In this study that we presented at the 2021 ASCO meeting, we looked at electronic health record derived data from the Flatiron database. This is essentially a database derived from electronic medical records, about 80% of which are from community practices in the United States. And we looked at the records from roughly 4,000 patients with mantle cell lymphoma, with the primary goal of looking at patterns of care, treatment outcomes, and also, in a younger population, what was the impact of stem cell transplantation.
We essentially found three findings that I think are relevant, potentially, to daily practice, but really are much more relevant to future research. The first thing we identified was that patterns of care in the "real world" do not necessarily mimic the patterns of care that might be suggested based on clinical trial data.
So, for example, in younger patients, most clinical trials are focused on cytarabine-based induction followed by autologous stem cell transplantation. In most older patients, treatment is primarily focused on bendamustine/rituximab-based therapies in these community-based practices, and actually some academic-based practices. We didn't find that the patterns of care lined up the way you might expect, at least not 100%, and there are some lessons there that I'll get to in a second.
The second thing we found was that the outcomes in the electronic health record derived data were not the same as the outcomes that might be suggested from clinical trial data. I think that's important.
Number three, we found that when we focused on a patient population that we felt was likely to be eligible for stem cell transplantation, we didn't see a big effect on either time to next treatment or overall survival in younger patients who were treated with stem cell transplant, compared to those patients who were not treated with stem cell transplant.
What does this all mean? Essentially, it means a couple of important things. One, I think it suggests that, potentially, when we do research in mantle cell lymphoma, we may be designing clinical trials that are either not applicable to the broad population with mantle cell lymphoma or are not easy to give in many office-based settings. And so, simply, they're not given.
The other thing, I think, that's important is that we see, when outcomes are not the same, one of the reasons for that is that the patients who are being seen in community practices often may be sicker, or for a variety of reasons, unable to travel to academic practices. And so, I don't buy in to the idea that if they were all treated in academic practices, that they would all do better. I think what we see is that there's a lot of heterogeneity with mantle cell lymphoma and when we design clinical trials, we have to design clinical trials that are applicable to the broader mantle cell lymphoma population, keeping in mind that many of them are older, or sicker, or have some degree of organ dysfunction that might result in different outcomes independent to what kinds of treatments they're receiving.
From my perspective, there are really sort of two take-home messages from the data. One, again, as a researcher, I think that we probably need to do a better job of designing and testing regimens that are broadly applicable to all patients with mantle cell lymphoma, regardless of where they're being treated.
And then, additionally, I think that, given the difference in practice patterns that we see in this population, I think it maybe does behoove, to some degree, all of us to pay a little bit of attention to the clinical trials that are being done, and to try to mirror our practice to guidelines in current clinical trials with the goal of achieving outcomes that are similar to those trials.
Hopefully, that will get easier as clinical trials become more broadly applicable to the patient population that we're really seeing with mantle cell lymphoma.
