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: | , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
22 May 2013
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| 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 |
| 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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| 245 | 1 | 0 | |a Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer |b a randomized phase II cardiac safety study (TRYPHAENA) |c 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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| 520 | |a 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. | ||
| 650 | 4 | |a early breast cancer | |
| 650 | 4 | |a HER2 | |
| 650 | 4 | |a LVSD | |
| 650 | 4 | |a neoadjuvant | |
| 650 | 4 | |a pertuzumab | |
| 650 | 4 | |a trastuzumab | |
| 700 | 1 | |a Chia, S. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Hickish, T. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Harvey, V. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Eniu, A. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Hegg, R. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Tausch, C. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Seo, J. H. |e VerfasserIn |4 aut | |
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| 700 | 1 | |a Ratnayake, J. |e VerfasserIn |4 aut | |
| 700 | 1 | |a McNally, V. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Ross, G. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Cortés, J. |e VerfasserIn |4 aut | |
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