Guillermo Garcia-Manero, MD
When envisioning the future treatment paradigms for myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML), researchers predict that hypomethylating agents, immunotherapies, and multikinase and BCL-2 inhibitors are just a few examples of what the field can expect in the coming years.
Guillermo Garcia-Manero, MD, lectured on current and likely future treatment strategies in MDS and AML during the 2016 OncLive
State of the Science Summit on Treatment of Hematologic Malignancies.
“I’m excited to be here and there is a lot of progress that is happening in both MDS and AML,” explains Garcia-Manero. “Over the next few years, we are actually going to start making a major impact on the lives and outcomes of our patients. [I focused on] where the research is going, what are the most important clinical trials that we have for our patients, and some other interventions that are quite innovative for the care of patients with MDS and AML.”
In an interview with OncLive
, Garcia-Manero, MD, professor of Medicine, chief, Section of Myelodysplastic Syndromes, in the Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discussed classification of MDS and AML, ongoing trials with the potential to impact management of these diseases, and ensuring research and treatment breakthroughs are translated to community practice.
OncLive: Please discuss the key points of your presentation.
: I discussed how we classify patients with myelodysplastic syndromes and not from typical standard classifications, but from more functional type of models. We talked about this concept of potential prevention strategies for patients with therapy-related myeloid leukemia. There is a discovery where we can, in a way, predict who may or may not be at risk for developing leukemia after being treated for a solid tumor. This is a major discovery that I think is going to have quite a bit of implication for the future.
I went through different therapeutic strategies for patients with low-risk MDS and high-risk MDS. Particularly, we are very interested in these patients who have failed on a hypomethylating agent. This is a difficult subset of patients. They have a different natural history, and we’re trying to develop new treatments for these patients.
There are also drugs that I see in common with MDS and AML. As I mentioned earlier, the use of BCL-2 inhibitors is going to be very important in combinations with second-generation hypomethylating agents, such as SGI-110 (guadecitabine) or CC-486 (oral azacitidine).
What are the ongoing clinical trials in this space?
First of all, we are talking about 2 different diseases—myelodysplastic syndromes (MDS) and acute myelogenous leukemia (AML). I focused more on MDS because it’s my primary area of interest. We divide this disease into low-risk and high-risk categories, and then we have a number of clinical trials for both patients who present with either high- or low-risk de novo, and patients who have actually been treated with these hypomethylating agents.
What are some of the main challenges in MDS that you would like to see addressed?
The main challenge is that, of course, it’s not a rare disease but it’s not the most common disease either. We have learned over the years that the disease at the molecular level is highly heterogeneous. The challenge is going to be how to basically get new drugs approved for small subsets of patients. The FDA is starting to think about treatments as not just for MDS in general, now that we are going into the times of targeted interventions and these types of approaches. What types of guidelines do we need to approve new compounds for our patients? The traditional dogma of a big survival-based randomized trial is not possible for some of these particular groups of patients.