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5FU-Leucovorin advanced (Mayo Clinic Regimen)
Abstract: Randomized comparison of two schedules of
fluorouracil and leucovorin in the treatment of advanced colorectal
cancer.
PURPOSE: To compare two commonly used schedules of fluorouracil (5FU) and
leucovorin in the treatment of patients with advanced metastatic colorectal
cancer. Each of these dosage administration schedules has been demonstrated to
be superior to single-agent bolus 5FU in previous controlled trials.
PATIENTS AND METHODS: Three hundred seventy-two ambulatory patients
with metastatic colorectal cancer were stratified according to performance
status, and presence and location of any measurable indicator lesion(s). They
were then randomized to receive chemotherapy with one of the following regimens:
(1) intensive-course 5FU plus low-dose leucovorin (5FU 425 mg/m2 plus leucovorin
20 mg/m2 intravenous [IV] push daily for 5 days with courses repeated at 4- to
5-week intervals); (2) weekly 5FU plus high-dose leucovorin (5FU 600 mg/m2 IV
push plus leucovorin 500 mg/m2 as a 2-hour infusion weekly for 6 weeks with
courses repeated every 8 weeks).
RESULTS: Three hundred sixty-two of 372 patients randomized (97.3%) were
eligible and included in the analysis. Three hundred forty-six patients (95.6%)
have died. There were no significant differences in therapeutic efficacy between
the two 5FU/leucovorin regimens tested with respect to the following parameters:
objective tumor response (35% v 31%),
survival (median, 9.3 v 10.7 months), and
palliative effects (as assessed by relief of symptoms, improved performance
status, and weight gain). There were significant (P < .05) differences in
toxicity, with more leukopenia and stomatitis seen with the intensive-course
regimen, and more
diarrhea and requirement for hospitalization to manage
toxicity with the weekly regimen. Financial cost was also higher with the weekly
regimen.
CONCLUSION: Intensive-course 5FU plus low-dose leucovorin appears to have a
superior therapeutic index compared with weekly 5FU plus high-dose leucovorin
using the dosage administration schedules applied in this study based on similar
therapeutic effectiveness, but lower financial cost, and less need for
hospitalization to manage chemotherapy toxicity.
References
Buroker TR, O'Connell MJ, Wieand HS, Krook JE, Gerstner JB, Mailliard JA,
Schaefer PL, Levitt R, Kardinal CG, Gesme DH Jr. Randomized comparison of two
schedules of fluorouracil and leucovorin in the treatment of advanced colorectal
cancer. J Clin Oncol 1994; 12:14 - 20.
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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 |
Comparison of
Mayo regimen vs. Roswell Park regimen in the treatment of advanced
colorectal cancer. |
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Objective Response
Rate |
35% v 31% |
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Median Survival |
9.3 v 10.7 months |
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Toxicity |
more leukopenia
and stomatitis seen with the Mayo regimen, and more
diarrhea and requirement
for hospitalization to manage toxicity with the weekly (Roswell Park)
regimen. Financial cost was also higher with the weekly regimen. |
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