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Role of Maintenance Therapy in AML

Panelists: Harry Erba, MD, PhD, Duke University; Jorge E. Cortes, MD, MD Anderson Cancer Center; Alexander E. Perl, MD, MS, Hospital of The University of Pennsylvania; Daniel Pollyea, MD, MS, University of Colorado, Anschutz Medical Campus; Eunice Wang, MD, Roswell Park Comprehensive Cancer Center
Published: Tuesday, Aug 13, 2019



Transcript: 

Harry Erba, MD, PhD: Besides gilteritinib and FLT3 inhibitors, any other maintenance strategies for AML [acute myeloid leukemia] in remission? You’ve finished induction, consolidation. Has anything been shown to improve outcomes there?

Jorge E. Cortes, MD: Not really. I think there’s been some hints and some suggestions that after transplant, the azacitadine data have been off and on positive.

Eunice Wang, MD: My impression of that data is a lot of times patients can’t tolerate the azacitadine, so though you do get some patients who may appear to benefit, there’s a huge number of patients who can’t tolerate it and have to go off it.

Jorge E. Cortes, MD: And that may be the difference, who does well and who can tolerate it.

Eunice Wang, MD: Right.

Daniel Pollyea, MD, MS: There will be a phase III oral azacitadine [study] in patients who achieved a remission after chemotherapy compared to I believe placebo that I think is pretty mature, and so that could help us.

Jorge E. Cortes, MD: Yes, that’s a registration study. I’m very hopeful about all these immunotherapies. There is actually an old study with this histamine analog with interleukin-2 [IL-2]. It was a positive study, it was approved actually in Europe. Nobody uses it because it’s toxic with the IL-2 and all of that, but it did improve the outcome of patients who had it. They didn’t do it by minimal residual disease, it was just a plain maintenance study. But I do think that perhaps some immune approach of that nature, kind of like blinatumomab, would be valuable. Of course, we don’t have the data. Those studies will take some time.

Harry Erba, MD, PhD: There was a recent publication of a European study looking at the role of azacitadine as a maintenance after first remission, in first remission after intensive chemotherapy. And the addition of azacitadine compared to not getting maintenance showed an improvement in relapse-free survival but not overall survival. My criticism of the study is those are patients who just got an induction.

So here they are, they’re well enough to get chemotherapy, they get induction, they’ve achieved a remission, and most patients have returned to a good functional status. And then a decision was made not to give them anything. It’s not that they got consolidation. And so it still brings me back to the question, a couple of cycles of consolidation, which many older patients can still tolerate, or prolonged maintenance with all of the issues with prolonged maintenance?

Eunice Wang, MD: Well, the CALGB [Cancer and Leukemia Group B] did that trial where they did patients at 7+3 [cytarabine and daunorubicin] and then got the high-dose cytarabine consolidation and then gave them a hypomethylating [agent] after that. And they really saw no benefit of addition of azacitadine to standard consolidation chemotherapy in terms of relapse rates.

Harry Erba, MD, PhD: Well, I think Jorge said it well with the European study with IL-2 and the histamine analog, that with a maintenance study we have to be very careful of impairing the quality of life in patients who may actually have a very limited quantity of life after achieving that remission.

Transcript Edited for Clarity

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Transcript: 

Harry Erba, MD, PhD: Besides gilteritinib and FLT3 inhibitors, any other maintenance strategies for AML [acute myeloid leukemia] in remission? You’ve finished induction, consolidation. Has anything been shown to improve outcomes there?

Jorge E. Cortes, MD: Not really. I think there’s been some hints and some suggestions that after transplant, the azacitadine data have been off and on positive.

Eunice Wang, MD: My impression of that data is a lot of times patients can’t tolerate the azacitadine, so though you do get some patients who may appear to benefit, there’s a huge number of patients who can’t tolerate it and have to go off it.

Jorge E. Cortes, MD: And that may be the difference, who does well and who can tolerate it.

Eunice Wang, MD: Right.

Daniel Pollyea, MD, MS: There will be a phase III oral azacitadine [study] in patients who achieved a remission after chemotherapy compared to I believe placebo that I think is pretty mature, and so that could help us.

Jorge E. Cortes, MD: Yes, that’s a registration study. I’m very hopeful about all these immunotherapies. There is actually an old study with this histamine analog with interleukin-2 [IL-2]. It was a positive study, it was approved actually in Europe. Nobody uses it because it’s toxic with the IL-2 and all of that, but it did improve the outcome of patients who had it. They didn’t do it by minimal residual disease, it was just a plain maintenance study. But I do think that perhaps some immune approach of that nature, kind of like blinatumomab, would be valuable. Of course, we don’t have the data. Those studies will take some time.

Harry Erba, MD, PhD: There was a recent publication of a European study looking at the role of azacitadine as a maintenance after first remission, in first remission after intensive chemotherapy. And the addition of azacitadine compared to not getting maintenance showed an improvement in relapse-free survival but not overall survival. My criticism of the study is those are patients who just got an induction.

So here they are, they’re well enough to get chemotherapy, they get induction, they’ve achieved a remission, and most patients have returned to a good functional status. And then a decision was made not to give them anything. It’s not that they got consolidation. And so it still brings me back to the question, a couple of cycles of consolidation, which many older patients can still tolerate, or prolonged maintenance with all of the issues with prolonged maintenance?

Eunice Wang, MD: Well, the CALGB [Cancer and Leukemia Group B] did that trial where they did patients at 7+3 [cytarabine and daunorubicin] and then got the high-dose cytarabine consolidation and then gave them a hypomethylating [agent] after that. And they really saw no benefit of addition of azacitadine to standard consolidation chemotherapy in terms of relapse rates.

Harry Erba, MD, PhD: Well, I think Jorge said it well with the European study with IL-2 and the histamine analog, that with a maintenance study we have to be very careful of impairing the quality of life in patients who may actually have a very limited quantity of life after achieving that remission.

Transcript Edited for Clarity
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