title: Multicenter trial of sentinel node biopsy for breast cancer using both technetium sulfur colloid and isosulfan blue dye.
abstract: OBJECTIVE
  To determine the factors associated with false-negative results on sentinel node biopsy and sentinel node localization (identification rate) in patients with breast cancer enrolled in a multicenter trial using a combination technique of isosulfan blue with technetium sulfur colloid (Tc99).
  
  
  BACKGROUND
  Sentinel node biopsy is a diagnostic test used to detect breast cancer metastases. To test the reliability of this method, a complete lymph node dissection must be performed to determine the false-negative rate. Single-institution series have reported excellent results, although one multicenter trial reported a false-negative rate as high as 29% using radioisotope alone. A multicenter trial was initiated to test combined use of Tc99 and isosulfan blue.
  
  
  METHODS
  Investigators (both private-practice and academic surgeons) were recruited after attending a course on the technique of sentinel node biopsy. No investigator participated in a learning trial before entering patients. Tc99 and isosulfan blue were injected into the peritumoral region.
  
  
  RESULTS
  Five hundred twenty-nine patients underwent 535 sentinel node biopsy procedures for an overall identification rate in finding a sentinel node of 87% and a false-negative rate of 13%. The identification rate increased and the false-negative rate decreased to 90% and 4.3%, respectively, after investigators had performed more than 30 cases. Univariate analysis of tumor showed the poorest success rate with older patients and inexperienced surgeons. Multivariate analysis identified both age and experience as independent predictors of failure. However, with older patients, inexperienced surgeons, and patients with five or more metastatic axillary nodes, the false-negative rate was consistently greater.
  
  
  CONCLUSIONS
  This multicenter trial, from both private practice and academic institutions, is an excellent indicator of the general utility of sentinel node biopsy. It establishes the factors that play an important role (patient age, surgical experience, tumor location) and those that are irrelevant (prior surgery, tumor size, Tc99 timing). This widens the applicability of the technique and identifies factors that require further investigation.
authors.affiliation: Breast Center, Anne Arundel Medical Center, Annapolis, Maryland 21401, USA. ltafra@AAHS.org
authors.forename: L
authors.initials: L
authors.lastname: Tafra
authors.forename: D R
authors.initials: DR
authors.lastname: Lannin
authors.forename: M S
authors.initials: MS
authors.lastname: Swanson
authors.lastname: Van Eyk JJ
authors.forename: K M
authors.initials: KM
authors.lastname: Verbanac
authors.forename: A N
authors.initials: AN
authors.lastname: Chua
authors.forename: P C
authors.initials: PC
authors.lastname: Ng
authors.forename: M S
authors.initials: MS
authors.lastname: Edwards
authors.forename: B E
authors.initials: BE
authors.lastname: Halliday
authors.forename: C A
authors.initials: CA
authors.lastname: Henry
authors.forename: L M
authors.initials: LM
authors.lastname: Sommers
authors.forename: C M
authors.initials: CM
authors.lastname: Carman
authors.forename: M R
authors.initials: MR
authors.lastname: Molin
authors.forename: J E
authors.initials: JE
authors.lastname: Yurko
authors.forename: R R
authors.initials: RR
authors.lastname: Perry
authors.forename: R
authors.initials: R
authors.lastname: Williams
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology* / Q000601:surgery; D005188:False Negative Reactions; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis / Q000000981:diagnostic imaging / Q000473:pathology*; D008875:Middle Aged; D011877:Radionuclide Imaging; D019275:Radiopharmaceuticals; D012394:Rosaniline Dyes; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*; D013671:Technetium Tc 99m Sulfur Colloid
chemical_list: D019275:Radiopharmaceuticals; D012394:Rosaniline Dyes; C025484:iso-sulfan blue; D013671:Technetium Tc 99m Sulfur Colloid