Vinorelbine and Trastuzumab for Metastatic Breast Cancer
Author Information
Author(s): De Maio Ermelinda, Pacilio Carmen, Gravina Adriano, Morabito Alessandro, Di Rella Francesca, Labonia Vincenzo, Landi Gabriella, Nuzzo Francesco, Rossi Emanuela, Silvestro Pasqualina, Botti Gerardo, Di Bonito Maurizio, Curcio Maria Pia, Formichelli Franca, La Vecchia Franca, Staiano Maria, Maurea Nicola, D'Aiuto Giuseppe, D'Aiuto Massimiliano, Thomas Renato, Signoriello Giuseppe, Perrone Francesco, de Matteis Andrea
Primary Institution: National Cancer Institute, Naples, Italy
Hypothesis
Can trastuzumab given every 3 weeks combined with vinorelbine be effective for HER2-positive metastatic breast cancer?
Conclusion
The combination of 3-weekly trastuzumab and vinorelbine is safe and effective for patients with HER2-positive metastatic breast cancer.
Supporting Evidence
- The overall response rate was 50%, with 7 complete and 13 partial responses.
- Median progression-free survival was 9.6 months.
- Median overall survival was 22.7 months.
Takeaway
This study tested a new way to give two cancer drugs together to help people with a specific type of breast cancer, and it worked pretty well.
Methodology
A single-stage phase 2 trial was conducted with patients receiving vinorelbine and trastuzumab to assess response rates and safety.
Potential Biases
Potential selection bias due to the single-center design.
Limitations
The sample size was small, and the study was conducted at a single center.
Participant Demographics
Median age was 54 years, with a range from 31 to 81; 20% were older than 65.
Statistical Information
Confidence Interval
95% CI 33.8–66.2
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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