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Dr. Brufsky: 
Hello, I'm Dr. Adam Brufsky. I am a Professor of Medicine at University of Pittsburgh. And we're going to talk today about Real World Use of Real-World Evidence in Hormone Receptor-Positive Metastatic Breast Cancer: From the Perspective of an Oncologist. And with me today is Dr. Christopher Gallagher from MedStar Washington Hospital. Dr. Gallagher, how are you doing today?

Dr. Gallagher: 
I'm great. Thank you for having me.

Dr. Brufsky: 
Great. So, you know, I guess the question is, we have these randomized clinical trials, and how do we really use them in everyday clinic decision-making? I mean, do you use it to help you out?

Dr. Gallagher: 
Well, you know, that's been what we've always had to use. But it's, you know, we're limited by, you know, our patients sitting in front of us wouldn't have qualified, whether they have comorbidities or they're taking medications that would have excluded them or their age or something with their performance status. But the person in front of you, you know, has metastatic breast cancer and is, you think, a candidate for a CDK4/6 inhibitor.

And what can we learn outside of clinical trials? I think the value in real-world datasets is, you know, we're closing some of those gaps because we're seeing real-world practice patterns and potentially seeing patients that have real-world medical problems like the patient sitting in front of us.

And as I’ll say an example of the P-REALITY X study where they compared palbociclib and an aromatase inhibitor to an aromatase inhibitor for metastatic breast cancer where they looked at the Flatiron database and had almost 3,000 patients, you know, when they did the evaluation of real-world progression-free survival and overall survival, you know, it was far exceeded, you know, the aromatase inhibitor by itself with the use of palbociclib. And then when you look at some of, you know, the patients that were enrolled, they were older, they had a lot of visceral disease, you know, and presumably more comorbidities.

So, I think, you know, having that little bit of information to sort of complement what you know from the real - randomized clinical trial, helps inform your conversation so you can sort of have a little more confidence, you know, in recommending something to your patient, where they may not have been a good candidate for the randomized clinical trial.

Dr. Brufsky: 
Yeah, and it really comes down to the patient in front of you. I mean, that's really what this is about, you know, I think that it's a doc making the decision about the individual patient in front of them. And we use all sorts of data. I mean, I think that, you know, again, in the days before randomized clinical trials, so say 40-50 years ago, and going beyond that, and even before that, I think that, you know, we would see a series of patients and we'd have, you know, maybe we would read a textbook or two potentially, to see if our patients like it, or go to the literature, whatever literature there was, but really use our clinical experience to tell us what to do. I think we still do that. I think at the end of the day, it's our clinical experience, our own internal real-world data that we use. And I think we use a lot of what happens, you know, both in randomized clinical trials, as well as the evidence that we've seen from real-world evidence to kind of really integrate that all into our practice.

I mean, we'll all go to ASCO, for example. And we'll see, you know, wow, this is practice changing. You know, you'll see a trial at the Presidential Session, you know, at the Plenary Session, or one of the oral sessions in breast cancer, and you'll go, you know, and everybody afterwards will go, ‘This is a practice-changing trial,’ and you go, okay, I'm going to try it in my practice. And then you go, and you go, wait a minute, you know, the patients in my practice weren't quite like that. You know, you know, the BMI of my patients is like 35, you know, where a BMI had to be under 30, or something like that. And I think that - or I have a lot of underserved African American patients in my population. Whereas, you know, I think some of these clinical trials maybe only had 2 or 3% in the trial. Or I have a lot of Asian patients in my population, you know, how these drugs work in an Asian population?

And I think the nice thing about real-world data is that it helps us; it kind of helps us in at least confirm our own experience. And it helps us when we try to use this in that individual patient. Maybe if we don't treat a lot of African American patients, but we happen to have one in front of us right then, we at least have some data that gives us comfort as to what we can do at that point in time.

And I think that's how I use it in my practice. I don't know if you have any thoughts on it?

Dr. Gallagher: 
No, I firmly agree. I take care of a lot of minority patients that, you know, are not typically included in clinical trials, you know. And I think seeing real-world data is very helpful because when only 2 or 3 or 4% of, you know, a certain type of patient is represented in a trial and you have to care for them, I think real-world data, especially when it looks at specific populations, is very reassuring to you as the physician and in having that conversation with the patient.

Dr. Brufsky: 
So again, I think at the end of the day, just to wrap everything up, it's the patient in front of you and it's data that gives you comfort in treating that patient, whether it's a randomized clinical trial or real-world evidence. I think real-world evidence really fills out those gaps and gives us confidence.

And so, you know, thank you all for listening to us. And again, thank you very much, Dr. Gallagher, for participating.

Dr. Gallagher: 
Great. Thanks. It was great to be part of this and I appreciate everyone listening as well.

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