title: Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound.
abstract: Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era in which tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesized that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care.
  
  
  
  Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (arm 1) vs SLNB (arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial.
  
  
  
  Sixty-eight subjects were enrolled in the pilot phase of the trial (34 subjects in arm 1, no further staging; 32 subjects in arm 2, SLNB; and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40 to 80 years) in arm 1 and 59 years (range 31 to 81 years) in arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1 to 32 months). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (>2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm.
  
  
  
  Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial.
authors.affiliation: Department of Surgery, Washington University School of Medicine, St Louis, MO. Electronic address: cyra@wudosis.wustl.edu.
authors.forename: Amy E
authors.initials: AE
authors.lastname: Cyr
authors.affiliation: Department of Surgery, Washington University School of Medicine, St Louis, MO.
authors.forename: Natalia
authors.initials: N
authors.lastname: Tucker
authors.affiliation: Department of Medicine, Washington University School of Medicine, St Louis, MO.
authors.forename: Foluso
authors.initials: F
authors.lastname: Ademuyiwa
authors.affiliation: Department of Surgery, Washington University School of Medicine, St Louis, MO.
authors.forename: Julie A
authors.initials: JA
authors.lastname: Margenthaler
authors.affiliation: Department of Surgery, Washington University School of Medicine, St Louis, MO.
authors.forename: Rebecca L
authors.initials: RL
authors.lastname: Aft
authors.affiliation: Department of Surgery, Washington University School of Medicine, St Louis, MO.
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Eberlein
authors.affiliation: Department of Radiology, Washington University School of Medicine, St Louis, MO.
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Appleton
authors.affiliation: Department of Radiation Oncology, Washington University School of Medicine, St Louis, MO.
authors.forename: Imran
authors.initials: I
authors.lastname: Zoberi
authors.affiliation: Department of Radiation Oncology, Washington University School of Medicine, St Louis, MO.
authors.forename: Maria A
authors.initials: MA
authors.lastname: Thomas
authors.affiliation: Department of Surgery, Washington University School of Medicine, St Louis, MO; Division of Biostatistics, Washington University School of Medicine, St Louis, MO.
authors.forename: Feng
authors.initials: F
authors.lastname: Gao
authors.affiliation: Department of Surgery, Washington University School of Medicine, St Louis, MO.
authors.forename: William E
authors.initials: WE
authors.lastname: Gillanders
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001365:Axilla; D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology* / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000000981:diagnostic imaging / Q000473:pathology* / Q000601:surgery; D018275:Carcinoma, Lobular / Q000000981:diagnostic imaging / Q000473:pathology* / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008198:Lymph Nodes / Q000000981:diagnostic imaging* / Q000473:pathology / Q000601:surgery; D008875:Middle Aged; D009367:Neoplasm Staging; D017063:Outcome Assessment, Health Care; D010865:Pilot Projects; D011446:Prospective Studies; D021701:Sentinel Lymph Node Biopsy; D014463:Ultrasonography