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

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

doi:10.21037/tlcr-22-852

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

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

Authors

Chong-Rui Xu¹, Qixun Chen², Chengzhi Zhou³, Lin Wu⁴, Wen Li⁵, Huizhong Zhang⁶, Yongsheng Li⁷, Fei Xu⁸, Jianping Xiong⁹, Qiming Wang¹⁰, Haibo Zhang¹¹, Yuequan Jiang¹², Haitao Yin¹³, Qingchen Wu¹⁴, Qiangsheng Dai¹⁵, Jian Hu¹⁶, Jianhua Chen¹⁷, Jian Zhang¹⁸, Gang Wu¹⁹, Jun Yin²⁰, Jianfu Zhao²¹, Baogang Liu²², Jianzhen Shan²³, Liming Sheng²⁴, Qunqing Chen²⁵, Zhengxiang Han²⁶, Huaqiu Shi²⁷, Yimin Liu²⁸, Jun Chen²⁹, Yi-Long Wu¹

Affiliations

¹ Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China.
² Department of Thoracic Oncological Surgery, Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou, China.
³ State Key Laboratory of Respiratory Disease, National Clinical Research Centre for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
⁴ Second Department of Thoracic Medicine, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.
⁵ Department of Respiratory Medicine, The Second Affiliated Hospital, Zhejiang University School Of Medicine, Hangzhou, China.
⁶ Department of Thoracic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
⁷ Department of Medical Oncology, Chongqing University Cancer Hospital, Chongqing, China.
⁸ Department of Respiratory Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, China.
⁹ Department of Medical Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, China.
¹⁰ Department of Internal Medicine, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
¹¹ First Department of Internal Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
¹² Department of Thoracic Surgery, Chongqing University Cancer Hospital, Chongqing, China.
¹³ Department of Radiotherapy, Xuzhou Central Hospital, Xuzhou, China.
¹⁴ Department of Cardiothoracic Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
¹⁵ Department of Medical Oncology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
¹⁶ Department of Thoracic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
¹⁷ Department of Thoracic Medical Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.
¹⁸ Department of Medical Oncology, Zhujiang Hospital of Southern Medical University, Guangzhou, China.
¹⁹ Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
²⁰ Department of Respiratory Medicine, The Third People's Hospital of Chengdu, Chengdu, China.
²¹ Department of Oncology, The First Affiliated Hospital of Jinan University, Guangzhou, China.
²² Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.
²³ Department of Medical Oncology, The First Affiliated Hospital, Zhejiang University School Of Medicine, Hangzhou, China.
²⁴ Department of Thoracic Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou, China.
²⁵ Department of Thoracic Surgery, Zhujiang Hospital of Southern Medical University, Guangzhou, China.
²⁶ Department of Medical Oncology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
²⁷ Department of Oncology, First Affiliated Hospital of Gannan Medical University, Ganzhou, China.
²⁸ Department of Radiotherapy, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
²⁹ Department of Medical Oncology, The Second Hospital of Dalian Medical University, Dalian, China.

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 (vs. 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.

Keywords: Non-small cell lung cancer (NSCLC); observational study; real-world; samrelizumab.