Effectiveness and safety of pembrolizumab for patients with advanced non-small cell lung cancer in real-world studies and randomized controlled trials: A systematic review and meta-analysis
BackgroundSeveral randomized controlled trials (RCTs) have confirmed the favorable clinical benefit of pembrolizumab in advanced non-small cell lung cancer (NSCLC). However, considering the strict inclusion and exclusion criteria in clinical research, there are certain differences between patients i...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
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Frontiers Media S.A.
2023-02-01
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| Series: | Frontiers in Oncology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2023.1044327/full |
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| author | Beibei Yang Bing Wang Bing Wang Yongbang Chen Yongbang Chen Ning Wan Ning Wan Ning Wan Fei Xie Fei Xie Ning Yang Liqing Lu Liqing Lu Weibin Xiao Weibin Xiao Jin Yuan Jin Yuan Jin Yuan Jian Li Jian Li Bo Xie Bo Ji Bo Ji |
| author_facet | Beibei Yang Bing Wang Bing Wang Yongbang Chen Yongbang Chen Ning Wan Ning Wan Ning Wan Fei Xie Fei Xie Ning Yang Liqing Lu Liqing Lu Weibin Xiao Weibin Xiao Jin Yuan Jin Yuan Jin Yuan Jian Li Jian Li Bo Xie Bo Ji Bo Ji |
| author_sort | Beibei Yang |
| collection | DOAJ |
| description | BackgroundSeveral randomized controlled trials (RCTs) have confirmed the favorable clinical benefit of pembrolizumab in advanced non-small cell lung cancer (NSCLC). However, considering the strict inclusion and exclusion criteria in clinical research, there are certain differences between patients in the real-world, it is unclear whether the findings of clinical trials are fully representative of the treatment efficacy in patients who will eventually use it. Therefore, to further comprehensively assess the efficacy and safety of pembrolizumab in NSCLC, we conducted a systematic review and meta-analysis based on the latest RCTs and real-world studies (RWSs).MethodsWe systematically searched PubMed, Embase, The Cochrane Library, The Web of Science, and clinical trials.gov as of December 2021. RCTs and RWSs of patients receiving pembrolizumab monotherapy or in combination with chemotherapy for advanced NSCLC were included.ResultsThe meta-analysis ultimately included 11 RCTs and 26 RWSs with a total of 10,695 patients. The primary outcomes of this study were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), serious adverse events (SAEs), the incidence of severe pneumonia reactions, and drug-related mortality. Direct meta-analysis results showed that in RCTs, pembrolizumab in combination with chemotherapy was superior to chemotherapy in terms of OS (HR=0.60, 95%CI:0.50-0.73), PFS (HR=0.47, 95%CI:0.38-0.58) and ORR (OR=3.22, 95%CI:2.57-4.03); pembrolizumab monotherapy was superior to chemotherapy in terms of OS (HR=0.73, 95%CI:0.66-0.80) and ORR (OR=1.90, 95%CI:1.17-3.09), but comparable to chemotherapy in terms of PFS (HR=0.83, 95%CI:0.66-1.04). The ORR values in retrospective single-arm studies were 45% (40%-51%).ConclusionIn RCTs, pembrolizumab monotherapy or in combination with chemotherapy is more effective and safer than chemotherapy for advanced NSCLC. In RWSs, ECOG PS 0-1 was shown to correlate with PFS and OS for patients with NSCLC. |
| first_indexed | 2024-04-10T16:55:43Z |
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| id | doaj.art-d5f0f6c0a1ea4938994ff2cc2835e897 |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-04-10T16:55:43Z |
| publishDate | 2023-02-01 |
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| series | Frontiers in Oncology |
| spelling | doaj.art-d5f0f6c0a1ea4938994ff2cc2835e8972023-02-07T08:15:37ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2023-02-011310.3389/fonc.2023.10443271044327Effectiveness and safety of pembrolizumab for patients with advanced non-small cell lung cancer in real-world studies and randomized controlled trials: A systematic review and meta-analysisBeibei Yang0Bing Wang1Bing Wang2Yongbang Chen3Yongbang Chen4Ning Wan5Ning Wan6Ning Wan7Fei Xie8Fei Xie9Ning Yang10Liqing Lu11Liqing Lu12Weibin Xiao13Weibin Xiao14Jin Yuan15Jin Yuan16Jin Yuan17Jian Li18Jian Li19Bo Xie20Bo Ji21Bo Ji22Department of Clinical Pharmacy, Baoji Central Hospital, Baoji, Shaanxi, ChinaDepartment of Clinical Pharmacy, General Hospital of Southern Theater Command, Guangzhou, ChinaSchool of Pharmaceutical Sciences, Southern Medical University, Guangzhou, ChinaDepartment of Clinical Pharmacy, General Hospital of Southern Theater Command, Guangzhou, ChinaCollege of Pharmacy, Jinan University, Guangzhou, ChinaDepartment of Clinical Pharmacy, General Hospital of Southern Theater Command, Guangzhou, ChinaSchool of Pharmaceutical Sciences, Southern Medical University, Guangzhou, ChinaGuangdong Branch Center, National Clinical Research Center for Geriatric Diseases (Chinese PLA General Hospital), Guangzhou, ChinaDepartment of Clinical Pharmacy, General Hospital of Southern Theater Command, Guangzhou, ChinaGuangdong Branch Center, National Clinical Research Center for Geriatric Diseases (Chinese PLA General Hospital), Guangzhou, ChinaDepartment of Oncology, General Hospital of Southern Theater Command, Guangzhou, ChinaDepartment of Clinical Pharmacy, General Hospital of Southern Theater Command, Guangzhou, ChinaGuangdong Branch Center, National Clinical Research Center for Geriatric Diseases (Chinese PLA General Hospital), Guangzhou, ChinaDepartment of Clinical Pharmacy, General Hospital of Southern Theater Command, Guangzhou, ChinaGuangdong Branch Center, National Clinical Research Center for Geriatric Diseases (Chinese PLA General Hospital), Guangzhou, ChinaDepartment of Clinical Pharmacy, General Hospital of Southern Theater Command, Guangzhou, ChinaSchool of Pharmaceutical Sciences, Southern Medical University, Guangzhou, ChinaGuangdong Branch Center, National Clinical Research Center for Geriatric Diseases (Chinese PLA General Hospital), Guangzhou, ChinaDepartment of Clinical Pharmacy, General Hospital of Southern Theater Command, Guangzhou, ChinaGuangdong Branch Center, National Clinical Research Center for Geriatric Diseases (Chinese PLA General Hospital), Guangzhou, ChinaDepartment of Oncology, General Hospital of Southern Theater Command, Guangzhou, ChinaDepartment of Clinical Pharmacy, General Hospital of Southern Theater Command, Guangzhou, ChinaGuangdong Branch Center, National Clinical Research Center for Geriatric Diseases (Chinese PLA General Hospital), Guangzhou, ChinaBackgroundSeveral randomized controlled trials (RCTs) have confirmed the favorable clinical benefit of pembrolizumab in advanced non-small cell lung cancer (NSCLC). However, considering the strict inclusion and exclusion criteria in clinical research, there are certain differences between patients in the real-world, it is unclear whether the findings of clinical trials are fully representative of the treatment efficacy in patients who will eventually use it. Therefore, to further comprehensively assess the efficacy and safety of pembrolizumab in NSCLC, we conducted a systematic review and meta-analysis based on the latest RCTs and real-world studies (RWSs).MethodsWe systematically searched PubMed, Embase, The Cochrane Library, The Web of Science, and clinical trials.gov as of December 2021. RCTs and RWSs of patients receiving pembrolizumab monotherapy or in combination with chemotherapy for advanced NSCLC were included.ResultsThe meta-analysis ultimately included 11 RCTs and 26 RWSs with a total of 10,695 patients. The primary outcomes of this study were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), serious adverse events (SAEs), the incidence of severe pneumonia reactions, and drug-related mortality. Direct meta-analysis results showed that in RCTs, pembrolizumab in combination with chemotherapy was superior to chemotherapy in terms of OS (HR=0.60, 95%CI:0.50-0.73), PFS (HR=0.47, 95%CI:0.38-0.58) and ORR (OR=3.22, 95%CI:2.57-4.03); pembrolizumab monotherapy was superior to chemotherapy in terms of OS (HR=0.73, 95%CI:0.66-0.80) and ORR (OR=1.90, 95%CI:1.17-3.09), but comparable to chemotherapy in terms of PFS (HR=0.83, 95%CI:0.66-1.04). The ORR values in retrospective single-arm studies were 45% (40%-51%).ConclusionIn RCTs, pembrolizumab monotherapy or in combination with chemotherapy is more effective and safer than chemotherapy for advanced NSCLC. In RWSs, ECOG PS 0-1 was shown to correlate with PFS and OS for patients with NSCLC.https://www.frontiersin.org/articles/10.3389/fonc.2023.1044327/fullpembrolizumabmeta-analysisnon-small cell lung cancerrandomized controlled trialsreal-world studies |
| spellingShingle | Beibei Yang Bing Wang Bing Wang Yongbang Chen Yongbang Chen Ning Wan Ning Wan Ning Wan Fei Xie Fei Xie Ning Yang Liqing Lu Liqing Lu Weibin Xiao Weibin Xiao Jin Yuan Jin Yuan Jin Yuan Jian Li Jian Li Bo Xie Bo Ji Bo Ji Effectiveness and safety of pembrolizumab for patients with advanced non-small cell lung cancer in real-world studies and randomized controlled trials: A systematic review and meta-analysis Frontiers in Oncology pembrolizumab meta-analysis non-small cell lung cancer randomized controlled trials real-world studies |
| title | Effectiveness and safety of pembrolizumab for patients with advanced non-small cell lung cancer in real-world studies and randomized controlled trials: A systematic review and meta-analysis |
| title_full | Effectiveness and safety of pembrolizumab for patients with advanced non-small cell lung cancer in real-world studies and randomized controlled trials: A systematic review and meta-analysis |
| title_fullStr | Effectiveness and safety of pembrolizumab for patients with advanced non-small cell lung cancer in real-world studies and randomized controlled trials: A systematic review and meta-analysis |
| title_full_unstemmed | Effectiveness and safety of pembrolizumab for patients with advanced non-small cell lung cancer in real-world studies and randomized controlled trials: A systematic review and meta-analysis |
| title_short | Effectiveness and safety of pembrolizumab for patients with advanced non-small cell lung cancer in real-world studies and randomized controlled trials: A systematic review and meta-analysis |
| title_sort | effectiveness and safety of pembrolizumab for patients with advanced non small cell lung cancer in real world studies and randomized controlled trials a systematic review and meta analysis |
| topic | pembrolizumab meta-analysis non-small cell lung cancer randomized controlled trials real-world studies |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2023.1044327/full |
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