title: Preoperative neoadjuvant chemotherapy using nanoparticle albumin-bound paclitaxel followed by epirubicin and cyclophosphamide for operable breast cancer: a multicenter phase II trial.
abstract: BACKGROUND
  Recently, the use of taxane-based regimens before anthracycline-based regimens has been shown to achieve high pathological complete response (pCR) rates in patients with breast cancer. Nanoparticle albumin-bound paclitaxel (nab-PTX) has been reported as highly effective and less toxic compared with Cremophor-based Taxol. This phase II clinical trial evaluated the safety and efficacy of preoperative neoadjuvant chemotherapy (NAC) with nab-PTX followed by an epirubicin plus cyclophosphamide (EC)-based regimen for operable breast cancer.
  
  
  METHODS
  From June 2012 to January 2014, four cycles of every-3-week (q3w) nab-PTX [plus q3w trastuzumab in cases of human epidermal growth factor 2 (HER2) positivity] followed by four cycles of q3w EC were administered to patients with operable breast cancer (stage IC-IIIA). The primary endpoint was the pCR rate (ypT0/TisypN0).
  
  
  RESULTS
  A total of 55 patients were enrolled, 54 of whom received at least one nab-PTX dose. All patients underwent radical surgery after chemotherapy. The overall pCR rate was 22.2% (p = 0.006). The pCR rates for patients with the luminal B, luminal/HER2, HER2-rich, and triple-negative breast cancer subtypes were 10.5, 29.4, 60, and 15.4%, respectively. Stepwise logistic regression analysis revealed only HER2 as a significant factor for pCR (odds ratio 5.603; p = 0.024). The expression of secreted protein acidic and rich in cysteine showed no association with pCR. The clinical response rate was 70.4% (38/54), and the safety profile was tolerable.
  
  
  CONCLUSIONS
  Preoperative NAC with nab-PTX followed by EC is effective and safe for operable breast cancer.
authors.affiliation: Department of Surgical Oncology, Graduate School of Medicine, Gifu University, Gifu, Japan. mfutamur@gifu-u.ac.jp.
authors.forename: Manabu
authors.identifier: http://orcid.org/0000-0001-5622-8352
authors.initials: M
authors.lastname: Futamura
authors.affiliation: Department of Breast Surgery, Gifu Prefectural General Medical Center, Gifu, Japan.
authors.forename: Yasuko
authors.initials: Y
authors.lastname: Nagao
authors.affiliation: Department of Surgery, Gihoku Kosei Hospital, Gifu, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Ishihara
authors.affiliation: Department of Breast Surgery, Kizawa Memorial Hospital, Minokamo, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Takeuchi
authors.affiliation: Department of Breast Surgery, Gifu Municipal Hospital, Gifu, Japan.
authors.forename: Takumi
authors.initials: T
authors.lastname: Nakada
authors.affiliation: Department of Breast Surgery, Murakami Memorial Hospital, Gifu, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Kawaguchi
authors.affiliation: Department of Surgery, Municipal Ena Hospital, Ena, Japan.
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Asano
authors.affiliation: Department of Surgery, Ibi Kosei Hospital, Gifu, Japan.
authors.forename: Iwao
authors.initials: I
authors.lastname: Kumazawa
authors.affiliation: Department of Surgery, Takayama Red Cross Hospital, Takayama, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Shiroko
authors.affiliation: Department of Regional Medicine, Graduate School of Medicine, Gifu University, Gifu, Japan.
authors.forename: Kasumi
authors.initials: K
authors.lastname: Morimitsu
authors.affiliation: Department of Surgical Oncology, Graduate School of Medicine, Gifu University, Gifu, Japan.
authors.forename: Ryutaro
authors.initials: R
authors.lastname: Mori
authors.affiliation: Department of Breast Surgery, Murakami Memorial Hospital, Gifu, Japan.
authors.forename: Masahito
authors.initials: M
authors.lastname: Nawa
authors.affiliation: Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.
authors.forename: Toshio
authors.initials: T
authors.lastname: Shimokawa
authors.affiliation: Department of Surgical Oncology, Graduate School of Medicine, Gifu University, Gifu, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yoshida
mesh_terms: D000328:Adult; D000368:Aged; D000418:Albumins / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000378:metabolism; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D003520:Cyclophosphamide / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D017239:Paclitaxel / Q000008:administration & dosage; D011300:Preoperative Care; D011379:Prognosis; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics / Q000378:metabolism; D011960:Receptors, Estrogen / Q000378:metabolism; D011980:Receptors, Progesterone / Q000378:metabolism; D015996:Survival Rate; D055815:Young Adult
chemical_list: D000418:Albumins; D014408:Biomarkers, Tumor; D003520:Cyclophosphamide; D015251:Epirubicin; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; C520255:130-nm albumin-bound paclitaxel; C508053:ERBB2 protein, human
keywords: Nab-PTX; Neoadjuvant chemotherapy; SPARC; pCR