Key result
Enalapril plus carvedilol fails to achieve full LVEF recovery during trastuzumab therapy.
Why the study?
ACE inhibitors and beta-blockers are suggested to prevent and treat trastuzumab-related cardiac toxicity, but prospective clinical trial data in women developing mild cardiac toxicity were needed.
Does early treatment with enalapril and carvedilol improve LVEF recovery in breast cancer patients developing mild cardiac toxicity during adjuvant trastuzumab therapy?
Does early treatment with enalapril and carvedilol improve LVEF recovery in breast cancer patients developing mild cardiac toxicity during adjuvant trastuzumab therapy?
Early intervention with ACE inhibitors and beta-blockers in patients developing mild trastuzumab-induced cardiotoxicity may facilitate faster LVEF recovery from nadir values.
May facilitate faster LVEF recovery from nadir in mild toxicity; hypothesis-generating and requires randomized confirmation before practice change.
BACKGROUND: Angiotensin Converting Enzyme inhibitors (ACEis) and beta-blockers (BB) are suggested to prevent and treat trastuzumab-related cardiac toxicity. We performed a prospective clinical trial in women experiencing mild cardiac toxicity (MCT) while on adjuvant treatment with trastuzumab. METHODS: MCT was defined as an asymptomatic absolute decrease in LVEF of ≥ 10 percentage units to >50%. Treatment consisted of enalapril 2.5 mg bid and carvedilol 3.75 mg bid, which were up-titrated to 10 mg bid for the enalapril and 6,25 mg bid of carvedilol. In patients receiving study drug, the primary study end-point was LVEF recovery, which was defined as a post-trastuzumab LVEF returning to no less than -5 percentage points of the baseline value. RESULTS: 103 patients were enrolled, 100 started trastuzumab, and 98 completed the planned treatment. Sixteen patients (16%) had MCT and received study drugs until trastuzumab completion. None of these patients achieved a post-trastuzumab LVEF recovery. Nevertheless, treated patients had significantly higher median LVEF recovery from nadir to post-trastuzumab LVEF in (8% points vs. 4% points, respectively, p = 0.004), resulting in no difference in post-treatment LVEF values compared to patients without MCT. CONCLUSION: Treatment of MCT with ACEis and BB allows faster LVEF recovery from nadir values and should be further studied in this setting.
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Geuna et al. (2020) studied HER2-positive localized breast cancer (n=103). Enalapril and carvedilol vs. Patients without mild cardiac toxicity (observational comparator) was evaluated on LVEF recovery (post-trastuzumab LVEF returning to no less than -5 percentage points of the baseline value). Treatment with enalapril and carvedilol in breast cancer patients developing mild cardiac toxicity during trastuzumab therapy did not achieve the primary endpoint of full LVEF recovery, but significantly improved median LVEF recovery from nadir compared to patients without toxicity (8% vs 4%, p=0.004).
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