This approval is based on the results of Study 304,(1) which was a multicenter, open-label, randomized, parallel group Phase III clinical study, to evaluate the efficacy and safety of Halaven and vinorelbine in 530 women with locally recurrent or metastatic breast cancer, previously treated with chemotherapy regimens, including an anthracycline and a taxane
. Halaven demonstrated a statistically significant extension in the study's primary endpoint of progression-free survival (PFS) over the comparator treatment vinorelbine according to independent imaging review (Hazard Ratio: 0.80; 95% Confidence Interval: 0.65-0.98; p = 0.036).
This approval is based on results of the Phase III KATHERINE study showing Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause (invasive disease-free survival; iDFS) by 50% (HR=0.50, 95% CI 0.39-0.64, p<0.0001) compared to Herceptin as an adjuvant treatment in people with HER2-positive EBC who have residual invasive disease after neoadjuvant taxane
and Herceptin-based treatment.
In conclusion, there was no significant difference in safety profiles between DTX and nab-PTX in patients with early-stage breast cancer, and HRQoL tended to decrease similarly during anticancer treatment with either taxane
. We suggest that the ability of the HRQoL questionnaire to evaluate different schedules of chemotherapy is limited, and further studies are needed to establish better evaluation methods in the future.
There was no significant correlation between the expression levels of STHMN1 and OPN, survival, and response to taxane
based regimen (p>0.05); however, OPN overexpression showed a significant correlation with lower Gleason scores (GS) (p:0.032).
(12) Because taxanes
are not completely cross-resistant, (9,14) the randomized phase 2 TAXYNERGY trial explored whether an early taxane
switch would benefit men who failed to achieve a sufficient PSA decline within four cycles of their original taxane
APP-111 is a platform technology that may have activity in other tumor types that have previously responded to taxanes
or vinca alkaloids.
Conclusion: Together, these results support that administration of PTX in the form of taxane
mixtures may become a novel approach to improve the poor bioavailability of PTX.
The decision is based on results from the Phase III study in which people previously treated with Herceptin and a taxane
for their HER2-positive advanced breast cancer were randomized to receive either Kadcyla or a standard treatment, lapatinib and Xeloda (capecitabine).
Tesetaxel is the leading oral taxane
in clinical development.
Chemotherapy: The patients in the study were receiving either platinum or taxane
In final guidance, the National Institute for Health and Clinical Excellence said it did not recommend Avastin for the treatment of advanced breast cancer when used in combination with a taxane
(a type of chemotherapy).
In final guidance, the National Institute for Health and Clinical Excellence (Nice) said it did not recommend Avastin (bevacizumab) for the treatment of advanced breast cancer when used in combination with a taxane
(a type of chemotherapy).