(Press-News.org) Results from the NRG Oncology RTOG 0631 clinical trial comparing stereotactic vs. conventional radiotherapy for localized vertebral metastases of the spine did not meet its primary endpoint. Data from the study suggests that radiosurgery was not considered superior in terms of pain responses at 3 months following treatment, and even displayed worse pain response, than the conventional external beam radiotherapy (cEBRT). These results were recently published in the JAMA Oncology.
cEBRT is currently the standard of care for treating spinal metastases because of its efficacy, but pain relief for patients who received this treatment was approximately 50-60% and only lasted for a median duration of four months. Due to the advancements in Stereotactic radiosurgery (SRS) techniques, NRG-RTOG 0631 sought to determine whether this approach lessened pain or extended the time with pain relief for patients on the trial. SRS has previously demonstrated safety and feasibility for treating patients with 1 to 3 sites of vertebral metastases in the Phase II portion of NRG-RTOG 0631. Phase III was designed to assess patient-reported pain relief at 3 months and treatment safety in the long-term follow-up of the trial.
Patients with 1 to 3 vertebral metastases enrolled onto NRG-RTOG 0631 were randomly assigned to receive either SRS or cEBRT. Patients on the SRS arm received a single dose 16 or 18 Gy delivered to the involved vertebral level or levels only, not including any additional spine levels, and patients on the cEBRT arm were treated with 8 Gy delivered to the involved vertebra plus one additional vertebra above and below. The primary endpoint was patient-reported pain response defined as greater than or equal to a 3-point improvement on the Numerical Rating Pain Scale (NRPS) without worsening pain at the secondary site or the use of pain medication at 3 months.
Secondary endpoints of this trial included long-term pain control, toxicity, quality of life, and long-term effects on vertebral bone and spinal cord.
The NRG-RTOG 0631 baseline mean pain score +/- standard deviation at the index vertebra was 6.06±2.61 in the SRS arm and 5.88±2.41 in the cEBRT arm. Pain response at 3 months favored the cEBRT arm (41.3% for SRS vs. 60.5% for cEBRT; difference=-19 percentage points, 95% confidence interval [CI]: -32.9, -5.5, one-sided p=0.99, two-sided p=0.01). Zubrod score was a significant factor influencing pain response. There were no differences in the proportion of acute or late adverse effects. Vertebral compression fractures at 24 months were19.5% with SRS and 21.6% with cEBRT (p=0.59). There were no spinal cord complications reported at 24 months.
“It is important to note that NRG-RTOG 0631 is the first phase II/III multicenter trial assessing the safety and efficacy of SRS for the treatment of vertebral metastases,” stated Samuel Ryu, MD, of the Stony Brook University Medical Center and the lead author of the NRG-RTOG 0631 manuscript. “The data collected from this trial could also inform future trials, especially those assessing SRS for epidural tumor decompression, spinal cord compression, and treating oligometastases where durable local tumor control improves survival.”
This project was supported by grants UG1CA189867 (NCORP) and the Division of Cancer Prevention from the National Cancer Institute (NCI).
Citation
Ryu S, Deshmukh S, Timmerman RD, et al. Stereotactic Radiosurgery vs Conventional Radiotherapy for Localized Vertebral Metastases of the Spine: Phase 3 Results of NRG Oncology/RTOG 0631 Randomized Clinical Trial. JAMA Oncol. Published online April 20, 2023. doi:10.1001/jamaoncol.2023.0356
About NRG Oncology
NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of patients with cancer. Founded in 2012, NRG Oncology is a Pennsylvania-based nonprofit corporation that integrates the research of the legacy National Surgical Adjuvant Breast and Bowel Project (NSABP), Radiation Therapy Oncology Group (RTOG), and Gynecologic Oncology Group (GOG) programs. The research network seeks to carry out clinical trials with emphases on gender-specific malignancies, including gynecologic, breast, and prostate cancers, and on localized or locally advanced cancers of all types. NRG Oncology’s extensive research organization comprises multidisciplinary investigators, including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians, and encompasses more than 1,300 research sites located world-wide with predominance in the United States and Canada. NRG Oncology is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI’s National Clinical Trials Network.
END
NRG Oncology study results confirm conventional external beam radiotherapy should remain standard of care in treating localized vertebral metastases of the spine
2023-04-27
ELSE PRESS RELEASES FROM THIS DATE:
Being hospitalized with acute kidney injury may increase risk for rehospitalization and death
2023-04-27
A study supported by the National Institutes of Health found that people who experienced acute kidney injury (AKI) during a hospitalization, including those admitted with AKI or who developed AKI in the hospital, were more likely to revisit the hospital or die shortly after discharge, compared to people hospitalized without AKI. AKI is a sudden loss of kidney function that usually lasts for a short time. The research, funded by NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), was ...
Inflammation and cancer: Identifying the role of copper paves the way for new therapeutic applications
2023-04-27
Inflammation is a complex biological process that can eradicate pathogens and promotes repair of damaged tissues. However, deregulation of the immune system can lead to uncontrolled inflammation and produce lesions instead. Inflammation is also involved in cancer. The molecular mechanisms underlying inflammation are not fully understood, and so developing new drugs represents a significant challenge.
As far back as 2020, Dr. Raphaël Rodriguez, CNRS research director and head of the Chemical Biology team at Institut Curie (Equipe ...
Newly developed hydrogel nanocomposite for the mass production of hydrogen
2023-04-27
A research team led by Prof. HYEON Taeghwan at the Center for Nanoparticle Research within the Institute for Basic Science (IBS) in Seoul, South Korea has developed a new photocatalytic platform for the mass production of hydrogen. The group’s study on the photocatalytic platform led to the development of a floatable photocatalytic matrix, which allows efficient hydrogen evolution reaction with clear advantages over conventional hydrogen production platforms such as film or panel types.
The importance of alternative energy has recently increased due to global challenges such as environmental ...
New study may advance use of spinal cord stimulation for chemotherapy-related pain and cancer treatment
2023-04-27
FOR IMMEDIATE RELEASE
Researchers at Johns Hopkins University School of Medicine say they have evidence from a new study in rats that spinal cord stimulation (SCS) may be useful in reducing chronic pain in people undergoing active treatment with a common anti-cancer drug.
The study found that the use of SCS measurably reduced pain response in rats that were implanted with human lung cancer tissue — without compromising effectiveness of treatment with paclitaxel, a drug used to treat a variety of cancers.
The study, published April 11 in Neuromodulation: Technology at the Neural ...
Mandatory vs recommendation: Norway assessed mobility during times of mandatory and non-mandatory COVID-19 measures
2023-04-27
Norway, like other Nordic countries, widely utilised non-mandatory advice during the COVID-19 pandemic in the attempt to reduce social contacts among people and occasionally turned to obligatory measures, specifically during peaks in transmission. In comparison with stricter interventions, non-mandatory measures are usually less invasive and costly and have been recommended in previous pandemics, including influenza.
Mobile phone data provides mobility metrics
In their research article published in Eurosurveillance today, Kamineni et al. compare the impact on mobility when previously non-mandatory ...
US should begin laying the foundation for new and advanced nuclear reactors, says new report
2023-04-27
WASHINGTON — New and advanced types of nuclear reactors could play an important role in helping the U.S. meet its long-term climate goals, but a range of technical, regulatory, economic, and societal challenges must first be overcome, says a new report from the National Academies of Sciences, Engineering, and Medicine. Development, testing, and widespread deployment of these reactors could take several decades. The report makes recommendations for the U.S. Department of Energy, the Nuclear Regulatory Commission, other federal and state agencies, and private industry to lay the groundwork required for advanced reactors to become a viable part of the U.S. energy system.
Currently, ...
Chinese medicine herb may have the power to help heart attack patients
2023-04-27
A plant-based compound purified from the traditional Chinese herb, Astragalus, has the potential to improve the outcome of heart attack patients, new research has revealed.
Experts at Newcastle University, UK, have found that the product, known as TA-65®, significantly reduces inflammation and, unlike current cardiovascular treatments, does not negatively impact immunity.
A study, published in GeroScience, showed that when TA-65® was given to older patients for over a year after their heart attack, it specifically increased lymphocytes, improving immunity ...
At least one in three family members of those with serious mental illness feel stigmatized
2023-04-27
TORONTO, April 27, 2023 – Families of those with serious mental health issues feel stigmatized and alone, say York University researchers in a new study.
“We are avoided. When we told our family, they shut us out, I am so hurt, and so angry” – 62-year-old mom with an adult son with serious mental illness, as described to York researchers.
It’s well known that those who have serious mental illnesses such as schizophrenia face a great deal of stigma in society, but what has been less understood is the concept of “stigma by ...
Researchers solve ancient mystery of Maya calendar
2023-04-27
The 819-day calendar used by ancient Mayans has long stumped researchers, but anthropologists from Tulane University may have finally deciphered its secrets.
Researchers long suspected the calendar followed astronomical events, specifically how long it takes a planet to appear in the same place in the night sky as seen from Earth, known as the synodic periods of planets. But, according to the study published in Ancient Mesoamerica, the cycles in the Maya calendar cover a much larger timeframe than scholars previously thought.
“Although prior research has sought to show planetary connections for the 819-day count, its four-part, color-directional scheme is too short to fit well with ...
A versatile deep-learning model for accurate prediction of plant growth
2023-04-27
Crop yield can be maximized when the best genetic variety and most effective crop management practices are used for cultivation. Scientists have developed various machine learning models to predict the factors that produce the greatest yield in specific crop plants. However, traditional models cannot accommodate high levels of variation in parameters or large data inputs. This can lead to the failure of models under certain circumstances. Also, since crop models are restricted to the types of input they can accommodate, ...