Toripalimab plus intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma: an open-label single-arm, phase II trial.
Toripalimab plus intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma: an open-label single-arm, phase II trial.
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特瑞普利单抗联合调强放疗治疗复发性鼻咽癌：一项开放标签单臂 II 期试验。
DOI：
10.1136/jitc-2021-003290
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发表时间：
2021-11
影响因子：
10.9
通讯作者：
Chen M
中科院分区：
文献类型：
--
作者：
Hua Y;You R;Wang Z;Huang P;Lin M;Ouyang Y;Xie Y;Zou X;Liu Y;Duan C;Liu Y;Gu C;Liu R;Yang Q;Jiang R;Zhang M;Ding X;Chen S;Lin C;Sun R;Chen M
背景多利帕利单抗是一种人源化抗程序性死亡的免疫球蛋白G4单克隆抗体。本研究旨在探讨托利哌单抗联合调强放疗（IMRT）治疗复发性鼻咽癌（rNPC）的疗效和安全性。方法：我们对活检证实疾病且不适合局部手术的rNPC患者进行了一项单臂II期试验。符合条件的患者接受IMRT联合托利莫单抗静脉输注240 mg，每3周1次，最多7个周期。主要终点是放疗后3个月的客观缓解率。次要终点包括安全性、无进展生存期（PFS）。结果2019年5月至2020年1月，共纳入25例rNPC患者，其中男性18例（72.0%），女性7例（28.0%）；中位（IQR）年龄49.0（43.5-52.5）岁)。中位（IQR）随访时间为14.6个月（13.1-16.2）个月，19例（79.2%）患者在放疗后3个月获得总体缓解，23例（95.8%）患者获得疾病控制。12个月PFS为91.8% （95% CI 91.7%至91.9%）。急性（≥3级）血甘油三酯升高、肌酸激酶升高、皮肤反应和粘膜炎的发生率分别为1（4.0%）、1（4.0%）、2（8.0%）和1（4.0%）。晚期重度（≥3级）鼻咽壁坏死、鼻出血和牙关的发生率分别为28.0%、12.0%和4.0%。结论托利帕单抗联合IMRT治疗rNPC患者可耐受，且具有良好的抗肿瘤活性。试验注册号NCT03854838。
Background Toripalimab is a humanized immunoglobulin G4 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. Trial registration number NCT03854838.
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影响因子：
7.7
作者：
Hieronymus H;Murali R;Tin A;Yadav K;Abida W;Moller H;Berney D;Scher H;Carver B;Scardino P;Schultz N;Taylor B;Vickers A;Cuzick J;Sawyers CL
通讯作者：
Sawyers CL
影响因子：
11.5
作者：
Bucci, B;D'Agnano, I;Vecchione, A
通讯作者：
Vecchione, A
DOI：
10.1016/j.ijrobp.2004.03.021
发表时间：
2004-10-01
影响因子：
7
作者：
Öksüz, DÇ;Meral, G;Turkan, S
通讯作者：
Turkan, S
DOI：
10.1073/pnas.1411446111
发表时间：
2014-07-29
影响因子：
11.1
作者：
Hieronymus, Haley;Schultz, Nikolaus;Sawyers, Charles L.
通讯作者：
Sawyers, Charles L.
影响因子：
45.3
作者：
Hsu, Chiun;Lee, Se-Hoon;Hansen, Aaron R.
通讯作者：
Hansen, Aaron R.