© 1998 by Oxford University Press
Journal Of The National Cancer Institute, Vol 90, 1810-1816, Copyright © 1998 by Oxford University Press
N Wolmark, J Bryant, R Smith, J Grem, C Allegra, D Hyams, J Atkins, N Dimitrov, R Oishi, D Prager, L Fehrenbacher, E Romond, L Colangelo and B Fisher
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%). CONCLUSION: The addition of IFN to
5-FU + LV adjuvant therapy confers no statistically significant benefit,
but it does increase toxicity.
ARTICLES
Adjuvant 5-fluorouracil and leucovorin with or without interferon alfa- 2a in colon carcinoma: National Surgical Adjuvant Breast and Bowel Project protocol C-05
NSABP Operations Center, Pittsburgh, PA 15212, USA.
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