Adjuvant 5-fluorouracil and leucovorin with or without interferon alfa- 2a in colon carcinoma: National surgical adjuvant breast and bowel project protocol C-05

Norman Wolmark, John Bryant, Roy Smith, Jean Grem, Carmen Allegra, David Hyams, James Atkins, Nikolay Dimitrov, Robert Oishi, David Prager, Louis Fehrenbacher, Edward Romond, Linda Colangelo, Bernard Fisher

Research output: Contribution to journalArticle

106 Citations (Scopus)

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

Original languageEnglish (US)
Pages (from-to)1810-1816
Number of pages7
JournalJournal of the National Cancer Institute
Volume90
Issue number23
DOIs
StatePublished - Dec 2 1998

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Leucovorin
Fluorouracil
Colon
Breast
Carcinoma
interferon alfa-2a
Therapeutics
Poisons
Self Care
Life Expectancy
Disease-Free Survival

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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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, Norman; Bryant, John; Smith, Roy; Grem, Jean; Allegra, Carmen; Hyams, David; Atkins, James; Dimitrov, Nikolay; Oishi, Robert; Prager, David; Fehrenbacher, Louis; Romond, Edward; Colangelo, Linda; Fisher, Bernard.

In: Journal of the National Cancer Institute, Vol. 90, No. 23, 02.12.1998, p. 1810-1816.

Research output: Contribution to journalArticle

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 1998, 'Adjuvant 5-fluorouracil and leucovorin with or without interferon alfa- 2a in colon carcinoma: National surgical adjuvant breast and bowel project protocol C-05', Journal of the National Cancer Institute, vol. 90, no. 23, pp. 1810-1816. https://doi.org/10.1093/jnci/90.23.1810
Wolmark, Norman ; Bryant, John ; Smith, Roy ; Grem, Jean ; Allegra, Carmen ; Hyams, David ; Atkins, James ; Dimitrov, Nikolay ; Oishi, Robert ; Prager, David ; Fehrenbacher, Louis ; Romond, Edward ; Colangelo, Linda ; Fisher, Bernard. / Adjuvant 5-fluorouracil and leucovorin with or without interferon alfa- 2a in colon carcinoma : National surgical adjuvant breast and bowel project protocol C-05. In: Journal of the National Cancer Institute. 1998 ; Vol. 90, No. 23. pp. 1810-1816.
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title = "Adjuvant 5-fluorouracil and leucovorin with or without interferon alfa- 2a in colon carcinoma: National surgical adjuvant breast and bowel project protocol C-05",
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{\%}). Conclusion: The addition of IFN to 5-FU + LV adjuvant therapy confers no statistically significant benefit, but it does increase toxicity.",
author = "Norman Wolmark and John Bryant and Roy Smith and Jean Grem and Carmen Allegra and David Hyams and James Atkins and Nikolay Dimitrov and Robert Oishi and David Prager and Louis Fehrenbacher and Edward Romond and Linda Colangelo and Bernard Fisher",
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T1 - Adjuvant 5-fluorouracil and leucovorin with or without interferon alfa- 2a in colon carcinoma

T2 - National surgical adjuvant breast and bowel project protocol C-05

AU - Wolmark, Norman

AU - Bryant, John

AU - Smith, Roy

AU - Grem, Jean

AU - Allegra, Carmen

AU - Hyams, David

AU - Atkins, James

AU - Dimitrov, Nikolay

AU - Oishi, Robert

AU - Prager, David

AU - Fehrenbacher, Louis

AU - Romond, Edward

AU - Colangelo, Linda

AU - Fisher, Bernard

PY - 1998/12/2

Y1 - 1998/12/2

N2 - 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.

AB - 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.

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