Factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment: A real‐world experience
Abstract Purpose The aim of this study was to investigate the factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment. Methods We conducted a retrospective study using a multi‐institutional electronic medical records database in Taiwan. We...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2023-07-01
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| Series: | Cancer Medicine |
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| Online Access: | https://doi.org/10.1002/cam4.6124 |
| _version_ | 1797744853571862528 |
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| author | Po‐Ting Lin Min‐Hua Hung Shih‐Chieh Shao Hui‐Yu Chen Yuk‐Ying Chan Kai‐Cheng Chang Shi‐Ming Lin Huang‐Tz Ou |
| author_facet | Po‐Ting Lin Min‐Hua Hung Shih‐Chieh Shao Hui‐Yu Chen Yuk‐Ying Chan Kai‐Cheng Chang Shi‐Ming Lin Huang‐Tz Ou |
| author_sort | Po‐Ting Lin |
| collection | DOAJ |
| description | Abstract Purpose The aim of this study was to investigate the factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment. Methods We conducted a retrospective study using a multi‐institutional electronic medical records database in Taiwan. We included advanced HCC patients newly receiving ramucirumab as second‐line or beyond systemic therapy between January 2016 and February 2022. The clinical outcomes were median progression‐free survival (PFS) based on the modified Response Evaluation Criteria in Solid Tumors (mRECIST), overall survival (OS) and adverse events. We applied Kaplan–Meier methods to estimate median PFS and OS. Uni‐variable and multi‐variable Cox regression models were applied to identify the prognostic factors. Results We included 39 ramucirumab naive users with a median age of 65.5 (IQR: 57.0–71.0) years and treatment time of 5.0 (3.0–7.0) cycles, of whom 82.1% were male and 84.6% were Barcelona Clinic Liver Cancer (BCLC) stage C. After median follow‐up time of 6.0 months, 33.3% of patients' AFP level had decreased more than 20% within 12 weeks. The median PFS and OS were 4.1 months and non‐reach, respectively. Moreover, tumor burden beyond the up‐to‐11 criteria (HR: 2.95, 95% CI: 1.04–8.38) and a decrease in estimated glomerular filtration rate of more than 10% within 12 weeks (HR: 0.31, 0.11–0.88) were significantly related to PFS in the multi‐variable analysis. No patient discontinued ramucirumab during the treatment on account of side effects. Conclusion Ramucirumab was an effective treatment option with good AFP response for advanced HCC patients in real‐world experience. Tumor burden beyond the up‐to‐11 criteria and a decrease in estimated glomerular filtration rate were independent predictive factors for progression‐free survival. |
| first_indexed | 2024-03-12T15:15:21Z |
| format | Article |
| id | doaj.art-c5a9cab3ae0b43b88340a7bf83c1bc8e |
| institution | Directory Open Access Journal |
| issn | 2045-7634 |
| language | English |
| last_indexed | 2024-03-12T15:15:21Z |
| publishDate | 2023-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj.art-c5a9cab3ae0b43b88340a7bf83c1bc8e2023-08-11T14:51:17ZengWileyCancer Medicine2045-76342023-07-011214149021491110.1002/cam4.6124Factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment: A real‐world experiencePo‐Ting Lin0Min‐Hua Hung1Shih‐Chieh Shao2Hui‐Yu Chen3Yuk‐Ying Chan4Kai‐Cheng Chang5Shi‐Ming Lin6Huang‐Tz Ou7Department of Gastroenterology and Hepatology Linkou Chang Gung Memorial Hospital Taoyuan TaiwanDepartment of Pharmacy Linkou Chang Gung Memorial Hospital Taoyuan TaiwanDepartment of Pharmacy Keelung Chang Gung Memorial Hospital Keelung TaiwanDepartment of Pharmacy Linkou Chang Gung Memorial Hospital Taoyuan TaiwanDepartment of Pharmaceutical Materials Management Chang Gung Medical Foundation Taoyuan TaiwanDepartment of Pharmacy Linkou Chang Gung Memorial Hospital Taoyuan TaiwanDepartment of Gastroenterology and Hepatology Linkou Chang Gung Memorial Hospital Taoyuan TaiwanSchool of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Science, College of Medicine National Cheng Kung University Tainan TaiwanAbstract Purpose The aim of this study was to investigate the factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment. Methods We conducted a retrospective study using a multi‐institutional electronic medical records database in Taiwan. We included advanced HCC patients newly receiving ramucirumab as second‐line or beyond systemic therapy between January 2016 and February 2022. The clinical outcomes were median progression‐free survival (PFS) based on the modified Response Evaluation Criteria in Solid Tumors (mRECIST), overall survival (OS) and adverse events. We applied Kaplan–Meier methods to estimate median PFS and OS. Uni‐variable and multi‐variable Cox regression models were applied to identify the prognostic factors. Results We included 39 ramucirumab naive users with a median age of 65.5 (IQR: 57.0–71.0) years and treatment time of 5.0 (3.0–7.0) cycles, of whom 82.1% were male and 84.6% were Barcelona Clinic Liver Cancer (BCLC) stage C. After median follow‐up time of 6.0 months, 33.3% of patients' AFP level had decreased more than 20% within 12 weeks. The median PFS and OS were 4.1 months and non‐reach, respectively. Moreover, tumor burden beyond the up‐to‐11 criteria (HR: 2.95, 95% CI: 1.04–8.38) and a decrease in estimated glomerular filtration rate of more than 10% within 12 weeks (HR: 0.31, 0.11–0.88) were significantly related to PFS in the multi‐variable analysis. No patient discontinued ramucirumab during the treatment on account of side effects. Conclusion Ramucirumab was an effective treatment option with good AFP response for advanced HCC patients in real‐world experience. Tumor burden beyond the up‐to‐11 criteria and a decrease in estimated glomerular filtration rate were independent predictive factors for progression‐free survival.https://doi.org/10.1002/cam4.6124advanced hepatocellular carcinomaramucirumabreal‐world evidence |
| spellingShingle | Po‐Ting Lin Min‐Hua Hung Shih‐Chieh Shao Hui‐Yu Chen Yuk‐Ying Chan Kai‐Cheng Chang Shi‐Ming Lin Huang‐Tz Ou Factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment: A real‐world experience Cancer Medicine advanced hepatocellular carcinoma ramucirumab real‐world evidence |
| title | Factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment: A real‐world experience |
| title_full | Factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment: A real‐world experience |
| title_fullStr | Factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment: A real‐world experience |
| title_full_unstemmed | Factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment: A real‐world experience |
| title_short | Factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment: A real‐world experience |
| title_sort | factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment a real world experience |
| topic | advanced hepatocellular carcinoma ramucirumab real‐world evidence |
| url | https://doi.org/10.1002/cam4.6124 |
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