Abstract
Introduction. We report cardiac tolerability of pertuzumab plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel observed in the phase III study CLEOPATRA in patients with HER2-positive first-line metastatic breast cancer (MBC). Patients and Methods. Left ventricular ejection fraction (LVEF) ≥50% and ECOG performance status of 0 or 1 were required for study entry. During the study, LVEF assessments took place every 9 weeks. Pertuzumab/placebo was given at 840 mg, then 420 mg q3w; trastuzumab was administered at 8 mg/kg, then 6 mg/kg q3w, and docetaxel was initiated at 75 mg/m2 q3w. Results. The incidence of cardiac adverse events (all grades) was 16.4% in the placebo arm and 14.5% in the pertuzumab arm, with left ventricular systolic dysfunction (LVSD, all grades) being the most frequently reported event (8.3% versus 4.4% in the placebo and pertuzumab arm). Declines in LVEF ≥by 10% points from baseline and to
Original language | English |
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Pages (from-to) | 257-264 |
Number of pages | 8 |
Journal | The oncologist |
Volume | 18 |
Issue number | 3 |
DOIs | |
Publication status | Published - Mar 2013 |
Keywords
- Cardiac safety
- HER2
- LVSD
- Metastatic breast cancer
- Pertuzumab
- Trastuzumab
ASJC Scopus subject areas
- Cancer Research
- Oncology