MARLBOROUGH, Mass.,
March 25, 2021 /PRNewswire/
-- Boston Scientific Corporation (NYSE: BSX) announced
positive data from the TARGET study of the TheraSphere™
Y-90 Glass Microspheres (TheraSphere)
– a type of radioembolization comprised of millions of microscopic
glass beads containing radioactive yttrium (Y-90) – during a late-breaking clinical trial
presentation at the annual scientific meeting for the Society of
Interventional Radiology (SIR).
The global, retrospective TARGET study evaluated the safety and
efficacy of TheraSphere therapy in patients with
hepatocellular carcinoma (HCC) – the most common type of primary
liver cancer – using a dosing method known as
multicompartment dosimetry, which maximizes the dose of
Y-90 reaching the tumor while
minimizing the radiation dose that reaches normal liver tissue. In
the study, imaging software was used retroactively to calculate the
dose delivered within each patient's liver tissue. Data confirmed
treatment was safe and well tolerated, with only 4.8% of patients
experiencing adverse events, defined in the primary endpoint as ≥
Grade 3 hyperbilirubinemia. Hyperbilirubinemia, commonly referred
to as jaundice, is the build-up of bilirubin in the blood and can
indicate abnormal liver function.
"The TARGET study findings create the opportunity for future
TheraSphere treatment optimization and Y-90 dose escalation without compromising
safety," said Prof. Marnix G.E.H.
Lam, M.D., Professor of Nuclear Medicine, University Medical
Center, Utrecht, Netherlands and
one of the principal investigators of the TARGET study. "The study
results are also generalizable and easily replicated as we included
a global patient population with a wide spectrum of early,
intermediate and advanced HCC."
Data from TARGET also demonstrated a correlation between the
level of radiation absorbed by the tumor and an increase in
survival probability through three years – with a median overall
survival of 20.3 months. These findings are in line with recently
published results showing that higher tumor absorbed dose leads to
longer survival.i,ii In addition, a dose-efficacy
relationship was established as the probability of tumor response
was positively associated with the level of radiation absorbed by
the tumor.
"TARGET adds to the robust body of evidence supporting
TheraSphere as a safe and effective treatment option for the
hundreds of thousands of patients around the world that are
diagnosed with HCC each year," said Peter
Pattison, president of Interventional Oncology, Peripheral
Interventions, Boston Scientific. "These study insights and the
Simplicit90Y™ software provide physicians the
opportunity to develop a personalized dosing approach for their
patients with the potential to improve tumor response and optimize
outcomes."
TheraSphere, which was approved by the U.S. Food and Drug
Administration earlier this month, is the only radioembolization
technology in the U.S. indicated for the treatment of unresectable
HCC.
For more information on TheraSphere, visit
www.therasphere.com.
About Boston Scientific
Boston Scientific transforms lives through innovative medical
solutions that improve the health of patients around the world. As
a global medical technology leader for more than 40 years, we
advance science for life by providing a broad range of high
performance solutions that address unmet patient needs and reduce
the cost of healthcare. For more information, visit and connect on
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CONTACTS:
Karin Dalsin
Media Relations
(763) 494-1914 (office)
Karin.Dalsin@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5670 (office)
BSXInvestorRelations@bsci.com
i Salem et al., 2019, EJNMMI,
46(8):1695-1704
ii Garin et al, 2021, Lancet Castroenterol Hepatol,
6(1):17-29
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SOURCE Boston Scientific Corporation