title: Gemcitabine/epirubicin/paclitaxel as neoadjuvant chemotherapy in locally advanced breast cancer: a phase II trial of the NSABP Foundation Research Group.
abstract: BACKGROUND
  This phase II protocol of neoadjuvant chemotherapy with gemcitabine/epirubicin/paclitaxel (GET) was designed to determine the pathologic complete response (pCR) rate in the breast, clinical response rate, disease-free survival, and overall survival at 2 years as well as toxicity in patients with locally advanced breast cancer. This trial also evaluated the feasibility of tissue collection for gene-expression profiling.
  
  
  METHODS
  Seventy-six women with stage IIB, IIIA, and IIIB breast cancer were entered into this trial. Patients received a maximum of 6 cycles of neoadjuvant GET chemotherapy every 21 days (gemcitabine 1000 mg/m2 intravenously [i.v.] on days 1 and 4, epirubicin 90 mg/m2 i.v. bolus on day 1, and paclitaxel 175 mg/m2 i.v. on day 1). After chemotherapy, patients underwent surgery and were assessed for pathologic response.
  
  
  RESULTS
  The pCR rate among the 74 patients evaluable for efficacy was 23% (95% CI, 14%-34.2%). Adverse events among the 76 patients evaluable for toxicity included anemia requiring transfusion (14.5%), infection with grade 3/4 neutropenia (10.5%), febrile neutropenia (7.9%), and platelet transfusion (6.6%). Infectious complications occurred in 24 patients (31.6%), of whom 18.4% were in the setting of neutropenia. High-quality RNA and successful probe synthesis were obtained from all pretreatment core biopsy specimens that contained tumor cells (n=66; 88%).
  
  
  CONCLUSIONS
  Neoadjuvant GET chemotherapy is an active regimen but with substantial toxicity. Tissue collection for gene-expression profiling is feasible in a multi-institutional setting.
authors.affiliation: National Surgical Adjuvant Breast and Bowel Project Operations Office and Biostatistical Center, Philadelphia, PA, USA.
authors.forename: John T
authors.initials: JT
authors.lastname: Hamm
authors.forename: John W
authors.initials: JW
authors.lastname: Wilson
authors.forename: Priya
authors.initials: P
authors.lastname: Rastogi
authors.forename: Barry C
authors.initials: BC
authors.lastname: Lembersky
authors.forename: George C
authors.initials: GC
authors.lastname: Tseng
authors.forename: Young K
authors.initials: YK
authors.lastname: Song
authors.forename: Wanseop
authors.initials: W
authors.lastname: Kim
authors.forename: André
authors.initials: A
authors.lastname: Robidoux
authors.forename: Jane M
authors.initials: JM
authors.lastname: Raymond
authors.forename: Carl G
authors.initials: CG
authors.lastname: Kardinal
authors.forename: Ibrahim A
authors.initials: IA
authors.lastname: Shalaby
authors.forename: Rafat
authors.initials: R
authors.lastname: Ansari
authors.forename: Soonmyung
authors.initials: S
authors.lastname: Paik
authors.forename: Charles E
authors.initials: CE
authors.lastname: Geyer
authors.forename: Norman
authors.initials: N
authors.lastname: Wolmark
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D020869:Gene Expression Profiling; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010349:Patient Compliance; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D015251:Epirubicin; D017239:Paclitaxel; D000093542:Gemcitabine