Ep. 265 The TheraSphere Story with Dr. Riad Salem and Peter Pattison

In this crossover episode between BackTable VI and BackTable Innovation, Dr. Chris Beck interviews Dr. Riad Salem (Chief of Interventional Radiology at Northwestern University) and Peter Pattison (President of Interventional Oncology at Boston Scientific) about how TheraSpheres for Y90 radioembolization became a mainstay in the IR toolkit for HCC and where the technology is heading next.

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SHOW NOTES

To begin, Peter outlines how the original concept of TheraSpheres began at the University of Missouri, as a collaboration between Drs. Delbert Day and Gary Ehrhardt, who combined their ceramic and nuclear chemistry expertises to create radioactive glass beads and published a paper in 1987. After animal and human testing, the product was licensed to the company Nordion, where Peter worked. The product was given a humanitarian device exemption (HDE) from the FDA, which allowed TheraSpheres to be used for investigational purposes.

In the late 1990s, Dr. Salem was in his early interventional oncology career and heard about TheraSpheres. He recognized the enormous potential that this technology had to ensure known amounts of radioactive doses were delivered to the tumor and minimize adverse effects. In fact, he noticed that his Y90 patients had less pain, post-embolization syndrome, and hospitalization than his transarterial chemoembolization (TACE) patients. In the mid 2000s, he collected and submitted data to various conferences and journals, but he was met with criticism from the IR world, which was more comfortable with TACE, since it was the current standard of care.

In 2011, Nordion decided to run a clinical trial, EPOCH, which eventually showed that the addition of TARE to systemic therapy for colorectal metastases to the liver led to longer progression free survival.

Dr. Riad has focused his efforts on training more IRs on the methodology of Y90, since this was an important step to increasing adoption and minimizing missteps with the new technology. He believes that the advent of Y90 has resulted in better angiography, since IRs are more cognizant of off-target embolization. Dr. Salem also petitioned at the US Nuclear Regulatory Committee to allow IRs to become the authorized users for Y90 injection and advocated to add TARE to the National Comprehensive Cancer Network guidelines for liver cancer. Both of these developments allowed TARE to become more widely adopted.

Finally, Peter discusses the competition that TheraSpheres has faced from TACE and SIRSpheres (resin-based radioembolization). He shares exciting new developments that have occurred since acquisition by Boston Scientific. These include exploration for the extra-hepatic use of TheraSpheres in glioblastoma and prostate cancer.

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RESOURCES

BackTable Ep. 223- Portal Vein Recan #ReCanDoIt with Dr. Riad Salem:

https://www.backtable.com/shows/vi/podcasts/223/portal-vein-recan-recandoit

Therapeutic Use of 90Y Microspheres:

https://pubmed.ncbi.nlm.nih.gov/3667306/

A phase I dose escalation trial of yttrium-90 microspheres in the treatment of primary hepatocellular carcinoma:

https://pubmed.ncbi.nlm.nih.gov/1327493/

Hepatic radioembolization with yttrium-90 containing glass microspheres: preliminary results and clinical follow-up:

https://pubmed.ncbi.nlm.nih.gov/7931662/

Humanitarian Device Exemption:

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/humanitarian-device-exemption

EPOCH Trial:

https://ascopubs.org/doi/full/10.1200/JCO.21.01839

Radioembolization with 90Yttrium Microspheres: A State-of-the-Art Brachytherapy Treatment for Primary and Secondary Liver Malignancies:

https://www.jvir.org/article/S1051-0443(07)60901-4/fulltext