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Effectiveness and safety of camrelizumab in inoperable or advanced non-small cell lung cancer patients: a multicenter real-world retrospective observational study (CTONG2004-ADV)
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 speci...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
AME Publishing Company
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9903092/ https://www.ncbi.nlm.nih.gov/pubmed/36762057 http://dx.doi.org/10.21037/tlcr-22-852 |
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author | 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 |
author_facet | 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 |
author_sort | Xu, Chong-Rui |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9903092 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | AME Publishing Company |
record_format | MEDLINE/PubMed |
spelling | pubmed-99030922023-02-08 Effectiveness and safety of camrelizumab in inoperable or advanced non-small cell lung cancer patients: a multicenter real-world retrospective observational study (CTONG2004-ADV) 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 Transl Lung Cancer Res Original Article 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. AME Publishing Company 2023-01-16 2023-01-31 /pmc/articles/PMC9903092/ /pubmed/36762057 http://dx.doi.org/10.21037/tlcr-22-852 Text en 2023 Translational Lung Cancer Research. All rights reserved. https://creativecommons.org/licenses/by-nc-nd/4.0/Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/) . |
spellingShingle | Original Article 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 Effectiveness and safety of camrelizumab in inoperable or advanced non-small cell lung cancer patients: a multicenter real-world retrospective observational study (CTONG2004-ADV) |
title | Effectiveness and safety of camrelizumab in inoperable or advanced non-small cell lung cancer patients: a multicenter real-world retrospective observational study (CTONG2004-ADV) |
title_full | Effectiveness and safety of camrelizumab in inoperable or advanced non-small cell lung cancer patients: a multicenter real-world retrospective observational study (CTONG2004-ADV) |
title_fullStr | Effectiveness and safety of camrelizumab in inoperable or advanced non-small cell lung cancer patients: a multicenter real-world retrospective observational study (CTONG2004-ADV) |
title_full_unstemmed | Effectiveness and safety of camrelizumab in inoperable or advanced non-small cell lung cancer patients: a multicenter real-world retrospective observational study (CTONG2004-ADV) |
title_short | Effectiveness and safety of camrelizumab in inoperable or advanced non-small cell lung cancer patients: a multicenter real-world retrospective observational study (CTONG2004-ADV) |
title_sort | effectiveness and safety of camrelizumab in inoperable or advanced non-small cell lung cancer patients: a multicenter real-world retrospective observational study (ctong2004-adv) |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9903092/ https://www.ncbi.nlm.nih.gov/pubmed/36762057 http://dx.doi.org/10.21037/tlcr-22-852 |
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