卡瑞利珠单抗治疗不可切除或晚期非小细胞肺癌患者的有效性和安全性：一项多中心真实世界回顾性观察研究（CTONG2004-ADV）

Effectiveness and safety of camrelizumab in inoperable or advanced non-small cell lung cancer patients: a multicenter real-world retrospective observational study (CTONG2004-ADV).

作者信息

Xu Chong-Rui, Chen Qixun, Zhou Chengzhi, Wu Lin, Li Wen, Zhang Huizhong, Li Yongsheng, Xu Fei, Xiong Jianping, Wang Qiming, Zhang Haibo, Jiang Yuequan, Yin Haitao, Wu Qingchen, Dai Qiangsheng, Hu Jian, Chen Jianhua, Zhang Jian, Wu Gang, Yin Jun, Zhao Jianfu, Liu Baogang, Shan Jianzhen, Sheng Liming, Chen Qunqing, Han Zhengxiang, Shi Huaqiu, Liu Yimin, Chen Jun, Wu Yi-Long

机构信息

Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China.

Department of Thoracic Oncological Surgery, Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou, China.

出版信息

Transl Lung Cancer Res. 2023 Jan 31;12(1):127-140. doi: 10.21037/tlcr-22-852. Epub 2023 Jan 16.

DOI:10.21037/tlcr-22-852

PMID:36762057

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9903092/

Abstract

BACKGROUND

Camrelizumab plus chemotherapy have been approved as standards for the treatment of advanced non-small cell lung cancer (NSCLC) patients based on two phase III trials. However, clinical trial results may not be representative of the general population, as clinical trials often have specific inclusion and exclusion criteria. Our research aims to investigate the real-world effectiveness and safety of camrelizumab in inoperable or advanced NSCLC patients.

METHODS

This multicenter retrospective observational study included inoperable or advanced pathologically confirmed NSCLC patients who received at least one dose of camrelizumab at 22 hospitals. Clinical and follow-up data of camrelizumab were collected retrospectively from the medical records. The primary outcome was the objective response rate (ORR) and secondary outcomes were disease control rate (DCR), 6-month progression-free survival (PFS), overall survival (OS), and treatment-related adverse events (TRAEs). Multivariate logistic and Cox regression analyses were applied to identify potential predictive factors of ORR and PFS, respectively.

RESULTS

Between July 2019 and March 2021, 336 patients were included. Adenocarcinoma was seen in 58.4% and stage IV disease in 69.3%. Twenty-nine (8.6%) had liver metastasis at baseline. Most patients received camrelizumab in the first-line setting (74.1%) and in combination with chemotherapy (60.7%). The ORR was 40.2% [95% confidence interval (CI): 34.9-45.6%] and DCR was 85.1% (95% CI: 81.3-88.9%), while the 6-month PFS and OS rates were 73.0% (95% CI: 67.1-78.0%) and 93.1% (95% CI: 89.8-95.4%), respectively. In multivariate analyses, liver metastasis [odds ratio (OR), 0.324; 95% CI: 0.115-0.915; P=0.033] and increasing lines of camrelizumab treatment ( first line, second line: OR, 0.347; 95% CI: 0.162-0.741; P=0.006; ≥ third line: OR, 0.126; 95% CI: 0.043-0.367; P<0.001) were negatively associated, while a longer duration of camrelizumab treatment was positively associated with ORR and PFS. TRAEs were recorded in 164 (48.8%) patients, without new safety signal.

CONCLUSIONS

We conducted a comprehensive overview of the effectiveness and safety profile of camrelizumab in a broader NSCLC population in real world NSCLC patients, and subgroup analysis indicated the presence of liver metastasis was associated with worse outcomes.

摘要

背景

基于两项III期试验，卡瑞利珠单抗联合化疗已被批准作为晚期非小细胞肺癌（NSCLC）患者的治疗标准。然而，临床试验结果可能无法代表一般人群，因为临床试验通常有特定的纳入和排除标准。我们的研究旨在调查卡瑞利珠单抗在不可切除或晚期NSCLC患者中的真实疗效和安全性。

方法

这项多中心回顾性观察性研究纳入了22家医院中接受至少一剂卡瑞利珠单抗治疗的不可切除或经病理确诊的晚期NSCLC患者。回顾性收集卡瑞利珠单抗的临床和随访数据。主要结局是客观缓解率（ORR），次要结局是疾病控制率（DCR）、6个月无进展生存期（PFS）、总生存期（OS）和治疗相关不良事件（TRAEs）。分别应用多变量逻辑回归和Cox回归分析来确定ORR和PFS的潜在预测因素。

结果

2019年7月至2021年3月期间，共纳入336例患者。腺癌占58.4%，IV期疾病占69.3%。29例（8.6%）患者基线时有肝转移。大多数患者在一线治疗中接受卡瑞利珠单抗（74.1%），并与化疗联合使用（60.7%）。ORR为40.2%[95%置信区间（CI）：34.9 - 45.6%]，DCR为85.1%（95% CI：81.3 - 88.9%），而6个月PFS率和OS率分别为73.（95% CI：67.1 - 78.0%）和93.1%（95% CI：89.8 - 95.4%）。在多变量分析中，肝转移[比值比（OR），为0.324；95% CI：0.115 - 0.915；P = 0.033]和卡瑞利珠单抗治疗线数增加（一线，二线：OR，0.347；95% CI：0.162 - 0.741；P = 0.006；≥三线：OR，0.126；95% CI：0.043 - 0.367；P < 0.001）呈负相关，而卡瑞利珠单抗治疗时间延长与ORR和PFS呈正相关。164例（48.8%）患者记录了TRAEs，未发现新的安全信号。