A phase II study of UFT with leucovorin administered as a twice daily schedule in the treatment of patients with metastatic colorectal cancer
2008

Twice Daily UFT with Leucovorin for Metastatic Colorectal Cancer

Sample size: 98 publication Evidence: moderate

Author Information

Author(s): Hoff P M, Kopetz S, Thomas M B, Langleben A, Rinaldi D, Anthony L, Wolff R A, Lassere Y, Abbruzzese J L

Primary Institution: The University of Texas M. D. Anderson Cancer Center

Hypothesis

Does UFT with leucovorin given twice daily provide comparable efficacy and tolerability to that reported for thrice daily administration?

Conclusion

The study suggests that twice daily administration of UFT with leucovorin has similar efficacy and tolerability to thrice daily administration for treating metastatic colorectal cancer.

Supporting Evidence

  • The median time to progression was 3.8 months.
  • The overall response rate was 11%.
  • The median overall survival was 12.8 months.
  • Thirty percent of patients experienced grade 3/4 treatment-related diarrhoea.

Takeaway

This study tested a new way to take a cancer medicine that might be easier for patients, and it worked just as well as the old way.

Methodology

This was a non-randomised, multicentre, open-label phase II study evaluating UFT with leucovorin given twice daily for 28 days in patients with metastatic colorectal cancer.

Potential Biases

Potential biases may arise from the non-randomised design and the open-label nature of the study.

Limitations

The study was non-randomised and had a small sample size, which may limit the generalizability of the results.

Participant Demographics

{"median_age":64,"sex_distribution":{"male":58,"female":40},"race_distribution":{"white":73,"black":12,"hispanic":7,"other":6}}

Statistical Information

Confidence Interval

{"median_TTP":"95% CI: 3.11–4.65","ORR":"95% CI: 6.1–19.2%","median_OS":"95% CI: 9.6–15.8"}

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604541

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