City of Hope Children’s Cancer Center, Children’s Oncology Group conduct largest clinical trial seeking to prevent heart failure among childhood cancer survivors

Results suggest that more childhood cancer survivors may benefit from a heart-saving medication called carvedilol, even long after their cancer treatment is over

Physicians at City of Hope, one of the largest cancer research and treatment organizations in the United States, in cooperation with the Children’s Oncology Group (COG), have conducted the largest clinical trial to date seeking to reduce the risk of people who have survived childhood cancer from developing heart failure. The findings published in The Lancet Oncology show that the blood vessel relaxing medication carvedilol is safe for childhood cancer survivors to take and may improve important markers of heart injury sustained as a result of chemotherapy exposure.

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Physicians at City of Hope Children's Cancer Center, in cooperation with the Children’s Oncology Group (COG), have conducted the largest clinical trial to date seeking to reduce the risk of people who have survived childhood cancer from developing heart failure. The findings published in The Lancet Oncology show that the blood vessel relaxing medication carvedilol is safe for childhood cancer survivors to take and may improve important markers of heart injury sustained as a result of chemotherapy exposure. (Photo Credit: City of Hope)

One devastating long-term side effect from a class of chemotherapy called anthracycline is increased risk of heart failure where the heart can’t pump enough blood to meet the body’s needs. This is a delayed process where the heart undergoes gradual changes over time characterized by the thinning of the heart muscle and enlargement of its chambers. Unfortunately, after the onset of heart function decline, the downward cascade is irreversible, highlighting an urgent need for early prevention strategies.

“The growing number of childhood cancer survivors makes the development of early interventions imperative. Just helping children survive cancer isn’t enough. We also need to optimize patients’ health so that they don’t have to face life-threatening side effects decades after they are cancer free,” said Saro H. Armenian, D.O., M.P.H., Barron Hilton Chair in Pediatrics at City of Hope Children’s Cancer Center and corresponding author of The Lancet Oncology study.

Physicians from City of Hope led the randomized, double-blind Phase 2B clinical trial conducted at 30 COG-member hospitals in the United States and Canada (COG Study ID: ALTE1621). Some 182 enrolled participants took relatively low doses of carvedilol or equivalent placebo for two years. There were no significant differences in side effects between the two study arms, and carvedilol appeared to be well-tolerated.

Although the clinical trial did not achieve its goal of decreasing the thinning of the heart muscle and enlargement of its chambers, there were significant improvements in heart left ventricular end-systolic wall stress, which is an earlier biomarker of worsening heart health.

“The greatest benefit was seen in participants who were very long-term survivors, as well as in those who were highly adherent to the study medication. Moreover, of the eight patients who developed clinically significant decline in heart function while on the study, six were randomized to placebo and two were receiving carvedilol,” Armenian said. “Our research sets the stage for a Phase 3 clinical trial that may demonstrate a significant benefit for certain patients who are at an especially high risk of irreversible heart function decline after completion of cancer therapy.”

Douglas S. Hawkins, M.D., COG group chair and a hematology-oncology professor at Seattle Children’s Hospital, added, “Conducting this study across 30 institutions and among long-term survivors of childhood cancer illustrates the strengths of the COG network. An intervention study on this scale would not be feasible outside of COG. Future research will need to focus on the optimal timing, duration and population for carvedilol intervention.”

This study is an important first step toward developing future studies that will seek to optimize the long-term well-being and health of survivors who are expected to live for decades after their initial cancer diagnosis.

The Lancet Oncology study entitled “Effect of carvedilol versus placebo on cardiac function in anthracycline-exposed survivors of childhood cancer: a randomised, controlled, phase2b trial (PREVENT-HF)” was supported by the National Cancer Institute of the National Institutes of Health (U10CA180886), the NCI Community Oncology Research Program (UG1CA189955), St. Baldrick’s Foundation, The Leukemia & Lymphoma Society, The Altschul Foundation, Rally Foundation and American Lebanese Syrian Associated Charities.

Part of this data was presented at the American Society of Clinical Oncology on June 5, 2023, and International Symposium on Late Complications After Childhood Cancer on June 15, 2023.

City of Hope Children’s Cancer Center has a Childhood, Adolescent and Young Adult Cancer Survivorship Program that provides specialized follow-up care for patients who were diagnosed with a childhood cancer or who underwent a bone marrow transplantation before they turned 40. In collaboration with City of Hope’s Department of Supportive Care Medicine, the program helps each survivor stay as healthy as possible by preventing problems from happening or catching them early, when they are most treatable.

About City of Hope

City of Hope's mission is to deliver the cures of tomorrow to the people who need them today. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics and training, and innovation initiatives. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope^TM. For more information about City of Hope, follow us on Facebook, Twitter, YouTube, Instagram and LinkedIn.

About The Children’s Oncology Group (COG)

COG (childrensoncologygroup.org) is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. Supported by the National Cancer Institute, one of the National Institutes of Health, COG unites over 10,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, and New Zealand in the fight against childhood cancer. Today, more than 90% of the 16,000 children and adolescents diagnosed with cancer each year in the United States are cared for at COG member institutions. Research performed by COG institutions over the past 50 years has transformed childhood cancer from a virtually incurable disease to one with a combined 5-year survival rate of 80%. COG’s mission is to improve the cure rate and outcomes for all children with cancer.

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