Toxicity Analysis of the 5-Day Bolus 5-Fluorouracil/Folinic Acid Regimen for the Treatment of ColorectalCarcinoma from 2 Randomized Controlled Trials: A Concern About Dose

The goal of this study was to ascertain the first cycle intolerability rate of the standard Mayo Clinic regimen, 5-fluorouracil (5-FU) 425 mg/m 2 with low-dose folinic acid (FA) 20 mg/m 2, as a rapid bolus intravenous injection (5-FU/FA) for 5 days every 4–5 weeks for advanced colorectal cancer chem...

Full description

Saved in:
Bibliographic Details
Published in:Clinical colorectal cancer 2002-08, Vol.2 (2), p.111-118
Main Authors: Vincent, Mark, Ho, Cheryl, Tomiak, Anna, Winquist, Eric, Whiston, Frances, Stitt, Larry
Format: Article
Language:English
Subjects:
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:The goal of this study was to ascertain the first cycle intolerability rate of the standard Mayo Clinic regimen, 5-fluorouracil (5-FU) 425 mg/m 2 with low-dose folinic acid (FA) 20 mg/m 2, as a rapid bolus intravenous injection (5-FU/FA) for 5 days every 4–5 weeks for advanced colorectal cancer chemotherapy. The 5-FU/FA arms of 2 large, randomized, controlled trials of 5-FU/FA versus raltitrexed, performed in Europe and North America, were analyzed for intolerability. Two hundred and twelve European patients and 200 North American patients with locally advanced or distant metastatic colorectal cancer were assigned to the Mayo Clinic regimen. During cycle 1, intolerability of the therapy was assessed. Intolerability was recognized as a protocol-driven, toxicity-mandated dose reduction in cycle 2, the inability to complete 5 days of cycle 1 due to toxicity, or failure to receive cycle 2 at all because of toxicity. After the first cycle of chemotherapy, the intolerability rate for the European trial was 41.0% (95% confidence interval [CI], 34.3–47.6) and 49.0% (95% CI, 42.0–56.0) for the North American trial. For the combined 5-FU/FA populations, the intolerability rate was 44.8% (95% CI, 40.0–49.7). The predominant toxicities were stomatitis, diarrhea, and leukopenia. The standard Mayo Clinic regimen was associated with a higher level of dose-limiting toxicities than the accepted maximum of up to 33% for standard chemotherapy.
ISSN:1533-0028
1938-0674
DOI:10.3816/CCC.2002.n.017