Journal article
Pilot randomized trial of selective internal radiation therapy vs. chemoembolization in unresectable hepatocellular carcinoma.
- Kolligs FT Department of Internal Medicine II, University of Munich, Munich, Germany.
- Bilbao JI Interventional Radiology, Clinica Universidad de Navarra and Instituto de Investigaciones Sanitarias de Navarra (IDISNA), Pamplona, Spain.
- Jakobs T Institute of Radiology, Krankenhaus der Barmherzigen Brüder, Munich, Germany.
- Iñarrairaegui M Department of Internal Medicine II, University of Munich, Munich, Germany.
- Nagel JM Department of Internal Medicine II, University of Munich, Munich, Germany.
- Rodriguez M Nuclear Medicine, Clinica Universidad de Navarra, Pamplona, Spain.
- Haug A Department of Nuclear Medicine, University of Munich, Munich, Germany.
- D'Avola D Liver Unit, Clinica Universidad de Navarra, Instituto de Investigaciones Sanitarias de Navarra (IDISNA) and Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas (CIBEREHD), Pamplona, Spain.
- op den Winkel M Department of Internal Medicine II, University of Munich, Munich, Germany.
- Martinez-Cuesta A Interventional Radiology, Hospital de Navarra, Pamplona, Spain.
- Trumm C Institute of Radiology, University of Munich, Munich, Germany.
- Benito A Department of Radiology, Clinica Universidad de Navarra, Pamplona, Spain.
- Tatsch K Department of Nuclear Medicine, Municipal Hospital Karlsruhe Inc., Karlsruhe, Germany.
- Zech CJ Clinic of Radiology and Nuclear Medicine, University of Basel, Basel, Switzerland.
- Hoffmann RT Institute and Policlinic of Radiology, University Hospital at the Technische Universitaet Dresden, Dresden, Germany.
- Sangro B Liver Unit, Clinica Universidad de Navarra, Instituto de Investigaciones Sanitarias de Navarra (IDISNA) and Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas (CIBEREHD), Pamplona, Spain.
- 2014-12-03
Published in:
- Liver international : official journal of the International Association for the Study of the Liver. - 2015
chemoembolization
intermediate-stage HCC
radioembolization
yttrium-90
Aged
Carcinoma, Hepatocellular
Chemoembolization, Therapeutic
Female
Humans
Liver Neoplasms
Male
Microspheres
Middle Aged
Neoplasm Staging
Pilot Projects
Prospective Studies
Quality of Life
Treatment Outcome
Yttrium Radioisotopes
English
BACKGROUND & AIMS
To compare selective internal radiation therapy (SIRT) with transarterial chemoembolization (TACE), the standard-of-care for intermediate-stage unresectable, hepatocellular carcinoma (HCC), as first-line treatment.
METHODS
SIRTACE was an open-label multicenter randomized-controlled pilot study, which prospectively compared primarily safety and health-related quality of life (HRQoL) changes following TACE and SIRT. Patients with unresectable HCC, Child-Pugh ≤B7, ECOG performance status ≤2 and ≤5 liver lesions (≤20 cm total maximum diameter) without extrahepatic spread were randomized to receive either TACE (at 6-weekly intervals until tumour enhancement was not observed on MRI or disease progression) or single-session SIRT (yttrium-90 resin microspheres).
RESULTS
Twenty-eight patients with BCLC stage A (32.1%), B (46.4%) or C (21.4%) received either a mean of 3.4 (median 2) TACE interventions (N = 15) or single SIRT (N = 13). Both treatments were well tolerated. Despite SIRT patients having significantly worse physical functioning at baseline, at week-12, neither treatment had a significantly different impact on HRQoL as measured by Functional Assessment of Cancer Therapy-Hepatobiliary total or its subscales. Both TACE and SIRT were effective for the local control of liver tumours. Best overall response-rate (RECIST 1.0) of target lesions were 13.3% and 30.8%, disease control rates were 73.3% and 76.9% for TACE and SIRT, respectively. Two patients in each group were down-staged for liver transplantation (N = 3) or radiofrequency ablation (N = 1).
CONCLUSIONS
Single-session SIRT appeared to be as safe and had a similar impact on HRQoL as multiple sessions of TACE, suggesting that SIRT might be an alternative option for patients eligible for TACE.
To compare selective internal radiation therapy (SIRT) with transarterial chemoembolization (TACE), the standard-of-care for intermediate-stage unresectable, hepatocellular carcinoma (HCC), as first-line treatment.
METHODS
SIRTACE was an open-label multicenter randomized-controlled pilot study, which prospectively compared primarily safety and health-related quality of life (HRQoL) changes following TACE and SIRT. Patients with unresectable HCC, Child-Pugh ≤B7, ECOG performance status ≤2 and ≤5 liver lesions (≤20 cm total maximum diameter) without extrahepatic spread were randomized to receive either TACE (at 6-weekly intervals until tumour enhancement was not observed on MRI or disease progression) or single-session SIRT (yttrium-90 resin microspheres).
RESULTS
Twenty-eight patients with BCLC stage A (32.1%), B (46.4%) or C (21.4%) received either a mean of 3.4 (median 2) TACE interventions (N = 15) or single SIRT (N = 13). Both treatments were well tolerated. Despite SIRT patients having significantly worse physical functioning at baseline, at week-12, neither treatment had a significantly different impact on HRQoL as measured by Functional Assessment of Cancer Therapy-Hepatobiliary total or its subscales. Both TACE and SIRT were effective for the local control of liver tumours. Best overall response-rate (RECIST 1.0) of target lesions were 13.3% and 30.8%, disease control rates were 73.3% and 76.9% for TACE and SIRT, respectively. Two patients in each group were down-staged for liver transplantation (N = 3) or radiofrequency ablation (N = 1).
CONCLUSIONS
Single-session SIRT appeared to be as safe and had a similar impact on HRQoL as multiple sessions of TACE, suggesting that SIRT might be an alternative option for patients eligible for TACE.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1111/liv.12750
- PMID 25443863
- Persistent URL
- https://fredi.hepvs.ch/global/documents/173881
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