Toripalimab plus intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma: an open-label single-arm, phase II trial

作者：Hua, Yijun; You, Rui; Wang, Zhiqiang; Huang, Peiyu; Lin, Mei; Ouyang, Yanfeng; Xie, Yulong; Zou, Xiong; Liu, Youping; Duan, Chongyang; Liu, Yonglong; Gu, Chenmei; Liu, Rongzeng; Yang, Qi; Jiang, Rou; Zhang, Mengxia; Ding, Xi; Chen, Siyuan; Lin, Chao; Sun, Rui; Chen, Mingyuan^*

来源：Journal for ImmunoTherapy of Cancer, 2021, 9(11): e003290.

DOI：10.1136/jitc-2021-003290

• SALVAGE ENDOSCOPIC NASOPHARYNGECTOMY
• LONG-TERM OUTCOMES
• RADIATION-THERAPY
• ANTITUMOR-ACTIVITY
• REIRRADIATION
• PEMBROLIZUMAB
• MULTICENTER
• BURDEN
• CELLS

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.

• 单位
  1; 中山大学; 南方医科大学