Five-Year Outcome of Camrelizumab Plus Chemotherapy in Recurrent or Metastatic Nasopharyngeal Carcinoma: A Secondary Analysis of the CAPTAIN-1st Randomized Clinical Trial.

However, the long-term survival benefits at the 5-year benchmark remain uncertain.

然而，5年生存率的长期益处仍然不确定。

Background

To determine whether adding camrelizumab to chemotherapy significantly improved 5-year overall survival(OS) as first-line treatment for RM-NPC, compared with chemotherapy alone.

为了确定将卡瑞利珠单抗加入化疗是否能显著改善作为复发/转移性鼻咽癌(RM-NPC)一线治疗的5年总生存期(OS)，与单独使用化疗相比。

DESIGN, SETTING, AND PARTICIPANTS: The CAPTAIN-1st trial was a randomized, double-blind, phase 3 trial conducted at 28 hospitals in China.

设计、环境和参与者：CAPTAIN-1st试验是一项在中国28家医院进行的随机、双盲、III期试验。

Between November 13, 2018, and November 29, 2019, patients with treatment-naive RM-NPC were enrolled.

2018年11月13日至2019年11月29日，招募了未经治疗的复发/转移性鼻咽癌(RM-NPC)患者。

This secondary analysis of the CAPTAIN-1st trial was prespecified.

这是CAPTAIN-1st试验的预先指定的次要分析。

Data analysis was conducted on June 1, 2025.

数据分析于2025年6月1日进行。

Methods

Patients were randomized (1:1) to receive camrelizumab or placebo in combination with gemcitabine and cisplatin for 4 to 6 cycles, followed by maintenance therapy with camrelizumab or placebo until disease progression, unacceptable toxic effects, or completion of 2 years of treatment.

患者按1:1的比例随机接受卡瑞利珠单抗或安慰剂联合吉西他滨和顺铂治疗，持续4至6个周期，随后使用卡瑞利珠单抗或安慰剂进行维持治疗，直至疾病进展、出现不可接受的毒性反应或完成2年的治疗。

main_outcome

The primary end point, progression-free survivalper independent review committee, has been reported previously.

主要终点，即独立审查委员会评估的无进展生存期，之前已有报道。

Herein, the secondary end point of OS is reported as prespecified in the protocol.

本文报告了总生存期这一次要终点，其报告方式已按方案预先规定。

Results

Among 263 randomized patients (134 in randomized to camrelizumab, 129 to placebo), baseline characteristics were generally balanced between groups, except for age.

在263名随机分配的患者中（134名随机接受卡瑞利珠单抗，129名接受安慰剂），除了年龄外，两组患者的基线特征总体上是均衡的。

The mean (SD) age was 49 (11.25) years, and 218 patients (82.9%) were male individuals, 45 (17.1%) were female individuals.

平均（标准差）年龄为49（11.25）岁，218名患者（82.9%）为男性，45名患者（17.1%）为女性。

With a median survival follow-up of 63.5 (95% CI, 61.2-64.6) months for the camrelizumab group and 63.0 (95% CI, 60.8-64.6) months for the placebo group, 85 (63.4%) and 95 (73.6%) deaths occurred, respectively.

卡瑞利珠单抗组的中位生存随访时间为63.5个月（95%置信区间，61.2-64.6个月），安慰剂组为63.0个月（95%置信区间，60.8-64.6个月），分别有85例（63.4%）和95例（73.6%）死亡。

Median OS was 34.5 months (95% CI, 29.4-45.7) with camrelizumab vs 26.6 months (95% CI, 19.8-33.5) with placebo (hazard ratio[HR], 0.74; 95% CI, 0.55-0.99; 2-sided P = .047).

卡瑞利珠单抗组的中位总生存期为34.5个月（95%置信区间，29.4-45.7个月），而安慰剂组为26.6个月（95%置信区间，19.8-33.5个月），风险比（HR）为0.74；95%置信区间为0.55-0.99；双侧P值为0.047。

After adjusting for age imbalance, the HR was 0.65 (95% CI, 0.48-0.89; P = .01).

在调整年龄不平衡后，风险比（HR）为0.65（95%置信区间，0.48-0.89；P = .01）。

The 5-year OS rates were 37.8% vs 24.2%, reflecting an absolute difference of 13.6% (95% CI, 2.4%-24.8%; P = .02) in favor of camrelizumab.

5年总生存率分别为37.8%对比24.2%，绝对差异为13.6%（95%置信区间，2.4%-24.8%；P = .02），这有利于卡瑞利珠单抗。

The OS benefits were generally consistent across subgroups.

总生存的益处通常在各个亚组中保持一致。

In the camrelizumab group, patients who achieved rapid clearance of Epstein-Barr virus (EBV) DNA had significantly longer OS compared with those without EBV DNA clearance (HR, 0.32; 95% CI, 0.18-0.58; P < .001).

在卡瑞利珠单抗组中，实现 Epstein-Barr 病毒（EBV）DNA快速清除的患者与没有实现EBV DNA清除的患者相比，总生存期显著更长（HR，0.32；95%置信区间，0.18-0.58；P < .001）。

conclusions_and_relevance

In this secondary analysis of a randomized clinical trial, the addition of camrelizumab to chemotherapy produced statistically significant and clinically meaningful 5-year OS benefits compared with chemotherapy alone in the first-line treatment of RM-NPC.

在这项随机临床试验的二次分析中，卡瑞利珠单抗联合化疗相较于单独化疗，在复发/转移性鼻咽癌一线治疗中产生了统计学上显著且具有临床意义的5年总生存期获益。

These findings provided the first 5-year evidence supporting the benefit of PD-1-based chemoimmunotherapy in this setting.

这些发现提供了首个5年证据，支持在此背景下基于PD-1的化疗免疫治疗的益处。

trial_registration

ClinicalTrials.gov Identifier: NCT03707509.

临床试验注册号：NCT03707509。