Article
作者: Li, Ling ; Chen, Wanqing ; Chen, Junqiang ; Yu, Zhilong ; Zhang, Wencheng ; Qie, Shuai ; Wang, Jianyang ; Wang, Wenqing ; Hu, Miaomiao ; Liang, Jun ; Zhou, Zongmei ; Bi, Nan ; Wang, Xiaomin ; Pang, Qingsong ; Li, Minghe ; Wang, Lan ; Wang, Wei ; Zhou, Haiwen ; Ge, Xiaolin ; Liu, Wenyang ; Han, Chun ; Shi, Hongyun ; Zhang, Kaixian ; Wang, Xin ; Wang, Junjie ; Xiao, Zefen ; Wang, Qifeng ; Zhang, Tao ; Shi, Yonggang ; Deng, Wei ; Han, Weiming ; Lu, Jianchao ; Zhai, Yirui ; Deng, Lei ; Sun, Xinchen ; Zhang, Jihong ; Chang, Xiao ; Liu, Ke ; Lin, Yu ; Zhao, Yidian
PURPOSE:This study reports the long-term outcomes of simultaneous integrated boost radiotherapy (SIB-RT) combined with oral S-1 chemotherapy (CRTCT) in inoperable patients aged ≥ 70 years with inoperable esophageal squamous cell carcinoma (ESCC).
METHODS:In this multicenter, phase III randomized trial, patients with inoperable, locally advanced stage II-IV ESCC were randomized to receive either CRTCT or RT alone. The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS), restricted mean survival time (RMST), and patterns of failure.
RESULTS:After a median follow-up of 75 months, patients in the CRTCT group had longer OS than those in the RT group (hazard ratio (HR), 0.74; 95 % confidence interval (CI), 0.57-0.95; P = 0.02), with better 5-year OS rates (34.1 % vs. 23.6 %,P = 0.02), PFS (31.1 % vs. 20.9 %,P = 0.02), and RMST (33.0 vs. 27.0 months,P = 0.02). CRTCT's effect on OS stabilized over 5 years. Locoregional failure was lower in the CRTCT group (HR, 0.64; 95 % CI, 0.45-0.92; P = 0.02), with similar distant and mixed failure risks.
CONCLUSIONS:SIB-RT combined with oral S-1 chemotherapy significantly improved long-term survival and therefore might be considered a standard of care for elderly patients with inoperable ESCC. TRIAL REGISTRATION Clinical Trials.gov Identifier: NCT0297969.