title: The efficacy and safety of preoperative chemotherapy with triweekly abraxane and cyclophosphamide followed by 5-Fluorouracil, epirubicin, and cyclophosphamide therapy for resectable breast cancer: a multicenter clinical trial.
abstract: BACKGROUND
  It has been reported that tri-weekly Abraxane therapy has better outcomes in recurrent breast cancer than tri-weekly Cremophor-based taxol therapy, and that cyclophosphamide combined with taxane shows an enhanced antitumor effect. We conducted a phase II clinical trial of preoperative chemotherapy with a combination of TRI-ABC.
  
  
  METHODS
  From September 2011 to September 2013, 4 cycles of preoperative chemotherapy with TRI-ABC followed by 4 cycles of FEC were administered in patients with resectable breast cancer. In patients with HER2-positive breast cancer, tri-weekly Trastuzumab was administered with TRI-ABC. The primary end point was the pathological complete response (pCR) rate in the breasts and lymph nodes.
  
  
  RESULTS
  The treatment outcomes and safety were evaluated in 54 patients who received at least 1 dose of chemotherapy. All patients underwent radical surgery, and the overall pCR rate of 37% (20 of 54) was achieved. The pCR rates according to each subtype were 8% (2 of 24) in hormone receptor (HR)-positive HER2-negative breast cancer, 56% (5 of 9) in HR-positive HER2-positive breast cancer, 63% (5 of 8) in HR-negative HER2-positive breast cancer, and 62% (8 of 13) in triple-negative breast cancer. Multivariate analysis revealed that HR negativity and HER2 positivity were predictive factors of pCR. Clinical response was observed in 49 patients (91%). The safety profile was acceptable.
  
  
  CONCLUSIONS
  Preoperative chemotherapy with TRI-ABC followed by FEC showed high efficacy and excellent safety. Further clinical studies should be conducted to compare the efficacy of TRI-ABC followed by FEC with conventional taxane-anthracycline regimens.
authors.affiliation: Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima-City, Hiroshima, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Shigematsu
authors.affiliation: Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima-City, Hiroshima, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Kadoya
authors.affiliation: Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima-City, Hiroshima, Japan.
authors.forename: Norio
authors.initials: N
authors.lastname: Masumoto
authors.affiliation: Department of Surgery, Onomichi General Hospital, Onomichi-City, Hiroshima, Japan.
authors.forename: Tatsunari
authors.initials: T
authors.lastname: Sasada
authors.affiliation: Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima-City, Hiroshima, Japan.
authors.forename: Akiko
authors.initials: A
authors.lastname: Emi
authors.affiliation: Department of Gastrointestinal, Breast, and Transplantation Surgery, Hiroshima Prefectural Hospital, Hiroshima-City, Hiroshima, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Ohara
authors.affiliation: Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima-City, Hiroshima, Japan.
authors.forename: Keiko
authors.initials: K
authors.lastname: Kajitani
authors.affiliation: Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima-City, Hiroshima, Japan. Electronic address: morihito1217@gmail.com.
authors.forename: Morihito
authors.initials: M
authors.lastname: Okada
mesh_terms: D000328:Adult; D000368:Aged; D000068196:Albumin-Bound Paclitaxel / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant / Q000379:methods*; D003520:Cyclophosphamide / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*
chemical_list: D000068196:Albumin-Bound Paclitaxel; D015251:Epirubicin; D003520:Cyclophosphamide; D005472:Fluorouracil
keywords: Abraxane; Breast cancer; Cyclophosphamide; Preoperative chemotherapy