Michele Nadeem-Baker: This is OBR. I’m Michele Nadeem-Baker, and we are at ASH, the American Society of Hematology Annual Conference. And I have with me Dr. Anand Jillella from the Georgia Cancer Center at Augusta University. Thank you so much for joining us, doctor.
Anand Jillella, MD: Thank you for having me.
Nadeem-Baker: So the trial that you have led has such exciting, exciting results. You presented data from the ECOG-ACRIN EA9131 trial on APL. Can you tell us about this?
Dr. Jillella: Okay, APL, or what is called acute promyelocytic leukemia is a very aggressive but highly curable leukemia. About 95% to 98% of patients with this disease are cured in clinical trials. However, in clinical trials, the patients are young and don’t have any health issues, but that’s not the case in the real world because patients are older and they might have other health conditions. So a third of the patients die during the first month after they’re diagnosed, but if they survive the first month, they’re cured and go back to living a normal life after that. So the purpose of this trial was to decrease the death during the first month, or what is called early deaths. And the purpose of the trial was to decrease the death rate from an estimated 30% to less than 15%.
Nadeem-Baker: That’s a high goal. And?
Dr. Jillella: Yeah. So actually, we did a pilot trial on this prior to the ECOG-ACRIN EA9131 trial at the Medical College of Georgia. We recognized this as a problem way back in 2009. Thirty-seven of our patients died during the first month, which was very frustrating to us. So we critically analyzed these patients. We looked at patients who survived and, more importantly, looked at patients who died. And we came up with a plan to decrease early deaths.
There were two things that we did. One was we recognized that there was no written algorithm or an operating procedure. So we wrote a standardized procedure, which was very simple and just two pages. It’s a rare disease. And the second thing that we did was we set up a panel of four experts that the community oncologist could call 24/7. So if there was a patient with APL in a small community hospital, they could call one of the experts, the expert and the community oncologist would discuss the patient, they would come up with a treatment plan, the patient would be treated in the community hospital.
But there was ongoing communication between the expert and the treating physician during the first month, during which most of the deaths took place. So we treated 120 patients in that pilot trial, and we decreased the death rate from an estimated 30% to 8.5%. So then we went to the next step where we presented this concept with the National Cancer Institute, and they sponsored the trial and the concept was pretty much the same. We used the same algorithm, and we set up seven experts who were available 24/7, and all patients were included. Whether they were old or had other health issues, there was absolutely no exclusion criteria. We enrolled patients in 43 centers, and out of 200 patients that we treated, only seven patients died, which was a death rate of 3.5%.
Nadeem-Baker: That is outstanding. I don’t know if I’ve ever seen results that drastic.
Dr. Jillella: I think yes. I think most of the investigators plus the participants who worked with us from small community hospitals, were very surprised at the outcome.
Nadeem-Baker: Given that access to APL experts is key to the results, how can community physicians work with these findings?
Dr. Jillella: So I think the next step would be what do we do with this information? There is actually a group from Latin America that also used a similar concept and showed that you could decrease early deaths tremendously. They decreased it from 30% to about 15%. So we have to find a way to scale this. We have to find a way to create a consortium of experts that will be available 24/7 nationwide. So that would be the next step. And so we are looking at how best to do that going forward.
Nadeem-Baker: Is more data required or is it just more that you need to somehow have everyone work collaboratively?
Dr. Jillella: Well, in my opinion, I don't think you need any more data. I think at least there are two groups that have unanimously proved this. Now we have to find a system to come up with a strategy to do this. And then secondly, we need to find the means to do this. It will take resources. So that’s the other thing that we would have to start thinking about. So we discussed this at the ECOG-ACRIN meeting, so that would be the next step. The concept definitely is proven. Now the question is how do you scale this and how do you make this a sustainable model?
Nadeem-Baker: Were there any other important APL abstracts that were presented at ASH?
Dr. Jillella: No. Actually, it’s such a curable disease right now, there’s hardly any research being done on this disease. It’s basically everything is done in this disease; 98% of patients are cured. Only 1% or 2% of patients relapse. The treatments are so stellar, but everybody understands that death during the first month is the biggest reason for failure in this disease. So that’s what we did. We fixed that problem.
Nadeem-Baker: And that's why being in touch with the experts that know what to do…
Dr. Jillella: I think it’s key. I think one is, you have to use the operating procedure or the algorithm, but just that is not going to be enough because there were two interventions. We used the algorithm and we also made an expert available 24/7. And I think both of them are equally important. So you have to have somebody who has more experience in taking care of this disease. To give you an idea, it’s a rare disease, but highly curable. There are 3,000 patients a year, but there are 15,000 oncologists in the U.S. who treat them. So you’d have one patient per every five oncologists per year. So you could see a patient now and you’re not going to see one for another 10 years. And the sad part is the disease is so aggressive that you could make one small mistake and it could result in the demise of the patient. So I think that is where the expertise comes.
Nadeem-Baker: Well, this has been great to learn all your information and now for the next step for the strategy and being able to have the resources to put it to you so that every patient who has APL can be part of those who are cured of it.
Dr. Jillella: That would be my hope.
