(Press-News.org) Both radiation and temozolomide, a generic chemotherapy treatment in pill form, have meaningful single-modality anti-tumor activity against slow-growing, low-grade gliomas. The randomized phase 3 trial E3F05 by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) tested whether combined therapy using temozolomide alongside radiation therapy is more effective than radiation therapy alone in these patients. The trial followed 172 patients for more than 10 years, and its results have an immediate clinical impact by providing the first evidence from a randomized phase 3 trial that temozolomide improves long-term survival for these patients.
“We found that the 10-year survival rate was 70% with the combined treatment with temozolomide chemotherapy and radiation, compared to 47% with radiation alone as the initial approach. This discovery is important because until now, we have not had compelling evidence that temozolomide improves overall survival in grade 2 gliomas,” said lead investigator David Schiff, MD, the Harrison Distinguished Professor of Neurology, Neurological Surgery and Medicine and co-director of the UVA Neuro-Oncology Center at the University of Virginia.
Dr. Schiff presented the striking results as a late-breaking abstract at the Society of Neuro-Oncology’s 2024 SNO Annual Meeting. The trial was funded by the US National Institutes of Health’s National Cancer Institute through its National Clinical Trials Network (NCTN).
The E3F05 trial started in September 2009 and enrolled patients with low-grade gliomas who had not received prior radiation or chemotherapy treatment. Trial participants were randomized 1:1 to receive either radiation alone (50.4 Gy in 28 fractions) or radiation (50.4 Gy) with temozolomide followed by 12 four-week cycles of post-radiation temozolomide).
Accrual stopped five years later, in 2014, after another cooperative group trial, RTOG 9802 (also funded by the NCI) reported benefit from the addition of PCV chemotherapy to radiation in grade 2 gliomas. PCV is procarbazine (P), CCNU (C), which generically is known as lomustine, and vincristine (V). By the time accrual stopped, 172 patients had enrolled in E3F05. The median age of the 172 participants was 44 (range 19-78), and 54% were male.
“Because the RTOG 9802 trial was positive for a benefit from PCV chemotherapy, it was no longer ethical to have a radiation-alone arm in E3F05, which is why our trial was closed to accrual. Even though we could not enroll the entire group as planned, after following all patients on the trial, results reached statistical significance showing the benefit of combined-modality temozolomide versus radiation alone,” said Dr. Schiff.
The results of this trial will have an immediate clinical impact.
“Since the results of RTOG 9802 came out in 2014, patients with grade 2 glioma are routinely receiving radiation plus chemotherapy. Some are getting PCV because that is what RTOG showed was beneficial. Others are getting radiation plus temozolomide because temozolomide is a lot easier for the oncologist to give and a lot less toxic for patients to take, and it doesn’t involve an intravenous infusion of vincristine. But until now, there really was no supporting evidence in grade 2 gliomas that temozolomide was beneficial,” said Dr. Schiff.
While grade 3 or higher toxicity was more common in E3F05 trial participants treated with temozolomide compared to radiation, toxicity was consistent with prior studies of temozolomide.
“There were no unexpected toxicities from the addition of temozolomide,” said Dr. Schiff. “We saw more fatigue, gastrointestinal distress (nausea), and myelosuppression (thrombocytopenia, neutropenia, etc.) but very similar to what has been reported many, many times.”
He added, “Importantly, the magnitude of survival benefit from the addition of temozolomide was similar in oligodendrogliomas and astrocytomas. This finding stands in contrast to some uncontrolled and retrospective studies suggesting that temozolomide may be significantly less effective against oligodendrogliomas than PCV.”
There is more to come from E3F05. Pending correlative studies are investigating the quality of life and neurocognitive data collected from patients on both arms of the study, as well as additional molecular analyses.
Abstract LTBK-07 is publicly available (Schiff D. Neuro-Oncology. November 2024). The ClinicalTrials.gov record for E3F05 is NCT00978458.
About ECOG-ACRIN
The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is a membership-based scientific organization known for advancing precision medicine and biomarker research through its leadership of major national clinical trials that integrate cutting-edge genomic approaches. Nearly 21,000 member researchers and advocates from approximately 1,400 academic medical centers and community hospitals collaborate across over 40 scientific committees to design studies spanning the cancer care spectrum, from early detection to management of advanced disease. These studies are funded primarily by the National Cancer Institute (NCI), part of the National Institutes of Health, through the National Clinical Trials Network (NCTN) and NCI Community Oncology Research Program (NCORP). To learn more, visit www.ecog-acrin.org and follow us on X/Twitter @EAonc, Facebook, LinkedIn, YouTube, and Instagram.
END
Clinical trial finds that adding the chemotherapy pill temozolomide to radiation therapy improves survival in adult patients with a slow-growing type of brain tumor
This is the first evidence from a randomized phase 3 trial that temozolomide improves survival in grade 2 gliomas. This chemotherapy pill is less toxic than other chemotherapies for this cancer. The Society of Neuro-Oncology is highlighting the discovery
2024-11-25
ELSE PRESS RELEASES FROM THIS DATE:
H.E.S.S. collaboration detects the most energetic cosmic-ray electrons and positrons ever observed
2024-11-25
The Universe teems with extreme environments, ranging from the very coldest temperatures to the highest energy sources possible. As a consequence, extreme objects such as supernova remnants, pulsars and active galactic nuclei are capable of emitting charged particles and gamma rays with incredibly high energies, so high that they exceed the energy produced by the nuclear fusion in stars by several orders of magnitude.
The gamma rays detected on Earth tell us a great deal about these sources, since they travel through space undisturbed. However, in the case of charged particles, ...
Novel supernova observations grant astronomers a peek into the cosmic past
2024-11-25
COLUMBUS, Ohio – An international team of researchers has made new observations of an unusual supernova, finding the most metal-poor stellar explosion ever observed.
This rare supernova, called 2023ufx, originated from the core collapse of a red supergiant star, exploded on the outskirts of a nearby dwarf galaxy. Results of the study showed that observations of both this supernova and the galaxy it was discovered in are of low metallicity, meaning they lack an abundance of elements heavier than hydrogen or helium.
Since the metals produced within supernovae ...
Association of severe maternal morbidity with subsequent birth
2024-11-25
About The Study: The findings of this study suggest that women who experience severe maternal morbidity in their first birth are less likely to have a subsequent birth. Adequate reproductive counseling and enhancing antenatal care are crucial for women with a history of severe maternal morbidity.
Corresponding Author: To contact the corresponding author, Eleni Tsamantioti, MD, MMedSc, email eleni.tsamantioti@ki.se.
To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/
(doi:10.1001/jama.2024.20957)
Editor’s ...
Herodotus' theory on Armenian origins debunked by first whole-genome study
2024-11-25
Armenians, a population in Western Asia historically inhabiting the Armenian highlands, were long believed to be descendants of Phrygian settlers from the Balkans. This theory originated largely from the accounts of the Greek historian Herodotus, who observed that Armenians were armed in Phrygian fashion when serving in the Persian army. Linguists further supported this theory, suggesting that the Armenian language shares ties with the Thraco-Phrygian subgroup of Indo-European languages.
But the first whole-genome study is challenging this long-held belief, revealing no significant genetic link between ...
Women who suffer pregnancy complications have fewer children
2024-11-25
Women who suffer severe complications during their first pregnancy or delivery are less inclined to have more babies, a study published in JAMA by researchers at Karolinska Institutet reports. Given the recent steady decline in birth rate in Sweden, the researchers propose monitoring in antenatal care to address the problem.
“The clinical monitoring of these women is essential, and they need individualised advice on possible future pregnancies,” says the study’s first author Eleni Tsamantioti, doctoral student at the Department of Medicine in Solna, Karolinska Institutet.
Birth rates and fertility have both been in steady decline ...
Home testing kits and coordinated outreach substantially improve colorectal cancer screening rates
2024-11-25
CHAPEL HILL, North Carolina—Colorectal cancer screening is an effective tool for catching the disease early when it's most treatable, yet it is underutilized in patient populations who receive primary care at federally qualified health centers (FQHC).
A new study by researchers at UNC Lineberger Comprehensive Cancer Center demonstrated that a targeted intervention can substantially increase screening rates in patients who are not current with recommended screening. The researchers report in JAMA Network Open that mailing at-home ...
COVID-19 vaccine reactogenicity among young children
2024-11-25
About The Study: No unexpected reactions were identified in this analysis of reactions to COVID-19 vaccines among children. Similar to this study, data from clinical trials and V-safe found that irritability was the most common systemic reaction among children ages 6 months to younger than 2 years, followed by fever and fatigue or sleepiness. In contrast to other studies observing a higher prevalence of reactions after the second COVID-19 vaccine dose, this study observed a higher prevalence after the first dose. This difference may reflect maternal vaccination; the ...
Generalizability of clinical trials of novel weight loss medications to the US adult population
2024-11-25
About The Study: This study estimates that approximately one-third of U.S. adults without diabetes who were eligible for weight loss treatment with glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GLP-1/GIP) were excluded from clinical trials supporting these medications’ safety and effectiveness. Until there is evidence from high-quality postmarketing studies, the FDA should consider updating labeling to advise caution on generalizing the safety and effectiveness of GLP-1 and GLP-1/GIP to populations excluded from pivotal trials.
Corresponding Author: To contact the corresponding author, Timothy S. Anderson, MD, MAS, email tsander@pitt.edu.
To ...
Wildfire smoke exposure and incident dementia
2024-11-25
About The Study: In this cohort study, after adjusting for measured confounders, long-term exposure to wildfire and non-wildfire fine particulate matter (PM2.5) over a 3-year period was associated with dementia diagnoses. As the climate changes, interventions focused on reducing wildfire PM2.5 exposure may reduce dementia diagnoses and related inequities.
Corresponding Author: To contact the corresponding author, Joan A. Casey, PhD, email jacasey@uw.edu.
To access the embargoed study: Visit our For ...
Health co-benefits of China's carbon neutrality policies highlighted in new review
2024-11-25
Researchers from the National Institute of Health Data Science at Peking University have conducted a comprehensive review of the health impacts of China's carbon mitigation strategies. Published in Health Data Science, this review emphasizes the significant health co-benefits of environmental policies aimed at reducing greenhouse gas emissions in China, the world's largest carbon emitter. These benefits include reducing deaths and diseases related to air pollution, particularly from PM2.5 and ozone (O3), as well as mitigating climate-related ...
LAST 30 PRESS RELEASES:
Top five rising star Texas researchers named in 2025 Edith and Peter O’Donnell Awards by TAMEST
Fast, rewritable computing with DNA origami registers
Uncovering the pigments and techniques used to paint the Berlin Wall
MD Anderson’s Lauren Averett Byers receives TAMEST O’Donnell Award for seminal contributions to lung cancer research
Chung-Ang University researchers unveil the biogenesis and role of transfer RNA fragments in cancer progression
Secret of the female orgasm uncovered by psychologists
Breakthrough in zinc-based rechargeable batteries: A safer, sustainable alternative
"Superman" bacteria offer a sustainable boost to chemical production
FunMap reveals a functional network of genes and proteins in human cancer
First full characterization of kidney microbiome unlocks potential to prevent kidney stones
IMDEA Software researchers present MixBuy, a protocol for secure and privacy-preserving digital purchases
Having a good breakfast reduces cardiovascular risk
New study reveals provincial and territorial inequities and inadequacies in access to medications and treatment for cardiovascular conditions in Canada
Pre-seed funding to recolor the world greener
New research unlocks jaw-dropping evolution of lizards and snakes
Cardiorespiratory fitness linked to preservation of cognitive abilities in older age
Around 1 in 5 of the world’s under 50s living with genital herpes (HSV)
Cutting early life exposure to parental smoking may lower MS risk in genetically prone
High-flow nasal oxygen vs noninvasive ventilation in patients with acute respiratory failure
Flexible hibernation could help hedgehogs adapt to environmental changes
What is a unit of nature? New framework shows the challenges involved with establishing a biodiversity credit market
NYCEDC and NYU Tandon launch applications for new digital game design incubator
Soda taxes don’t just affect sales. They help change people’s minds.
Early restrictive vs liberal oxygen for trauma patients
Enabling AI to explain its predictions in plain language
A greener, cleaner way to extract cobalt from ‘junk’ materials
Better environmental performance boosts profits and cuts costs
Making self-driving cars safer, less accident prone
Rethinking the quantum chip
When does waiting stop being worth it?
[Press-News.org] Clinical trial finds that adding the chemotherapy pill temozolomide to radiation therapy improves survival in adult patients with a slow-growing type of brain tumorThis is the first evidence from a randomized phase 3 trial that temozolomide improves survival in grade 2 gliomas. This chemotherapy pill is less toxic than other chemotherapies for this cancer. The Society of Neuro-Oncology is highlighting the discovery