Standard chemoradiotherapy with concurrent and adjuvant camrelizumab in patients with high risk nasopharyngeal carcinoma: multicentre, randomised, open label, phase 3 trial.

Methods

Multicentre, randomised, open label, phase 3 trial.

一项多中心、随机、开放标签、III期临床试验。

Seven hospitals in China between 18 August 2020 and 21 June 2022.

2020年8月18日至2022年6月21日期间，中国七家医院。

Adults aged 18-70 years with newly diagnosed high risk nasopharyngeal carcinoma after three cycles of induction chemotherapy with gemcitabine and cisplatin (stage 4a, stage 2-3 with stable or progressive disease, or detectable Epstein-Barr virus DNA).

18至70岁的成年人，在接受吉西他滨和顺铂诱导化疗三个周期后，新诊断为高风险鼻咽癌（4a期，2-3期伴有稳定或进展性疾病，或可检测到的Epstein-Barr病毒DNA）。

Patients were randomly assigned (1:1) to receive combination chemoradiotherapy based on cisplatin (standard treatment group) or standard treatment with 19 cycles of intravenous camrelizumab (200 mg) once every three weeks (radiotherapy plus two concurrent cycles and 17 adjuvant cycles; camrelizumab group).

患者被随机分配（1:1）接受基于顺铂的联合放化疗（标准治疗组）或标准治疗加上19个周期的静脉注射卡瑞利珠单抗（每三周一次，200毫克），其中两次同步治疗和17次辅助治疗（卡瑞利珠单抗组）。

The primary endpoint in the intention-to-treatgroup was progression-free survival, defined as the time from randomisation to disease recurrence (locoregional or distant) or death from any cause.

意向治疗组的主要终点是无进展生存期，定义为从随机分组到疾病复发（局部或远处）或因任何原因死亡的时间。

Secondary endpoints included safety and overall survival.

次要终点包括安全性评估和总生存期。

Results

390 patients were enrolled and randomly assigned to the camrelizumab group (n=194) or the standard treatment group (n=196).

共有390名患者入组，并随机分配至卡瑞利珠单抗组（n=194）或标准治疗组（n=196）。

At median follow-up of 39.9 months (interquartile range 36.8-43.4 months), progression-free survivalwas higher in the camrelizumab group than the standard treatment group (36 months: 83.4%, 95% confidence interval78.3% to 88.8% v 71.3%, 65.2% to 77.9%; stratified hazard ratio0.51, 95% confidence interval0.34 to 0.77, P=0.001).

在中位随访时间为39.9个月（四分位数范围36.8-43.4个月）时，卡瑞利珠单抗组的无进展生存期高于标准治疗组（36个月：卡瑞利珠单抗组为83.4%，95%置信区间78.3%至88.8%；标准治疗组为71.3%，95%置信区间65.2%至77.9%；分层风险比为0.51，95%置信区间0.34至0.77，P=0.001）。

The incidenceof acute and late adverse events (grade 3 or 4) was 50.5% and 3.2% in the camrelizumab group compared with 48.7% and 3.7% in the standard treatment group.

卡瑞利珠单抗组的急性和晚期不良事件（3级或4级）发生率分别为50.5%和3.2%，而标准治疗组的发生率分别为48.7%和3.7%。

Immunological adverse events (grade 3 or 4) occurred in 19 patients (10.2%) in the camrelizumab group.

在卡瑞利珠单抗组中，有19名患者（占10.2%）发生了3级或4级免疫相关不良事件。

Conclusions

The addition of camrelizumab to concurrent chemoradiotherapy and as a maintenance treatment improved progression-free survivalamong patients with high risk nasopharyngeal carcinoma after induction chemotherapy.

将卡瑞利珠单抗加入同步放化疗以及作为维持治疗，改善了接受诱导化疗后高风险鼻咽癌患者的无进展生存期。

trial_registration

ClinicalTrials.gov NCT04453826.

ClinicalTrials.gov 注册号 NCT04453826。