Early access programmes were established to allow eligible patients with mCRPC access to cabazitaxel before regulatory approval.
The safety profile of cabazitaxel in this pooled analysis of two cabazitaxel early access programmes was manageable and consistent with previous Phase III trials.
Dr. Zafar Malik from the Clatterbridge Cancer Centre NHS Foundation Trust in Wirral, UK said "Prostate cancer is the second most commonly occurring cancer in men worldwide."
Figure 1: Patient enrolment by region.
A substantial proportion of patients in TROPIC had shown early progression during previous treatment with docetaxel: 72% of patients had progressed within 3 months of their last dose of docetaxel, and 30% had progressed during treatment itself.
Prior to the TROPIC study, patients who progressed would have either continued on docetaxel, switched to palliative, non-chemotherapeutic treatments or received no treatment.
In a follow-up survival analysis of TROPIC,the probability of survival at 24 months was 27% for cabazitaxel compared with 16% for mitoxantrone; this analysis also highlighted the benefit of cabazitaxel over mitoxantrone across multiple patient sub-groups.
The Zafar research team concluded, "this global, real-world pooled analysis of CUP/EAP further demonstrates the manageable safety profile of cabazitaxel and supports its use as a treatment option for patients with mCRPC, including those who are refractory or unresponsive to first-line treatment with docetaxel."
Full text - https://doi.org/10.18632/oncotarget.27031
Correspondence to - Zafar Malik - [email protected]
Keywords - mCRPC, cabazitaxel, CUP, EAP, real-world
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