Faculty Collaboration Database

Radioembolisation for liver metastases: results from a prospective 151 patient multi-institutional phase II study. Eur J Cancer 2013 Oct;49(15):3122-30

Date

06/20/2013

Pubmed ID

23777743

DOI

10.1016/j.ejca.2013.05.012

Scopus ID

2-s2.0-84884907521 (requires institutional sign-in at Scopus site)   67 Citations

Abstract

PURPOSE: 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.

CONCLUSION: 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.

Author List

Benson AB 3rd, Geschwind JF, Mulcahy MF, Rilling W, Siskin G, Wiseman G, Cunningham J, Houghton B, Ross M, Memon K, Andrews J, Fleming CJ, Herman J, Nimeiri H, Lewandowski RJ, Salem R

Author

William S. Rilling MD, FSIR Vice Chair, Professor in the Radiology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Aged
Aged, 80 and over
Disease-Free Survival
Embolization, Therapeutic
Female
Humans
Liver Neoplasms
Male
Microspheres
Middle Aged
Prospective Studies
Radiopharmaceuticals
Survival Analysis
Yttrium Radioisotopes