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Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA)

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 br...

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Main Authors: Schneeweiss, Andreas (Author) , Chia, S. (Author) , Hickish, T. (Author) , Harvey, V. (Author) , Eniu, A. (Author) , Hegg, R. (Author) , Tausch, C. (Author) , Seo, J. H. (Author) , Tsai, Y. -F. (Author) , Ratnayake, J. (Author) , McNally, V. (Author) , Ross, G. (Author) , Cortés, J. (Author)
Format: Article (Journal)
Language:English
Published: 22 May 2013
In: Annals of oncology
Year: 2013, Volume: 24, Issue: 9, Pages: 2278-2284
ISSN:1569-8041
DOI:10.1093/annonc/mdt182
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1093/annonc/mdt182
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0923753419369297
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Author Notes:A. Schneeweiss, S. Chia, T. Hickish, V. Harvey, A. Eniu, R. Hegg, C. Tausch, J.H. Seo, Y. -F. Tsai, J. Ratnayake, V. McNally, G. Ross & J. Cortés
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Summary: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.
Item Description:Gesehen am 12.07.2021
Physical Description:Online Resource
ISSN:1569-8041
DOI:10.1093/annonc/mdt182

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