(Press-News.org) Patients with acute myeloid leukemia (AML), the most common form of acute leukemia in adults, that has gone into remission following initial chemotherapy remain in remission longer and have improved overall survival when they are given a pill form of the cancer drug azacitidine as a maintenance treatment, according to a randomized, international phase 3 clinical trial for which Weill Cornell Medicine and NewYork-Presbyterian are trial sites. This is the first time a maintenance treatment for AML has shown such a strong benefit for patients, and it is already being adopted as part of standard care.
The results, which were published Dec. 24 in the New England Journal of Medicine, led to the U.S. Food and Drug Administration's approval in September 2020 of oral azacitidine, known by the trade name Onureg, as a maintenance therapy for AML.
"At last, we have an effective treatment that can be given in the post-remission setting to help keep AML patients in remission and improve their survival," said senior author Dr. Gail Roboz, professor of medicine in the Division of Hematology and Medical Oncology and director of the Clinical and Translational Leukemia Program at Weill Cornell Medicine, a hematologist/oncologist at NewYork-Presbyterian/Weill Cornell Medical Center and principal investigator of the clinical trial at Weill Cornell Medicine and NewYork-Presbyterian. "We are especially gratified that the drug is very well-tolerated, so that quality of life is not compromised."
AML is a devastating, life-threatening hematological cancer. According to the National Cancer Institute, AML strikes about 20,000 people per year in the United States, and kills more than 11,000. It mainly affects middle-aged and older adults. The five-year survival rate is about 30 percent overall, but only about 10 percent for patients older than 65. Patients with AML frequently relapse, even after achieving complete remission with initial chemotherapy.
The randomized phase 3 clinical trial of 472 patients from 148 medical centers around the world, known as the QUAZAR AML-001 Trial, tested whether relapse could be delayed using oral azacitidine as a maintenance therapy. The investigators found that patients taking 300 mg of the drug for two weeks every month had statistically and clinically significant improvements in relapse-free survival (RFS) and overall survival (OS). Median RFS and OS were, respectively, 10.2 months and 24.7 months with oral azacitidine, versus only 4.8 and 14.8 months for patients taking placebo. Two years from the start of the maintenance treatment, 50.6 percent of the azacitidine patients had survived, compared with 37.1 percent of the placebo patients. Side effects were moderate and manageable.
Azacitidine is thought to work principally as a "hypomethylating" drug that removes chemical marks called methyl groups from DNA in cells. Methyl groups regulate gene activity, usually by silencing nearby genes, and removal of methyl groups is thought to restore activity of tumor suppressor genes that counter cancerous cell proliferation.
Side effects with oral azacitidine that were somewhat more common in the treatment group included vomiting, low white blood cell counts, and infections, but these were generally considered manageable and did not result in treatment discontinuation. QUAZAR was the first large international AML maintenance trial to systematically assess quality of life throughout the trial, and patients in the treatment and placebo groups scored similarly on quality of life-related measures, demonstrating the tolerability of oral azacitidine.
Dr. Roboz, who is also a member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and a paid consultant for Celgene and Bristol Myers-Squibb, sponsors of the research, notes that some patients taking the new maintenance therapy have survived for many years.
"One of my patients on the trial was so critically ill when she was initially diagnosed that she was told to get her affairs in order, but her AML was put into remission, and she has been receiving oral azacitidine maintenance therapy as part of the QUAZAR trial since 2013," Dr. Roboz said.
INFORMATION:
Many college students fully recover from infectious mononucleosis (which is almost always caused by Epstein-Barr virus) within 1-6 weeks, but some go on to develop chronic fatigue syndrome, also called myalgic encephalomyelitis (ME/CFS). A longitudinal study from DePaul University and Northwestern University followed 4,501 college students to examine risk factors that may trigger longer illness. The research appears in the journal Clinical Infectious Diseases and was funded by the National Institute of Allergy and Infectious Diseases.
Previous retrospective studies found that risk factors ...
By 2050, most people on Earth will live downstream of tens of thousands of large dams built in the 20th century, many of them already operating at or beyond their design life, according to a UN University analysis.
The report, "Ageing water infrastructure: An emerging global risk," by UNU's Canadian-based Institute for Water, Environment and Health, says most of the 58,700 large dams worldwide were constructed between 1930 and 1970 with a design life of 50 to 100 years, adding that at 50 years a large concrete dam "would most probably begin to express signs of aging."
Ageing ...
The tracking of eye movement is one of the key elements of virtual and amplified reality technologies (VR/AR). A team from MSU together with a professor from RUDN University developed a mathematical model that helps accurately predict the next gaze fixation point and reduces the inaccuracy caused by blinking. The model would make VR/AR systems more realistic and sensitive to user actions. The results of the study were published in the SID Symposium Digest of Technical Papers.
Foveated rendering is a basic technology of VR systems. When a person looks at something, their gaze is focused on the so-called foveated region, and everything else is covered by peripheral vision. Therefore, a computer has to render the images in the ...
Becoming a parent often brings great joy, but not always. Parenthood also entails challenges, stress and, for some people, it can trigger depression. A new study from Lund University in Sweden shows that male postnatal depression is more common in men who are insecure in their relationship with their partner.
Depression affects around 10-12 per cent of new mothers, and at least 8 per cent of new fathers. The figures are even higher when looking at depressive symptoms; as many as one in five new fathers experience troublesome symptoms, according to the new study conducted by Elia Psouni, registered psychologist and associate professor of ...
Most lung cancers are of a type called non-small-cell lung carcinoma (NSCLC). This type of cancer is relatively insensitive to chemotherapy, so NSCLC therapies are usually based on drug treatment. Alectinib is a drug commonly used for treating patients with NSCLC. It addresses a gene rearrangement known as ALK that occurs in 3 to 5% of NSCLC patients (alectinib belongs to a class of drugs called ALK tyrosine kinase inhibitors). It has been unclear, however, whether there is a correlation between the use of alectinib and the poorer prognosis in ALK-NSCLC patients in which secondary cancer mutations ...
Metals such as gold or platinum are often used as catalysts. In the catalytic converters of vehicles, for example, platinum nanoparticles convert poisonous carbon monoxide into non-toxic CO2. Because platinum and other catalytically active metals are expensive and rare, the nanoparticles involved have been made smaller and smaller over time.
"Single-atom" catalysts are the logical end point of this downsizing: The metal is no longer present as particles, but as individual atoms that are anchored on the surface of a cheaper support material. Individual atoms can no longer be described using the rules developed from larger pieces of metal, so the rules used to predict which metals will ...
Normal ageing causes disruptions in the brain that can lead to cognitive decline. Resting-state functional magnetic resonance imaging studies have found significant age-related alterations in functional connectivity across various networks. However, most of the studies have focused primarily on static functional connectivity.
The authors of a recent study published in Cerebral Cortex based their research on the idea that studying the dynamics of resting-state brain activity across the whole-brain functional network can provide a better characterization of age-related changes.
The study was led by Gustavo Deco, director of the Center for Brain and Cognition (CBC) and ICREA research professor at the UPF Department of Information and Communication Technologies (DTIC), and Anira ...
Chimpanzees, one of the closest relatives of humans, cooperate on a group level - in combative disputes, they even cooperate with group members to whom they are not related. Those involved in fights with neighbouring groups put themselves at risk of serious injury or even death.
Within the context of the Tai Chimpanzee Project researchers observed three chimpanzee communities in Tai National Park in Cote d'Ivoire documenting social relationships, territory range and intergroup encounters amongst others. "We have been able to analyze almost 500 vocal and physical battles from the last 25 years with participation of at least one ...
Good news for the green transition: Flowery diets help predatory insects help farmers keep pests in check
Predatory insects have been shown to live longer when they have access to nectar and pollen, according to a new study by researchers at the University of Copenhagen. Thus, flowers don't just benefit insects, they help farmers farm sustainably. Predatory insects are skilled pest controllers whose hunting reduces the need for agricultural pesticides.
Until now, it was believed that predatory insects needed prey to survive. But in a systematic review conducted at the University ...
Researchers in WMG at the University of Warwick, in collaboration with Imperial College London, have found a way to enhance hybrid flow batteries and their commercial use. The new approach can store electricity in these batteries for very long durations for about a fifth the price of current technologies, with minimal location restraints and zero emissions.
The researchers enhanced three hybrid flow cells using nitrogen doped graphene (exposed to nitrogen plasma) in a binder-free electrophoresis technique (EPD).
Wind and solar power are increasingly popular sources for renewable energy. Unfortunately, intermittency issues keep them ...
