SIR 2024
Interventional Oncology
Robert J. Abraham, MD, FSIR, FRCPC
Professor
Dalhousie University/QEII Health Sciences Center, Canada
Financial relationships: Full list of relationships is listed on the CME information page.
Amit Verma, DrPH, MPH
Clinical Program Director
ABK Biomedical Inc., Canada
Disclosure information not submitted.
David Dobrowski, n/a
VP Clinical Development & Regulatory Affairs
ABK Biomedical Inc., Canada
Disclosure information not submitted.
Cheenu Kappadath, PhD
Professor
University of Texas MD Anderson Cancer Center
Disclosure information not submitted.
David Liu, MD, FSIR, FRCPC
Associate Professor
University of British Columbia, Canada
Financial relationships: Full list of relationships is listed on the CME information page.
Andrew Holden, ONZM, MBChB, FRANZCR, EBIR
Associate Professor
Aukland District Health Board / Auckland Hospital, New Zealand
Disclosure information not submitted.
Aravind Arepally, MD, FSIR
Interventional Radiology
Piedmont Healthcare
Financial relationships: Full list of relationships is listed on the CME information page.
To describe 6-month safety and efficacy and 3-month liver volume changes after multimodal imageable glass Y-90 Radioembolization for Hepatocellular Carcinoma (HCC) in a FIH Clinical Trial
Materials and Methods:
Eye90 microspheres® (Eye90) is a unique imageable glass Y-90 microsphere providing therapeutic beta radiation with multi-modality imaging capabilities through CT, SPECT/CT and TOF PET/CT. In a prospective trial, 6 patients underwent selective (≤ 2 segments) Eye90 therapy. Inclusion criteria included liver only HCC, ECOG ≤ 1, total lesion length < 9 cm, one lesion > 2 cm, Child–Pugh A, BCLC A-B. Prospective partition dosimetry was utilized. Clinical safety, ECOG status, hematological/hepatic/renal biochemistry, incidence of toxicity ≥ Grade 3 and related Treatment Emergent Serious Adverse Events (TESAEs) were assessed at intervals up to 6 months. Tumor response was evaluated by local modified RECIST (mRECIST) at 3 and 6 months. CT volumes were obtained with semi-automated software (MIM SurePlan Y90™) for liver, ipsilateral lobe, contralateral lobe, caudate and spleen. Percent change of combined average volumes between baseline and 90-day imaging were analyzed.
Results:
Six patients with LIRADS 5 HCC were treated with Eye90 (≤ 2 segments) and followed to 180 days in this interim analysis. Technical success was 100%. Eye90 radiopacity distribution on CT confirmed tumor targeting and correlated with post Eye90 SPECT/CT. At 90 and 180 days, complete response (CR) was observed in 3 of 6 patients (50%) and stable disease (SD) in one (17%). 2 patients with partial response (PR) (33%) at 90 days were treated with TACE. All patients reported adverse events. 5 of 6 (83.3%) reported AEs related to treatment but no treatment related serious adverse events (SAEs). There was no evidence of radioembolization induced liver disease (REILD) or radiation induced lung injury (RILI). At 90 days, there was significant increase in contralateral lobe (20.9%) and caudate segment (26.9%) volume with no change in bilirubin, platelet count or splenic volume and no ascites or portal hypertension.
Conclusion:
Eye90 Radioembolization was demonstrated to be safe and effective in HCC patients up to 6 months after selective Eye90 microsphere radioembolization. Significant contralateral and caudate hypertrophy was observed 3 months after selective Eye90 radioembolization.