PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

NRG Oncology trial supports radiotherapy and cisplatin should remain the standard of care for p16+ oropharyngeal cancer

2024-09-30
(Press-News.org) The NRG Oncology NRG-HN005 phase II/III clinical trial did not meet the non-inferiority criteria to proceed to the phase III portion of the study. The phase II portion of the NRG-HN005 evaluated two experimental treatment arms against a control arm for patients with p16-positive (p16+, accepted as a surrogate for HPV+ status), locoregionally advanced oropharyngeal cancer. The interim futility results were recently reported during the Plenary Session of the American Society for Radiation Oncology Annual Meeting in Washington, DC.

“This study, despite the overall failure of the experimental arms, is extremely important as an affirmation that this group of patients achieves genuinely outstanding outcomes with traditional chemoradiation. Furthermore, as shown by the incredibly good prognosis of patients in the control arm, this study sets a new very high bar for deintensification studies in the future.” stated Sue S. Yom, MD, PhD, of the University of California San Francisco and the lead author of the NRG-HN005 abstract.

NRG-HN005 compared standard dose, slightly accelerated intensity modulated radiotherapy (IMRT) and 2 cycles of cisplatin chemotherapy given every 3 weeks to a lower dose of IMRT with the same cisplatin schedule or slightly accelerated IMRT with 6 cycles of the immunotherapy drug nivolumab given before, during, and after radiation. The control arm dose and schedule for the IMRT and cisplatin regimen stemmed from the findings in the RTOG 1016 clinical trial which deemed radiotherapy and cisplatin to be the standard of care for patients with p16-positive oropharyngeal cancer. The primary aim of the phase II portion of this study was to determine if the lower dose IMRT combined with either chemotherapy or immunotherapy would be non-inferior in progression-free survival (PFS) for this patient population when compared to the standard treatment.

The study enrolled 384 patients with p16+ oropharyngeal squamous cell carcinoma and ≤ 10 pack-years history of smoking. Following stratification by Zubrod Performance Status, patients were randomly assigned to one of three potential treatment arms. Treatment arm 1 was the control arm of 70 Gy of radiation in 6 weeks, 6 fractions per week with cisplatin every 3 weeks. Treatment arm 2 included a lower dose of radiation at 60 Gy over 6 weeks in 5 fractions per week with cisplatin. Treatment arm 3 was the lower dose of 60 Gy of radiation in 5 weeks and 6 fractions per week with nivolumab starting 1 week before radiation and given every 2 weeks.

The futility analysis for Treatments 1 and 2 was conducted at 11 PFS events which occurred with a median follow-up of 1.1 years and crossed the futility boundary. The futility analysis for Treatments 1 and 3 was triggered after 11 PFS events after the phase II portion of the trial had already completed accrual and it also crossed the futility boundary. At the present median follow up of 2.2 years, 2-year PFS estimates are 98.1% (95% CI 95.4, 100) for the control arm, 88.6% (95% CI 82.4, 94.7) for the lower dose radiation and cisplatin arm, and 90.3% (95% CI 84.5, 96.1) for the lower dose radiation and nivolumab arm. The very high 98% PFS rate at 2 years of the control arm is part of the reason for the failure of the experimental arms to satisfy non-inferiority.

This study was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and was supported by grants UG1CA189867 (NCORP), U10CA180822 (NRG Oncology SDMC), U10CA180868 (NRG Oncology Operations), U24CA180803 (IROC) from the NCI and Bristol Myers Squibb under a Cooperative Research and Development Agreement between NCI and BMS.

Special Podcast Episode

Follow The NRG Oncology Podcast on Spotify, Apple Podcasts, Audible, and YouTube for a special episode interviewing Drs. Kristin Higgins and Sue Yom on the findings of the 2024 ASTRO Plenary Session Presentations for NRG-LU005 and NRG-HN005. Podcast information is available on the NRG website as well.

Citation
Yom SS, Harris J, Caudell JJ, Geiger JL, Waldron J, Gillison M, Subramanian R, Yao M, Xiao C, Kovalchuk N, Martino R, Jordan R, Henson C, Echevarria M, Lominska C, Dorth JA, Stokes WA, Chan JW, Gensheimer MF, Le QT. (2024, September-October). Interim Futility Results of NRG-HN005, A Randomized, Phase II/III Non-Inferiority Trial for Non-Smoking p16+ Oropharyngeal Cancer Patients. Paper presented during the Plenary Session at the annual meeting of the American Society for Radiation Oncology. Washington, DC.

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.

www.nrgoncology.org

END


ELSE PRESS RELEASES FROM THIS DATE:

Progression of subclinical atherosclerosis predicts all-cause mortality risk

Progression of subclinical atherosclerosis predicts all-cause mortality risk
2024-09-30
A study carried out at Mount Sinaí Fuster Heart Hospital in New York in collaboration with the Centro Nacional de Investigaciones Cardiovasculares (CNIC) in Madrid provides important new information about atherosclerosis, a disease in which lipids (cholesterol) and other substances accumulate in plaques on the arterial wall, causing the vessels to harden and narrow, and increasing the risk of severe cardiovascular conditions.  The study, published in The Journal of the American College of Cardiology (JACC), was led by Dr. Valentín Fuster, Director of the Cardiovascular ...

Presence of subclinical atherosclerosis is marker of mortality and its progression increases risk of death

Presence of subclinical atherosclerosis is marker of mortality and its progression increases risk of death
2024-09-30
The progression of atherosclerosis in people who have no symptoms of it is independently associated with the risk of dying from any cause, according to a new study led by researchers from Mount Sinai Fuster Heart Hospital, published September 30 in the Journal of the American College of Cardiology. This research is also the first to show that advanced imaging can detect atherosclerotic disease of the large vessels long before the appearance of symptoms—an approach that could be used worldwide to prevent cardiovascular disease and risk of death. Together, the findings ...

Wang unlocking complex heterogeneity in large spatial-temporal data with scalable quantile learning

2024-09-30
Lily Wang, Professor, Statistics, College of Engineering and Computing (CEC), received funding for the project: “Collaborative Research: Unlocking Complex Heterogeneity in Large Spatial-Temporal Data with Scalable Quantile Learning.” Wang and her collaborator, Huixia Judy Wang, Department Chair and Professor of Statistics at The George Washington University, are developing scalable and efficient quantile learning techniques and theories to address challenges in analyzing large-scale heterogeneous spatial and temporal data. These new analytical techniques will have wide-ranging applications, revolutionizing scientists’ understanding of spatial and temporal ...

Heart transplant patients from socioeconomically deprived areas face higher risk for postoperative complications, earlier death than others

2024-09-30
Heart transplant patients who live in socioeconomically disadvantaged areas are more likely to experience post-surgical complications and die within five years than patients who live in more advantaged areas, even when those patients were transplanted at topnotch high-volume hospitals, new UCLA research suggests. The findings, to be published September 30 in the peer-reviewed Journal of Heart and Lung Transplantation, the official publication of the International Society for Heart and Lung Transplantation, suggest that a lack of access ...

Research alert: skin barrier protein also protects against inflammation

2024-09-30
Researchers at University of California San Diego School of Medicine have identified a new mechanism underlying inflammatory skin diseases, such as psoriasis and seborrheic dermatitis. They found that a protein essential in forming the skin’s protective barrier (ZNF750) also plays a role in controlling inflammation in skin cells, shedding light on why some people are more susceptible to inflammatory skin diseases than others. The study paves the way for more effective and personalized therapies for these debilitating diseases and also offers broader ...

Saint Luke’s and UMKC to lead nationwide study on pregnant people with heart disease in effort to help combat maternal morbidity, mortality

2024-09-30
KANSAS CITY, Mo. (September 30, 2024) – The University of Missouri-Kansas City Healthcare Institute for Innovations in Quality and Saint Luke’s Mid America Heart Institute today announced a nationwide, four-year observational study of U.S. pregnant people with cardiovascular disease to better understand and combat maternal mortality and morbidity. The National Heart, Lung, and Blood Institute of the National Institutes of Health awarded more than $7.9 million to the UMKC Healthcare Institute for Innovations in Quality to fund the study, Heart Outcomes in Pregnancy Expectations (HOPE) ...

Spiritual themes, distrust may factor into Black patients’ reluctance to participate in cancer clinical trials

2024-09-30
WASHINGTON, September 30, 2024 — Spiritual beliefs and a historically-based distrust of clinical research may factor into Black patients’ decisions about whether to participate in cancer trials, according to surveys of patients treated at two Baltimore medical centers. Findings will be presented today at the American Society for Radiation Oncology (ASTRO) Annual Meeting.  This cross-sectional, descriptive study found lingering distrust in clinical research among Black patients, despite their self-reported trust in their cancer medical teams. The surveys sought to shed light on what might be contributing to the growing underrepresentation of Black people in cancer trials ...

Brigham study finds older adults who experience a fall are at increased risk of dementia

2024-09-30
In a retrospective study of Medicare claims data, researchers found dementia was more frequently diagnosed within one year of a fall compared to other types of injuries. KEY TAKEAWAYS In a retrospective cohort study involving more than 2 million older adults who sustained an injury, 10.6% of patients who experienced a fall were subsequently diagnosed with dementia. Compared to other types of injuries, falls were associated with a 21% increased risk for future dementia diagnosis. Findings support implementing cognitive screenings for older adults who have experienced a fall resulting in an emergency room visit or hospital admission. Researchers ...

Trends in female physicians entering high-compensation specialties

2024-09-30
About The Study: This study found that female physicians were underrepresented among residents entering high-compensation specialties compared with non–high-compensation specialties. However, while high-compensation surgical specialties experienced a steady increase in the proportion of female applicants and matriculants over time, high-compensation nonsurgical specialties experienced an overall decrease in the proportion of female applicants and no significant changes in the proportion of female matriculants. Corresponding Author: To contact the corresponding author, Karina Pereira-Lima, PhD, ...

A river is pushing up Mount Everest’s peak

2024-09-30
Mount Everest is about 15 to 50 metres taller than it would otherwise be because of uplift caused by a nearby eroding river gorge, and continues to grow because of it, finds a new study by UCL researchers. The study, published in Nature Geoscience, found that erosion from a river network about 75 kilometres from Mount Everest is carving away a substantial gorge. The loss of this landmass is causing the mountain to spring upwards by as much as 2 millimetres a year and has already increased its height by between 15 and 50 metres over the past 89,000 years. At 8,849 metres high, Mount Everest, also known as Chomolungma in Tibetan or Sagarmāthā ...

LAST 30 PRESS RELEASES:

Hot dragonfly summer: species with darker wings have evolved to withstand heat and attract partners

Development of a new electrolyte synthesis method for next-generation fuel cells: a step closer to green hydrogen production

Rage clicks: Study shows how political outrage fuels social media engagement

E-waste experts urge public: Stop trashing electronic products with ordinary garbage (International E-Waste Day)

Hospitals that are understaffed for infection prevention and control have higher rates of infection, study says

Study reveals 85% of women prefer choice between self-sampling and traditional cervical screening

Global advances and future trends in cervical cancer research from 2013 to 2022

Inspired by Spider-Man, a lab recreates web-slinging technology

Applied Microbiology International’s 2024 Honorary Fellowship goes to Dr Chikwe Ihekweazu

Pitt scientists validate new lab test platform for blood biomarkers of Alzheimer's disease

No bolts about it: New technology improves structural strength

Medical professionals must lead the fight against climate misinformation

Should doctors be suspended for unlawful climate activism?

Extreme rainfall linked to heightened risk of death

New research highlights the overlooked dangers of subtle and covert abuse in intimate relationships

Snowflake dance analysis could improve rain forecasts

ASPB welcomes Hong Ma as Society President

Can advanced AI can solve visual puzzles and perform abstract reasoning?

West Health-Gallup poll: Healthcare may be sleeper issue in U.S. presidential campaign

UC Irvine scientists track and analyze lofted embers that cause spot fires

Uncovering pandemic inequities

Microbiome researcher awarded NIH Transformative Research Award to pursue personalized treatment for gut diseases

Teresa Bowman, Ph.D., named Chair of Developmental & Molecular Biology at Albert Einstein College of Medicine

Legal system fails to protect people from malicious copyright cases at the cost of sexual privacy, study warns

Ancient climate analysis reveals unknown global processes

Gene therapy shows long-term benefit for patients with a rare pediatric brain disease

Do people with MS have an increased risk of cancer?

New research on octopus-inspired technology successfully maneuvers underwater objects

Newly discovered Late Cretaceous birds may have carried heavy prey like extant raptors

Bat species richness in San Diego, C.A. decreases as artificial lights, urbanization, and unconserved land increase, with Townsend's big-eared bat especially affected

[Press-News.org] NRG Oncology trial supports radiotherapy and cisplatin should remain the standard of care for p16+ oropharyngeal cancer