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

被引:12
作者
Chen, Si-Yuan [1 ,2 ]
Duan, Xiao-Tong [1 ,2 ]
Li, Hui-Feng [1 ,2 ]
Peng, Lan [1 ,2 ]
Wang, Zhi-Qiang [3 ]
Xu, Gui-Qiong [4 ]
Hua, Yi-Jun [1 ,2 ]
Zou, Xiong [1 ,2 ]
You, Rui [1 ,2 ]
Ouyang, Yan-Feng [1 ,2 ]
Liu, You-Ping [1 ,2 ,5 ]
Gu, Chen-Mei [1 ,2 ]
Yang, Qi [1 ,2 ]
Jiang, Rou [1 ,2 ]
Zhang, Meng-Xia [1 ,2 ]
Lin, Mei [1 ,2 ]
Xie, Yu-Long [1 ,2 ]
Lin, Chao [1 ,2 ]
Ding, Xi [1 ,2 ]
Xie, Ruo-Qi [1 ,2 ]
Duan, Chong-Yang [6 ]
Zhang, Wei-Jing [2 ,7 ]
Huang, Pei-Yu [1 ,2 ]
Chen, Ming-Yuan [1 ,2 ,5 ]
机构
[1] Sun Yat Sen Univ, Dept Nasopharyngeal Carcinoma, Canc Ctr, Guangzhou, Guangdong, Peoples R China
[2] Sun Yat Sen Univ, Guangdong Key Lab Nasopharyngeal Carcinoma Diag &, Collaborat Innovat Ctr Canc Med, State Key Lab Oncol South China,Canc Ctr, Guangzhou, Guangdong, Peoples R China
[3] Kunming Med Univ, Dept Psychiat, Affiliated Hosp 1, Kunming 650000, Yunnan, Peoples R China
[4] Zhongshan City Peoples Hosp, Dept Head & Neck Carcinoma & Radiotherapy, Zhongshan 528400, Guangdong, Peoples R China
[5] Sun Yat Sen Univ, NanChang Hosp, Nasopharyngeal Canc Ctr, Hosp Nanchang 1, Nanchang, Jiangxi, Peoples R China
[6] Southern Med Univ, Sch Publ Hlth, Dept Biostat, Guangzhou 510000, Guangdong, Peoples R China
[7] Sun Yat sen Univ, Dept Radiol, Canc Ctr, Guangzhou 510000, Guangdong, Peoples R China
基金
中国国家自然科学基金;
关键词
DISTANT METASTASIS; 1ST-LINE TREATMENT; ANTITUMOR-ACTIVITY; RECURRENT; MULTICENTER; CHEMOTHERAPY; CISPLATIN; CANCER; SAFETY;
D O I
10.1016/j.xcrm.2023.101279
中图分类号
Q2 [细胞生物学];
学科分类号
071009 ; 090102 ;
摘要
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(4) cps/mL) show worse PFS. Addition of toripalimab to sequential chemoradiotherapy suggests promising tumor response in patients with primary mNPC.
引用
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页数:11
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