title: Pilot randomized trial of selective internal radiation therapy vs. chemoembolization in unresectable hepatocellular carcinoma.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Internal Medicine II, University of Munich, Munich, Germany.
authors.forename: Frank T
authors.initials: FT
authors.lastname: Kolligs
authors.affiliation: Interventional Radiology, Clinica Universidad de Navarra and Instituto de Investigaciones Sanitarias de Navarra (IDISNA), Pamplona, Spain.
authors.forename: Jose I
authors.initials: JI
authors.lastname: Bilbao
authors.affiliation: Institute of Radiology, Krankenhaus der Barmherzigen Brüder, Munich, Germany.
authors.forename: Tobias
authors.initials: T
authors.lastname: Jakobs
authors.affiliation: Department of Internal Medicine II, University of Munich, Munich, Germany.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Iñarrairaegui
authors.affiliation: Department of Internal Medicine II, University of Munich, Munich, Germany.
authors.forename: Jutta M
authors.initials: JM
authors.lastname: Nagel
authors.affiliation: Nuclear Medicine, Clinica Universidad de Navarra, Pamplona, Spain.
authors.forename: Macarena
authors.initials: M
authors.lastname: Rodriguez
authors.affiliation: Department of Nuclear Medicine, University of Munich, Munich, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Haug
authors.affiliation: 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.
authors.forename: Delia
authors.initials: D
authors.lastname: D'Avola
authors.affiliation: Department of Internal Medicine II, University of Munich, Munich, Germany.
authors.forename: Mark
authors.initials: M
authors.lastname: op den Winkel
authors.affiliation: Interventional Radiology, Hospital de Navarra, Pamplona, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Martinez-Cuesta
authors.affiliation: Institute of Radiology, University of Munich, Munich, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Trumm
authors.affiliation: Department of Radiology, Clinica Universidad de Navarra, Pamplona, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: Benito
authors.affiliation: Department of Nuclear Medicine, Municipal Hospital Karlsruhe Inc., Karlsruhe, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Tatsch
authors.affiliation: Clinic of Radiology and Nuclear Medicine, University of Basel, Basel, Switzerland.
authors.forename: Christoph J
authors.initials: CJ
authors.lastname: Zech
authors.affiliation: Institute and Policlinic of Radiology, University Hospital at the Technische Universitaet Dresden, Dresden, Germany.
authors.forename: Ralf-Thorsten
authors.initials: RT
authors.lastname: Hoffmann
authors.affiliation: 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.
authors.forename: Bruno
authors.initials: B
authors.lastname: Sangro
mesh_terms: D000368:Aged; D006528:Carcinoma, Hepatocellular / Q000473:pathology / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D009367:Neoplasm Staging; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome; D015021:Yttrium Radioisotopes / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D015021:Yttrium Radioisotopes
keywords: chemoembolization; intermediate-stage HCC; radioembolization; yttrium-90