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Internal view of patient's torso demonstrating targeted accuracy of TheraSphere Y-90 Glass Microspheres in liver.

TheraSphere™ Y-90 Glass Microspheres

PROACTIF study
ICC data

ICC data overview

PROACTIF: A prospective, real-world Y-90 study with TheraSphere for the treatment of liver malignancies: Interim data of 168 intrahepatic cholangiocarcinoma (ICC) patients.

PROACTIF ICC data sheet

Filename
PROACTIF-ICC-data-sheet.pdf
Size
619 KB
Format
application/pdf
Download PROACTIF ICC data sheet

Use of TheraSphere in treatment of ICC is outside the labeled indications as safety and effectiveness has not been established.

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TheraSphere Y-90 glass microspheres demonstrated overall survival of 18.1 months for 168 ICC patients in PROACTIF.


Interim data of 168 ICC patients across 32 sites

Overall survival

Median overall survival of 18.1 months (95% CI 16.3 - 23.9).

Data from 32 sites used contemporary techniques and dosing

63% multi-compartment dosimetry; 54% selective administration.

Reason for treatment 

Pie chart showing 59.5 (n-100) disease control, 16.7 (n=28) downstage or bridge to surgery, 13.7 (n=23) obtain complete response, 6.0 (n=10) other or unknown, 4.2 (n=7) missing.

Majority of patients had single lesion with index lesions > 5cm

Patient demographics and disease characteristics

Patient demographics and disease characteristics.

*Non-malignant thrombus

Conclusion


Appropriately selected ICC patients treated with TheraSphere demonstrated an overall survival of 18.1 months using Y-90. This dataset helps build foundational real-world data for an under-studied disease state.

This study is sponsored by Boston Scientific. Final results are expected in 2025 and will include full patient population with additional information on quality of life, safety and dosimetry.

Garin E, Brenot-Rossi I, Tlili G et al. Abstract 222.4 Treatment of intrahepatic cholangiocarcinoma with Y-90 glass microspheres in the PROACTIF study. ECIO 2024 Book of Abstracts. Cardiovasc Intervent Radiol 47 (Suppl 4); 2024. p.60 https://doi.org/10.1007/s00270-024-03732-x

Boston Scientific is not responsible for the collection, analysis or reporting of the investigator-sponsored research output which is the sole responsibility of the investigators. Boston Scientific’s involvement in investigator-sponsored research is limited to providing financial support for research that advances medical and scientific knowledge about our products. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Use of TheraSphere in treatment of ICC is outside the labeled indications as safety and effectiveness has not been established.