I’m not sure when I first noticed I had the right levels of entrepreneurial spirit in my DNA to create my own products, services and companies in my chosen field of radiotherapy. When I say “chosen” I really mean that I got into it completely by accident as I am sure did others in the early eighties as I have already described in past blogs.
I guess when I left Mount Vernon Hospital and got my first job in “sales” was the starting point and the critical cross over between being a clinical radiographer and a product manager with a remit to sell high value capital equipment. I believe that others in the field can see quickly whether you have it or not and Mike Sweeney saw something in me to take me on as the product manager for the range of Theratronics radiotherapy equipment in the UK and Ireland initially, when a company called Vinten that he worked for acquired the distribution contract for this leading Canadian organisation.
Radiotherapy is a “small world”, be careful!
As I always remind people Radiotherapy is a small world and I still see Mike at trade shows and conferences and so his longevity is longer than mine but is still a friend and confidant today. I think that is one of the benefits of working in this field for an entire career, you make colleagues and acquaintances into friends for life and so that is very gratifying.
Another Mike I met in 2012 had a burgeoning desire to deliver innovative Proton Beam Therapy services in the UK and so I made an appointment to meet him to see if he would like to furnish his planned centres with my DHA radiation/neutron shielding and heavy door solutions. While this was of interest, as a serial entrepreneur and business investor Mike turned the tables on me and asked if I had any related business ideas and if so, based on me creating a realistic business plan he would likely invest as he liked my story. Mike Sinclair was the then Chairman and CEO of the newly named Advanced Oncotherapy PLC and focusing on a new strategy in the cancer diagnosis and treatment fields. Oncotherapy Resources Ltd was soon set up by us to deliver Intra-Operative Radiotherapy or IORT for early stage breast cancer at the time of surgery with me as Managing Director and on a fully managed service only basis with no capital outlay required.
Advanced Oncotherapy PLC or AVO today is one of the world’s leading Proton Beam Therapy companies integrating its innovative and ground breaking LIGHT system designed at CERN and the Large Hadron Collider into a busy radiotherapy treatment setting. AVO eventually sold-on ORL in 2016 to another radiotherapy company. You can find out more about AVO here:
At the start we bought two 50 kV electronic brachytherapy machines to deliver the IORT treatments with one as a back-up, the beauty of these units for a managed service was that they were small and lightweight and could be transported in special cases between hospitals and so signed a contract with Lupprians, a leading medical logistics company to store and deliver the systems in a timely manner on a daily basis to our customer sites. They also managed and supplied the consumables and spares required for daily clinical use and had special air-ride trucks to prevent any damage caused by logistics issues.
I employed a great Radiographer as a niche product specialist to deliver the treatments and sell the service to new clients and a long-time colleague and Physicist to create the required documentation from a health and safety, dosimetry, quality assurance and radiation protection perspective. We also subcontracted engineers to service and maintain the units.
The system could be used in a standard theatre environment with acceptable local rules, controlled areas, a radiation risk assessment and suitable IRMER policies which we created for each client site.
So now the framework was in place to deliver the treatments, we just needed some customers to call us! The business model was very simple, a hospital would order our “managed service” online and ask us to come on a certain time and date and we would invoice them a very cost-effective fee per patient we treated. As soon as the surgeon had completed the wide-local excision, he/she would insert the single use balloon applicator, we would connect the machine and the treatment delivered in a matter of 15 minutes or so with usually 20 G given to the surface of the applicator. We would then pack up and leave while the surgeon completed the procedure.
From a patient’s perspective, if you are diagnosed with early stage breast cancer, have a small low-grade tumour then the concept of having your surgery and radiotherapy on the same day is a no-brainer. You wake up and your treatment is complete with far less psychological burden and emotional stress. There is no need to travel to attend a radiotherapy centre for 3 weeks of EBRT and a further weeks’ boost once the wound has healed. Our main thrust and that of our supportive clinical colleagues was that it simply came down to properly informed patient choice.
However, while the Private sector thought this was great idea and most leading Private health care companies signed up for our service as it raised the profile of their cancer service provision the NHS was less enthusiastic. Private health insurers also found the service more cost effective than EBRT and so it saved them money too and so were largely supportive.
Importantly, if a patient does relapse and have a recurrence after IORT, then a further IORT treatment or EBRT is possible post-surgery. If a patient relapses after a primary course of EBRT then mastectomy is the usual intervention. Also, if after IORT the patient requires EBRT for whatever clinical reason then the IORT can be considered the boost and a course of EBRT delivered and so it is never a “wasted” treatment.
There is an interesting recent paper here that provides an update on the field of breast based intraoperative radiotherapy called: new challenges and issues.
Click here to read more: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5804714/
In order to deliver IORT you need to have a surgeon and clinical oncologist wedded and be happy to work together, one to perform the surgical technique and the other to prescribe the dose and consent the patient appropriately under IRMER regulations. While the TARGIT-A breast IORT trial showed that the treatment was “non-inferior” at least on an absolute basis to EBRT, the data was not considered mature enough for the NHS, NICE and the RCR.
This led to often very heated debates at breast cancer meetings and between members of the Association of Breast Surgery or ABS and Royal College of Radiologists or RCR and where agreeing to deliver IORT had a certain element of putting your head above the parapet! It is fair to say however that we had more surgeons than clinical oncologists who wanted to start.
IORT suddenly became very contentious and a marmite subject within the radiotherapy community often at the expense of the breast cancer patient who as long as they were consented appropriately in that there was a very slightly higher risk of recurrence with IORT in absolute terms: the current data considered slightly immature by some, that their tumour was very low grade and that ASTRO clinical guidelines for IORT were followed with all cases enrolled on a prospective level 3 observational clinical study, the treatment and our managed service was supported by many forward thinking clinical oncologists and breast surgeons who adopted the technique in their Private practises.
There was also some data collected by the TARGIT-A trial that showed a potential reduction in cardiac toxicity and a lower rate of non-breast cancer morbidity but this was argued to be an anomaly by some clinicians even though much of today’s equipment innovation in radiotherapy is linked to breath-hold and motion tracking, adaptive radiotherapy and protons that try to ensure we miss the heart in these circumstances.
In fact, current NICE guidance for breast IORT is largely based on the points contained in the paragraph above that we essentially created ourselves years ago as a working protocol. In the NHS IORT is still only to be used in a research setting using a few existing alternative NHS machines and to this day there is are no tariff based and fully commissioned breast IORT treatments ongoing in the NHS which is a great shame for all those women it would really benefit. NICE and the RCR still formally support the current standard of care of 15 fractions of EBRT and a dose of 40 Gy for all cases aside from the ongoing FAST forward 5-day trials.
Eventually we purchased a further machine that was only used in a Veterinary setting treating skin cancers and other superficial tumours in cats, dogs and horses and provided alternative revenues and still on a managed service basis. Meeting Vets provided an alternative and interesting side-line to the usual suspects.
More ON IORT!
IORT really is Adaptive Radiotherapy
As a Radiographer I am a great believer in IORT and the benefits it can provide patients and am still actively involved in the field today and regularly meet pancreas and colorectal surgeons who are keen to offer IORT to their patients with data showing some real clinical benefits with enhanced local control.
IORT is a truly adaptive treatment where you can see in real time the position of the tumour or tumour bed post-resection and visualise/calculate the margins that you want to irradiate and so while I see the huge potential for MRI guided treatments from the next generation of MRI Linacs and the advances these machines will bring to patient treatment and am not sure why IORT has not progressed in the UK as a standard of care for certain cancers.
Critical structures and organs at risk can simply be moved out of the treatment field by hand or shielded using basic sterilised lead sheet. Margins can be clipped for subsequent analysis and regions close to bone, nerves and blood vessels where the surgeon fears to tread are easily treatable while finally patients who have failed EBRT have a further treatment option available to them.
Let me have your comments or questions on IORT to email@example.com
Lastly, there is a meeting coming up for anyone with a professional interest in IORT
1st National Intra Operative Electron Radiotherapy (IOERT) Symposium
Date: 21, June, 2019
Venue: Southampton General Hospital, Southampton
Click here to book a slot: http://www.radpro.org.uk/2019/04/09/1st-national-intra-operative-electron-radiotherapy-ioert-symposium/