New Drug Makes AML Maintenance Therapy Possible
- In a study, azacitidine (Onureg) improved overall survival and relapse-free survival in people ages 55 and older with AML who were in complete remission.
- In September 2020, the FDA approved Onureg for the maintenance treatment of people with AML who had achieved a complete remission after initial chemotherapy and were not able to get a stem cell transplant.
- This is the first time a maintenance therapy has shown a significant survival benefit for patients with AML.
“Since the introduction of 7+3 induction chemotherapy in 1973, very few treatments in AML have increased overall survival,” Dr. Aaron Gerds, a Cleveland Clinic hematologist who treats patients with AML, tells SurvivorNet. That’s one of the reasons why this new maintenance treatment is such a significant advancement.
Read MoreThen they'll typically get more chemo called consolidation therapy to kill any cancer cells that remain. After that, disease management either involves observation or an allogeneic stem cell transplant which can cure the disease, but isn't realistic for everyone.
The Search for an Effective Maintenance Therapy
A number of studies have tested out different drugs for AML maintenance therapy a treatment that is meant to prevent the cancer from relapsing and extend survival. Until now, there has been very little success with these drugs. "The AML community has been trying to validate the role of maintenance therapies to extend initial treatment responses for many decades and until now without success," Dr. Andrew H. Wei of the Alfred Hospital in Melbourne, Australia, said in a news release.
But the QUAZAR study, published this past December in The New England Journal of Medicine, found that the drug azacitidine (Onureg) improved both overall survival and relapse-free survival in people ages 55 and older who were in complete remission. "Median survival was improved by 9.9 months, from 14.8 months in the placebo arm, to 24.7 months in the oral azacitidine arm," Dr. Gail Roboz, director of the Clinical and Translational Leukemia Programs at Weill Cornell Medicine and NewYork-Presbyterian, and co-author of the study, tells SurvivorNet.
Related: Acute Myeloid Leukemia (AML) What Are The Symptoms?
This was the first time a maintenance treatment for AML has benefitted patients this significantly. "From the point of view of everyday practice, the improvement in relapse-free survival is important," Dr. Gerds says. He adds that not everyone who may benefit from a potentially curative stem cell transplant is able to get one. “Anything we can do in that setting to delay, or even reduce relapse is certainly welcomed."
In September, the FDA approved Onureg for the maintenance treatment of people with AML who had achieved a complete remission after initial induction chemotherapy, with or without recovery of their blood cell counts.
The drug is already being incorporated into AML care at cancer hospitals around the country. "Oral azacitidine is now considered the standard of care for patients over 55 years old who have been treated with intensive induction chemotherapy, but who aren't eligible for allogeneic stem cell transplantation," Dr. Roboz says.
Why knowing your risk group is important to AML treatment
"Rather than observing patients and waiting for them to relapse, we can now actively engage in trying to reduce relapse risk and improve survival in the post-remission phase," Dr. Wei says.
How This Treatment Works
Onureg is a type of drug called a nucleoside metabolic inhibitor. It's part of a group of drugs that slow the growth of cancer cells, which ultimately leads to their death.
Related: What Are The Options For Patients When Acute Myeloid Leukemia (AML) Returns?
You take Onureg as a pill once a day for two weeks. Then you take a two-week break from treatment.
What are the Side Effects?
Patients generally tolerate Onureg well, says Dr. Roboz. "There can be some gastrointestinal side effects and patients will also need to have their blood counts monitored, but these are all usually easily managed."
Related: Advancements in Treating Acute Myeloid Leukemia (AML)
The most common side effects from this drug are:
- Nausea and vomiting
- Diarrhea
- Tiredness and weakness
- Constipation
- Belly pain
- Pneumonia
- Joint pain
- A low white blood cell count
Anti-nausea medicine and other treatments from your doctor can help to minimize these side effects.
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