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Ontada: MDS [2023] Real-World Treatment and Survival USOncology – Ira Zackon MD

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Treatment Patterns and Overall Survival (OS) Among Patients with Myelodysplastic Syndromes (MDS) Treated in the US Community Oncology Setting: A Real-World Retrospective Ontada Observational Study

by: Ira Zackon, MD – USOncology Network

So our study is a retrospective we call descriptive study, really looking at treatment patterns and improve patient outcomes with myelodysplastic syndromes or MDS. So this is leveraging the data within the electronic health record called Ontada, which is within USOncology.

1,400 physicians taking care of advance cancer care patients

So again, reflective of the community based real world setting and it’s a large database with over 1,400 physicians taking care of patients.  So retrospective is this particular study from the Ontada EHR. Back on patterns of care and patient outcomes in over a decade of time from 2011 through 2021.

We had over 2,700 patients and with MDS

The Ontada EHR study is really looking back at you know, what how are these patients doing and how are we treating them in the community oncology practices. This is to our knowledge, the largest aggregate group of patients studied. We had over 2,700 patients and with MDS you know, this is a, we understand this to be an, a difficult disease space that primarily is in the elderly population and we’ve had limited therapy options. 

Median age was 75 years old, about 40% women, 60% men

So, First, that the data set from the real world Ontada EHR study is that the median age was 75 years old, about 40% women, 60% men. And so importantly that that does reflect what we see, you know, in these patients. And when we’re looking at retrospective and real world data we’re really capturing what is an unselected population, you know, with clinical trials that we, first of all, A small percentage of the overall patients participate in clinical trials as important as they are to bring new therapies to us and to take care of our patients but they’re also a more selected population. We know they don’t represent the full demographics of America.  and so translating that, To the real world Ontada EHR data. We have a lot of assumptions.  and so it is important to look back at the retrospective data. And I think what the data that we were showing of importance was that the majority of patients with MDS have what we might call.

Higher risk MDS  that as, you know, limited long-term survival.  and the primary therapy we’ve had has been hypomethylating agents, so drugs like Azacitidine or Decitabine. So these are not new drugs.  These are the established drugs. Since we’re looking back at, you know, what has, what has been the patterns of care I think important than data points in, in our Ontada EHR study was that when we look. I would call non low risk because it’s a really different subset of patients with MDS.  that About 75% of those patients went onto a hypomethylating agent.  so that leaves about a quarter of the patients who. At least in our database, we could not identify that they had any treatment in the first line setting.

Allogeneic STEM cells transplant

The Ontada EHR study does not exclude that they had other treatment.  when again since it’s not prospective and controlled some of those patients may have had treatment outside of the network or gone onto a clinical trial out. Inside of the USOncology network. We do know that only 10% of these patients went to allogeneic STEM cells transplant, which is the only curative therapy for MDS at this time and that’s reflective of the age of this patient population. Most patients, median 75 or older are not.  likely as good candidates for stem cells transplant, but in the real world it is certainly other factors that may have mitigated against going on therapy. I think the other next important data was that of those that went onto a hypomethylating agent, the majority was Azacitidine.

Median duration of therapy was 4.8 months

The median duration of therapy was 4.8 months. So just over four or four to five months.  We know with these agents, you have to give them at least four monthly cycles before evaluating their impact. So that’s an insight into the real world. It’s. Experience that the majority of patient access are not on therapy for very long. And even the outliers beyond that median were generally less than a year telling us that there’s a limited impact, you know, of these therapies and really opening up what we understand to be a real need for, for new therapies in this space. You know, there’s different purposes that you can use for retrospective data.  I think one of the perhaps best use cases is looking back at the Ontada EHR data. What really happened out there because as you know, the clinical trials again, reflect a more selective population and it can open up new needs and new questions.

 

So I think that the most important information from this would be that in the Ontada EHR real world of patient care at the community oncology providers level, Majority of oncology patients are either not getting therapy or are on therapy, but with limited impact. And that is really speaking to the need for new paradigms of therapy. Now in this disease space, you know, we’ll be seeing changes.

We’re getting a much broader molecular genetics profiling

We’re getting a much broader molecular genetics profiling of these diseases now, which was not part of how we diagnosed and evaluated MDS for example, in that past decade as much.  This will give us more insight into understanding the. Where MDS Falls. As you know, these diseases evolve into acute myeloid leukemia, which, and that remains a very difficult disease in the elderly to treat effectively.

We define MDS as if you have more than 20% leukemic blasts in your bone marrow cells

And we know it has generally poor outcomes but I think what we’re gonna be seeing is really a paradigm change in how we look at MDS. Currently. We define MDS as if you have more than 20% leukemic blasts in your bone marrow cells, or. We say that’s acute myeloid leukemia. If you have less than 20%, we say that’s MDS or, or pre-leukemia. But biologically these are probably really the same disease in a different phase of their evolution. And I think that we’ll be classifying what we currently call MDS with excess. To be acute myeloid leukemia with a lower blast burden and start to treat that like we would AML in the elderly, which does open up at least currently new therapy paradigms beyond a hypomethylating agent, or at least adding to a hypomethylating agent currently that could be with an oral BC2 inhibitors, such as a Venetoclax.

FLIT3 inhibitors

As we profiled the diseases hopefully, Actionable mutations that we’re beginning to see in the that we’ve been using now in AML  such as IDH 1 or 2 inhibitors FLIT3 inhibitors. These are specific mutations that we see in myeloid malignancies and acute myeloid leukemia. And there are trials already in advance you know, phases where. We are incorporating these agents and of course, looking for innovative new agents with new mechanisms of action as science continues to reveal the underlying biology of these diseases.

Ontada EHR database

I think the importance of retrospective data on its own as an important data set really gives us a whole picture.  and so the importance of being able to extract high quality data from different databases. You know, our database is based on patient care and the entry of that. Um both what we call structured, where there’s specific data points that, you know, we click on to define certain aspects, but richly the documentation of decisions, adverse effects, some of that granularity that really help inform you know how patients are being taken care of. And I think it needs to compliment our prospective data, both to inform how translatable has that data been to the real. But also giving us a larger picture.  and I, and you know, the FDA has a real interest in high quality data from an EHR database like Ontada that can be used to, for example, have what we call a synthetic control.

 

This would be going into patients treated not on the prospective randomized arm, but are matched up by their demographics, by the prognostic factors of the disease to to match up like you would in a prospective trial. And that could advance the time to completing a clinical trial, the cost of completing that clinical trial, and hopefully then developing regulatory mechanisms for approvals. But that data has to be of a very high grade, we call it high quality. And that’s certainly one of our efforts is to be able to provide synthetic controls or sometimes contemporaneous real world data. You have a trial going on that’s prospective, but at the same time be collecting in that disease space of real world data so that  we can have a more holistic view of that particular therapy intervention.

How we can use the Ontada data to fully inform not only the stories of our patients, their journeys

How we can use the EHR Onctada data to fully inform not only the stories of more patients lives, their journeys but importantly how we can understand the value.  You know, we are. We have moved increasingly into what we call value-based care, where it’s not just pure outcomes, it’s also the quality of life as well as the cost effectiveness of therapy. And we need our data to inform this. You know we didn’t talk about cost. Care. But being used, using databases to be able to provide that type of information is increasingly important in really fully evaluating the therapies that deliver and hopefully directing it to the right patients where you make the most impact.

 

About The Author: Ira Zackon, MD – USoncology Network

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