The primary importance of collecting data from registries would be to establish outcome data to prove the value of the interventional oncologic therapies to healthcare administrations and governments; ie. to establish interventional oncology’s value in healthcare. Further, it could help gather data to confirm that interventional oncology treatments of cancer impact patients’ lives and the quality of their survival.
“There is a strong need for registries, especially for prevalent cancers treated by interventional oncologists: lung primaries, metastatic disease, liver, lung, kidney and bone cancers. These registries would also capture data on the complications of interventional oncology therapies.
“This is a call for more mature, higher quality research within interventional oncology,” said Constantinos Sofocleous, Memorial Sloan Kettering Cancer Center, New York, USA and professor of Radiology, Weill Medical College of Cornell University, New York. He is also a director-at-large of the Society of Interventional Oncology (SIO). Both Sofocleous and Matthew Callstrom, professor of Radiology, Mayo Clinic College of Medicine, Rochester, Minnesota, USA, and scientific programme chair of the World Conference on Interventional Oncology (WCIO) 2017 spoke to Interventional News at the WCIO annual meeting in Boston, USA, in June.
Graeme Poston, professor of Surgery, University of Liverpool, Liverpool, UK, speaking at the European Conference on Interventional Oncology (ECIO; April, Bilbao, Spain) meeting noted that while randomised controlled trials remained the gold standard to underpin evidence based practice, it was well recognised that such trials addressing a surgical/interventional radiology procedure may be difficult to design and recruit to.
“There will be situations where it will not be practically possible to recruit patients to large phase III surgical/interventional radiology randomised controlled trial. Alternative prospective study strategies, including registries, are possible, and although not perfect, should be considered as alternatives to randomised controlled trials,” he said.
David J Breen, clinical director of Radiology, Southampton University Hospitals, Southampton, UK, concurs: “High level trials in interventional oncology are particularly problematic due to the increasing complexity of cancer treatment pathways, multiple competing therapies and not least the ‘transdisciplinary’ nature of many interventions in this field, where perceived clinical equipoise may still be controversial. Registries, whilst representing dirty but real world data, can quickly accrue and prove the technical and to a large extent the oncological merit of a particular intervention.
“Renal cancer ablation is a good case in point where attempts at randomised studies against surgery have failed, yet there is considerable activity, and the safety, procedural outcome and recurrence rates of this therapy can be determined in relatively short order. We have great hopes for the European EuRECA and North American ARMOR renal ablation registries which are currently open,” he says.
Govindarajan Narayanan (chairman of Vascular/Interventional Radiology) and Riccardo Lencioni (director of Interventional Oncology Research) from the University of Miami-Miller School of Medicine, Miami, USA, who organise the Synergy Miami meeting, also note that gathering registry data is the way forward. They say: “We strongly believe that interventional oncologists should focus more and more on collecting outcome data in the context of well-designed, multicentre, prospective registries. This is the most powerful tool to be able to produce high-quality data. We should also focus on the ability of these therapies to improve quality of life, a metric that has been finally recognised as a key endpoint for cancer clinical care.”
Sofocleous reiterates the point: “There are a lot of data that we can capture right now even if they are not the gold standard that may never arrive. Thirty years from now, if we do not set up registries and collect data, and prove our value as a specialty, we are not going to exist as a specialty. Other specialties will be doing image-guided intervention. If we do not prove our value and there is an economic change in healthcare reforms such that there is no reimbursement, we will be shut down.
“Image-guided oncological therapies will then need to go through another cycle of development through other specialties, which would not necessarily mean the extinction of the therapies, however, it will have an impact on the survival of interventional oncology. The value of our treatments is under question when we do not have randomised level one evidence. So what we need is to collect data from prospective registries with well-defined data points. Surgery and radiation oncology have done this; we have not,” he says.
Callstrom adds: “Registries are a way to establish a better foundation of the data across the spectrum of people that do these procedures. This type of data is a notch above single-centre data. In renal tumour ablation, for example, which has good outcomes, with registry data we are going to be able to say to patients, you can go to any of the centres in the country that participate in this registry, and this is going to be your likely outcome. It is a very valid measure.”
Both make the point that valuable prospective registry data will require centres to achieve a high level of performance and appropriate patient selection. In order to participate in the registry, physicians will have to ideally contribute a minimal standard of acceptable data to it. So for example, in a pre-defined prospective registry for liver ablation, the registry would mandate the inclusion of patients that have liver-only disease; patients should have no more than three lesions, each one of them being no more than 3cm. The outcomes obtained would then pertain to this pool of patients.
“Right now we have a lot of dirty data because you are pooling together cases of patients who have 3cm, 5cm and 8cm lesions who were treated by ablation, which may not be what is considered optimal care. This makes the data look worse than it should if appropriate patient selection had been used,” explains Callstrom.
Need for an ICOG group
The Eastern Cooperative Oncology Group (ECOG) is one of the largest clinical cancer research organisations in the USA, and conducts clinical trials in all types of adult cancers. Many thought leaders at the WCIO meeting noted that the creation of an Interventional Cooperative Group (ICOG) would be important.
“We are challenged as a specialty; we do not have an oncology group. If we establish a similar framework, we can rapidly collect prospective data. It does not have to be randomised. At least it gets us to that higher level of evidence. Establishing such a framework to collect that data would be invaluable. We need an organisation that creates registries for all interventional therapists,” Callstrom said.
Sofocleous adds: “What we need is the set-up of a cooperative group, so that we accumulate data that are not based on vendor-type or biased by financial interest of what therapy we are choosing. We want to see the outcome of the different therapies, and then as much as there are subtype differences between devices and tools; that can be a secondary aspect.”
The current IO registries that are running, often tend to be by device type, in a particular region. Sofocleous notes that “ideally, I would like to see disease-based outcomes. I want to see the outcomes of metastatic bone disease treated by ablation, for example. Or, I would like to see the outcomes of renal cell carcinoma treated by ablation. With these data we are going to be able to characterise the treatment to a very high level, if you do a good job in terms of how you establish the data collection.”
One of the current aspects of registries pertaining to interventional oncology is that they are basically vendor oriented. “Vendors have tried to support the use of their devices, which is valid, particularly in the application in which they might dominate, or have investment in. But I think as you move to registries that are broader or generic, you can still collect the information on the device that is used, and potentially even filter data based on this, but these data will provide a very broad perspective of outcome, which is valuable,” said Callstrom.
Interventional oncology experts agree that it is time to do this. “We have to move aggressively to establish the value of what we do, provide objective measures, and collecting registry data is one step in that direction,” says Callstrom.
“I hope we are able to get together all the relevant stakeholders in image-guided intervention in cancer to get this done as efficiently and in an as unbiased a way as possible,” concluded Sofocleous.