Y J Xu1, W G Zhu2, Z X Liao3, Y Kong1, W W Wang2, J C Li4, R Huang5, H He5, X M Yang6, L P Liu7, Z W Sun7, H J He8, Y Bao9, M Zeng10, J Pu11, W Y Hu12, J Ma13, H Jiang14, Z G Liu15, T T Zhuang16, B X Tan17, X H Du1, G Q Qiu1, X Zhou1, Y L Ji1, X Hu1, J Wang1, H L Ma1, X Zheng1, J Huang18, A W Liu19, X D Liang20, H Tao21, J Y Zhou22, Y Liu23, M Chen1. 1. Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China. 2. the Department of Radiation Oncology, Huai'an First People's Hospital, Huai'an 223300, China. 3. the Department of Radiation Oncology, University of Taxes, M.D. Anderson Cancer Center, Houston 77030, the United States. 4. the Department of Thoracic Radiation Oncology, Fujian Cancer Hospital, Fuzhou 350014, China. 5. the Department of Radiation Oncology, Foshan First People's Hospital, Foshan 528000, China. 6. the Department of Medical Oncology, Jiaxing First People's Hospital, Jiaxing 314000, China. 7. the Department of Oncology, Jining First People's Hospital, Jining 272011, China. 8. the Department of Radiation Oncology, Quzhou People's Hospital, Quzhou 324000, China. 9. the Department of Radiation Oncology, Affiliated Cancer Hospital, Sun Yat-Sen University, Guangzhou 510080, China(is working in the First Affiliated Hospital of Sun Yat-Sen University). 10. the Department of Radiation Oncology, Sichuan Provincial People's Hospital, Chengdu 610072, China. 11. the Department of Radiation Oncology, Lianshui People's Hospital, Lianshui 223400, China. 12. the Department of Radiation Oncology, Jinhua Central Hospital, Jinhua 321000, China. 13. the Department of Radiation Oncology, Anhui Provincial Hospital, Hefei 230001, China. 14. the Department of Radiation Oncology, Affiliated Hospital of Bengbu Medical College, Bengbu 233004, China. 15. the Department of Radiation Oncology, Hunan Cancer Hospital, Changsha 410013, China(is working in the Fifth Affiliated Hospital of Sun Yat-Sen University now). 16. the Department of Radiation Oncology, Affiliated Cancer Hospital of Shantou University Medical College, Shantou 515031, China. 17. the Department of Radiation Oncology, Affiliated Hospital of North Sichuan Medical College, Nanchong 637000, China. 18. the Department of Radiation Oncology, Changzhou First People's Hospital, Changzhou 213003, China. 19. the Department of Radiation Oncology, Second Affiliated Hospital of Nanchang University, Nanchang 330006, China. 20. the Department of Radiation Oncology, Zhejiang People's Hospital, Hangzhou 310014, China. 21. the Department of Radiation Oncology, Jiangsu Cancer Hospital, Nanjing 210009, China. 22. the Department of Radiation Oncology, First Affiliated Hospital of Suzhou University, Suzhou 215006, China. 23. the Department of Radiation Oncology, Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou 510095, China.
Abstract
Objective: To determine whether 60 Gy is superior to standard 50 Gy for definitive concurrent chemoradiation(CCRT) in esophageal squamous cell carcinoma (ESCC) using modern radiation technology in a phase Ⅲ prospective randomized trial. Methods: From April 2013 to May 2017, 331 patients from 22 hospitals who were pathologically confirmed with stage ⅢA-ⅣA ESCC were randomized to 60 Gy or 50 Gy with random number table. Total of 305 patients were analyzed, including 152 in 60 Gy group and 153 in 50 Gy group. The median age was 63 years, 242(79.3%) males and 63(20.7%) females. The median length of primary tumor was 5.6 cm. The clinical characteristics between two groups were comparable. All patients were delivered 2 Gy per fraction, 5 fractions per week. Concurrent weekly chemotherapy with docetaxel (25 mg/m(2)) and cisplatin (25 mg/m(2)) and 2 cycles consolidation chemotherapy with docetaxel (70 mg/m(2)) and cisplatin (25 mg/m(2), d1-3) were administrated. The primary endpoint was local/regional progression-free survival (LRPFS). The data were compared with Pearson chi-square test or Fisher's exact test. Results: At a median follow-up of 27.3 months, the disease progression rate was 37.5% (57/152), 43.8% (67/153) in the high and standard-dose group, respectively (χ(2)=1.251, P=0.263). The 1, 2, 3-year LRPFS rate was 75.4%, 56.8%, 52.1% and 74.2%, 58.4%, 50.1%, respectively (HR: 0.95, 95%CI: 0.69-1.31, P=0.761). The 1, 2, 3-year overall survival rate was 84.1%, 64.8%, 54.1% and 85.4%, 62.9%, 54.0%, respectively (HR: 0.98, 95%CI: 0.71-1.38, P=0.927). The 1, 2, 3-year progression-free survival rate was 70.8%, 54.2%, 48.5% and 65.5%, 51.9%, 45.1%, respectively (HR: 0.93, 95%CI: 0.68-1.26, P=0.621). The incidence rates in toxicities between the two groups were similar except for higher rate of severe pneumonitis in high dose group (χ(2)=11.596, P=0.021). Conclusions: The efficacy in disease control is similar between 60 Gy and 50 Gy using modern radiation technology concurrent with chemotherapy for ESCC. The 50 Gy should be recommended as the regular radiation dose with CCRT for ESCC.
RCT Entities:
Objective: To determine whether 60 Gy is superior to standard 50 Gy for definitive concurrent chemoradiation(CCRT) in esophageal squamous cell carcinoma (ESCC) using modern radiation technology in a phase Ⅲ prospective randomized trial. Methods: From April 2013 to May 2017, 331 patients from 22 hospitals who were pathologically confirmed with stage ⅢA-ⅣA ESCC were randomized to 60 Gy or 50 Gy with random number table. Total of 305 patients were analyzed, including 152 in 60 Gy group and 153 in 50 Gy group. The median age was 63 years, 242(79.3%) males and 63(20.7%) females. The median length of primary tumor was 5.6 cm. The clinical characteristics between two groups were comparable. All patients were delivered 2 Gy per fraction, 5 fractions per week. Concurrent weekly chemotherapy with docetaxel (25 mg/m(2)) and cisplatin (25 mg/m(2)) and 2 cycles consolidation chemotherapy with docetaxel (70 mg/m(2)) and cisplatin (25 mg/m(2), d1-3) were administrated. The primary endpoint was local/regional progression-free survival (LRPFS). The data were compared with Pearson chi-square test or Fisher's exact test. Results: At a median follow-up of 27.3 months, the disease progression rate was 37.5% (57/152), 43.8% (67/153) in the high and standard-dose group, respectively (χ(2)=1.251, P=0.263). The 1, 2, 3-year LRPFS rate was 75.4%, 56.8%, 52.1% and 74.2%, 58.4%, 50.1%, respectively (HR: 0.95, 95%CI: 0.69-1.31, P=0.761). The 1, 2, 3-year overall survival rate was 84.1%, 64.8%, 54.1% and 85.4%, 62.9%, 54.0%, respectively (HR: 0.98, 95%CI: 0.71-1.38, P=0.927). The 1, 2, 3-year progression-free survival rate was 70.8%, 54.2%, 48.5% and 65.5%, 51.9%, 45.1%, respectively (HR: 0.93, 95%CI: 0.68-1.26, P=0.621). The incidence rates in toxicities between the two groups were similar except for higher rate of severe pneumonitis in high dose group (χ(2)=11.596, P=0.021). Conclusions: The efficacy in disease control is similar between 60 Gy and 50 Gy using modern radiation technology concurrent with chemotherapy for ESCC. The 50 Gy should be recommended as the regular radiation dose with CCRT for ESCC.
Authors: Kim Hay Be; Richard Khor; Daryl Lim Joon; Ben Starvaggi; Michael Chao; Sweet Ping Ng; Michael Ng; Leonardo Zorron Cheng Tao Pu; Marios Efthymiou; Rhys Vaughan; Sujievvan Chandran Journal: World J Gastroenterol Date: 2021-11-14 Impact factor: 5.742