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


Adjuvant 5-fluorouracil and leucovorin with or without interferon alfa- 2a in colon carcinoma: National Surgical Adjuvant Breast and Bowel Project protocol C-05
Wolmark N; Bryant J; Smith R; Grem J; Allegra C; Hyams D; Atkins J; Dimitrov N; Oishi R; Prager D; Fehrenbacher L; Romond E; Colangelo L; Fisher B
Journal of the National Cancer Institute 90:23:1810-6, 1998

Abstract
Background: National Surgical Adjuvant Breast and Bowel Project (NSABP) protocol C-03 showed a benefit from leucovorin (LV)-modulated 5-fluorouracil (5-FU) adjuvant therapy (5-FU + LV) in patients with Dukes' stage B or C carcinoma of the colon. Preclinical and clinical phase I/II data suggested that interferon alfa-2a (IFN) enhanced the efficacy of 5-FU therapy. Accordingly, in NSABP protocol C-05, the addition of recombinant IFN to 5-FU + LV adjuvant therapy was evaluated.

Methods: Data are presented for 2176 patients with Dukes' stage B or C cancer entered onto protocol C-05 during the period from October 1991 through February 1994. Individuals with an Eastern Cooperative Oncology Group performance status of 0-2 (ranges from fully active to ambulatory and capable of self-care but unable to work), a life expectancy of at least 10 years, and curative resection were stratified by sex, disease stage, and number of involved lymph nodes and were randomly assigned to receive either 5-FU + LV or 5-FU + LV + IFN; the mean time on the study as of June 30, 1997, was 54 months. All statistical tests were two-sided.

Results: There was no statistically significant difference in either disease-free survival (5-FU + LV, 69%; 5-FU + LV + IFN, 70%) or overall survival (5-FU + LV, 80%; 5-FU + LV + IFN, 81%) at 4 years of follow-up. Toxic effects of grade 3 or higher were observed in 61.8% of subjects in the group treated with 5-FU + LV and in 72.1% of subjects in the group treated with 5-FU + LV + IFN; fewer patients in the latter group completed protocol-mandated 5-FU + LV therapy than in the former group (77.1% versus 88.5%).

Conclusions: The addition of IFN to 5-FU + LV adjuvant therapy confers no statistically significant benefit, but it does increase toxicity.

National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA.