More than 450 patients with breast cancer across 21 U.S. sites are now enrolled in the Global Cardio-Oncology Registry (G-COR) since the launch of its pilot phase in March 2023.
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The G-COR is the first multinational, multicenter prospective observational cohort registry addressing cancer therapy related cardiovascular toxicity (CTR-CVT). The global collaboration, which involves 119 academic and community medical centers from 21 countries across five continents, will ultimately enroll approximately 5,000 patients worldwide.
“Our goal is to improve the overall survival and quality of life of patients with cancer by identifying and addressing regional and international differences in the delivery of cardio-oncology care and outcomes,” says Diego Sadler, MD, Section Head of Cardio-Oncology at Cleveland Clinic in Florida and principal investigator for the global registry.
In April, Dr. Sadler begins his term as chair-elect of the American College of Cardiology’s (ACC) Cardio-Oncology Section Leadership Council. He also serves on the International Cardio-Oncology Society’s (IC-OS) Education & Training Advisory Committee, a role he’s held since 2020.
Cardio-oncology is a rapidly growing subspecialty focused on the prevention, detection, and treatment of cardiotoxicity in patients with cancer. Studies have shown patients with cancer have a 2- to 6-times higher cardiovascular disease mortality risk than the general population.
As outlined in an IC-OS consensus statement published in 2022, a mounting body of research has linked many cancer treatments, including radiation therapy, chemotherapeutic agents, targeted therapies, and immunotherapies, to increased risk for cardiovascular disease. “As cancer survivorship improves with these therapeutics, it is critical to be aware of the cardiovascular risk and to facilitate early detection, prevention and treatment of potential cardiotoxicities,” says Dr. Sadler.
Examples include left ventricular systolic dysfunction associated with anthracyclines and trastuzumab and myocarditis related to immune checkpoint inhibitors (ICIs). Traditional chemotherapy agents, like 5-fluorouracil (5-FU), taxanes and platinum-based treatments, as well as novel targeted therapies and tyrosine kinase inhibitors can lead to other forms of early and late onset cardiotoxicity. These include heart failure, valvular heart disease, myocardial ischemia and infarction, arrhythmia, hypertension, and thromboembolism.
“There are nearly 20 million cancer survivors in the United States, and cardiovascular events are up among this patient population,” observes Dr. Sadler. “With cancer deaths declining and new cases on the rise, many people stand to benefit from the cardio-oncology treatment strategies and guidance that will result from the research supported by this registry.”
By collecting clinical, laboratory, imaging, demographic, and socioeconomic data, Dr. Sadler says the global registry will help establish the incidence of CTR-CVT, identify risk factors, and lead to the development of validated risk score models to guide treatment decisions in different geographic locations throughout the world.
“It’s been nearly 25 years since the first cardio-oncology program was established, and there is much we still do not know,” says Dr. Sadler. “Even worse, many patients are not benefitting from what we have learned about mitigating cancer therapy cardiotoxicity.”
Patients treated in community settings often have limited access to this advanced level of care because cardio-oncology programs are most commonly established in academic centers. Dr. Sadler is hopeful the G-COR will help raise awareness and allow the medical community to reach a larger population with cardio-oncology care.
The global phase of the registry will launch this year and include three distinct patient populations: individuals with breast cancer, hematological malignancies, and those treated with check point inhibitors immunotherapy.
“These pillars were identified as the cardio-oncology care priorities during our initial survey of potential site participants,” explains Dr. Sadler, senior author of the recent article outlining survey findings and registry design published in Circulation: Cardiovascular Quality and Outcomes. He wrote the protocol for the registry and helped develop the database and electronic case report forms that are used for data collection.
The registry is built using a REDCap Cloud platform and conducted with the logistical support of C5 Clinical Research Division and the Cardiovascular Outcomes Registries and Research (CORR) group at Cleveland Clinic’s main campus in Ohio.
Dr. Sadler also has been heavily involved in registry site recruitment and activation. “We look forward to having all our sites up and running, both here in the U.S. and aboard, so that we can capture the data that will ultimately allow us to improve care pathways,” he says.
Cleveland Clinic Weston Hospital in Florida has already enrolled 90 patients in the registry and is the lead enrollment site for the breast cancer pilot.
“Like our U.S. and global counterparts, we will be opening enrollment this year to patients treated with ICIs and those diagnosed with lymphoma, leukemia, or multiple myeloma,” notes Dr. Sadler, who has been a driving force behind the establishment of the G-COR.
As Cardio-Oncology Committee chair for the American College of Cardiology’s Florida Chapter, Dr. Sadler initiated a partnership with the Florida Chapter of the American Society of Clinical Oncology (FLASCO) that resulted in a joint survey evaluating cardio-oncology awareness among Florida clinicians as well as the development of an online education program. Subsequent national collaborations between the ACC and ASCO, along with the International Cardio-Oncology Society, led to the collaborative network that became the foundation for the G-COR.
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