Degradable Starch Microspheres Transarterial Chemoembolization (DSM-TACE) in Patients with Unresectable Hepatocellular Carcinoma: Results from the Prospective Multicenter Observational HepaStar Trial

Overview

Journal Eur Radiol

Specialty Radiology

Date 2024 Dec 20

PMID 39702628

Authors

Federico Collettini

Tomas Andrasina

Peter Reimer

Wolfgang Schima

Christian Stroszczynski

Yasmina Lamprecht

Timo Alexander Auer

Tomas Rohan

Moritz Wildgruber

Bernhard Gebauer

Max Masthoff

Affiliations

Soon will be listed here.

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: Question Although degradable starch microspheres transarterial chemoembolization is widely used in clinical practice across Europe, prospective data on its application in hepatocellular carcinoma patients remains limited. Findings Degradable starch microspheres transarterial chemoembolization results in promising survival rates, good tumor response rates, and low rates of treatment-related adverse events. Clinical relevance In 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.

Citing Articles

Integrating CT Radiomics and Clinical Features to Optimize TACE Technique Decision-Making in Hepatocellular Carcinoma.

Masthoff M, Irle M, Kaldewey D, Rennebaum F, Morgul H, Pohler G Cancers (Basel). 2025; 17(5).

PMID: 40075740 PMC: 11899091. DOI: 10.3390/cancers17050893.

References

Akinyemiju T, Abera S, Ahmed M, Alam N, Alemayohu M, Allen C . The Burden of Primary Liver Cancer and Underlying Etiologies From 1990 to 2015 at the Global, Regional, and National Level: Results From the Global Burden of Disease Study 2015. JAMA Oncol. 2017; 3(12):1683-1691. PMC: 5824275. DOI: 10.1001/jamaoncol.2017.3055. View

Llovet J, Kelley R, Villanueva A, Singal A, Pikarsky E, Roayaie S . Hepatocellular carcinoma. Nat Rev Dis Primers. 2021; 7(1):6. DOI: 10.1038/s41572-020-00240-3. View

Reig M, Forner A, Rimola J, Ferrer-Fabrega J, Burrel M, Garcia-Criado A . BCLC strategy for prognosis prediction and treatment recommendation: The 2022 update. J Hepatol. 2021; 76(3):681-693. PMC: 8866082. DOI: 10.1016/j.jhep.2021.11.018. View

De Baere T, Arai Y, Lencioni R, Geschwind J, Rilling W, Salem R . Treatment of Liver Tumors with Lipiodol TACE: Technical Recommendations from Experts Opinion. Cardiovasc Intervent Radiol. 2015; 39(3):334-43. DOI: 10.1007/s00270-015-1208-y. View

Facciorusso A . Drug-eluting beads transarterial chemoembolization for hepatocellular carcinoma: Current state of the art. World J Gastroenterol. 2018; 24(2):161-169. PMC: 5768935. DOI: 10.3748/wjg.v24.i2.161. View

Schicho A, Pereira P, Putzler M, Michalik K, Albrecht T, Nolte-Ernsting C . Degradable Starch Microspheres Transcatheter Arterial Chemoembolization (DSM-TACE) in Intrahepatic Cholangiocellular Carcinoma (ICC): Results from a National Multi-Center Study on Safety and Efficacy. Med Sci Monit. 2017; 23:796-800. PMC: 5319442. DOI: 10.12659/msm.902901. View

Pieper C, Meyer C, Vollmar B, Hauenstein K, Schild H, Wilhelm K . Temporary arterial embolization of liver parenchyma with degradable starch microspheres (EmboCept®S) in a swine model. Cardiovasc Intervent Radiol. 2014; 38(2):435-41. DOI: 10.1007/s00270-014-0966-2. View

Auer T, Jonczyk M, Collettini F, Marth A, Wieners G, Hamm B . Trans-arterial chemoembolization with degradable starch microspheres (DSM-TACE) versus selective internal radiation therapy (SIRT) in multifocal hepatocellular carcinoma. Acta Radiol. 2020; 62(3):313-321. DOI: 10.1177/0284185120926474. View

Orlacchio A, Chegai F, Roma S, Merolla S, Bosa A, Francioso S . Degradable starch microspheres transarterial chemoembolization (DSMs-TACE) in patients with unresectable hepatocellular carcinoma (HCC): long-term results from a single-center 137-patient cohort prospective study. Radiol Med. 2019; 125(1):98-106. DOI: 10.1007/s11547-019-01093-x. View

10.

Orlacchio A, Chegai F, Francioso S, Merolla S, Monti S, Angelico M . Repeated Transarterial Chemoembolization with Degradable Starch  Microspheres (DSMs-TACE) of Unresectable Hepatocellular Carcinoma: A Prospective Pilot Study. Curr Med Imaging Rev. 2018; 14(4):637-645. PMC: 6110039. DOI: 10.2174/1573405613666170616123657. View

11.

Iezzi R, Pompili M, Rinninella E, Annicchiarico E, Garcovich M, Cerrito L . TACE with degradable starch microspheres (DSM-TACE) as second-line treatment in HCC patients dismissing or ineligible for sorafenib. Eur Radiol. 2018; 29(3):1285-1292. DOI: 10.1007/s00330-018-5692-8. View

12.

Gross A, Albrecht T . Transarterial Chemoembolisation (TACE) with Degradable Starch Microspheres (DSM) and Anthracycline in Patients with Locally Extensive Hepatocellular Carcinoma (HCC): Safety and Efficacy. Cardiovasc Intervent Radiol. 2019; 43(3):402-410. DOI: 10.1007/s00270-019-02364-w. View

13.

Lucatelli P, Burrel M, Guiu B, De Rubeis G, van Delden O, Helmberger T . CIRSE Standards of Practice on Hepatic Transarterial Chemoembolisation. Cardiovasc Intervent Radiol. 2021; 44(12):1851-1867. DOI: 10.1007/s00270-021-02968-1. View

14.

Miksad R, Ogasawara S, Xia F, Fellous M, Piscaglia F . Liver function changes after transarterial chemoembolization in US hepatocellular carcinoma patients: the LiverT study. BMC Cancer. 2019; 19(1):795. PMC: 6693268. DOI: 10.1186/s12885-019-5989-2. View

15.

Schicho A, Pereira P, Haimerl M, Niessen C, Michalik K, Beyer L . Transarterial chemoembolization (TACE) with degradable starch microspheres (DSM) in hepatocellular carcinoma (HCC): multi-center results on safety and efficacy. Oncotarget. 2017; 8(42):72613-72620. PMC: 5641156. DOI: 10.18632/oncotarget.19997. View

16.

Haubold J, Reinboldt M, Wetter A, Li Y, Ludwig J, Lange C . DSM-TACE of HCC: Evaluation of Tumor Response in Patients Ineligible for Other Systemic or Loco-Regional Therapies. Rofo. 2020; 192(9):862-869. DOI: 10.1055/a-1111-9955. View

17.

Niessen C, Unterpaintner E, Goessmann H, Schlitt H, Mueller-Schilling M, Wohlgemuth W . Degradable starch microspheres versus ethiodol and doxorubicin in transarterial chemoembolization of hepatocellular carcinoma. J Vasc Interv Radiol. 2013; 25(2):240-7. DOI: 10.1016/j.jvir.2013.10.007. View

18.

Lammer J, Malagari K, Vogl T, Pilleul F, Denys A, Watkinson A . Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study. Cardiovasc Intervent Radiol. 2009; 33(1):41-52. PMC: 2816794. DOI: 10.1007/s00270-009-9711-7. View

19.

Auer T, Muller L, Schulze D, Anhamm M, Bettinger D, Steinle V . CT-guided High-Dose-Rate Brachytherapy versus Transarterial Chemoembolization in Patients with Unresectable Hepatocellular Carcinoma. Radiology. 2024; 310(2):e232044. DOI: 10.1148/radiol.232044. View

20.

Han G, Berhane S, Toyoda H, Bettinger D, Elshaarawy O, Chan A . Prediction of Survival Among Patients Receiving Transarterial Chemoembolization for Hepatocellular Carcinoma: A Response-Based Approach. Hepatology. 2019; 72(1):198-212. PMC: 7496334. DOI: 10.1002/hep.31022. View