PRADA Trial: Is Routine Cardioprotection Required With Early Breast Cancer Therapy?
Posted: Tuesday, July 6, 2021
Anthracycline-containing adjuvant therapy may not require cardioprotective treatment in patients with early breast cancer and without preexisting cardiovascular disease, according to findings presented during the virtual edition of the 2021 American College of Cardiology (ACC) Scientific Session. In addition, there appeared to be no differences in long-term cardiac protection between patients who received the angiotensin blocker candesartan during adjuvant therapy and those who did not. This research from the Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy (PRADA) trial was also published in the journal Circulation.
“The focus of future studies should be to identify subgroups at high risk of cardiotoxicity who may benefit from cardioprotective therapy in a precision medicine fashion,” stated Torbjørn Omland, MD, PhD, MPH, of Akershus University Hospital, Norway, and colleagues.
The study was a 2 x 2 factorial, randomized, placebo-controlled, double-blind, single-center trial. Women who were scheduled for adjuvant anthracycline-containing therapy following surgery for early breast cancer were enrolled (n = 240). Patients with preexisting cardiovascular disease, impairments in left ventricular ejection fraction (LVEF), and/or abnormal blood pressure were excluded. Participants were randomly assigned to receive concomitant treatment with candesartan cilexetil, metoprolol succinate, or matching placebos. Following adjuvant therapy, the experimental drugs were discontinued.
Cardiovascular magnetic resonance imaging results indicated that all participants appeared to exhibit slight decreases in LVEF, ranging from 1.6% to 1.9%, from baseline to a median follow-up of 23 months. Similarly, there were no apparent differences between the groups in terms of cardiac troponin concentrations. However, candesartan treatment during adjuvant therapy was associated with a modest decline in left ventricular end-diastolic volume (P = .02) and global longitudinal strain (P = .04) at extended follow-up, compared with the non-candesartan group.
The authors concluded: “…The effect size of these secondary endpoints was small and unlikely to confer long-term clinically relevant benefits. Broadly administered, general cardioprotective therapy in this patient group seems unwarranted.”
Disclosure: For full disclosures of the study authors, visit ahajournals.org.