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European Journal of Nuclear Medicine and Molecular Imaging

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01-03-2014 | Original Article

Sustained safety and efficacy of extended-shelf-life ⁹⁰Y glass microspheres: long-term follow-up in a 134-patient cohort

Authors: Robert J. Lewandowski, Jeet Minocha, Khairuddin Memon, Ahsun Riaz, Vanessa L. Gates, Robert K. Ryu, Kent T. Sato, Reed Omary, Riad Salem

Published in: European Journal of Nuclear Medicine and Molecular Imaging | Issue 3/2014

Abstract

Purpose

To validate our initial pilot study and confirm sustained safety and tumor response of extended-shelf-life ⁹⁰Y glass microspheres. We hypothesized that for the same planned tissue dose, the increase in number of glass microspheres (decayed to the second week of their allowable shelf-life) administered for the same absorbed dose would result in better tumor distribution of the microspheres without causing additional adverse events.

Methods

Between June 2007 and January 2010, 134 patients underwent radioembolization with extended-shelf-life ⁹⁰Y glass microspheres; data from 84 new patients were combined with data from our 50-patient pilot study cohort. 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 prospectively captured and categorized according to the Common Terminology Criteria. Response in the index lesion was assessed using WHO and EASL guidelines.

Results

The mean delivered radiation dose was 123 Gy to the target liver tissue. The mean increase in number of microspheres with this approach compared to standard ⁹⁰Y glass microsphere 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 %), and nausea/vomiting (25 patients, 18.7 %). Grade 3/4 bilirubin toxicity was seen in three patients (2 %). Two (1 %) of the initial 50-patient cohort showed gastroduodenal ulcers; gastroduodenal ulcers were not seen in any of the subsequent 84 patients. According to WHO and EASL guidelines, response rates were 48 % and 57 %, respectively, and 21 % demonstrated a complete EASL response.

Conclusion

This study showed sustained safety and efficacy of extended-shelf-life ⁹⁰Y glass microspheres in a larger, 134-patient cohort. The increase in number of microspheres administered theoretically resulted in better tumor distribution of the microspheres without an increase in adverse events.

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Title: Sustained safety and efficacy of extended-shelf-life 90Y glass microspheres: long-term follow-up in a 134-patient cohort
Authors: Robert J. Lewandowski
Jeet Minocha
Khairuddin Memon
Ahsun Riaz
Vanessa L. Gates
Robert K. Ryu
Kent T. Sato
Reed Omary
Riad Salem
Publication date: 01-03-2014
Publisher: Springer Berlin Heidelberg
Published in: European Journal of Nuclear Medicine and Molecular Imaging / Issue 3/2014
Print ISSN: 1619-7070
Electronic ISSN: 1619-7089
DOI: https://doi.org/10.1007/s00259-013-2575-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Sustained safety and efficacy of extended-shelf-life ⁹⁰Y glass microspheres: long-term follow-up in a 134-patient cohort

Abstract

Purpose

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

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