Adjuvant 5-fluorouracil and leucovorin with or without interferon alfa-2a in colon carcinoma: National Surgical Adjuvant Breast and Bowel Project protocol C-05

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 inter...

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Published in:JNCI : Journal of the National Cancer Institute Vol. 90; no. 23; p. 1810
Main Authors: 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
Format: Journal Article
Language:English
Published: United States 02.12.1998
Subjects:
Antimetabolites, Antineoplastic - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Chemotherapy, Adjuvant
Colonic Neoplasms - drug therapy
Colonic Neoplasms - pathology
Disease-Free Survival
Drug Administration Schedule
Female
Fluorouracil - administration & dosage
Humans
Interferon alpha-2
Interferon-alpha - administration & dosage
Leucovorin - administration & dosage
Male
Middle Aged
Neoplasm Staging
Recombinant Proteins
Survival Analysis
Treatment Outcome
ISSN:0027-8874
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Summary: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. 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. 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%). The addition of IFN to 5-FU + LV adjuvant therapy confers no statistically significant benefit, but it does increase toxicity.
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ISSN:0027-8874
DOI:10.1093/jnci/90.23.1810