1. Phase II open-label study of bevacizumab combined with neoadjuvant anthracycline and taxane therapy for locally advanced breast cancer
- Author
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Antonio Durando, M. Turazza, Ornella Garrone, Enrico Aitini, Giancarlo Bisagni, Claudia Bighin, Alessia Levaggi, Matteo Clavarezza, Roberto Scalamogna, Lucia Del Mastro, Anna Galli, Silvana Saracchini, Eleonora Restuccia, Sabino De Placido, Matteo, Clavarezza, Monica, Turazza, Enrico, Aitini, Silvana, Saracchini, Ornella, Garrone, Antonio, Durando, DE PLACIDO, Sabino, Giancarlo, Bisagni, Alessia, Levaggi, Claudia, Bighin, Eleonora, Restuccia, Roberto, Scalamogna, Anna, Galli, and Lucia Del, Mastro
- Subjects
Oncology ,Adult ,medicine.medical_specialty ,Bevacizumab ,Anthracycline ,Paclitaxel ,medicine.medical_treatment ,Angiogenesis Inhibitors ,Breast Neoplasms ,Triple Negative Breast Neoplasms ,Antibodies, Monoclonal, Humanized ,Breast cancer ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Cyclophosphamide ,Neoadjuvant therapy ,Aged ,Epirubicin ,Chemotherapy ,Taxane ,business.industry ,Carcinoma ,General Medicine ,Middle Aged ,medicine.disease ,Neoadjuvant Therapy ,Regimen ,Treatment Outcome ,Surgery ,Drug Therapy, Combination ,Female ,Inflammatory Breast Neoplasms ,Fluorouracil ,business ,medicine.drug - Abstract
Background Neoadjuvant anthracycline- and taxane-based chemotherapy is frequently administered in breast cancer. Pathological complete response (pCR) rates vary according to clinical disease stage and biology of breast cancer. The critical role of angiogenesis in the progression of breast cancer, together with significantly improved efficacy when bevacizumab is combined with chemotherapy in the metastatic setting, provides a strong rationale for evaluating the integration of bevacizumab into neoadjuvant chemotherapy regimens. Methods A single-arm, multicentre, phase II, open-label study evaluated four 3-weekly cycles of FEC (5-fluorouracil 600 mg/m 2 , epirubicin 90 mg/m 2 and cyclophosphamide 600 mg/m 2 ) followed by 12 cycles of weekly paclitaxel (80 mg/m 2 ) in combination with bevacizumab 10 mg/kg every 2 weeks as neoadjuvant therapy for HER2-negative stage III locally advanced or inflammatory breast carcinoma. The primary endpoint was pCR rate. Results Planned treatment was completed in 49 of the 56 enrolled patients. In the intent-to-treat population, the pCR rate was 21% and the clinical response rate was 59%. Breast-conserving surgery was achieved in 34% of patients. In the subgroup of 15 patients with triple-negative disease, the pCR rate was 47%. Grade 3 adverse events in ≥5% of patients were neutropenia, leucopenia, asthenia, and rash. One case each of hypertensive retinopathy and post-operative wound complication, both after treatment completion, were considered probably related to bevacizumab. There were no treatment-related deaths and no cardiac function abnormalities. Conclusions This study indicates that FEC followed by weekly paclitaxel with bevacizumab is an active neoadjuvant regimen for locally advanced breast cancer, with no major safety concerns. Clinical trial registration NCT00559845.
- Published
- 2012