机构:[1]State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China[2]Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China[3]Department of Radiation Oncology, First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China肿瘤放疗科昆明医科大学附属第一医院[4]Nasopharyngeal Cancer Center, NanChang Hospital, Sun Yat-sen University (The First Hospital of Nanchang), Nanchang, Jiangxi, China中山大学附属第一医院[5]Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, Guangdong, China
Background Toripalimab is a humanized immunoglobulin G(4) monoclonal antibody against programmed death 1. We aimed to investigate the efficacy and safety of toripalimab in combination with intensity-modulated radiotherapy (IMRT) for recurrent nasopharyngeal carcinoma (rNPC). Methods We conducted a single-arm, phase II trial with patients with rNPC who had biopsy-proven disease and were unsuitable for local surgery. Eligible patients received IMRT in combination with toripalimab administered via intravenous infusion of 240 mg once every 3 weeks for a maximum of seven cycles. The primary endpoint was the objective response rate at 3 months post radiotherapy. The secondary endpoints included safety profiles, progression-free survival (PFS). Results Between May 2019 and January 2020, a total of 25 patients with rNPC were enrolled (18 men (72.0%) and 7 women (28.0%); median (IQR) age, 49.0 (43.5-52.5) years). With a median (IQR) follow-up duration of 14.6 months (13.1-16.2) months, 19 patients (79.2%) achieved an overall response, and disease control was achieved in 23 (95.8%) patients at 3 months post radiotherapy. The 12-month PFS was 91.8% (95% CI 91.7% to 91.9%). The incidences of acute (grade >= 3) blood triglyceride elevation, creatine kinase elevation, skin reaction, and mucositis were 1 (4.0%), 1 (4.0%), 2 (8.0%), and 1 (4.0%), respectively. The incidences of late severe (grade >= 3) nasopharyngeal wall necrosis, nasal bleeding, and trismus were 28.0%, 12.0%, and 4.0%, respectively. Conclusions Toripalimab combined with IMRT was tolerable and showed promising antitumor activity in patients with rNPC.
基金:
Key-Area Research and Development of Guangdong Province [2020B1111190001]; National Natural Science Foundation of ChinaNational Natural Science Foundation of China (NSFC) [82002857, 81772895, 81874134]; Special Support Program for High-level Talents in Sun Yat-sen University Cancer Center, the Guangzhou Science and Technology Plan Project [202103010001]; National 'Ten Thousand Talents Program' Science and Technology Innovation Leading Talents [84 000-41180005]; Sun Yat-Sen University Clinical Research 5010 Program [2018015]; CSCO-JunShi Cancer Immunotherapy Clinical Research Fund [Y-JS2019-002]
第一作者机构:[1]State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China[2]Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
共同第一作者:
通讯作者:
通讯机构:[1]State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China[2]Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China[4]Nasopharyngeal Cancer Center, NanChang Hospital, Sun Yat-sen University (The First Hospital of Nanchang), Nanchang, Jiangxi, China
推荐引用方式(GB/T 7714):
Hua Yijun,You Rui,Wang Zhiqiang,et al.Toripalimab plus intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma: an open-label single-arm, phase II trial[J].JOURNAL FOR IMMUNOTHERAPY OF CANCER.2021,9(11):doi:10.1136/jitc-2021-003290.
APA:
Hua, Yijun,You, Rui,Wang, Zhiqiang,Huang, Peiyu,Lin, Mei...&Chen, Mingyuan.(2021).Toripalimab plus intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma: an open-label single-arm, phase II trial.JOURNAL FOR IMMUNOTHERAPY OF CANCER,9,(11)
MLA:
Hua, Yijun,et al."Toripalimab plus intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma: an open-label single-arm, phase II trial".JOURNAL FOR IMMUNOTHERAPY OF CANCER 9..11(2021)