Pertuzumab, trastuzumab, and standard anthracycline- and taxane-based chemotherapy for the neoadjuvant treatment of patients with HER2-positive localized breast cancer (BERENICE): a phase II, open-label, multicenter, multinational cardiac safety study
Key result
Neoadjuvant pertuzumab, trastuzumab, and anthracyclines show a low ~2% rate of NYHA III/IV heart failure.
- n=397
Why the study?
Anti-HER2 therapies combined with anthracycline-containing regimens carry a risk of increased cardiac toxicity in HER2-positive early breast cancer patients.
What is the cardiac safety of pertuzumab, trastuzumab, and anthracycline-containing chemotherapy in patients with HER2-positive early breast cancer?
Structured PICO
What is the cardiac safety of pertuzumab, trastuzumab, and anthracycline-containing chemotherapy in patients with HER2-positive early breast cancer?
P
Population
397 patients with HER2-positive early breast cancer and normal cardiac function receiving neoadjuvant pertuzumab, trastuzumab, and anthracycline- and taxane-based chemotherapy.
I
Intervention
Neoadjuvant treatment with pertuzumab, trastuzumab, and anthracycline/taxane-based chemotherapy (Cohort A: 4 cycles dose-dense doxorubicin/cyclophosphamide followed by 12 doses paclitaxel + 4 cycles trastuzumab/pertuzumab; Cohort B: 4 cycles fluorouracil/epirubicin/cyclophosphamide followed by 4 cycles docetaxel + 4 cycles trastuzumab/pertuzumab)
O
Outcome
Cardiac safety during neoadjuvant treatment, assessed by the incidence of New York Heart Association class III/IV heart failure and of left ventricular ejection fraction declines (≥10 percentage-points from baseline and to a value of <50%)safety
Neoadjuvant treatment with pertuzumab, trastuzumab, and anthracycline-containing regimens in HER2-positive early breast cancer demonstrated an acceptable cardiac safety profile.
Authors
Discussion
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Implication
Low cardiac event rates with neoadjuvant pertuzumab-trastuzumab plus anthracyclines support monitoring in practice; extends descriptive safety data from prior nonrandomized studies.
Cite This Study
Swain et al. (2017) studied HER2-positive early breast cancer (n=397). Pertuzumab, trastuzumab, and standard anthracycline- and taxane-based chemotherapy was evaluated on Incidence of New York Heart Association class III/IV heart failure and of left ventricular ejection fraction declines (≥10 percentage-points from baseline and to a value of <50%). Neoadjuvant pertuzumab, trastuzumab, and anthracycline-based chemotherapy in early breast cancer resulted in low rates of NYHA class III/IV heart failure (1.5%) and LVEF declines (6.5% and 2.0%).