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Degradable starch microspheres transarterial chemoembolization (DSM-TACE) in patients with unresectable hepatocellular carcinoma: results from the Prospective Multicenter Observational HepaStar Trial.

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Title: Degradable starch microspheres transarterial chemoembolization (DSM-TACE) in patients with unresectable hepatocellular carcinoma: results from the Prospective Multicenter Observational HepaStar Trial.
Authors: Collettini, Federico1,2 (AUTHOR) federico.collettini@charite.de, Andrašina, Tomáš3 (AUTHOR), Reimer, Peter4 (AUTHOR), Schima, Wolfgang5 (AUTHOR), Stroszczynski, Christian6 (AUTHOR), Lamprecht, Yasmina1 (AUTHOR), Auer, Timo Alexander1,2 (AUTHOR), Rohan, Tomáš3 (AUTHOR), Wildgruber, Moritz7 (AUTHOR), Gebauer, Bernhard1 (AUTHOR), Masthoff, Max8 (AUTHOR)
Source: European Radiology. Jul2025, Vol. 35 Issue 7, p4132-4140. 9p.
Subjects: Hepatocellular carcinoma, Chemoembolization, Safety, Adverse health care events, Biomaterials, Clinical trials, Overall survival, Cancer prognosis
Geographic Terms: Europe
Abstract: Objectives: Despite increasing interest, prospective data on the use of degradable starch microsphere-transarterial chemoembolization (DSM-TACE) in the management of patients with unresectable HCC are still scarce. The objective of the HepaStar study was to collect prospective safety and effectiveness data in a prospective multicenter observational study. Materials and methods: Between January 2017 and December 2022, consecutive participants with unresectable or recurrent HCC treated with DSM-TACE as standard of care at 6 participating centers in Europe were enrolled. Tumor response was evaluated according to the mRECIST criteria. Overall survival (OS), progression-free survival (PFS), and adverse events (AEs) were assessed by using Kaplan–Meier analysis and Common Terminology Criteria for Adverse Events, version 5. Liver function deterioration was assessed by monitoring changes in liver blood tests during the follow-up. Results: Seventy-nine participants (median age, 69 years (IQR, 51–87 years); 67 men (85%)) were enrolled and treated. The median follow-up time was 18 months (IQR 9.5–38.0 months). The estimated median OS and PFS for the entire cohort was 32 months (CI, 95% 21-NaN) and 9 months (CI, 95% 7-NaN), respectively. Eleven (13.9%) participants experienced at least one grade 3 or 4 AE. The most frequent grade 3–4 AE was elevated bilirubin (2.2%, 5 of 79). Deterioration of bilirubin, AST, ALT, and albumin were observed in 24.1%, 23.7%, 19%, and 24% of participants, respectively. Conclusion: DSM-TACE achieves promising survival in patients with unresectable or recurrent HCC. This technique shows a favorable safety profile both in terms of treatment-related AEs and liver function deterioration. Key Points: QuestionAlthough degradable starch microspheres transarterial chemoembolization is widely used in clinical practice across Europe, prospective data on its application in hepatocellular carcinoma patients remains limited. FindingsDegradable starch microspheres transarterial chemoembolization results in promising survival rates, good tumor response rates, and low rates of treatment-related adverse events. Clinical relevanceIn patients with unresectable hepatocellular carcinoma, degradable starch microspheres transarterial chemoembolization represents a safe and effective alternative to more well-established chemoembolization techniques like conventional transarterial chemoembolization and drug-eluting beads transarterial chemoembolization. [ABSTRACT FROM AUTHOR]
Copyright of European Radiology is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Degradable starch microspheres transarterial chemoembolization (DSM-TACE) in patients with unresectable hepatocellular carcinoma: results from the Prospective Multicenter Observational HepaStar Trial.
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  Data: <searchLink fieldCode="AR" term="%22Collettini%2C+Federico%22">Collettini, Federico</searchLink><relatesTo>1,2</relatesTo> (AUTHOR)<i> federico.collettini@charite.de</i><br /><searchLink fieldCode="AR" term="%22Andrašina%2C+Tomáš%22">Andrašina, Tomáš</searchLink><relatesTo>3</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Reimer%2C+Peter%22">Reimer, Peter</searchLink><relatesTo>4</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Schima%2C+Wolfgang%22">Schima, Wolfgang</searchLink><relatesTo>5</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Stroszczynski%2C+Christian%22">Stroszczynski, Christian</searchLink><relatesTo>6</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lamprecht%2C+Yasmina%22">Lamprecht, Yasmina</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Auer%2C+Timo+Alexander%22">Auer, Timo Alexander</searchLink><relatesTo>1,2</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Rohan%2C+Tomáš%22">Rohan, Tomáš</searchLink><relatesTo>3</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wildgruber%2C+Moritz%22">Wildgruber, Moritz</searchLink><relatesTo>7</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gebauer%2C+Bernhard%22">Gebauer, Bernhard</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Masthoff%2C+Max%22">Masthoff, Max</searchLink><relatesTo>8</relatesTo> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22European+Radiology%22">European Radiology</searchLink>. Jul2025, Vol. 35 Issue 7, p4132-4140. 9p.
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  Data: <searchLink fieldCode="DE" term="%22Hepatocellular+carcinoma%22">Hepatocellular carcinoma</searchLink><br /><searchLink fieldCode="DE" term="%22Chemoembolization%22">Chemoembolization</searchLink><br /><searchLink fieldCode="DE" term="%22Safety%22">Safety</searchLink><br /><searchLink fieldCode="DE" term="%22Adverse+health+care+events%22">Adverse health care events</searchLink><br /><searchLink fieldCode="DE" term="%22Biomaterials%22">Biomaterials</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink><br /><searchLink fieldCode="DE" term="%22Overall+survival%22">Overall survival</searchLink><br /><searchLink fieldCode="DE" term="%22Cancer+prognosis%22">Cancer prognosis</searchLink>
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  Label: Abstract
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  Data: Objectives: Despite increasing interest, prospective data on the use of degradable starch microsphere-transarterial chemoembolization (DSM-TACE) in the management of patients with unresectable HCC are still scarce. The objective of the HepaStar study was to collect prospective safety and effectiveness data in a prospective multicenter observational study. Materials and methods: Between January 2017 and December 2022, consecutive participants with unresectable or recurrent HCC treated with DSM-TACE as standard of care at 6 participating centers in Europe were enrolled. Tumor response was evaluated according to the mRECIST criteria. Overall survival (OS), progression-free survival (PFS), and adverse events (AEs) were assessed by using Kaplan–Meier analysis and Common Terminology Criteria for Adverse Events, version 5. Liver function deterioration was assessed by monitoring changes in liver blood tests during the follow-up. Results: Seventy-nine participants (median age, 69 years (IQR, 51–87 years); 67 men (85%)) were enrolled and treated. The median follow-up time was 18 months (IQR 9.5–38.0 months). The estimated median OS and PFS for the entire cohort was 32 months (CI, 95% 21-NaN) and 9 months (CI, 95% 7-NaN), respectively. Eleven (13.9%) participants experienced at least one grade 3 or 4 AE. The most frequent grade 3–4 AE was elevated bilirubin (2.2%, 5 of 79). Deterioration of bilirubin, AST, ALT, and albumin were observed in 24.1%, 23.7%, 19%, and 24% of participants, respectively. Conclusion: DSM-TACE achieves promising survival in patients with unresectable or recurrent HCC. This technique shows a favorable safety profile both in terms of treatment-related AEs and liver function deterioration. Key Points: QuestionAlthough degradable starch microspheres transarterial chemoembolization is widely used in clinical practice across Europe, prospective data on its application in hepatocellular carcinoma patients remains limited. FindingsDegradable starch microspheres transarterial chemoembolization results in promising survival rates, good tumor response rates, and low rates of treatment-related adverse events. Clinical relevanceIn patients with unresectable hepatocellular carcinoma, degradable starch microspheres transarterial chemoembolization represents a safe and effective alternative to more well-established chemoembolization techniques like conventional transarterial chemoembolization and drug-eluting beads transarterial chemoembolization. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of European Radiology is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1007/s00330-024-11272-8
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