TY - JOUR
T1 - A Phase III Multicenter Randomized Clinical Trial of 60 Gy versus 50 Gy Radiation Dose in Concurrent Chemoradiotherapy for Inoperable Esophageal Squamous Cell Carcinoma
AU - Xu, Yujin
AU - Dong, Baiqiang
AU - Zhu, Weiguo
AU - Li, Jiancheng
AU - Huang, Rong
AU - Sun, Zongwen
AU - Yang, Xinmei
AU - Liu, Liping
AU - He, Han
AU - Liao, Zhongxing
AU - Guan, Ni
AU - Kong, Yue
AU - Wang, Wanwei
AU - Chen, Jianxiang
AU - He, Huijuan
AU - Qiu, Guoqin
AU - Zeng, Ming
AU - Pu, Juan
AU - Hu, Wangyuan
AU - Bao, Yong
AU - Liu, Zhigang
AU - Ma, Jun
AU - Jiang, Hao
AU - Du, Xianghui
AU - Hu, Jin
AU - Zhuang, Tingting
AU - Cai, Jing
AU - Huang, Jin
AU - Tao, Hua
AU - Liu, Yuan
AU - Liang, Xiaodong
AU - Zhou, Juying
AU - Tao, Guangzhou
AU - Zheng, Xiao
AU - Chen, Ming
N1 - Publisher Copyright:
© 2022 American Association for Cancer Research
PY - 2022/5/1
Y1 - 2022/5/1
N2 - Purpose: In this multicenter phase 3 trial, the efficacy and safety of 60 Gy and 50 Gy doses delivered with modern radiotherapy technology for definitive concurrent chemoradiotherapy (CCRT) in patients with inoperable esophageal squamous cell carcinoma (ESCC) were evaluated. Patients and Methods: Patients with pathologically confirmed stage IIA‒IVA ESCC were randomized 1:1 to receive conventional fractionated 60 Gy or 50 Gy to the tumor and regional lymph nodes. Concurrent weekly chemotherapy (docetaxel 25 mg/m2; cisplatin 25 mg/m2) and two cycles of consolidation chemotherapy (docetaxel 70 mg/m2; cisplatin 25 mg/m2 days 1‒3) were administered. Results: A total of 319 patients were analyzed for survival, and the median follow-up was 34.0 months. The 1- and 3-year locoregional progression-free survival (PFS) rates for the 60 Gy group were 75.6% and 49.5% versus 72.1% and 48.4%, respectively, for the 50 Gy group [HR, 1.00; 95% confidence interval (CI), 0.75‒1.35; P ¼ 0.98]. The overall survival rates were 83.7% and 53.1% versus 84.8% and 52.7%, respectively (HR, 0.99; 95% CI, 0.73‒1.35; P ¼ 0.96), whereas the PFS rates were 71.2% and 46.4% versus 65.2% and 46.1%, respectively (HR, 0.97; 95% CI, 0.73‒1.30; P ¼ 0.86). The incidence of grade 3þ radiotherapy pneumonitis was higher in the 60 Gy group (nominal P ¼ 0.03) than in the 50 Gy group. Conclusions: The 60 Gy arm had similar survival endpoints but a higher severe pneumonitis rate compared with the 50 Gy arm. Fifty Gy should be considered as the recommended dose in CCRT for ESCC.
AB - Purpose: In this multicenter phase 3 trial, the efficacy and safety of 60 Gy and 50 Gy doses delivered with modern radiotherapy technology for definitive concurrent chemoradiotherapy (CCRT) in patients with inoperable esophageal squamous cell carcinoma (ESCC) were evaluated. Patients and Methods: Patients with pathologically confirmed stage IIA‒IVA ESCC were randomized 1:1 to receive conventional fractionated 60 Gy or 50 Gy to the tumor and regional lymph nodes. Concurrent weekly chemotherapy (docetaxel 25 mg/m2; cisplatin 25 mg/m2) and two cycles of consolidation chemotherapy (docetaxel 70 mg/m2; cisplatin 25 mg/m2 days 1‒3) were administered. Results: A total of 319 patients were analyzed for survival, and the median follow-up was 34.0 months. The 1- and 3-year locoregional progression-free survival (PFS) rates for the 60 Gy group were 75.6% and 49.5% versus 72.1% and 48.4%, respectively, for the 50 Gy group [HR, 1.00; 95% confidence interval (CI), 0.75‒1.35; P ¼ 0.98]. The overall survival rates were 83.7% and 53.1% versus 84.8% and 52.7%, respectively (HR, 0.99; 95% CI, 0.73‒1.35; P ¼ 0.96), whereas the PFS rates were 71.2% and 46.4% versus 65.2% and 46.1%, respectively (HR, 0.97; 95% CI, 0.73‒1.30; P ¼ 0.86). The incidence of grade 3þ radiotherapy pneumonitis was higher in the 60 Gy group (nominal P ¼ 0.03) than in the 50 Gy group. Conclusions: The 60 Gy arm had similar survival endpoints but a higher severe pneumonitis rate compared with the 50 Gy arm. Fifty Gy should be considered as the recommended dose in CCRT for ESCC.
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U2 - 10.1158/1078-0432.CCR-21-3843
DO - 10.1158/1078-0432.CCR-21-3843
M3 - Article
C2 - 35190815
AN - SCOPUS:85129781416
SN - 1078-0432
VL - 28
SP - 1792
EP - 1799
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 9
ER -