title: High pathologic complete response in Her2-positive, early-stage breast cancer to a novel nonanthracycline neoadjuvant chemotherapy.
abstract: BACKGROUND
  Neoadjuvant chemotherapy is widely used to downstage breast cancers before surgery and is an accepted standard of care among patients with early-stage breast cancer in whom adjuvant chemotherapy would be recommended. Pathologic complete response (pCR) rate is a robust predictor of outcome for certain breast cancer subtypes, including Her2-overexpressing breast cancer. The incorporation of Her2-targeted therapies has significantly increased the pCR rate in the neoadjuvant setting. Although regimens composed of trastuzumab, nab-paclitaxel, and vinorelbine have demonstrated clinical efficacy in patients with metastatic breast cancer, few studies have examined this combination in early-stage Her2+ breast cancer. We hypothesized that the combination of neoadjuvant nab-paclitaxel followed by vinorelbine could represent a nonanthracycline-based treatment option for early-stage Her2-overexpressing breast cancer.
  
  
  METHODS
  Patients received 4 cycles of nab-paclitaxel 260 mg/m(2) intravenously (IV) every 14 days for 4 cycles followed by vinorelbine 25 mg/m(2) IV weekly for 12 weeks with concurrent trastuzumab (4 mg/kg loading dose, and then 2 mg/kg/wk). The primary endpoint was the rate of pCR. Secondary endpoints included clinical response, toxicity, and survival rates.
  
  
  RESULTS
  A total of 27 patients were accrued to the trial. The median tumor size was 4.0 cm, and more than 50% of patients had axillary lymph node involvement. The pCR rate was 48.1%. Among the 40% of patients who had hormone receptor-positive disease, the pCR rate was 18.2%, compared with 68.8% among patients with estrogen receptor/progesterone receptor-negative tumors.
  
  
  CONCLUSIONS
  The combination of trastuzumab with nab-paclitaxel followed by vinorelbine was well tolerated and had promising activity in the neoadjuvant setting.
authors: Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA. Electronic address: amelia.zelnak@emory.edu.
authors: Amelia B
authors: AB
authors: Zelnak
authors: Georgia Center for Oncology Research and Education, Atlanta, GA.
authors: Petros
authors: P
authors: Nikolinakos
authors: Georgia Center for Oncology Research and Education, Atlanta, GA.
authors: Jayanthi
authors: J
authors: Srinivasiah
authors: Georgia Center for Oncology Research and Education, Atlanta, GA.
authors: William
authors: W
authors: Jonas
authors: Georgia Center for Oncology Research and Education, Atlanta, GA.
authors: Andrew
authors: A
authors: Pippas
authors: Department of Biostatistics and Bioinformatics, Winship Cancer Institute, Emory University School of Public Health, Atlanta, GA.
authors: Yuan
authors: Y
authors: Liu
authors: Department of Pathology, Emory University School of Medicine, Atlanta, GA.
authors: Xiaoxian
authors: X
authors: Li
authors: Department of Radiation Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA.
authors: Mylin
authors: M
authors: Torres
authors: Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA.
authors: Ruth M
authors: RM
authors: O'Regan
mesh_terms: D000328:Adult; D000418:Albumins / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D012008:Recurrence; D012074:Remission Induction; D016019:Survival Analysis; D000068878:Trastuzumab; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D000418:Albumins; D061067:Antibodies, Monoclonal, Humanized; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; D014747:Vinblastine; D000077235:Vinorelbine; C520255:130-nm albumin-bound paclitaxel; C508053:ERBB2 protein, human
keywords: Breast cancer; Nab-paclitaxel; Neoadjuvant chemotherapy; Pathologic complete response; Trastuzumab