Randomised phase III trial of concurrent chemoradiotherapy with extended nodal irradiation and erlotinib in patients with inoperable oesophageal squamous cell cancer

Autor: Dexi Du, Gang Li, Congying Xie, Hui Liu, Bing Xia, Wei Hu, Xiuhua Bian, Xuebang Zhang, Hao Jiang, Jianhua Wang, Ming Chen, Zhi-Feng Tian, Xilong Lian, Wen-feng Li, Duojie Li, Lvhua Wang, Anping Zheng, Fu-Jun Zhao, Ke-Wei Huang, Shixiu Wu, Bangxian Tan, Lin Du, Hong-Bo Zhang, Ni Zhang, Zhao Jing, Jin Hu, Honglei Luo, Ruifei Xie, Ping Zhang, Hongyan Zhang, Conghua Xie
Rok vydání: 2017
Předmět:
Zdroj: European journal of cancer (Oxford, England : 1990). 93
ISSN: 1879-0852
Popis: Background This randomised phase III study was conducted to investigate the efficacy of extended nodal irradiation (ENI) and/or erlotinib in inoperable oesophageal squamous cell cancer (ESCC). Patients and methods Patients with histologically confirmed locally advanced ESCC or medically inoperable disease were randomly assigned (ratio 1:1:1:1) to one of four treatment groups: group A, radiotherapy adoption of ENI with two cycles of concurrent TP chemotherapy (paclitaxel 135 mg/m2 day 1 and cisplatin 20 mg/m2 days 1–3, every 4 weeks) plus erlotinib (150 mg per day during chemoradiotherapy); group B, radiotherapy adoption of ENI with two cycles of concurrent TP; group C, radiotherapy adoption of conventional field irradiation (CFI) with two cycles of concurrent TP plus erlotinib; group D, radiotherapy adoption of CFI with two cycles of concurrent TP. Results A total of 352 patients (88 assigned to each treatment group) were enrolled. The 2-year overall survival rates of group A, B, C and D were 57.8%, 49.9%, 44.9% and 38.7%, respectively (P = 0.015). Group A significantly improved 2-year overall survival compared with group D. The ENI significantly improved overall survival in patients with inoperable ESCC (P = 0.014). The addition of erlotinib significantly decreased loco-regional recurrence (P = 0.042). Aside from rash and radiation oesophagitis, the incidence of grade 3 or greater toxicities did not differ among 4 groups. Conclusion Chemoradiotherapy with ENI and erlotinib might represent a substantial improvement on the standard of care for inoperable ESCC. ENI alone should be adopted in concurrent chemoradiotherapy for ESCC patients.
Databáze: OpenAIRE