NEJM evidence · 2025
Induction versus Concurrent Chemotherapy for Advanced Nasopharyngeal Carcinoma.
СтатьяКлиническое исследование III фазыРандомизированное исследованиеСравнительное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Huang Pei-Yu, Chen Xu-Yin, Ding Xi, Guo Ling, Mo Hao-Yuan, Zou Xiong, Duan Chong-Yang, Ling Li, You Rui, Yang Xin, Liu You-Ping, Xie Yu-Long, Zhang Yi-Nuan, Cao Jing-Yu, Liu Si-Han, Wang Zi-Meng, Yang Qi, Lin Chao, Chen Si-Yuan, Ouyang Yan-Feng, Liu Yong-Long, Wen Kai, Duan Xiao-Tong, Jiang Rou, Liu Rong-Zeng, Yu Tao, Qiu Fang, Hua Yi-Jun, Cao Ka-Jia, Luo Dong-Hua, Chen Ming-Yuan
Аннотация
BACKGROUND: Cisplatin-based concurrent chemoradiotherapy (CCRT) is the mainstay treatment for locoregionally advanced nasopharyngeal carcinoma (LA-NPC), which usually leads to intolerable toxicities. We investigated whether or not induction chemotherapy (IC) plus intensity-modulated radiation therapy (IMRT) could replace CCRT.
METHODS: This is an open-label, phase 3, noninferiority trial. Patients with stage T1-4N2-3 or T3-4N0-1 LA-NPC were randomly assigned (1:1) to receive gemcitabine (1000 mg/m2) and cisplatin (80 mg/m2) for two cycles followed by IMRT, or IMRT plus concomitant weekly cisplatin (40 mg/m2) for up to seven cycles. Two-year failure-free survival (FFS) was the primary end point, and noninferiority was confirmed by an upper limit of the 95% confidence interval (CI) for a hazard ratio of less than 2.12 (absolute margin of -10 percentage points). Secondary end points include overall survival, locoregional recurrence-free survival, distant metastasis-free survival, toxicity profile, and quality of life (QoL).
RESULTS: We enrolled 124 patients in the IC group and 125 patients in the CCRT group. The median follow-up was 60 months. Two-year FFS was 90.2% for IC versus 86.3% for CCRT, with a hazard ratio of 0.636 (95% CI, 0.267 to 1.514) and an absolute difference of 3.9 percentage points (95% CI, -5.2 to 13.0). Compared with the CCRT group, fewer grade ≥3 adverse events occurred in the IC group (47.5% vs. 61.5%; P=0.029), including leukopenia, anemia, mucositis, nausea, and dysphagia. IC was associated with better QoL, including global health status, social and cognitive functioning, fatigue, nausea and vomiting, pain, appetite loss, and constipation.
CONCLUSIONS: For 2-year FFS for LA-NPC, gemcitabine and cisplatin IC plus IMRT alone was noninferior to CCRT. (Funded by Key-Area Research and Development of Guangdong Province and others.).
METHODS: This is an open-label, phase 3, noninferiority trial. Patients with stage T1-4N2-3 or T3-4N0-1 LA-NPC were randomly assigned (1:1) to receive gemcitabine (1000 mg/m2) and cisplatin (80 mg/m2) for two cycles followed by IMRT, or IMRT plus concomitant weekly cisplatin (40 mg/m2) for up to seven cycles. Two-year failure-free survival (FFS) was the primary end point, and noninferiority was confirmed by an upper limit of the 95% confidence interval (CI) for a hazard ratio of less than 2.12 (absolute margin of -10 percentage points). Secondary end points include overall survival, locoregional recurrence-free survival, distant metastasis-free survival, toxicity profile, and quality of life (QoL).
RESULTS: We enrolled 124 patients in the IC group and 125 patients in the CCRT group. The median follow-up was 60 months. Two-year FFS was 90.2% for IC versus 86.3% for CCRT, with a hazard ratio of 0.636 (95% CI, 0.267 to 1.514) and an absolute difference of 3.9 percentage points (95% CI, -5.2 to 13.0). Compared with the CCRT group, fewer grade ≥3 adverse events occurred in the IC group (47.5% vs. 61.5%; P=0.029), including leukopenia, anemia, mucositis, nausea, and dysphagia. IC was associated with better QoL, including global health status, social and cognitive functioning, fatigue, nausea and vomiting, pain, appetite loss, and constipation.
CONCLUSIONS: For 2-year FFS for LA-NPC, gemcitabine and cisplatin IC plus IMRT alone was noninferior to CCRT. (Funded by Key-Area Research and Development of Guangdong Province and others.).