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Colorectal metastatic MAYO (fluorouracil and leucovorin) DISCONTINUED

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It is the consensus opinion of the medical oncology reference committee that the MAYO 5FU/FA regimen is too toxic and and should not be used in this patient population.

Treatment Schedule Summary

Drug Dose Route Day
Calcium Folinate (Leucovorin) 50 mg IV 1 to 5
Fluorouracil 425 mg/m2 IV 1 to 5

Frequency: 28 days

Cycles: Continuous until disease progression or unacceptable toxicity

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Bibliography

O'Connell, M.,J. 1989. " A phase III trial of 5-fluorouracil and leucovorin in the treatment of advanced colorectal cancer. A Mayo Clinic/North Central Cancer Treatment Group study." Cancer. 63(6 Suppl):1026-1030

The Mayo Clinic and the North Central Cancer Treatment Group (NCCTG) conducted a randomized clinical trial comparing five different combination chemotherapeutic regimens to single-agent 5-fluorouracil (5-FU), given by intravenous bolus technique (500 mg/m2 for 5 days) as a control, in the treatment of advanced colorectal cancer. This report summarizes the results of treatment in 208 patients who were randomized to 5-FU alone or 5-FU with leucovorin in either a high-dose (200 mg/m2) or a low-dose regimen (20 mg/m2) intravenously for 5 days. Both of the 5-FU with leucovorin regimens were associated with improved survival compared with single-agent 5-FU (P less than 0.03). The interval to tumor progression, measurable tumor response rates, and measures of quality of life (performance status, weight gain, and symptomatic relief) were also improved significantly with the addition of leucovorin. There was no therapeutic advantage associated with the use of high-dose compared with low-dose leucovorin. The dose-limiting toxicity of 5-FU/leucovorin was stomatitis. There was one treatment-related fatality (due to sepsis) among the 138 patient receiving 5-FU/leucovorin (0.7%). The most favorable regimen in this trial was 5-FU with low-dose leucovorin, based upon considerations of therapeutic effectiveness, toxicity, and cost. A national intergroup trial is being coordinated by the National Cancer Institute that will test the efficacy of low-dose leucovorin with 5-FU as one approach to adjuvant therapy after a curative surgical resection in selected patients with Dukes' Stage B2 or C colon cancer.

Version 3

Date Summary of changes
01/12/2005 Superseded after discussion at reference committee.
25/08/2009 Review and transferred to eviQ.
01/07/2010 Haematological dose modifications updated ( 20% changed to 25% dose reduction).
25/01/2011 New format to allow for export of protocol information.
Protocol version number changed to V.2.
Antiemetics and premedications added to the treatment schedule.
Additional Clinical Information, Key Prescribing table and Key Administration table combined into new section titled Clinical Considerations.
Drug specific information placed behind the drug name link.
26/03/2012 PHC OMIS view updated.
13/09/2013 Protocol review at Medical Oncology Reference Committee.
Group consensus to discontinue protocol as toxic regimen and safer alternatives are available.
25/08/2014 PHC View category removed.
16/10/2016 Patient information sheet updated to include more fluorouracil toxicity symptom warnings.
31/05/2017 Transferred to new eviQ website.

The information contained in this protocol is based on the highest level of available evidence and consensus of the eviQ reference committee regarding their views of currently accepted approaches to treatment. Any clinician (medical oncologist, haematologist, radiation oncologist, medical physicist, radiation therapist, pharmacist or nurse) seeking to apply or consult this protocol is expected to use independent clinical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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The currency of this information is guaranteed only up until the date of printing, for any updates please check:

https://www.eviq.org.au/p/118

23 May 2019