PT  - JOURNAL ARTICLE
AU  - Jip F. Prince
AU  - Maurice A.A.J. van den Bosch
AU  - Johannes F.W. Nijsen
AU  - Maarten L.J. Smits
AU  - Andor F. van den Hoven
AU  - Stavros Nikolakopoulos
AU  - Frank J. Wessels
AU  - Rutger C.G. Bruijnen
AU  - Manon N.G.J.A. Braat
AU  - Bernard A. Zonnenberg
AU  - Marnix G.E.H. Lam
TI  - Efficacy of Radioembolization with <sup>166</sup>Ho-Microspheres in Salvage Patients with Liver Metastases: A Phase 2 Study
AID  - 10.2967/jnumed.117.197194
DP  - 2018 Apr 01
TA  - Journal of Nuclear Medicine
PG  - 582--588
VI  - 59
IP  - 4
4099  - http://jnm.snmjournals.org/content/59/4/582.short
4100  - http://jnm.snmjournals.org/content/59/4/582.full
SO  - J Nucl Med2018 Apr 01; 59
AB  - Radioembolization of liver malignancies with 166Ho-microspheres has been shown to be safe in a phase 1 dose-escalation study. The purpose of this study was to investigate the efficacy of 166Ho radioembolization. Methods: In this prospective single-arm study, 56 patients were enrolled, all with liver metastases refractory to systemic therapy and ineligible for surgical resection. The primary outcome was a response by 2 target lesions on triphasic liver CT scans 3 mo after therapy, as assessed using RECIST, version 1.1. Secondary outcomes included overall tumor response, time to imaging progression, overall survival, toxicity, quality of life, and quantification of the microspheres on SPECT and MRI. Results: Between May 2012 and March 2015, 38 eligible patients were treated, one of whom was not evaluable. In 27 (73%) of 37 patients, the target lesions showed complete response, partial response, or stable disease (disease control) at 3 mo (95% confidence interval [CI], 57%–85%). The median overall survival was 14.5 mo (95% CI, 8.6–22.8 mo). For colorectal cancer patients (n = 23), the median overall survival was 13.4 mo (95% CI, 8.2–15.7 mo). Grade 3 or 4 toxic events after treatment (according to the Common Terminology Criteria for Adverse Events, version 4.03) included abdominal pain (in 18% of patients), nausea (8%), ascites (3%), fatigue (3%), gastric stenosis (3%), hepatic failure (3%), liver abscesses (3%), paroxysmal atrial tachycardia (3%), thoracic pain (3%), upper gastrointestinal hemorrhage (3%), and vomiting (3%). On SPECT, 166Ho could be quantified with high accuracy and precision, with a mean overestimation of 9.3% ± 7.1% in the liver. Conclusion: Radioembolization with 166Ho-microspheres induced a tumor response with an acceptable toxicity profile in salvage patients with liver metastases.