title: Prospective randomized study comparing sentinel lymph node evaluation with standard pathologic evaluation for the staging of colon carcinoma: results from the United States Military Cancer Institute Clinical Trials Group Study GI-01.
abstract: BACKGROUND
  The principal role of sentinel lymph node (SLN) sampling and ultrastaging in colon cancer is enhanced staging accuracy. The utility of this technique for patients with colon cancer remains controversial.
  
  
  OBJECTIVE
  This multicenter randomized trial was conducted to determine if focused assessment of the SLN with step sectioning and immunohistochemistry (IHC) enhances the ability to stage the regional nodal basin over conventional histopathology in patients with resectable colon cancer.
  
  
  METHODS
  Between August 2002 and April 2006 we randomly assigned 161 patients with stage I-III colon cancer to standard histopathologic evaluation or SLN mapping (ex vivo, subserosal, peritumoral, 1% isosulfan blue dye) and ultrastaging with pan-cytokeratin IHC in conjunction with standard histopathology. SLN-positive disease was defined as individual tumor cells or cell aggregates identified by hematoxylin and eosin (H&E) and/or IHC. Primary end point was the rate of nodal upstaging.
  
  
  RESULTS
  Significant nodal upstaging was identified with SLN ultrastaging (Control vs. SLN: 38.7% vs. 57.3%, P = 0.019). When SLNs with cell aggregates < or =0.2 mm in size were excluded, no statistically significant difference in node-positive rate was apparent between the control and SLN arms (38.7% vs. 39.0%, P = 0.97). However, a 10.7% (6/56) nodal upstaging was identified by evaluation of H&E stained step sections of SLNs among study arm patients who would have otherwise been staged node-negative (N0) by conventional pathologic assessment alone.
  
  
  CONCLUSIONS
  SLN mapping, step sectioning, and immunohistochemistry (IHC) identifies small volume nodal disease and improves staging in patients with resectable colon cancer. A prospective trial is ongoing to determine the clinical significance of colon cancer micrometastasis in sentinel lymph nodes.
authors.affiliation: Department of Surgery, Division of Surgical Oncology, and United States Military Cancer Institute, Walter Reed Army Medical Center, 6900 Georgia Avenue N.W., Washington, D.C. 20307, USA. alexander.stojadinovic@na.amedd.army.mil
authors.forename: Alexander
authors.initials: A
authors.lastname: Stojadinovic
authors.forename: Aviram
authors.initials: A
authors.lastname: Nissan
authors.forename: Mladjan
authors.initials: M
authors.lastname: Protic
authors.forename: Carol F
authors.initials: CF
authors.lastname: Adair
authors.forename: Diana
authors.initials: D
authors.lastname: Prus
authors.forename: Slavica
authors.initials: S
authors.lastname: Usaj
authors.forename: Robin S
authors.initials: RS
authors.lastname: Howard
authors.forename: Dragan
authors.initials: D
authors.lastname: Radovanovic
authors.forename: Milan
authors.initials: M
authors.lastname: Breberina
authors.forename: Craig D
authors.initials: CD
authors.lastname: Shriver
authors.forename: Ronit
authors.initials: R
authors.lastname: Grinbaum
authors.forename: Jeffery M
authors.initials: JM
authors.lastname: Nelson
authors.forename: Tommy A
authors.initials: TA
authors.lastname: Brown
authors.forename: Herbert R
authors.initials: HR
authors.lastname: Freund
authors.forename: John F
authors.initials: JF
authors.lastname: Potter
authors.forename: Tamar
authors.initials: T
authors.lastname: Peretz
authors.forename: George E
authors.initials: GE
authors.lastname: Peoples
mesh_terms: D000368:Aged; D016009:Chi-Square Distribution; D003110:Colonic Neoplasms / Q000473:pathology*; D004396:Coloring Agents; D005260:Female; D006801:Humans; D007124:Immunoenzyme Techniques; D007633:Keratins; D016015:Logistic Models; D008198:Lymph Nodes / Q000473:pathology*; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D008889:Military Personnel; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D012394:Rosaniline Dyes; D021701:Sentinel Lymph Node Biopsy; D016896:Treatment Outcome; D014481:United States
chemical_list: D004396:Coloring Agents; D012394:Rosaniline Dyes; C025484:iso-sulfan blue; D007633:Keratins