title: Initial study of radiological and clinical efficacy radioembolization using 188Re-human serum albumin (HSA) microspheres in patients with progressive, unresectable primary or secondary liver cancers.
abstract: BACKGROUND
  The aim of this initial study was to evaluate the clinical and radiological effectiveness of radioembolization (RE) using 188Re-Human Serum Albumin (HSA) microspheres in patients with advanced, progressive, unresectable primary or secondary liver cancers, not suitable to any other form of therapy.
  
  
  METHODS
  Overall, we included 13 patients with 20 therapy sessions. Clinical and radiological responses were assessed at 6 weeks after therapy, and then every 3 months. The objective radiological response was classified according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 by sequential MRI. Adverse events were evaluated using NCI CTCAE v.4.03.
  
  
  RESULTS
  There were 4 patients with hepatocellular carcinoma (HCC), 6 with metastatic colorectal cancer (mCRC), 2 with neuroendocrine carcinoma (NEC), and 1 patient with ovarian carcinoma. Mean administered activity of 188Re HSA was 7.24 GBq (range 3.8-12.4) A high microspheres labeling efficacy of over 97±2.1% and low urinary excretion of 188Re (6.5±2.3%) during first 48-h follow-up. Median overall survival (OS) for all patients was 7.1 months (CI 6.2-13.3) and progression-free survival (PFS) was 5.1 months (CI 2.4-9.9). In those patients who had a clinical partial response (PR), stable disease (SD), and disease progression (DP) as assessed 6 weeks after therapy, the median OS was 9/5/4 months, respectively, and PFS was 5/2/0 months, respectively. The treatment adverse events (toxicity) were at an acceptable level. Initially and after 6 weeks, the CTC AE was grade 2, while after 3 months it increased to grade 3 in 4 subjects. This effect was mostly related to rapid cancer progression in this patient subgroup.
  
  
  CONCLUSIONS
  The results of this preliminary study indicate that RE using 188Re HSA is feasible and a viable option for palliative therapy in patients with extensive progressive liver cancer. It was well tolerated by most patients, with a low level of toxicity during the 3 months of follow-up.
authors.affiliation: Department of Radiology and Diagnostic Imaging, Hospital Ministry of Internal Affairs, Warsaw, Poland.
authors.forename: Mirosław L
authors.initials: ML
authors.lastname: Nowicki
authors.affiliation: Faculty of Medical Sciences, University of Varmia and Masuria, Olsztyn, Poland.
authors.forename: Jarosław B
authors.initials: JB
authors.lastname: Cwikla
authors.affiliation: Department of Radiology and Diagnostic Imaging, Hospital Ministry of Internal Affairs, Warsaw, Poland.
authors.forename: Artur J
authors.initials: AJ
authors.lastname: Sankowski
authors.affiliation: Medical Imaging Research Group, University of British Columbia, Vnacouver, Canada.
authors.forename: Sergey
authors.initials: S
authors.lastname: Shcherbinin
authors.affiliation: Medical Imaging Research Group, University of British Columbia, Vnacouver, Canada.
authors.forename: Josh
authors.initials: J
authors.lastname: Grimmes
authors.affiliation: Medical Imaging Research Group, University of British Columbia, Vnacouver, Canada.
authors.forename: Anna
authors.initials: A
authors.lastname: Celler
authors.affiliation: Department of Nuclear Medicine and PET, Addenbrooke's Hospital, Cambridge, United Kingdom.
authors.forename: John R
authors.initials: JR
authors.lastname: Buscombe
authors.affiliation: Department of Radiology and Diagnostic Imaging, Hospital Ministry of Internal Affairs, Warsaw, Poland.
authors.forename: Andrzej
authors.initials: A
authors.lastname: Bator
authors.affiliation: Clinic of Radiology and Nuclear Medicine, Otto-von-Guericke-University, Magdeburg, Germany.
authors.forename: Maciej
authors.initials: M
authors.lastname: Pech
authors.affiliation: Centre POLATOM, National Centre for Nuclear Research Radioisotope, Otwock, Poland.
authors.forename: Renata
authors.initials: R
authors.lastname: Mikołajczak
authors.affiliation: Centre POLATOM, National Centre for Nuclear Research Radioisotope, Otwock, Poland.
authors.forename: Dariusz
authors.initials: D
authors.lastname: Pawlak
mesh_terms: D000328:Adult; D000368:Aged; D004621:Embolization, Therapeutic / Q000379:methods*; D005260:Female; D006801:Humans; D007091:Image Processing, Computer-Assisted; D008113:Liver Neoplasms / Q000532:radiotherapy*; D008279:Magnetic Resonance Imaging; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D010166:Palliative Care / Q000379:methods*; D011868:Radioisotopes / Q000627:therapeutic use*; D012211:Rhenium / Q000627:therapeutic use*; D012709:Serum Albumin / Q000378:metabolism / Q000627:therapeutic use*; D016019:Survival Analysis
chemical_list: D011868:Radioisotopes; D012709:Serum Albumin; D012211:Rhenium
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