Shi-Xiu Wu1, Lv-Hua Wang2, Hong-Lei Luo3, Cong-Ying Xie4, Xue-Bang Zhang4, Wei Hu5, An-Ping Zheng6, Duo-Jie Li7, Hong-Yan Zhang8, Cong-Hua Xie9, Xi-Long Lian10, De-Xi Du11, Ming Chen12, Xiu-Hua Bian13, Bang-Xian Tan14, Hao Jiang7, Hong-Bo Zhang8, Jian-Hua Wang5, Zhao Jing15, Bing Xia15, Ni Zhang15, Ping Zhang4, Wen-Feng Li4, Fu-Jun Zhao6, Zhi-Feng Tian11, Hui Liu12, Ke-Wei Huang13, Jin Hu14, Rui-Fei Xie15, Lin Du16, Gang Li16. 1. Department of Radiation Oncology, Hangzhou Cancer Hospital, Hangzhou, China. Electronic address: wushixiu@zju.edu.cn. 2. Department of Radiation Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China. 3. Department of Radiation Oncology, No.1 People's Hospital of Huaian, Huaian, China. 4. Department of Radiation Oncology, The First Affiliated Hospital of Wenzhou Medical College, Wenzhou, China. 5. Department of Radiation Oncology, Taizhou Hospital of Zhejiang Province, Linhai, China. 6. Department of Radiation Oncology, Anyang Cancer Hospital, Anyang, China. 7. Department of Radiation Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China. 8. Department of Radiation Oncology, Anhui Provincial Hospital, Anhui, China. 9. Department of Radiation Oncology, Zhongnan Hospital of Wuhan University, Wuhan, China. 10. Department of Radiation Oncology, Kaohsiung Medical University Hospital Cancer Centre, Kaohsiung, Taiwan. 11. Department of Radiation Oncology, Central Hospital of Lishui City, Lishui, China. 12. Department of Radiation Oncology, Sun Yat-Sen University Cancer Centre, Guangzhou, China. 13. Department of Radiation Oncology, Jiangsu Cancer Hospital, Nanjing, China. 14. Department of Radiation Oncology, Affiliated Hospital of North Sichuan Medical College, Nanchong, China. 15. Department of Radiation Oncology, Hangzhou Cancer Hospital, Hangzhou, China. 16. Department of Biostatistics, School of Public Health, University of California at Los Angeles, USA; Department of Biomathematics, School of Medicine, University of California at Los Angeles, USA.
Abstract
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.
RCT Entities:
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.
Authors: Leila T Tchelebi; Emma Batchelder; Ming Wang; Eric J Lehrer; Joseph J Drabick; Navesh Sharma; Mitchell Machtay; Daniel M Trifiletti; Nicholas G Zaorsky Journal: JNCI Cancer Spectr Date: 2021-05-19