De-escalation is a principle applied in many fields throughout medicine to reduce the duration, dose and number of therapies a patient receives to preserve quality of life. The concept is rooted in ensuring the financial sustainability and accessibility of interventional treatments worldwide—a critical action amid the rising cost of global healthcare. In Frano Orsi’s (Istituto Europeo di Oncologia, Milan, Italy) view, cryoablation encapsulates this philosophy, providing patients seeking treatment for breast cancer with a minimally invasive alternative to surgery. Here, he discusses why he believes this to be true and what needs to happen to secure cryoablation as ‘standard’ for breast cancer intervention.
Why is cryoablation the ‘ultimate expression’ of IO’s de-escalation philosophy?
The philosophy of de-escalation is based on a principle of minimising treatment toxicity, preserving the patient’s quality of life without compromising the oncologic effectiveness.
Generally speaking, interventional radiology (IR) has applied this concept in many other areas, but when we apply this to breast cancer treatment, it amplifies the philosophy, enabling physicians to replace invasive surgical approaches and aggressive adjuvant therapies.
In the last few decades, the treatment of breast cancer has undergone a significant reduction in invasiveness, considering how we have scaled down from highly destructive procedures such as radical mastectomy, to more conservative approaches via lumpectomy, to very minimally invasive techniques like cryoablation.
Nowadays, more patients are being diagnosed with small, early breast cancer thanks to screening protocols available in many countries. When these small lesions are identified we aim to take advantage of this early diagnosis by descaling and reducing our invasiveness, which is a concept intrinsic to IO.
In the literature, de-escalation has become more prominent. Particularly since the publication of the COLLISION trial results, we have seen that thermal ablation for colorectal liver metastases has been demonstrated as an equal to resection in terms of efficacy, and we know that the percutaneous approach will dramatically reduce the invasiveness of the treatment, benefitting the patient.
You are principal investigator of the Percutaneous Cryoablation of Low-risk Early Breast Cancer (PRECISE) study. How is this progressing?
The trial which is currently enrolling at the European Institute of Oncology in Milan, Italy, where I am based, is the first European protocol aimed to demonstrate cryoablation as a viable alternative to surgical resection in women 50 years of age and older with unifocal, small—up to 15mm in diameter— clinically node-negative, luminal A and B breast cancer.
A similar trial—ICE3—was conducted in the USA which had very good results in support of cryoablation as a comparable alternative to surgical lumpectomy. In our study, we have sought to fine-tune our protocol to show that we can successfully replace surgical resection entirely with cryoablation for these patients.
PRECICE is a multidisciplinary trial involving surgeons, pathologists, radiologists and interventional radiologists, and to date, we have enrolled 52 patients out of our intended 244. Our enrolment rate is lower than we would like; we have experienced friction, not only from surgeons, but even from patients—this is a very strange situation. It may be due to the common thinking that surgical approaches can cure all kinds of disease as this concept is embedded in our DNA. Surgery has been around for at least 4,000 years, so the general population has grown up thinking that surgery is the best option, particularly in oncology.
Often, the patient is not familiar with minimally invasive approaches as this pathway is far from the traditional one, and so they are afraid to expose themselves to something unknown. I have witnessed this process occur with ablation for liver disease for instance, which today, is very well established and patients often self-refer for this treatment.
This is not true of breast cancer just yet. We are absolutely a new player in the field, and it won’t be easy to be included in the standard treatment pathway for breast cancer. But, in order to do that in the best way, we need to produce and consolidate data.
Will the PRECISE data only apply to comparable healthcare systems? Is cryoablation accessible/applicable to low- and middle-income countries?
This is one of our main aims in conducting the PRECICE trial; by replacing surgical resection with cryoablation for select patients, the minimally invasive approach should have less of an impact on the healthcare system.
We don’t need general anaesthesia to carry out cryoablation and the patient is able to walk in and walk out in no more than 40 minutes. If we can show that this treatment may really replace surgical resection, we can hope to export this concept to developing countries where surgical approaches may cost significantly more or are hindered by infection which can often be a problem following resection.
There is a cost for the device, of course, but the cost of the device and the procedure is much lower than the cost of surgery or anaesthesiologists. Plus, the impact on the patients’ social or working lives is less significant, enabling a return to normal activities that day or the day after. I believe that in most countries, especially developing regions where surgical activities are less established, cryoablation could offer a more affordable and straightforward alternative.
Orsi is set to present his Andreas Gruentzig Honorary Lecture on Monday 15 September at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress (13–17 September, Barcelona, Spain).
