Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma

作者：Yuan Zhang, Lei Chen, Guoqing Hu, Ning Zhang, Xiaodong Zhu, Kunyu Yang, Feng Jin, Mei Shi, Yu‐Pei Chen, Wei‐Han Hu, Zhibin Cheng, Siyang Wang, Ye Tian, Xicheng Wang, Yan Sun, Jingao Li, Wen‐Fei Li, Yuhong Li, Ling‐Long Tang, Yan‐Ping Mao, Guan‐Qun Zhou, Rui Sun, Xu Liu, Rui Guo, Guoxian Long, Shaoqiang Liang, Ling Li, Jing Huang, Jinhua Long, Jian Zang, Qiaodan Liu, Li Zou, Qiong-Fei Su, Baomin Zheng, Yun Xiao, Ying Guo, Fei Han, Hao‐Yuan Mo, Jia‐Wei Lv, Xiaojing Du, Cheng Xu, Na Liu, Ying‐Qin Li, Melvin L.K. Chua, Fang‐Yun Xie, Ying Sun, Jun Ma · 发表于：New England Journal of Medicine · 年份：2019 · DOI：10.1056/nejmoa1905287 · 被引用次数：967 · 研究领域：Head and Neck Cancer Studies、Head and Neck Surgical Oncology、Esophageal Cancer Research and Treatment

BACKGROUND: Platinum-based concurrent chemoradiotherapy is the standard of care for patients with locoregionally advanced nasopharyngeal carcinoma. Additional gemcitabine and cisplatin induction chemotherapy has shown promising efficacy in phase 2 trials. METHODS: In a parallel-group, multicenter, randomized, controlled, phase 3 trial, we compared gemcitabine and cisplatin as induction chemotherapy plus concurrent chemoradiotherapy with concurrent chemoradiotherapy alone. Patients with locoregionally advanced nasopharyngeal carcinoma were randomly assigned in a 1:1 ratio to receive gemcitabine (at a dose of 1 g per square meter of body-surface area on days 1 and 8) plus cisplatin (80 mg per square meter on day 1), administered every 3 weeks for three cycles, plus chemoradiotherapy (concurrent cisplatin at a dose of 100 mg per square meter every 3 weeks for three cycles plus intensity-modulated radiotherapy) or chemoradiotherapy alone. The primary end point was recurrence-free survival (i.e., freedom from disease recurrence [distant metastasis or locoregional recurrence] or death from any cause) in the intention-to-treat population. Secondary end points included overall survival, treatment adherence, and safety. RESULTS: A total of 480 patients were included in the trial (242 patients in the induction chemotherapy group and 238 in the standard-therapy group). At a median follow-up of 42.7 months, the 3-year recurrence-free survival was 85.3% in the induction chemotherapy group...