title: Prognostic Effect of Ultra-Staging Node-Negative Colon Cancer Without Adjuvant Chemotherapy: A Prospective National Cancer Institute-Sponsored Clinical Trial.
abstract: BACKGROUND
  We recently reported, in a prospective randomized trial, that ultra-staging of patients with colon cancer is associated with significantly improved disease-free survival (DFS) compared with conventional staging. That trial did not control for lymph node (LN) number or adjuvant chemotherapy use.
  
  
  METHODS
  The current international prospective multicenter cooperative group trial (ClinicalTrials.gov identifier NCT00949312; "Ultra-staging in Early Colon Cancer") evaluates the 12-LN quality measure and nodal ultra-staging impact on DFS in patients not receiving adjuvant chemotherapy. Eligibility criteria included biopsy-proven colon adenocarcinoma; absence of metastatic disease; >12 LNs staged pathologically; pan-cytokeratin immunohistochemistry (IHC) of hematoxylin and eosin (H&E)-negative LNs; and no adjuvant chemotherapy.
  
  
  RESULTS
  Of 445 patients screened, 203 patients were eligible. The majority of patients had intermediate grade (57.7%) and T3 tumors (64.9%). At a mean follow-up of 36.8 ± 22.1 months (range 0 to 97 months), 94.3% remain disease free. Recurrence was least likely in patients with ≥12 LNs, H&E-negative LNs, and IHC-negative LNs (pN0i-): 2.6% vs 16.7% in the pN0i+ group (p < 0.0001).
  
  
  CONCLUSIONS
  This is the first prospective report to demonstrate that patients with optimally staged node-negative colon cancer (≥12 LNs, pN0i-) are unlikely to benefit from adjuvant chemotherapy; 97% remain disease free after primary tumor resection. Both surgical and pathologic quality measures are imperative in planning clinical trials in nonmetastatic colon cancer.
authors.affiliation: Clinic of Surgical Oncology, Oncology Institute of Vojvodina, Sremska Kamenica, Serbia; University of Novi Sad - Faculty of Medicine, Novi Sad, Serbia.
authors.forename: Mladjan
authors.initials: M
authors.lastname: Protic
authors.affiliation: Uniformed Services University of the Health Sciences, Bethesda, MD.
authors.forename: Alexander
authors.initials: A
authors.lastname: Stojadinovic
authors.affiliation: Sheba General Hospital, The Chaim Sheba Medical Center, Tel-Hashomer, Israel.
authors.forename: Aviram
authors.initials: A
authors.lastname: Nissan
authors.affiliation: University of California, Los Angeles, Los Angeles, CA.
authors.forename: Zev
authors.initials: Z
authors.lastname: Wainberg
authors.affiliation: Madigan Army Medical Center, Tacoma, WA; University Hospitals, Case Western Reserve University, Cleveland, OH.
authors.forename: Scott R
authors.initials: SR
authors.lastname: Steele
authors.affiliation: University of California, Los Angeles, Los Angeles, CA.
authors.forename: David C
authors.initials: DC
authors.lastname: Chen
authors.affiliation: Uniformed Services University of the Health Sciences, Bethesda, MD.
authors.forename: Itzhak
authors.initials: I
authors.lastname: Avital
authors.affiliation: University of California, Los Angeles, Los Angeles, CA; John Wayne Cancer Institute at Providence Saint John's Health Center, Santa Monica, CA; California Oncology Research Institute, Santa Monica, CA. Electronic address: bilchika@jwci.org.
authors.forename: Anton J
authors.initials: AJ
authors.lastname: Bilchik
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D000368:Aged; D000369:Aged, 80 and over; D017024:Chemotherapy, Adjuvant; D003082:Colectomy; D003110:Colonic Neoplasms / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies