UK Private Programme
What is the OncoSil™ UK Private Programme?
The UK Private Programme is intended for patients who have:
- Private medical insurance (note: not all private medical insurance providers cover OncoSil™). Patients should enquire with an approved OncoSil™ treatment centre to find out more.
- Private funds to pay for the treatment. Patients should enquire with an approved OncoSil™ treatment centre to find out how much treatment will cost.
What is OncoSil™?
OncoSil™ is a single-use brachytherapy (internal radiation) device used to deliver a pre-determined dose of beta radiation directly into cancerous tissue. OncoSil™ has received breakthrough1,2 device designation in the European Union, United Kingdom and the United States for the treatment of unresectable locally advanced pancreatic cancer in combination with chemotherapy.2
OncoSil™ carries the active component radioactive Phosphorous (P-32) microparticles. These microparticles are tiny, and range in diameter from 28 to 32 micrometres, which is smaller than the width of a human hair. Once implanted, the OncoSil™ microparticles will remain permanently in the tumour.
OncoSil™ is available to suitable patients at approved treatment centres via private medical insurance or self-pay.
How OncoSil™ works
OncoSil™ is injected directly into the pancreatic tumour under endoscopic ultrasound image guidance.
The purpose of the OncoSil™ device is to deliver radiation from Phosphorous-32 (P-32) directly into the tumour to destroy cancer cells.
Once implanted, 98% of the radiation will be delivered in 81 days and the OncoSil™ microparticles will remain permanently in the tumour; they have been tested to ensure long-term safety.
The beta radiation emitted by OncoSil™ travels a short distance within the tumour tissue causing direct damage to the cancer cell DNA. This damage makes the cancer cells incapable of further cell division and proliferation.
By stopping cell division and proliferation, OncoSil™ can prevent the cancer cells from multiplying and may ultimately shrink the tumour mass as the cancer cells eventually die.
Mode of Action
Intended use and indication
OncoSil™ is intended for intratumoural implantation into a pancreatic tumour via injection under endoscopic ultrasound guidance.3
OncoSil™ is indicated for the treatment of patients with locally advanced unresectable pancreatic cancer, in combination with gemcitabine-based chemotherapy.3
For more information on the OncoSil™ device, click here.
Clinical Data
PanCO: Results of a single-arm pilot study of 32P microparticles in unresectable locally advanced pancreatic adenocarcinoma with gemcitabine/nab-paclitaxel or FOLFIRINOX chemotherapy.4
The PanCO Study
The PanCO Study was an international, multi-centre, single-arm, open-label pilot study to evaluate the safety of OncoSil™ in a patient population undergoing standard-of-care chemotherapy for unresectable locally advanced pancreatic cancer (LAPC).
The clinical investigation was conducted at approximately 10 sites in Australia, the United Kingdom and Europe (Belgium) involving 50 patients.
Objective
- The primary objective of PanCO was to assess the safety of the device and determine the feasibility of the administration approach in the setting of unresectable locally advanced pancreatic cancer (LAPC)
- The primary efficacy measure was Local Disease Control Rate at 16 weeks (LDCR 16 weeks)
- Null hypothesis HO p=0.55; H1: p=0.75;
- Level of significance: 0.05 with a 2-sided test to achieve a power of 80%
- 33% patients (14/42) were either surgically resected OR were technically sufficiently downstaged to be considered for resection*
- 23.8% patients (10/42) were resected
*Four patients did not undergo surgery due to concomitant co-morbidities and/or other considerations (advanced age, patient choice).
Think you may have patients who are suitable for OncoSil™?
- Discuss the potential suitability of OncoSil™ with your patient.
- Discuss treatment with the Oncology team at the nearest approved treatment centre.
- If patient suitability is confirmed, they will be referred to the nearest approved treatment centre.
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References
- US Food and Drug Administration (FDA) breakthrough device designation for use in combination with systemic chemotherapy, March 2020.
- The British Standards Institute (BSI) designated the device as a breakthrough product under MEDDEV, April 2020, for use in combination with gemcitabine-based chemotherapy.
- OncoSil™ System Instructions for Use.
- Ross PJ, Wasan HS, Croagh D et al. Results of a Single-Arm Pilot Study of 32P Microparticles in Unresectable Locally Advanced Pancreatic Adenocarcinoma with Gemcitabine/Nab-Paclitaxel or FOLFIRINOX Chemotherapy. ESMO Open February 2022; 7 (1): 100356.
