Phase II,Multicenter, Single-arm Trial of Eribulin as First-line Therapy for Patients With Aggressive Taxane-pretreated HER2-Negative Metastatic Breast Cancer: The MERIBEL Study |
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Authors: | Vanesa Ortega Antonio Antón Isabel Garau Noemia Afonso Lourdes Calvo Yolanda Fernández María Martínez-García Esperanza Blanco Pilar Zamora Mirta García José Juan Illarramendi César Augusto Rodríguez Sánchez Miguel Sampayo Elena Aguirre José Manuel Pérez-García Javier Cortés Antonio Llombart-Cussac |
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Institution: | 1. Hospital General de Granollers, Barcelona, Spain;2. Hospital Vall d’Hebron, Barcelona, Spain;3. Hospital Miguel Servet, Zaragoza, Spain;4. Hospital Son Llatzer, Palma de Mallorca, Spain;5. IPO Porto, Porto, Portugal;6. Complejo Hospitalario Universitario A Coruña, A Coruña, Spain;7. Hospital Central de Asturias, Oviedo, Spain;8. Hospital del Mar, Barcelona, Spain;9. Hospital Universitario Infanta Cristina, Badajoz, Spain;10. Hospital Universitario La Paz, Madrid, Spain;11. Hospital Insular de Las Palmas, Las Palmas de Gran Canaria, Spain;12. Hospital General de Navarra, Pamplona, Spain;13. Hospital Universitario de Salamanca IBSAL, Salamanca, Spain;14. Medica Scientia Innovation Research (MedSIR), Barcelona, Spain;15. IOB Institute of Oncology, Quironsalud Group, Madrid and Barcelona, Spain;16. Ramon y Cajal University Hospital, Madrid, Spain;17. Vall d''Hebron Institute of Oncology, Barcelona, Spain;18. Hospital Arnau de Vilanova, Valencia, Spain |
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Abstract: | BackgroundEribulin has efficacy in patients with progression after ≥ 1 chemotherapeutic regimen for metastatic breast cancer (MBC). A short disease-free interval (DFI) and previous use of taxanes in the neoadjuvant or adjuvant setting have been associated with worse outcomes for patients receiving first-line chemotherapy for HER2-negative MBC. The aim of the present trial was to evaluate the efficacy and safety of eribulin as first-line therapy for patients with HER2-negative MBC with these poor prognostic factors.Patients and MethodsEribulin monotherapy was administered until disease progression or unacceptable toxicity. The principal selection criteria were HER2 negativity without previous chemotherapy for MBC, the previous use of taxanes for early-stage breast cancer, and a DFI of < 36 months (subsequently amended to 48 months). The primary endpoint was the investigator-assessed time to progression. The secondary endpoints included overall survival, progression-free survival, objective response rate, clinical benefit rate, duration of response, and toxicity profile. A total of 53 patients were enrolled and received ≥ 1 dose of eribulin.ResultsThe median patient age was 47 years (range, 23-82.8 years). The median DFI was 15.7 months (range, 0.1-46.4 months). The median investigator-assessed time to progression was 4.1 months (range, 0.2-27.8 months; 95% confidence interval, 3.2-6.2 months). The objective response and clinical benefit rate was 20.8% and 26.4%, respectively. All-grade and grade 3/4 adverse events developed in 96.2% and 69.8% of patients, respectively. The most common treatment-related adverse events were neutropenia, leukopenia, alopecia, nausea, and anemia.ConclusionEribulin is effective and safe as first-line therapy for aggressive taxane-pretreated HER2-negative MBC. |
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Keywords: | Aggressive taxane-pretreated patients Eribulin First-line chemotherapy HER2-negative Metastatic breast cancer |
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