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The combined treatment group received mFOLFOX6/XELOX regimen treatment, the single-drug group used Mayo Clinic regimen.
In both phase III studies, gastrointestinal toxicity, including diarrhoea, stomatitis, nausea, and vomiting, were more frequent with the Mayo Clinic regimen as were hand-foot syndrome and myelotoxicity.
Patients whose treatment started before June 2003 received Mayo clinic regimen (n=95), whereas those treated after October 2003 were given mFOLFOX6 or XELOX chemotherapy (n=160).
A phase III trial with previously untreated mCRC patients randomised to either oral capecitabine or i.v. bolus 5-FU/LV (Mayo Clinic regimen) demonstrated a significantly superior RR of capecitabine compared with 5-FU/LV (26 vs 17% P<0.0002).
The Mayo Clinic regimen (Poon et al, 1989) combines bolus intravenous 5-FU with the biomodulator leucovorin (5-FU/LV), and acts as a comparator in many international trials of new therapies.
Mayo Clinic regimen was used for administration of 5-FU: six cycles of rapid intravenous infusion of 20 mg/m2 leucovorin, followed immediately by an intravenous bolus of 425 mg/m2 fluorouracil, on days 1 to 5 every four weeks.
Similar(49)
The primary objective of the ongoing X-ACT trial in almost 2000 Dukes' C colon cancer patients is to demonstrate at least equivalent disease-free survival between capecitabine and the Mayo Clinic regimen.
Capecitabine produced an equivalent median TTP to the Mayo Clinic regimen (Table 3).
All four new therapies demonstrated superior safety profiles compared with the Mayo Clinic regimen.
If the Mayo Clinic regimen is assumed to have the same efficacy as the De Gramont regimen, the mean incremental cost-effectiveness of FOLFOX4 compared with the Mayo Clinic regimen would be around £10 000 per QALY gained.
In both trials the objective response rates were very similar to those with the Mayo Clinic regimen.
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