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5FU-Leucovorin adjuvant (Mayo Clinic Regimen)
Abstract: Controlled trial of fluorouracil and low-dose leucovorin given for
6 months as postoperative adjuvant therapy for colon cancer.
The goal of this study was to determine the efficacy of
intensive-course fluorouracil (5FU) plus low-dose leucovorin given for
6 months following potentially curative resection of colon cancer.
PATIENTS AND METHODS: Three hundred seventeen patients with high-risk
stage II or stage III colon cancer were randomly assigned 3 to 4 weeks
following surgery to receive either (1) chemotherapy with six cycles
of 5FU (425 mg/m2) plus leucovorin (20 mg/m2) by rapid intravenous
injection daily for 5 consecutive days every 4 to 5 weeks, or (2)
observation.
RESULTS: The median follow-up duration is 72 months for
patients still alive. Patients who received postoperative 5FU plus leucovorin experienced significant improvement in time to relapse (P <
.01) and survival (P = .02) compared with control patients treated
with surgery alone. Stomatitis,
diarrhea, and leukopenia were the
predominant chemotherapy toxicities. There were no treatment-related
deaths.
CONCLUSION: These results indicate that intensive-course 5FU
plus low-dose leucovorin is effective in preventing tumor relapse and
improving survival in patients with high-risk colon cancer. These
benefits were seen with only six cycles of treatment, using low-dose
leucovorin in combination with 5FU on a schedule convenient for
outpatient administration.
References
O'Connell MJ, Mailliard JA, Kahn MJ, et al.: Controlled trial of
fluorouracil and low-dose leucovorin given for 6 months as
postoperative adjuvant therapy for colon cancer. Journal of Clinical
Oncology 15(1): 246-250, 1997.
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| Regimen |
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fluorouracil.... 425 mg/sqm by rapid IV injection daily for
5
consecutive days 1 hour after start of leucovorin.
leucovorin...... 20 mg/sqm IV daily for 5 consecutive days.
FREQUENCY....... Repeat every 4 to 5 weeks. |
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Summary |
Fluorouracil and low-dose leucovorin given for
6 months as postoperative adjuvant therapy for colon cancer. |
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Results |
significant
improvement in time to relapse (P < .01) and survival (P = .02) compared
with control patients treated with surgery alone. |
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Toxicity |
Stomatitis,
diarrhea, and leukopenia. |
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