title: Prospective multicenter trial of staging adequacy in colon cancer: preliminary results.
abstract: OBJECTIVE
  Lymph node evaluation is an important prognostic factor in colorectal cancer (CRC). A 25% recurrence rate in patients with node-negative CRC suggests that current staging practices are inadequate. Focused analysis of the sentinel node (SN) by multiple sectioning and immunohistochemistry improves staging accuracy.
  
  
  METHODS
  Prospective phase 2 multicenter trial.
  
  
  METHODS
  Tertiary referral cancer centers.
  
  
  METHODS
  Between March 2001 and June 2005, 132 patients were enrolled with clinical stage I and II CRC in a prospective multicenter trial (R01-CA90484).
  
  
  METHODS
  During a standard oncologic resection, lymphatic mapping was performed and the SN identified either by the surgeon or the pathologist. Hematoxylin-eosin staining was performed on all lymph nodes and immunohistochemistry, on lymph nodes negative by hematoxylin-eosin staining.
  
  
  METHODS
  Micrometastases greater than 0.2 mm but less than 2 mm and isolated tumor cells less than 0.2 mm were defined according to the sixth edition of the American Joint Committee on Cancer Cancer Staging Manual.
  
  
  RESULTS
  The 63 men and 69 women had a median age of 74 years. Sixty-eight patients (52%) underwent a right hemicolectomy; 3 (2.3%), a transverse colectomy; 9 (7%), a left colectomy; 15 (11%), a sigmoid colectomy; 34 (26%), a low anterior resection; 1 (1%), an abdominal perineal resection; and 2 (2%), a total colectomy. Of the 111 evaluable primary tumors, 19 (17%) were T1 lesions; 17 (15%), T2; 72 (65%), T3; and 3 (2.7%), T4 tumors. Thirty-three patients (30%) were classified as stage I; 46 (41%), stage II, and 32 (29%), stage III. The SN was identified by the surgeon in 127 patients (96%) and by the pathologist in 5 patients (4%). The median number of SNs and total lymph nodes examined were 3 and 14.5, respectively. The sensitivity of lymphatic mapping and SN analysis was 88.2% and the false-negative rate, 7.4% (6/81). Of the 6 false-negative results, 4 were attributed to lymphatic channels obliterated by tumor. Upstaging occurred in 28 patients (23.6%).
  
  
  CONCLUSIONS
  In a multicenter trial, ultrastaging of colon cancer is feasible and accurate. In stage II CRC, 24% of patients had nodal carcinoma cells not detected by conventional staging methods. Surgical technique (adequate lymph node retrieval) and focused pathological analysis may improve staging accuracy and the selection of patients for chemotherapy. The unnecessary toxicity and expense of chemotherapy may be avoided in those patients who are truly node negative.
authors.affiliation: John Wayne Cancer Institute and Saint Johns Health Center, Santa Monica, CA 90404, USA. bilchikA@jwci.org
authors.forename: Anton J
authors.initials: AJ
authors.lastname: Bilchik
authors.forename: Maggie
authors.initials: M
authors.lastname: DiNome
authors.forename: Sukamal
authors.initials: S
authors.lastname: Saha
authors.forename: Roderick R
authors.initials: RR
authors.lastname: Turner
authors.forename: David
authors.initials: D
authors.lastname: Wiese
authors.forename: Martin
authors.initials: M
authors.lastname: McCarter
authors.forename: Dave S B
authors.initials: DS
authors.lastname: Hoon
authors.forename: Donald L
authors.initials: DL
authors.lastname: Morton
mesh_terms: D000368:Aged; D003082:Colectomy; D003110:Colonic Neoplasms / Q000473:pathology* / Q000601:surgery; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D008207:Lymphatic Metastasis; D008297:Male; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D012394:Rosaniline Dyes; D021701:Sentinel Lymph Node Biopsy
chemical_list: D012394:Rosaniline Dyes; C025484:iso-sulfan blue