Factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment: A real‐world experience
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...
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| Published in | Cancer medicine (Malden, MA) Vol. 12; no. 14; pp. 14902 - 14911 |
|---|---|
| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
John Wiley & Sons, Inc
01.07.2023
John Wiley and Sons Inc Wiley |
| Subjects | |
| Online Access | Get full text |
| ISSN | 2045-7634 2045-7634 |
| DOI | 10.1002/cam4.6124 |
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| 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. |
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| AbstractList | The aim of this study was to investigate the factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment.
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.
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.
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. PurposeThe aim of this study was to investigate the factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment.MethodsWe 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.ResultsWe 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.ConclusionRamucirumab 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. The aim of this study was to investigate the factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment.PURPOSEThe aim of this study was to investigate the factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment.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.METHODSWe 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.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.RESULTSWe 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.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.CONCLUSIONRamucirumab 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. 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. 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. |
| Author | Lin, Shi‐Ming Shao, Shih‐Chieh Chen, Hui‐Yu Chan, Yuk‐Ying Lin, Po‐Ting Ou, Huang‐Tz Hung, Min‐Hua Chang, Kai‐Cheng |
| AuthorAffiliation | 4 Department of Pharmacy Linkou Chang Gung Memorial Hospital Taoyuan Taiwan 2 College of Medicine Chang Gung University Taoyuan Taiwan 6 School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Science, College of Medicine National Cheng Kung University Tainan Taiwan 5 Department of Pharmacy Keelung Chang Gung Memorial Hospital Keelung Taiwan 3 Graduate Institute of Clinical Medical Sciences, College of Medicine Chang Gung University 8 Department of Pharmacy National Cheng Kung University Hospital Tainan Taiwan 7 Department of Pharmaceutical Materials Management Chang Gung Medical Foundation Taoyuan Taiwan 1 Department of Gastroenterology and Hepatology Linkou Chang Gung Memorial Hospital Taoyuan Taiwan 9 School of Pharmacy, College of Medicine National Cheng Kung University Tainan Taiwan |
| AuthorAffiliation_xml | – name: 1 Department of Gastroenterology and Hepatology Linkou Chang Gung Memorial Hospital Taoyuan Taiwan – name: 4 Department of Pharmacy Linkou Chang Gung Memorial Hospital Taoyuan Taiwan – name: 2 College of Medicine Chang Gung University Taoyuan Taiwan – name: 3 Graduate Institute of Clinical Medical Sciences, College of Medicine Chang Gung University – name: 7 Department of Pharmaceutical Materials Management Chang Gung Medical Foundation Taoyuan Taiwan – name: 6 School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Science, College of Medicine National Cheng Kung University Tainan Taiwan – name: 8 Department of Pharmacy National Cheng Kung University Hospital Tainan Taiwan – name: 9 School of Pharmacy, College of Medicine National Cheng Kung University Tainan Taiwan – name: 5 Department of Pharmacy Keelung Chang Gung Memorial Hospital Keelung Taiwan |
| Author_xml | – sequence: 1 givenname: Po‐Ting surname: Lin fullname: Lin, Po‐Ting organization: Chang Gung University – sequence: 2 givenname: Min‐Hua surname: Hung fullname: Hung, Min‐Hua organization: Linkou Chang Gung Memorial Hospital – sequence: 3 givenname: Shih‐Chieh surname: Shao fullname: Shao, Shih‐Chieh organization: National Cheng Kung University – sequence: 4 givenname: Hui‐Yu surname: Chen fullname: Chen, Hui‐Yu organization: Linkou Chang Gung Memorial Hospital – sequence: 5 givenname: Yuk‐Ying surname: Chan fullname: Chan, Yuk‐Ying organization: Chang Gung Medical Foundation – sequence: 6 givenname: Kai‐Cheng orcidid: 0000-0002-7986-7971 surname: Chang fullname: Chang, Kai‐Cheng email: thuope@hotmail.com organization: National Cheng Kung University – sequence: 7 givenname: Shi‐Ming surname: Lin fullname: Lin, Shi‐Ming email: lsmpaicyto@cgmh.org.tw organization: Linkou Chang Gung Memorial Hospital – sequence: 8 givenname: Huang‐Tz surname: Ou fullname: Ou, Huang‐Tz organization: National Cheng Kung University |
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| Copyright | 2023 The Authors. published by John Wiley & Sons Ltd. 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
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| Keywords | advanced hepatocellular carcinoma ramucirumab real-world evidence |
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The aim of this study was to investigate the factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab... The aim of this study was to investigate the factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab... PurposeThe aim of this study was to investigate the factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab... Abstract Purpose The aim of this study was to investigate the factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving... |
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| SubjectTerms | advanced hepatocellular carcinoma Aged alpha-Fetoproteins - analysis Ascites Body mass index Cancer therapies Carcinoma, Hepatocellular - pathology Chemotherapy Chronic illnesses Chronic obstructive pulmonary disease Clinical outcomes Comorbidity Electronic medical records Female Glomerular filtration rate Hepatocellular carcinoma Hospitals Humans Immunotherapy Kaplan-Meier Estimate Liver cancer Liver Neoplasms - pathology Male Medical prognosis Medical research Middle Aged Monoclonal antibodies Patients Ramucirumab real‐world evidence Regression analysis Retrospective Studies Solid tumors Survival Targeted cancer therapy Treatment Outcome |
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| Title | Factors predictive of clinical outcome in advanced hepatocellular carcinoma patients receiving ramucirumab treatment: A real‐world experience |
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