NSABP Members' Area
  Password Protected - Access
  Limited to NSABP Participating
  Institutions Only


NSABP Foundation, Inc.



General NSABP Information
  Financial Conflicts of
     Interest Policy
  Coalition Comment:
     Reconfiguration
  IOM Report Group Comment
  Contact the NSABP
  Pathology Section
  Future Meetings
  NSABP Newsletters
  Media Info on STAR
  Employment

Clinical Trials Information
  Clinical Trials Overview
  Protocol Chart
  Never Say Lost

Treatment Trials Information
  Protocol B-43
  Protocol B-47
  Protocol B-51

Prevention Trials Information
  Protocol P-1 - BCPT
  Protocol P-2 - STAR
  Protocol P-5
  BreastCancerPrevention.com

Scientific Publications

Related Web Sites



Medical Search Engines



To report problems, ask
questions or make comments,
please send e-mail to:
Webmaster@nsabp.pitt.edu

Annotated Bibliography of NSABP Publications


Oxaliplatin Combined With Weekly Bolus Fluorouracil and Leucovorin as Surgical Adjuvant Chemotherapy for Stage II and III Colon Cancer: Results from NSABP C-07.
Kuebler JP, Wieand HS, O’Connell MJ, Smith RE, Colangelo LH, Yothers G, Petrelli NJ, Findlay MP, Seay TE, Atkins JN, Zapas JL, Goodwin JW, Fehrenbacher L, Ramanathan RK, Conley BA, Flynn PJ, Soori G, Colman LK, Levine EA, Lanier KS, Wolmark N.
J Clin Oncol. 2007 Jun 1;25(16):2198-204. Epub 2007 Apr 30.

Abstract
Purpose: This phase III clinical trial evaluated the impact on disease-free survival (DFS) of adding oxaliplatin to bolus weekly fluorouracil (FU) combined with leucovorin as surgical adjuvant therapy for stage II and III colon cancer.

Patients and Methods: Patients who had undergone a potentially curative resection were randomly assigned to either FU 500 mg/m2 intravenous (IV) bolus weekly for 6 weeks plus leucovorin 500 mg/m2 IV weekly for 6 weeks during each 8-week cycle for three cycles (FULV), or the same FULV regimen with oxaliplatin 85 mg/m2 IV administered on weeks 1, 3, and 5 of each 8-week cycle for three cycles (FLOX).

Results: A total of 2,407 patients (96.6%) of the 2,492 patients randomly assigned were eligible. Median follow-up for patients still alive is 42.5 months. The hazard ratio (FLOX v FULV) is 0.80 (95% CI, 0.69 to 0.93), a 20% risk reduction in favor of FLOX (P < .004). The 3- and 4-year disease-free survival (DFS) rates were 71.8% and 67.0% for FULV and 76.1% and 73.2% for FLOX, respectively. Grade 3 neurosensory toxicity was noted in 8.2% of patients receiving FLOX and in 0.7% of those receiving FULV (P < .001). Hospitalization for diarrhea associated with bowel wall thickening occurred in 5.5% of the patients receiving FLOX and in 3.0% of the patients receiving FULV (P < .01). A total of 1.2% of patients died as a result of any cause within 60 days of receiving chemotherapy, with no significant difference between regimens.

Conclusion: The addition of oxaliplatin to weekly FULV significantly improved DFS in patients with stage II and III colon cancer. FLOX can be recommended as an effective option in clinical practice.


PMID: 17470851