Efficacy of sequential chemoradiotherapy combined with toripalimab in de novo metastatic nasopharyngeal carcinoma: A phase II trial

Locoregional radiotherapy added to chemotherapy has significantly improved survival in de novo metastatic nasopharyngeal carcinoma (mNPC). However, only 54% of de novo mNPC patients who received sequential chemoradiotherapy have complete or partial response 3 months after radiotherapy. This Simon�...

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Published in:Cell reports. Medicine 2023-11, Vol.4 (11), p.101279-101279, Article 101279
Main Authors: Chen, Si-Yuan, Duan, Xiao-Tong, Li, Hui-Feng, Peng, Lan, Wang, Zhi-Qiang, Xu, Gui-Qiong, Hua, Yi-Jun, Zou, Xiong, You, Rui, Ouyang, Yan-Feng, Liu, You-Ping, Gu, Chen-Mei, Yang, Qi, Jiang, Rou, Zhang, Meng-Xia, Lin, Mei, Xie, Yu-Long, Lin, Chao, Ding, Xi, Xie, Ruo-Qi, Duan, Chong-Yang, Zhang, Wei-Jing, Huang, Pei-Yu, Chen, Ming-Yuan
Format: Article
Language:English
Subjects:
Chemoradiotherapy - adverse effects
Epstein-Barr Virus Infections
Herpesvirus 4, Human
Humans
Nasopharyngeal Carcinoma - drug therapy
Nasopharyngeal Neoplasms - drug therapy
Nasopharyngeal Neoplasms - pathology
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Summary:Locoregional radiotherapy added to chemotherapy has significantly improved survival in de novo metastatic nasopharyngeal carcinoma (mNPC). However, only 54% of de novo mNPC patients who received sequential chemoradiotherapy have complete or partial response 3 months after radiotherapy. This Simon's optimal two-stage design phase II study (NCT04398056) investigates whether PD-1 inhibitor could improve tumor control in combination with chemoradiation. The primary endpoint is objective response rate (ORR) at 3 months after radiotherapy. Twenty-two patients with primary mNPC are enrolled. The ORR at 3 months after radiotherapy is 81.8% (22.7% complete response, n = 5; 59.1% partial response, n = 13), and the disease control rate is 81.8%. The 3-year progression-free survival (PFS) rate is 44.9% (95% confidence interval 26.4%-76.3%). Fifteen patients (68.2%) experienced grade 3-4 adverse events. Patients with high baseline plasma Epstein-Barr virus DNA copy number (>10 cps/mL) show worse PFS. Addition of toripalimab to sequential chemoradiotherapy suggests promising tumor response in patients with primary mNPC.
ISSN:2666-3791
2666-3791
DOI:10.1016/j.xcrm.2023.101279