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Cardiac Safety of Paclitaxel Plus Trastuzumab and Pertuzumab in Patients With HER2-Positive Metastatic Breast Cancer.
- Source :
- Oncologist; Apr2016, Vol. 21 Issue 4, p418-424, 7p, 1 Diagram, 2 Charts, 2 Graphs
- Publication Year :
- 2016
-
Abstract
- Introduction. Myocardial strain imaging and blood biomarkers have been proposed as adjuncts to left ventricular ejection fraction (LVEF) monitoring for the early detection of cardiotoxicity during cancertherapy.We report the results of a preplanned cardiac safety analysis of global longitudinal strain (GLS), and troponin-I (TnI) and brain natriuretic peptide (BNP) levels in the phase II study of paclitaxel, trastuzumab, and pertuzumab (THP) for metastatic HER2-positive breast cancer. Patients and Methods. Patients with 0-1 lines of prior therapy were treated with weekly paclitaxel (80 mg/m²) plus trastuzumab (8 mg/kg loading dose followed by 6 mg/kg) and pertuzumab (840 mg loading dose followed by 420 mg) every 3 weeks. Exploratory endpoints were GLS measured with speckle-tracking echocardiography every 3 months and TnI and BNP levels measured every 6 weeks (immediately pre- and postchemotherapy infusion) at 6 time points. Results. Sixty-seven of 69 enrolled patients were treated with THP: 19 (28%) had hypertension, 8 (12%) had diabetes, 11 (16%) had hyperlipidemia, and 26 (38%) had smoking history. After a median follow-up of 21 months (range: 3-38 months), no patients developed symptomatic heart failure. Two patients (3.0%) experienced asymptomatic LVEF decline (grade 2). The mean GLS (6SD) was 19% ± 2% (baseline), 19% ± 2% (month 6), and 19% ± 3% (month 12). Detectable TnI (>0.06 ng/mL) and elevated BNP (>100 pg/mL) levels were observed in 3 (4.3%) and 2 (3.0%) patients, respectively, but were not associated with LVEF decline. Conclusion. The absence of any significant changes in GLS and cardiac biomarkers (TnI and BNP) further support the cardiac safety of THP in patients with metastatic HER2-positive breast cancer. [ABSTRACT FROM AUTHOR]
- Subjects :
- THERAPEUTIC use of monoclonal antibodies
TRASTUZUMAB
BIOMARKERS
BREAST tumors
COMBINATION drug therapy
CONFIDENCE intervals
ECHOCARDIOGRAPHY
HEART
METASTASIS
MONOCLONAL antibodies
ONCOGENES
PACLITAXEL
PEPTIDE hormones
RESEARCH funding
PRE-tests & post-tests
DATA analysis software
TROPONIN
DESCRIPTIVE statistics
ONE-way analysis of variance
INTRACLASS correlation
VENTRICULAR ejection fraction
THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 10837159
- Volume :
- 21
- Issue :
- 4
- Database :
- Complementary Index
- Journal :
- Oncologist
- Publication Type :
- Academic Journal
- Accession number :
- 114525796
- Full Text :
- https://doi.org/10.1634/theoncologist.2015-0321