Physicians at cancer research and treatment organization City of Hope have published new results from a study that shows the blood vessel relaxing medication carvedilol may benefit childhood cancer survivors who are at risk of developing heart failure.
Heart failure developed in later years can be a serious complication for childhood cancer survivors who have been treated with the chemotherapy anthracycline. In this delayed process, the heart experiences gradual changes over the course of years that is characterized by a thinning of the heart muscle and enlargement of the heart’s chambers. This results in heart failure, where the heart is not able to pump enough blood to keep the patient healthy and once this function starts to decline the worsening of the condition is irreversible.
The City of Hope team’s findings were published this week in The Lancet Oncology.
“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, DO, Barron Hilton Chair in Pediatrics at City of Hope Children’s Cancer Center and corresponding author of the study.
For this study, the investigators conducted a randomized, double-blind Phase IIB clinical trial at 30 City of Hope Children’s Oncology group affiliated hospitals in North America. Of 182 patients enrolled in the trial, roughly half were treated with relatively low doses of carvedilol, while the other half receive a placebo over the course of two years. Median age was 24.7 years with 50% of participants female, 50% male, and 65% were non-Hispanic White. The drug was well tolerated in the group who received it and there appeared to be no significant difference in side effects between the carvedilol group and the placebo group.
While the trial did not ultimately achieve its goal of decreasing the thinning of heart muscle and enlargement of the heart’s chamber that are characteristic of heart failure in these patients, the study team noted that it did provide improvement in the heart left ventricular end-systolic wall stress, which is an earlier biomarker of declining 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,” said Armenian. “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.”
The team noted that the study was an important first step in developing the urgently needed prevention strategies for this population at risk of heart failure, especially considering these cancer survivors are expected to live for decades after their initial cancer diagnoses.
“Our research sets the stage for a Phase III 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,” Armenian concluded.