiao Tong University Affiliated Thoracic Hospital, Tianjin Medical University Affiliated Tumor Hospital, Zhejiang Cancer Hospital, Shanghai Fudan University Affiliated Tumor Hospital and Sichuan Cancer Hospital. Patient enrollment was completed in 2014, followed in 2015-2016 by data collection and quality control completion. The interim analysis of this study was presented in an oral presentation at the annual ESMO conference in October 2016 and at the annual ESTS conference in May 2017. Finally in 2017-2018, data analysis were carried out and subsequent article submitted.

In 2017, after ten years of perseverance and endeavor, the study finally yielded a positive result. From July 2007 to December 2014, 451 patients were enrolled and randomly allocated into preoperative chemoradiotherapy-surgery group (CRT-surgery group) and surgery alone group of 224 and 227 patients respectively. As of December 2016, the median follow-up was 41.0 months in the CRT-surgery group and 34.6 months in the surgery alone group. The R0 resection rate was higher in the CRT-surgery group than in the surgery alone group (98.4% vs 91.2%, p=0.002), and the complete pathological response rate stood at 43.2%. Long-term survival was remarkably improved with a median overall survival of 100.1 months in the CRT-surgery group vs 66.5 months in the surgery alone group (p=0.025), and a disease-free survival of 100.1 months vs. 41.7 months respectively (p<0 .001). therefore, neoadjuvant chemoradiotherapy plus surgery can prolong the overall survival of patients with locally advanced esophageal squamous cell carcinoma and extend their median overall survival by nearly 50%, hence bringing them greater hope.

Summary

These results lift a veil on an issue of international importance related to the role and place of preoperative neoadjuvant chemoradiotherapy in combination with surgery in the management of esophageal cancer domestically and abroad. This will play a significant role nationwide and worldwide in optimizing the treatment guidelines, improving the therapeutic efficacy, promoting the concept of integrative treatment, highly beneficial to patients with esophageal squamous cell carcinoma.

Link to the article: http://ascopubs.org/doi/abs/10.1200/JCO.2018.79.1483