Study of DaunoXome in Metastatic Breast Cancer
Author Information
Author(s): O'Byrne K J, Thomas A L, Sharma R A, DeCatris M, Shields F, Beare S, Steward W P
Primary Institution: University Department of Oncology, Leicester Royal Infirmary
Hypothesis
What is the maximum tolerated dose and safety profile of DaunoXome in treating metastatic breast cancer?
Conclusion
DaunoXome is associated with mild, manageable toxicities and has anti-tumour activity in metastatic breast cancer.
Supporting Evidence
- DaunoXome was administered intravenously over 2 hours in 21-day cycles.
- The maximum tolerated dose was found to be 120 mg/m2.
- Two patients had objective responses, six had stable disease, and seven had progressive disease.
- Grade 4 neutropenia was encountered in 11 patients, indicating significant myelosuppression.
Takeaway
This study tested a new cancer drug called DaunoXome on patients with advanced breast cancer to see how much they could safely take and if it helped them.
Methodology
A phase I dose-escalating study was conducted with 16 patients receiving DaunoXome in increasing doses over 21-day cycles.
Limitations
The study had a small sample size and was limited to patients who were anthracycline-naïve.
Participant Demographics
The median age of participants was 51 years, with a range of 34 to 68 years; 12 of the 16 patients had visceral disease.
Digital Object Identifier (DOI)
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