title: Comparison of outcomes after fluorouracil-based adjuvant therapy for stages II and III colon cancer between 1978 to 1995 and 1996 to 2007: evidence of stage migration from the ACCENT database.
abstract: OBJECTIVE
  With improved patient care, better diagnosis, and more treatment options after tumor recurrence, outcomes after fluorouracil (FU) -based treatment are expected to have improved over time in early-stage colon cancer. Data from 18,449 patients enrolled onto 21 phase III trials conducted from 1978 to 2002 were evaluated for potential differences in time to recurrence (TTR), time from recurrence to death (TRD), and overall survival (OS) with regard to FU-based adjuvant regimens.
  
  
  METHODS
  Trials were predefined as old versus newer era using initial accrual before or after 1995. Outcomes were compared between patients enrolled onto old- or newer-era trials, stratified by stage.
  
  
  RESULTS
  Within the first 3 years, recurrence rates were lower in newer- versus old-era trials for patients with stage II disease, with no differences among those with stage III disease. Both TRD and OS were significantly longer in newer-era trials overall and within each stage. The lymph node (LN) ratio (ie, number of positive nodes divided by total nodes harvested) in those with stage III disease declined over time. TTR improved slightly, with larger number of LNs examined in both stages.
  
  
  CONCLUSIONS
  Improved TRD in newer trials supports the premise that more aggressive intervention (oxaliplatin- and irinotecan-based chemotherapy and/or surgery for recurrent disease) improves OS for patients previously treated in the adjuvant setting. Lower recurrence rates with identical treatments in those with stage II disease enrolled onto newer-era trials reflect stage migration over time, calling into question historical data related to the benefit of FU-based adjuvant therapy in such patients.
authors: Qian Shi, Axel Grothey, Brian M. Bot, and Daniel J. Sargent, North Central Cancer Treatment Group, Mayo Clinic, Rochester, MN; Thierry Andre, Hôpital Saint Antoine, Paris, France; Greg Yothers and Michael J. O'Connell, National Surgical Adjuvant Breast and Bowel Project, Pittsburgh; Daniel G. Haller, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Stanley R. Hamilton, University of Texas MD Anderson Cancer Center, Houston, TX; Brian M. Bot, Sage Bionetworks; Jacqueline K. Benedetti, Southwest Oncology Group Statistical Center, Seattle, WA; Eric Van Cutsem, University Hospital Gasthuisberg, Gasthuisberg, Belgium; and Chris Twelves, St James's University Hospital, Leeds, United Kingdom.
authors: Qian
authors: Q
authors: Shi
authors: Thierry
authors: T
authors: Andre
authors: Axel
authors: A
authors: Grothey
authors: Greg
authors: G
authors: Yothers
authors: Stanley R
authors: SR
authors: Hamilton
authors: Brian M
authors: BM
authors: Bot
authors: Daniel G
authors: DG
authors: Haller
authors: Eric
authors: E
authors: Van Cutsem
authors: Chris
authors: C
authors: Twelves
authors: Jacqueline K
authors: JK
authors: Benedetti
authors: Michael J
authors: MJ
authors: O'Connell
authors: Daniel J
authors: DJ
authors: Sargent
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005472:Fluorouracil
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