PMID- 36914788
OWN - NLM
STAT- MEDLINE
DCOM- 20230707
LR  - 20230726
IS  - 1432-086X (Electronic)
IS  - 0174-1551 (Print)
IS  - 0174-1551 (Linking)
VI  - 46
IP  - 7
DP  - 2023 Jul
TI  - Predictive Factors for Adverse Event Outcomes After Transarterial 
      Radioembolization with Yttrium-90 Resin Microspheres in Europe: Results from the 
      Prospective Observational CIRT Study.
PG  - 852-867
LID - 10.1007/s00270-023-03391-4 [doi]
AB  - BACKGROUND: Using data collected in the prospective observational study CIRSE 
      Registry for SIR-Spheres Therapy, the present study aimed at identifying 
      predictors of adverse events (AEs) following transarterial radioembolization 
      (TARE) with Yttrium-90 resin microspheres for liver tumours. METHODS: We analysed 
      1027 patients enrolled between January 2015 and December 2017 and followed up for 
      24 months. Four hundred and twenty-two patients with hepatocellular carcinoma 
      (HCC), 120 with intrahepatic carcinoma (ICC), 237 with colorectal liver 
      metastases and 248 with liver metastases from other primaries were included. 
      Prognostic factors were calculated with a univariable analysis by using the 
      overall AEs burden score (AEBS). RESULTS: All-cause AEs were reported in 401/1027 
      (39.1%) patients, with AEs associated with TARE, such as abdominal pain (16.6%), 
      fatigue (17%), and nausea (11.7%) reported most frequently. Grade 3 or higher AEs 
      were reported in 92/1027 (9%) patients. Reports on grade >/= 3 gastrointestinal 
      ulcerations (0.4%), gastritis (0.3%), radiation cholecystitis (0.2%) or 
      radioembolization-induced liver disease (0.5%) were uncommon. Univariable 
      analysis showed that in HCC, AEBS increased for Eastern Cooperative Oncology 
      Group (ECOG) 0 (p = 0.0045), 1 tumour nodule (0.0081),  > 1 TARE treatment 
      (p = 0.0224), no prophylactic embolization (p = 0.0211), partition model 
      dosimetry (p = 0.0007) and unilobar treatment target (0.0032). For ICC,  > 1 TARE 
      treatment was associated with an increase in AEBS (p = 0.0224), and for 
      colorectal liver metastases, ECOG 0 (p = 0.0188), > 2 prior systemic treatments 
      (p = 0.0127), and 1 tumour nodule (p = 0.0155) were associated with an increased 
      AEBS. CONCLUSION: Our study confirms that TARE is a safe treatment with low 
      toxicity and a minimal impact on quality of life.
CI  - (c) 2023. The Author(s).
FAU - Maleux, Geert
AU  - Maleux G
AD  - Radiology, Universitair Ziekenhuis Leuven, Herestraat 49, 3000, Leuven, Belgium.
FAU - Albrecht, Thomas
AU  - Albrecht T
AD  - Department for Radiology and Interventional Therapy, Vivantes Klinikum Neukolln, 
      Rudower Str. 48, 12351, Berlin, Germany.
FAU - Arnold, Dirk
AU  - Arnold D
AD  - Oncology and Hematology, Asklepios Tumorzentrum Hamburg, AK Altona, 
      Paul-Ehrlich-Str. 1, 22763, Hamburg, Germany.
FAU - Bargellini, Irene
AU  - Bargellini I
AD  - Department of Vascular and Interventional Radiology, Careggi University Hospital, 
      Largo Brambilla 3, 50134, Florence, Italy.
FAU - Cianni, Roberto
AU  - Cianni R
AD  - Department of Interventional Radiology, S. Camillo Hospital, Circonvallazione 
      Gianicolense, 85, 00149, Rome, Italy.
FAU - Helmberger, Thomas
AU  - Helmberger T
AD  - Department of Radiology, Neuroradiology and Minimal-Invasive Therapy, Klinikum 
      Bogenhausen, Englschalkinger Str. 77, 81925, Munich, Germany.
FAU - Kolligs, Frank
AU  - Kolligs F
AD  - Department of Internal Medicine and Gastroenterology, Helios Klinikum 
      Berlin-Buch, Schwanebecker Chaussee 50, 13125, Berlin, Germany.
FAU - Munneke, Graham
AU  - Munneke G
AD  - Interventional Oncology, University College London Hospitals NHS Foundation 
      Trust, 250 Euston Road, London, NW1 2PG, UK.
FAU - Peynircioglu, Bora
AU  - Peynircioglu B
AD  - Department of Radiology, School of Medicine, Hacettepe University, Sihhiye 
      Campus, 06100, Ankara, Turkey.
FAU - Sangro, Bruno
AU  - Sangro B
AD  - Liver Unit and HPB Oncology Area, Clinica Universidad de Navarra and CIBEREHD, 
      Avda. Pio XII 36, 31008, Pamplona, Spain.
FAU - Schaefer, Niklaus
AU  - Schaefer N
AD  - Service de Medecine Nucleaire et Imagerie Moleculaire, University Hospital of 
      Lausanne (CHUV), Rue du Bugnon 46, 1011, Lausanne, Switzerland.
FAU - Pereira, Helena
AU  - Pereira H
AD  - Assistance Publique-Hopitaux de Paris, Hopital Europeen Georges-Pompidou, Unite 
      de Recherche Clinique, Paris, France.
AD  - Centre d'Investigation Clinique 1418 (CIC1418), INSERM, Paris, France.
FAU - Zeka, Bleranda
AU  - Zeka B
AD  - Clinical Research Department, Cardiovascular and Interventional Radiological 
      Society of Europe, Neutorgasse 9, 1010, Vienna, Austria.
FAU - de Jong, Niels
AU  - de Jong N
AUID- ORCID: 0000-0002-2377-2973
AD  - Clinical Research Department, Cardiovascular and Interventional Radiological 
      Society of Europe, Neutorgasse 9, 1010, Vienna, Austria. dejong@cirse.org.
FAU - Bilbao, Jose I
AU  - Bilbao JI
AD  - Interventional Radiology, Clinica Universidad de Navarra, Avenida Pio XII, No 36, 
      31008, Pamplona, Spain.
CN  - CIRT Principal Investigators
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20230313
PL  - United States
TA  - Cardiovasc Intervent Radiol
JT  - Cardiovascular and interventional radiology
JID - 8003538
RN  - 1K8M7UR6O1 (Yttrium-90)
RN  - 0 (Yttrium Radioisotopes)
SB  - IM
MH  - Humans
MH  - *Carcinoma, Hepatocellular/radiotherapy/pathology
MH  - *Liver Neoplasms/therapy
MH  - Microspheres
MH  - Quality of Life
MH  - Yttrium Radioisotopes/adverse effects
MH  - *Embolization, Therapeutic/adverse effects/methods
MH  - Europe/epidemiology
MH  - *Colorectal Neoplasms/therapy
PMC - PMC10322946
COIS- Thomas Albrecht received speaker's honoraria from Sirtex Medical and Pharmacept, 
      he consulted for Siemens Healthineers and operated as a proctor for Sirtex. Dirk 
      Arnold received consulting fees and honoraria for presentations and lectures and 
      travel support from Boston Scientific and Terumo, MSD, BMS, AstraZeneca, Roche, 
      Servier, Sanofi and Merck Serono. He is on the guidelines committee of the 
      European Society for Medical Oncology and supported oncopolicy manuscripts for 
      the European Cancer Organisation. Irene Bargellini received: Institutional 
      research grant from Boston Scientific; consulting fees from AstraZeneca, EISAI, 
      Ge Healthcare, Guerbet, Merck, Sirtex, Terumo; honoraria for lectures from 
      AstraZeneca, Bayer, Boston Scientific, Eisai, Guerbet, Merck, Sirtex, Sobi, 
      Terumo; participation on Independent Data Safety Monitoring Board for 
      AstraZeneca. Frank Kolligs participated on a data safety monitoring or advisory 
      board of Bayer, MSD, and Roche. Geert Maleux received honoraria for speaker's 
      bureau from Sirtex Medical and operated as a proctor for Sirtex Medical. Bruno 
      Sangro received grants or contracts from Sirtex and BMS, consulting fees from 
      Adaptimmune, Astra Zeneca, Bayer, BMS, Boston Scientific, Eisai, Eli Lilly, 
      Incyte, Ipsen, Roche, Sirtex Medical, Terumo; Payment or honoraria for lectures, 
      presentations, speakers bureaus, manuscript writing or educational events from 
      Astra Zeneca, Bayer, BMS, Eisai, Incyte, Ipsen, Roche, Sirtex Medical; 
      Participation on a Data Safety Monitoring Board or Advisory Board from 
      Adaptimmune, Astra Zeneca, Bayer, BMS, Boston Scientific, Eisai, Eli Lilly, 
      Incyte, Ipsen, Roche, Sirtex Medical, Terumo, and has a leadership or fiduciary 
      role in the International Liver Cancer Association. Jose I. Bilbao operated as 
      proctor for Sirtex Medical. Niklaus Schaefer, Graham Munneke, Roberto Cianni, 
      Bora Peynircioglu, Helena Pereira, Bleranda Zeka, Niels de Jong and Thomas 
      Helmberger had nothing to declare.
FIR - Albrecht, Thomas
IR  - Albrecht T
FIR - D'Archambeau, Olivier
IR  - D'Archambeau O
FIR - Balli, Tugsan
IR  - Balli T
FIR - Bilgic, Sadik
IR  - Bilgic S
FIR - Bloom, Allan
IR  - Bloom A
FIR - Cioni, Roberto
IR  - Cioni R
FIR - Fischbach, Roman
IR  - Fischbach R
FIR - Flamen, Patrick
IR  - Flamen P
FIR - Gerard, Laurent
IR  - Gerard L
FIR - Golfieri, Rita
IR  - Golfieri R
FIR - Grozinger, Gerd
IR  - Grozinger G
FIR - Katoh, Marcus
IR  - Katoh M
FIR - Koehler, Michael
IR  - Koehler M
FIR - Kroger, Jan Robert
IR  - Kroger JR
FIR - Kuhl, Christiane
IR  - Kuhl C
FIR - Orsi, Franco
IR  - Orsi F
FIR - Ozgun, Murat
IR  - Ozgun M
FIR - Reimer, Peter
IR  - Reimer P
FIR - Ronot, Maxime
IR  - Ronot M
FIR - Schmid, Axel
IR  - Schmid A
FIR - Vit, Alessandro
IR  - Vit A
FIR - Maleux, Geert
IR  - Maleux G
FIR - Sangro, Bruno
IR  - Sangro B
FIR - Pech, Maciej
IR  - Pech M
FIR - Helmberger, Thomas
IR  - Helmberger T
FIR - Cianni, Roberto
IR  - Cianni R
FIR - Pfammatter, Thomas
IR  - Pfammatter T
EDAT- 2023/03/15 06:00
MHDA- 2023/07/07 06:42
PMCR- 2023/03/13
CRDT- 2023/03/14 00:42
PHST- 2022/08/31 00:00 [received]
PHST- 2023/02/08 00:00 [accepted]
PHST- 2023/07/07 06:42 [medline]
PHST- 2023/03/15 06:00 [pubmed]
PHST- 2023/03/14 00:42 [entrez]
PHST- 2023/03/13 00:00 [pmc-release]
AID - 10.1007/s00270-023-03391-4 [pii]
AID - 3391 [pii]
AID - 10.1007/s00270-023-03391-4 [doi]
PST - ppublish
SO  - Cardiovasc Intervent Radiol. 2023 Jul;46(7):852-867. doi: 
      10.1007/s00270-023-03391-4. Epub 2023 Mar 13.