Abstract
Background: Pertuzumab (P) combined with trastuzumab (H)-based chemotherapy improves efficacy in early and advanced HER2-positive breast cancer. We assessed the tolerability, with particular focus on cardiac safety, of H and P with chemotherapy in the neoadjuvant treatment of HER2-positive early breast cancer. Patients and methods: In this multicenter, open-label phase II study, patients with operable, locally advanced, or inflammatory breast cancer were randomized 1: 1: 1 to receive six neoadjuvant cycles q3w (Arm A: 5-fluorouracil, epirubicin, cyclophosphamide [FEC] + H + P ×3→ docetaxel [T] + H + P ×3; Arm B: FEC ×3 →T + H + P ×3; Arm C: T + carboplatin + H [TCH]+P ×6). pCR was assessed at surgery and adjuvant therapy given to complete 1 year of H. Results: Two hundred twenty-five patients were randomized. During neoadjuvant treatment, two patients (2.7%; Arm B) experienced symptomatic left ventricular systolic dysfunction (LVSD) and 11 patients (Arm A: 4 [5.6%]; Arm B: 4 [5.3%]; Arm C: 3 [3.9%]) had declines in left ventricular ejection fraction of ≥10% points from baseline to <50%. Diarrhea was the most common adverse event. pCR (ypT0/is) was reported for 61.6% (Arm A), 57.3% (Arm B), and 66.2% (Arm C) of patients. Conclusion: The combination of P with H and standard chemotherapy resulted in low rates of symptomatic LVSD.
Original language | English |
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Article number | mdt182 |
Pages (from-to) | 2278-2284 |
Number of pages | 7 |
Journal | Annals of Oncology |
Volume | 24 |
Issue number | 9 |
DOIs | |
Publication status | Published - 2013 Sept |
Keywords
- Early breast cancer
- HER2
- LVSD
- Neoadjuvant
- Pertuzumab
- Trastuzumab
ASJC Scopus subject areas
- Hematology
- Oncology