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Anthracycline, taxane, and trastuzumab-based neoadjuvant chemotherapy in HER2-positive early breast cancer: phase II trial.
- Source :
-
Tumori [Tumori] 2023 Feb; Vol. 109 (1), pp. 71-78. Date of Electronic Publication: 2022 Jan 06. - Publication Year :
- 2023
-
Abstract
- Objective: Neoadjuvant chemotherapy has become the preferred treatment in HER2-positive early breast cancer. Several trials investigated the neoadjuvant efficacy of dual HER2 blockade with anthracycline-free chemotherapy, whereas few data are available on single-agent trastuzumab and anthracycline-based regimens, which represent the standard of care in the adjuvant setting. This phase II, single-arm trial assessed anthracycline-based chemotherapy and trastuzumab as neoadjuvant treatment for high-risk HER2-positive breast cancer.<br />Methods: Forty-three patients with stage II-III HER2-positive breast cancer were treated with 4 courses of neoadjuvant 5-fluorouracil 600 mg/m <superscript>2</superscript> , epirubicin 90 mg/m <superscript>2</superscript> , cyclophosphamide 600 mg/m <superscript>2</superscript> (FEC ×4) every 21 days, followed by 12 courses of weekly paclitaxel 80 mg/m <superscript>2</superscript> and trastuzumab 2 mg/Kg IV (loading dose 4 mg/kg).<br />Results: Pathologic complete response (pCR) was observed in 22 (51%) of 43 patients. After a median follow-up of 6 years, the 5-year disease-free survival and overall survival were 85.8% (95% confidence interval 75.9%-97%) and 89.6% (80.4%-99.8%), respectively. A temporary decrease in left ventricular ejection fraction was observed in two patients. No cardiac death or congestive heart failure occurred. One patient died due to febrile neutropenia.<br />Conclusions: FEC ×4 followed by paclitaxel and trastuzumab was associated with high pCR rates and favorable long-term outcomes. However, this regimen was associated with relevant hematologic toxicity.
- Subjects :
- Humans
Female
Trastuzumab
Neoadjuvant Therapy adverse effects
Anthracyclines adverse effects
Stroke Volume
Receptor, ErbB-2 analysis
Antibodies, Monoclonal, Humanized
Ventricular Function, Left
Epirubicin adverse effects
Paclitaxel adverse effects
Taxoids
Cyclophosphamide
Antineoplastic Combined Chemotherapy Protocols adverse effects
Breast Neoplasms pathology
Subjects
Details
- Language :
- English
- ISSN :
- 2038-2529
- Volume :
- 109
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Tumori
- Publication Type :
- Academic Journal
- Accession number :
- 34989265
- Full Text :
- https://doi.org/10.1177/03008916211067568