TGen helps develop an analysis tool, leading to
PHOENIX, Arizona – December 20, 2021 – An international team of scientists, including those from Institute for Translational Research in Genomics (TGen), affiliate city of hope, has designed a tool that could help design more successful clinical trials for new brain tumor drug treatments.
The results of an international study published in the Journal of Neuro-Oncology suggest that a tool called a nomogram could help predict how long each patient will likely survive with glioblastoma, the most common malignant brain cancer in adults, with an average survival of less than two years.
However, survival times vary from patient to patient due to many factors, including: age, location of tumor, amount of tumor removed by surgery, and, most importantly in this study, the sex of the patient.
It is now well established that males are more likely to develop glioblastomas than females, and that females respond to treatments at almost twice the rate of males. If these factors are not considered in the selection of clinical trial participants, results could be skewed due to an imbalance between those receiving a new treatment and those receiving the current standard of care. Erroneous results could lead to the approval of a drug that has little or no value, or the rejection of a drug that might actually benefit some patients.
“The more balanced the experimental and control treatment arms are, the more likely researchers are to draw efficacy conclusions that stand up to routine clinical use,” said Michael Berens, Ph.D., professor and director of TGen’s Cancer and Cell Biology Division, and one of the study’s authors.
“If we run out of active drugs because we’re stacking the game against ourselves, that would be tragic,” said Dr. Berens, who is also TGen’s deputy director of institutional initiatives. “You need to find subsets of patients who have a better chance of benefiting from a specific new treatment. Give them the drug. This is called precision medicine.
Study based on more than 1,300 patients
In creating a nomogram for glioblastoma, the study looked at the results of two clinical trials in 1,359 patients newly diagnosed with glioblastoma.
“The differences in nomograms by sex presented here indicate that the prognosis of women and men may be different, and that these nomograms are useful tools for estimating patient-level survival probabilities,” the study concludes, recommending that further research should be conducted to better characterize the exact biological mechanisms underlying sex differences in glioblastoma.
Nomograms for other cancers are used in oncology and medicine to generate the probability of clinical events by integrating variables to produce biological and clinical models that aid in treatment decisions. The predictive glioblastoma nomogram developed in this study can be found at: https://npatilshinyappcalculator.shinyapps.io/SexDifferencesInGBM/
“Glioblastoma nomograms fill a significant unmet need in the design of clinical trials of new treatments for this deadly brain cancer, for which patients have few treatment options,” said Jill Barnholtz-Sloan, Ph.D., lead author of the study, previously the Sally S. Morley Designated Professor for Brain Tumor Research at Case Western Reserve University School of Medicine and Director of Health Analytics Research at University Hospitals of Cleveland (both in Cleveland, Ohio).
“Despite advances in treatment and biological understanding, the prognosis for patients with glioblastoma remains poor and we do not understand the biological mechanisms underlying these known sex differences in incidence and survival,” said Dr. Barnholtz-Sloan.
Also contributing to this study: Barrow Neurology Clinics Accruals, Arizona Oncology Services Foundation, Case Comprehensive Cancer Center, Cleveland Clinic Foundation, Penn State University, Washington University (St. Louis), University of Texas-MD Anderson Cancer Center, Thomas Jefferson University Hospital, Intermountain Medical Center, USON-Willamette Valley Cancer Center, University of Wisconsin School of Medicine and Public Health, American College of Radiology, Miami Cancer Institute, Tel-Aviv Medical Center (Israel) and McGill University Health Center (Canada).
The study – Independently Validated Sex-Specific Nomograms to Predict Survival in Patients with Newly Diagnosed Glioblastoma: NRG Oncology RTOG 0525 and 0825 – was supported by grants from the National Cancer Institute, Merck & Co. Inc., and Genentech BioOncology.
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About TGen, a subsidiary of City of Hope
Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based nonprofit organization dedicated to conducting groundbreaking research with life-changing results. TGen is affiliated with City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases: CityofHope.org. This precision medicine affiliation allows the two institutes to complement each other in research and patient care, with City of Hope providing an important clinical setting to advance the scientific discoveries made by TGen. TGen is focused on helping patients with neurological disorders, cancer, diabetes, and infectious diseases through cutting-edge translational research (the process of rapidly moving research toward the benefit of the patient). Doctors and scientists at TGen work to unravel the genetic components of common and complex rare diseases in adults and children. By working with collaborators in the scientific and medical communities around the world, TGen makes a substantial contribution to helping our patients through the efficiency and effectiveness of the translation process. For more information visit: tgen.org. Follow TGen on Facebook, LinkedIn and Twitter @TGen.
TGen Senior Scientific Writer
Journal of Neuro-Oncology
The title of the article
Independently Validated Sex-Specific Nomograms to Predict Survival in Patients with Newly Diagnosed Glioblastoma: NRG Oncology RTOG 0525 and 0825
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