Timed flat infusion of 5-fluorouracil increases the tolerability of 5-fluorouracil/docetaxel regimen in metastatic breast cancer: a dose-finding study
2004

Timed infusion of 5-fluorouracil improves treatment for breast cancer

Sample size: 14 publication Evidence: moderate

Author Information

Author(s): Ficorella C, Morelli M F, Ricevuto E, Cannita K, Porzio G, Baldi P Lanfiuti, Cianci G, Rocco ZC Di, Natoli C, Tinari N, Galitiis F De, Calista F, Marchetti P

Primary Institution: University of L'Aquila, Italy

Hypothesis

The study aims to determine the maximum-tolerated dose and recommended dose of a timed infusion of 5-fluorouracil combined with docetaxel in metastatic breast cancer patients.

Conclusion

The study found that a specific timed infusion of 5-fluorouracil combined with docetaxel is well tolerated and effective in treating metastatic breast cancer.

Supporting Evidence

  • Patients received a median of six treatment cycles.
  • Five of ten patients at the maximum-tolerated dose experienced dose-limiting toxicities.
  • The overall response rate was 61%, with two complete and six partial responses.
  • The median time to disease progression was 10 months.
  • The median overall survival was 25 months.

Takeaway

Doctors tested a new way to give medicine to breast cancer patients, and it worked well without making them too sick.

Methodology

Patients received a 1-hour infusion of docetaxel followed by a 12-hour timed infusion of 5-fluorouracil over 5 days, every 21 days, with dose escalation based on toxicity.

Limitations

The study had a small sample size and was limited to specific patient eligibility criteria.

Participant Demographics

Median age was 52 years, with a range of 36 to 69 years; most patients had a WHO performance status of 0.

Statistical Information

Confidence Interval

±28

Digital Object Identifier (DOI)

10.1038/sj.bjc.6601971

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