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

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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

11 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)486-493
Number of pages8
JournalEuropean Journal of Nuclear Medicine and Molecular Imaging
Volume41
Issue number3
DOIs
StatePublished - Mar 1 2014

Keywords

  • Extended-shelf-life Y glass microspheres
  • Liver cancer
  • Radioembolization

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

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