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5FU-Leucovorin adjuvant (Roswell Park Memorial Institute
regimen)
Abstract: The benefit of leucovorin-modulated fluorouracil
as postoperative adjuvant therapy for primary colon cancer: results
from National Surgical Adjuvant Breast and Bowel Project protocol
C-03.
PURPOSE: This study was designed to evaluate the efficacy of
leucovorin-modulated fluorouracil (5-FU) as adjuvant therapy for
patients with Dukes' stage B and C colon cancer.
PATIENTS AND
METHODS: Data are presented from 1,081 patients with Dukes' stage B
and C carcinoma of the colon entered into National Surgical Adjuvant
Breast and Bowel Project (NSABP) protocol C-03 between August 1987
and April 1989. Patients were randomly assigned to receive either
lomustine (MeCCNU), vincristine, and 5-FU (MOF), or leucovorin-modulated
5-FU (LV + 5-FU). The mean time on study was 47.6 months.
RESULTS:
Comparison between the two groups indicates a disease-free survival
advantage for patients treated with LV + 5-FU (P = .0004). The
3-year disease-free survival rate for patients in this group was
73%
(95% confidence interval, 69% to 77%), compared with
64% (95%
confidence interval, 60% to 68%) for patients receiving MOF. The
corresponding percentage of patients surviving was 84% for those
randomized to receive LV + 5-FU and 77% for the MOF-treated cohort
(P = .003). At 3 years of follow-up, patients treated with
postoperative LV + 5-FU had a 30% reduction in the risk of
developing a treatment failure and a 32% reduction in mortality risk
compared with similar patients treated with MOF.
CONCLUSION:
Treatment with LV + 5-FU significantly prolongs disease-free
survival and results in a significant benefit relative to overall
survival. These findings, when considered together with results from
a recent meta-analysis demonstrating a benefit from LV + 5-FU in
advanced disease, provide evidence to support the concept of
metabolic modulation of 5-FU.
References
Wolmark N, Rockette H, Fisher B, Wickerham DL, Redmond C, Fisher
ER, Jones J, Mamounas EP, Ore L, Petrelli NJ, et al. The benefit of leucovorin-modulated fluorouracil
as postoperative adjuvant therapy for primary colon cancer: results
from National Surgical Adjuvant Breast and Bowel Project protocol
C-03. J Clin Oncol 1993; 11:1879 - 1887.
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| Regimen |
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Leucovorin.... 500 mg / M2 IV (over 2 h)
- followed 1 hour later by
5 - FU...... 500 mg / M2 IV bolus weekly for 6 wks.
FREQUENCY....... Repeat every 56 days
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Summary |
Comparison of
Roswell Park regimen to MOF regimen as adjuvant therapy for Duke's B and C
colon cancer. |
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3yr Disease Free
Survival |
73% v 64% |
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