Radioembolisation for liver metastases: Results from a prospective 151 patient multi-institutional phase II study

• Published in: European journal of cancer (1990) 2013-10, Vol.49 (15), p.3122-3130
• Main Authors: Benson, Al B, Geschwind, Jean-Francois, Mulcahy, Mary F, Rilling, William, Siskin, Gary, Wiseman, Greg, Cunningham, James, Houghton, Bonny, Ross, Mason, Memon, Khairuddin, Andrews, James, Fleming, Chad J, Herman, Joseph, Nimeiri, Halla, Lewandowski, Robert J, Salem, Riad
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Biological and medical sciences; Chemotherapy; Disease-Free Survival; Embolization, Therapeutic - methods; Female; Hematology, Oncology and Palliative Medicine; Humans; Liver metastases; Liver Neoplasms - drug therapy; Liver Neoplasms - radiotherapy; Liver Neoplasms - secondary; Liver Neoplasms - therapy; Male; Medical sciences; Microspheres; Middle Aged; Multiple tumors. Solid tumors. Tumors in childhood (general aspects); Pharmacology. Drug treatments; Progressive disease; Prospective Studies; Radioembolisation; Radiopharmaceuticals - administration & dosage; Radiopharmaceuticals - adverse effects; Survival Analysis; TheraSphere; Tumors; Yttrium Radioisotopes - administration & dosage; Yttrium Radioisotopes - adverse effects; Yttrium-90
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2013.05.012

Abstract Purpose To investigate the safety, response rate, progression-free and overall survival of patients with liver metastases treated with90 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 from90 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 with90 Y microspheres. This study is the first to demonstrate technical and dose reproducibility of90 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.