title: Phase II open-label study of bevacizumab combined with neoadjuvant anthracycline and taxane therapy for locally advanced breast cancer.
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.
  
  
  BACKGROUND
  NCT00559845.
authors: EO Ospedali Galliera, Mura delle Cappuccine 14, 16128 Genoa, Italy. matclava78@libero.it
authors: Matteo
authors: M
authors: Clavarezza
authors: Monica
authors: M
authors: Turazza
authors: Enrico
authors: E
authors: Aitini
authors: Silvana
authors: S
authors: Saracchini
authors: Ornella
authors: O
authors: Garrone
authors: Antonio
authors: A
authors: Durando
authors: Sabino
authors: S
authors: De Placido
authors: Giancarlo
authors: G
authors: Bisagni
authors: Alessia
authors: A
authors: Levaggi
authors: Claudia
authors: C
authors: Bighin
authors: Eleonora
authors: E
authors: Restuccia
authors: Roberto
authors: R
authors: Scalamogna
authors: Anna
authors: A
authors: Galli
authors: Lucia
authors: L
authors: Del Mastro
mesh_terms: D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D003520:Cyclophosphamide / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D015251:Epirubicin / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D058922:Inflammatory Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D017239:Paclitaxel / Q000008:administration & dosage; D016896:Treatment Outcome; D064726:Triple Negative Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D015251:Epirubicin; D003520:Cyclophosphamide; D017239:Paclitaxel; D005472:Fluorouracil