Background
Patients with advanced or metastatic breast cancer have very few effective treatment options. The lack of successful therapeutic strategies is reflected by a low 5-year survival.
There continues to be a significant unmet need for additional treatment options that are effective, well tolerated and easily administered for women with metastatic brest cancer who have received several treatment lines with conventional chemotherapies.
About the study
This study, BG01-1323L, is a multicenter phase III trial which evaluated the efficacy of Utidelone plus Xeloda versus Xeloda alone, monotherapy, in 405 metastatic breast cancer patients who received several lines of treatments before.
Utidelone is a genetically engineered chemotherapy substance.
Results
- The median survival was 19.8 months in the combination group versus 16.0 months in the monotherapy group.
- The 2-year estimated survival was 41.3% in the combination group versus 30.3% in the monotherapy group.
- Similarly, the until the disease had progressed was prolonged with the addition of Utidelone .
- 45.6% in the Utidelone group experienced their tumors stopped from growing and/or had shrunken versus 23.7% in the monotherapy group.
Side Effects
The most commonly noted side effects in the Utidelone group were peripheral neuropathy, palmer–planter erythrodesia, leukopenia, neutropenia and anemia.
Utidelone caused only mild myelosuppression and no significant hepatic toxicity.
Conclusions
- Utidelone plus Xeloda significantly improved survival vs Xeloda alonein patients with metastatic breast cancer and appears to be associated with less severe side effects than similar medications.
- These results support the use of Utidelone plus Xeloda as a novel therapeutic regimen for patients with metastatic breast cancer.
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About Breast Cancer
One out of seven women will develop breast cancer sometime throughout her life. Approx. 1% of all breast cancer cases appear in men.
Breast cancer is diagnosed following taking a biopsy or removal of cells from the afflicted tissue during surgery and diagnostic analysis.
Early detection affects the disease treatment plan and also treatment success.
The existing therapies used for stage 4 metastatic breast cancer are not curative, and this is a source of the need for innovative and effective treatment strategies in order to fight the disease.
