Abstract
In 2008 we presented results from a pilot study using extended-shelf-life Yttrium-90 (Y90) glass microspehres. In this study, we aimed to validate the safety and efficacy of this radioembolic device. We hypothesized that this approach, for the same planned tissue dose of 120 Gy, would increase embolic load, improve distribution, and result in enhanced tumor response without causing additional adverse events. Between June 2007 and January 2010, 134 patients with extensive tumor burden and/or markedly hypervascular tumors underwent radioembolization with extended-shelf-life glass microspheres at a planned dose of 120 Gy. Baseline and follow-up imaging and laboratory data were obtained 1 and 3 months after therapy and every 3 months thereafter. Clinical and biochemical toxicities were categorized according to the Common Terminology Criteria for Adverse Events of the National Cancer Institute. Response in a target lesion was assessed with cross-sectional imaging by using World Health Organization (WHO) and European Association for the Study of the Liver (EASL) guidelines. The mean delivered radiation dose was 123 Gy. The mean increase in embolic load with this approach compared to standard dosimetry was 103%, corresponding to an increase from 3.84 to 7.78 million microspheres. Clinical toxicities included fatigue (89 patients, 66%), abdominal pain (49 patients, 36.6%), nausea (25 patients, 18.7%), and vomiting (19 patients, 14%). Grade 3–4 bilirubin toxicity was seen in three patients (2%). Two (1%) gastroduodenal ulcers were observed. Response rates according to WHO and EASL guidelines were 47% and 57%, respectively. 32 (21%) patients demonstrated complete response according to EASL guidelines at follow-up. The results of this study validate the safety and efficacy of extended-shelf-life Y90 glass microspheres. The increased embolic load and lowered activity per microsphere theoretically resulted in better tumor coverage and, hence, improved response rates.
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