Study of Yondelis in Advanced Breast Cancer
Author Information
Author(s): Zelek L, Yovine A, Brain E, Turpin F, Taamma A, Riofrio M, Spielmann M, Jimeno J, Misset J L
Primary Institution: Institut Gustave-Roussy, Villejuif, France
Hypothesis
Does Yondelis (trabectedin) show activity in women with advanced breast cancer previously treated with conventional therapies?
Conclusion
Trabectedin can induce tumor response and control in previously treated advanced breast cancer with manageable toxicity.
Supporting Evidence
- Three confirmed partial responses were observed in patients with measurable disease.
- Median survival was 10 months.
- The overall response rate was 14%.
Takeaway
This study tested a new cancer drug called Yondelis in women with advanced breast cancer who had already tried other treatments. It showed that the drug can help shrink tumors and is safe to use.
Methodology
This was a multicenter, open-label, phase II nonrandomised study where trabectedin was administered as a 24-h continuous infusion every 3 weeks to patients with advanced breast cancer.
Potential Biases
Potential biases may arise from the nonrandomised design and the open-label nature of the study.
Limitations
The study had a small sample size and was nonrandomised, which may limit the generalizability of the results.
Participant Demographics
The median age of participants was 54 years, with 63% having two metastatic sites.
Statistical Information
Confidence Interval
95% CI: 4.88–15.18
Digital Object Identifier (DOI)
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