Phase II multicentre study of docetaxel plus 5-fluorouracil in patients with anthracycline-pretreated metastatic breast cancer
2003

Docetaxel and 5-Fluorouracil for Metastatic Breast Cancer

Sample size: 41 publication 10 minutes Evidence: moderate

Author Information

Author(s): Lortholary A, Delozier T, Monnier A, Bourgeois H, Bougnoux P, Tubiana-Mathieu N, Riffaud J Ch, Besson D, Lotz V, Gamelin E

Primary Institution: Centre Paul Papin, Angers, France

Hypothesis

The combination of docetaxel and 5-fluorouracil will improve treatment outcomes in patients with anthracycline-pretreated metastatic breast cancer.

Conclusion

The combination of docetaxel and 5-fluorouracil resulted in a 53.7% objective response rate in patients with metastatic breast cancer previously treated with anthracyclines.

Supporting Evidence

  • The objective response rate was 53.7% in the intent-to-treat population.
  • The median duration of response was 8.4 months.
  • The median time to progression was 6.7 months.
  • The combination was well tolerated with manageable toxicities.

Takeaway

Doctors tested a new medicine combination to help women with breast cancer that didn't get better with other treatments, and it worked for more than half of the patients.

Methodology

This was a phase II multicentre study involving 41 women with metastatic breast cancer who received docetaxel and 5-FU over several cycles.

Potential Biases

Potential selection bias due to the specific eligibility criteria for patient inclusion.

Limitations

The study had a small sample size and was limited to patients previously treated with anthracyclines.

Participant Demographics

Women aged 18–75 years with a median age of 53 years, previously treated with anthracycline-based chemotherapy.

Statistical Information

P-Value

0.006

Confidence Interval

95% CI: 38.4–68.9%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6600989

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