A real-world drug safety surveillance study from the FAERS database of hepatocellular carcinoma patients receiving pembrolizumab alone and plus lenvatinib
Abstract Pembrolizumab plus Lenvatinib is regarded as a significant treatment option for advanced unresectable hepatocellular carcinoma (HCC). This study aims to meticulously monitor and identify adverse events (AEs) related to this combined therapy, enhance patient safety, and offer evidence-based...
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Nature Portfolio
2025-01-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-025-85831-4 |
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| author | Huaxiang Wang Junjun Li Xiuling Zhu Ruling Wang Yunyan Wan |
| author_facet | Huaxiang Wang Junjun Li Xiuling Zhu Ruling Wang Yunyan Wan |
| author_sort | Huaxiang Wang |
| collection | DOAJ |
| description | Abstract Pembrolizumab plus Lenvatinib is regarded as a significant treatment option for advanced unresectable hepatocellular carcinoma (HCC). This study aims to meticulously monitor and identify adverse events (AEs) related to this combined therapy, enhance patient safety, and offer evidence-based recommendations for the appropriate use of these drugs. We gathered adverse drug reactions (ADRs)-related data from the FAERS database for HCC patients who received Pembrolizumab, both alone and in combination with Lenvatinib from the first quarter of 2014 to the fourth quarter of 2023. ADRs signal detection was performed using the ROR, PRR, BCPNN, MHRA, and MGPS methods. We gathered data on 459 and 358 AEs from patients with HCC treated with pembrolizumab alone and in combination with lenvatinib, respectively. Using four signal quantification techniques, we identified 50 and 38 distinct AEs, which were classified into 15 different System organ class (SOC) categories. Notably, the most common AEs associated with pembrolizumab were gastrointestinal disorders and hepatobiliary disorders. In both patient groups, the most frequently reported AEs were hepatic encephalopathy, blood bilirubin increased and diarrhea. We also observed some unexpected significant AEs, such as dehydration, skin ulcers, and intestinal perforation. The countries reporting the highest number of AEs were the United States, followed by China, France, and Japan. The median onset time for AEs related to pembrolizumab alone and its combination with lenvatinib was 80.5 days (interquartile range 20.0–217.3 days) and 77.5 days (interquartile range 19.7–212.3 days), respectively. This study offers new insights into the monitoring and management of ADRs in HCC patients receiving pembrolizumab alone or in combination with lenvatinib. It is crucial to closely monitor the safety of this treatment regimen in HCC patients to avoid serious AEs. |
| format | Article |
| id | doaj-art-2f8fb9f043b848978914509fe4cacc33 |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Nature Portfolio |
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| series | Scientific Reports |
| spelling | doaj-art-2f8fb9f043b848978914509fe4cacc332025-01-12T12:18:13ZengNature PortfolioScientific Reports2045-23222025-01-0115111210.1038/s41598-025-85831-4A real-world drug safety surveillance study from the FAERS database of hepatocellular carcinoma patients receiving pembrolizumab alone and plus lenvatinibHuaxiang Wang0Junjun Li1Xiuling Zhu2Ruling Wang3Yunyan Wan4Department of Hepatobiliary and Pancreatic Surgery, Taihe Hospital, Affiliated Hospital of Hubei University of MedicineDepartment of Emergency Department, The Third People’s Hospital of Fujian University of Traditional Chinese MedicineDepartment of Hepatobiliary Medicine, 900 Hospital of the Joint Logistic TeamDepartment of Hepatobiliary and Pancreatic Surgery, Taihe Hospital, Affiliated Hospital of Hubei University of MedicineDepartment of Hepatobiliary and Pancreatic Surgery, Taihe Hospital, Affiliated Hospital of Hubei University of MedicineAbstract Pembrolizumab plus Lenvatinib is regarded as a significant treatment option for advanced unresectable hepatocellular carcinoma (HCC). This study aims to meticulously monitor and identify adverse events (AEs) related to this combined therapy, enhance patient safety, and offer evidence-based recommendations for the appropriate use of these drugs. We gathered adverse drug reactions (ADRs)-related data from the FAERS database for HCC patients who received Pembrolizumab, both alone and in combination with Lenvatinib from the first quarter of 2014 to the fourth quarter of 2023. ADRs signal detection was performed using the ROR, PRR, BCPNN, MHRA, and MGPS methods. We gathered data on 459 and 358 AEs from patients with HCC treated with pembrolizumab alone and in combination with lenvatinib, respectively. Using four signal quantification techniques, we identified 50 and 38 distinct AEs, which were classified into 15 different System organ class (SOC) categories. Notably, the most common AEs associated with pembrolizumab were gastrointestinal disorders and hepatobiliary disorders. In both patient groups, the most frequently reported AEs were hepatic encephalopathy, blood bilirubin increased and diarrhea. We also observed some unexpected significant AEs, such as dehydration, skin ulcers, and intestinal perforation. The countries reporting the highest number of AEs were the United States, followed by China, France, and Japan. The median onset time for AEs related to pembrolizumab alone and its combination with lenvatinib was 80.5 days (interquartile range 20.0–217.3 days) and 77.5 days (interquartile range 19.7–212.3 days), respectively. This study offers new insights into the monitoring and management of ADRs in HCC patients receiving pembrolizumab alone or in combination with lenvatinib. It is crucial to closely monitor the safety of this treatment regimen in HCC patients to avoid serious AEs.https://doi.org/10.1038/s41598-025-85831-4 |
| spellingShingle | Huaxiang Wang Junjun Li Xiuling Zhu Ruling Wang Yunyan Wan A real-world drug safety surveillance study from the FAERS database of hepatocellular carcinoma patients receiving pembrolizumab alone and plus lenvatinib Scientific Reports |
| title | A real-world drug safety surveillance study from the FAERS database of hepatocellular carcinoma patients receiving pembrolizumab alone and plus lenvatinib |
| title_full | A real-world drug safety surveillance study from the FAERS database of hepatocellular carcinoma patients receiving pembrolizumab alone and plus lenvatinib |
| title_fullStr | A real-world drug safety surveillance study from the FAERS database of hepatocellular carcinoma patients receiving pembrolizumab alone and plus lenvatinib |
| title_full_unstemmed | A real-world drug safety surveillance study from the FAERS database of hepatocellular carcinoma patients receiving pembrolizumab alone and plus lenvatinib |
| title_short | A real-world drug safety surveillance study from the FAERS database of hepatocellular carcinoma patients receiving pembrolizumab alone and plus lenvatinib |
| title_sort | real world drug safety surveillance study from the faers database of hepatocellular carcinoma patients receiving pembrolizumab alone and plus lenvatinib |
| url | https://doi.org/10.1038/s41598-025-85831-4 |
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