Docetaxel and Cyclophosphamide for Metastatic Breast Cancer
Author Information
Author(s): Vasey P A, Roché H, Bisset D, Terret C, Vernillet L, Riva A, Ramazeilles C, Azli N, Kaye S B, Twelves C J
Primary Institution: Cancer Research UK Department of Medical Oncology, Glasgow, UK
Hypothesis
What is the maximum tolerated dose and safety profile of docetaxel in combination with cyclophosphamide for metastatic breast cancer?
Conclusion
The study established a recommended dose of docetaxel 75 mg/m² in combination with cyclophosphamide 600 mg/m² for phase II evaluation.
Supporting Evidence
- The maximum tolerated dose was docetaxel 85 mg/m² with cyclophosphamide 600 mg/m².
- Overall response rate was 42% with activity observed at all dose levels.
- Febrile neutropenia was the dose-limiting toxicity.
Takeaway
Doctors tested a new combination of two cancer drugs to see how much of each one can be safely given to help women with advanced breast cancer.
Methodology
This was a phase I, open-label, non-randomised, dose-finding study conducted at two centres.
Potential Biases
Potential bias due to the non-randomised design.
Limitations
The study was small and primarily focused on safety rather than efficacy.
Participant Demographics
Women aged 18 to 75 with locally advanced or metastatic breast cancer.
Statistical Information
P-Value
0.042
Confidence Interval
95% CI 22–61%
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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