title: Preoperative carboplatin-paclitaxel-bevacizumab in triple-negative breast cancer: final results of the phase II Ca.Pa.Be study.
abstract: OBJECTIVE
  The phase II Ca.Pa.Be trial evaluated preoperative carboplatin-paclitaxel in combination with bevacizumab in triple-negative breast cancer patients with previously untreated stage II-III disease. The primary aim was the assessment of the rate of pathologic complete response (pCR). Secondary aims included safety, breast-conserving surgery rate, and early response assessment with dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).
  
  
  METHODS
  Patients with hormone receptor-negative, HER-2-negative stage II-III breast cancer were eligible. Treatment included paclitaxel 80 mg/mq + carboplatin area under the curve (AUC) 2 on days 1, 8, and 15, combined with bevacizumab 10 mg/kg on days 1 and 15 each 28 days, for 5 courses. At baseline, patients underwent breast DCE-MRI, followed by a single dose of bevacizumab 5 mg/kg (day -6). DCE-MRI was repeated before the initiation of chemotherapy.
  
  
  RESULTS
  Forty-four patients were enrolled. Forty-three patients underwent surgery, and 22 (50 %) received breast-conserving surgery (conversion rate from mastectomy indication at baseline, 34.4 %). A pCR in breast and axillary lymph nodes occurred in 22 patients (50 %). Bevacizumab-associated adverse events (AEs) were mild: G1-2 hypertension and bleeding occurred in 6 (13.6 %) and 12 (27 %) patients, respectively. No G4 nonhematologic AEs were recorded. More frequent G3 AEs were liver function test abnormalities (6.8 %), and diarrhea and fatigue (4.5 % each). The only G3-4 hematologic toxicity was neutropenia (G3, 25 %; G4, 9 %). Early assessed DCE-MRI response parameters failed to predict pCR.
  
  
  CONCLUSIONS
  The neoadjuvant anthracycline-free combination of weekly paclitaxel and carboplatin plus bevacizumab is active and safe in triple-negative breast cancer, and the rate of pCR is comparable to that observed with more intensive carboplatin- and bevacizumab-containing regimens. Further investigation is warranted.
authors.affiliation: Department of Surgery, Oncology, and Gastroenterology, University of Padova, Padua, Italy, valentina.guarneri@unipd.it.
authors.forename: Valentina
authors.initials: V
authors.lastname: Guarneri
authors.forename: Maria Vittoria
authors.initials: MV
authors.lastname: Dieci
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Bisagni
authors.forename: Corrado
authors.initials: C
authors.lastname: Boni
authors.forename: Katia
authors.initials: K
authors.lastname: Cagossi
authors.forename: Fabio
authors.initials: F
authors.lastname: Puglisi
authors.forename: Annarita
authors.initials: A
authors.lastname: Pecchi
authors.forename: Federico
authors.initials: F
authors.lastname: Piacentini
authors.forename: PierFranco
authors.initials: P
authors.lastname: Conte
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage; D016190:Carboplatin / Q000008:administration & dosage; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy* / Q000473:pathology; D003287:Contrast Media / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011300:Preoperative Care; D011379:Prognosis; D064726:Triple Negative Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D003287:Contrast Media; D000068258:Bevacizumab; D016190:Carboplatin; D017239:Paclitaxel