title: Radioembolisation for liver metastases: results from a prospective 151 patient multi-institutional phase II study.
abstract: OBJECTIVE
  To investigate the safety, response rate, progression-free and overall survival of patients with liver metastases treated with (90)Y (glass) radioembolisation in a prospective, multicenter phase II study.
  
  
  METHODS
  151 patients with liver metastases (colorectal n=61, neuroendocrine n=43 and other tumour types n=47) refractory to standard of care therapies were enrolled in this prospective, multicenter, phase II study under an investigational device exemption. Clinical/laboratory/imaging follow-up were obtained at 30 days followed by 3-month intervals for 1 year and every 6 months thereafter. The primary end-point was progression-free survival (PFS); secondary end-points included safety, hepatic progression-free survival (HPFS), response rate and overall survival.
  
  
  RESULTS
  Median age was 66 (range 25-88). Grade 3/4 adverse events included pain (12.8%), elevated alkaline phospatase (8.1%), hyperbilirubinemia (5.3%), lymphopaenia (4.1%), ascites (3.4%) and vomiting (3.4%). Treatment parameters including dose delivery were reproducible among centers. Disease control rates were 59%, 93% and 63% for colorectal, neuroendocrine and other primaries, respectively. Median PFS was 2.9 and 2.8 months for colorectal and other primaries, respectively. PFS was not achieved in the neuroendocrine group. Median survival from (90)Y treatment was 8.8 months for colorectal and 10.4 months for other primaries. Median survival for neuroendocrine patients has not been reached.
  
  
  CONCLUSIONS
  Patients with liver metastases can be safely treated with (90)Y microspheres. This study is the first to demonstrate technical and dose reproducibility of (90)Y glass microspheres between centers in a prospective setting. Based on these promising data, three international, multicenter, randomised phase III studies in colorectal and hepatocellular carcinoma have been initiated.
authors.affiliation: Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA.
authors.forename: Al B
authors.initials: AB
authors.lastname: Benson
authors.forename: Jean-Francois
authors.initials: JF
authors.lastname: Geschwind
authors.forename: Mary F
authors.initials: MF
authors.lastname: Mulcahy
authors.forename: William
authors.initials: W
authors.lastname: Rilling
authors.forename: Gary
authors.initials: G
authors.lastname: Siskin
authors.forename: Greg
authors.initials: G
authors.lastname: Wiseman
authors.forename: James
authors.initials: J
authors.lastname: Cunningham
authors.forename: Bonny
authors.initials: B
authors.lastname: Houghton
authors.forename: Mason
authors.initials: M
authors.lastname: Ross
authors.forename: Khairuddin
authors.initials: K
authors.lastname: Memon
authors.forename: James
authors.initials: J
authors.lastname: Andrews
authors.forename: Chad J
authors.initials: CJ
authors.lastname: Fleming
authors.forename: Joseph
authors.initials: J
authors.lastname: Herman
authors.forename: Halla
authors.initials: H
authors.lastname: Nimeiri
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Lewandowski
authors.forename: Riad
authors.initials: R
authors.lastname: Salem
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018572:Disease-Free Survival; D004621:Embolization, Therapeutic / Q000379:methods*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000556:secondary* / Q000628:therapy*; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D011446:Prospective Studies; D019275:Radiopharmaceuticals / Q000008:administration & dosage* / Q000009:adverse effects; D016019:Survival Analysis; D015021:Yttrium Radioisotopes / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D019275:Radiopharmaceuticals; D015021:Yttrium Radioisotopes
keywords: Chemotherapy; Liver metastases; Progressive disease; Radioembolisation; TheraSphere; Yttrium-90