Combining Vinorelbine and High-Dose 5-FU for Advanced Breast Cancer
Author Information
Author(s): Yeh K H, Lu Y S, Hsu C H, Lin J F, Chao H J, Huang T C, Chung C Y, Chang C S, Yang C H, Cheng A L
Primary Institution: National Taiwan University Hospital
Hypothesis
Can the combination of weekly vinorelbine and high-dose 5-fluorouracil plus leucovorin be an effective first-line treatment for advanced breast cancer?
Conclusion
The vinorelbine–HDFL regimen is an effective and well-tolerated first-line treatment for advanced breast cancer.
Supporting Evidence
- The overall response rate was 70.0%, with eight complete responses and 20 partial responses.
- The median time to progression was 8.0 months.
- The median overall survival was 25.0 months.
- Main toxicities included grade 3/4 leucopenia and neutropenia in 18.0% and 38.0% of cycles, respectively.
Takeaway
Doctors tested a new medicine combination to help women with advanced breast cancer, and it worked well for many of them.
Methodology
This was a phase II clinical trial where patients received vinorelbine and high-dose 5-FU with leucovorin every three weeks.
Potential Biases
Potential biases may arise from the single-institution study design and patient selection criteria.
Limitations
The study was limited to a specific patient population and may not be generalizable to all breast cancer patients.
Participant Demographics
Median age of participants was 49 years, with a range of 36 to 68 years; included both recurrent and metastatic breast cancer patients.
Statistical Information
P-Value
0.001
Confidence Interval
95% CI: 54–84%
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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