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Cabazitaxel Pre-Approval Report: Metastatic Hormone-Refractory Prostate Cancer Progressing After Docetaxel: Updated TROPIC Data Confirm Benefit vs Mitoxantrone Added to Prednisone

doi: 10.1097/01.COT.0000387945.43929.64

For men with metastatic castrate-resistant prostate cancer that progresses after treatment with docetaxel, use of cabazitaxel instead of mitoxantrone in conjunction with prednisone/prednisolone produces longer overall survival, time to progression, and higher response rates.

That was the conclusion of researchers reporting the final results of the Phase III 755-patient TROPIC study at the ASCO Annual Meeting, updated from what was reported earlier in the year at the Genitourinary Cancer Symposium (OT, 4/25/10).

Just a few days after the ASCO report, cabazitaxel, made by Sanofi-aventis under the brand name Jevtana, received FDA approval for this indication, an approval granted about three months earlier than the goal date received when the drug was given priority review status.



In his presentation at the ASCO meeting, lead author Johann Sebastian de Bono, MD, PhD, of the Prostate Cancer Team at Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, reported that the combination of cabazitaxel and prednisone/prednisolone reduced the risk of death by 28%, with an improvement in median overall survival time of 15.1 months vs 12.7 months in the mitoxantrone-combination arm.

The most frequent Grade 3/4 hematologic adverse events with cabazitaxel were neutropenia (82% of patients), leukopenia (68%), anemia (10.5%), and febrile neutropenia (7.5%). The most frequent Grade 3/4 non-hematologic toxicities were diarrhea (6% of patients), fatigue (5%), and asthenia (5%).

More patients receiving cabazitaxel did have to discontinue treatment due to adverse events compared with the mitoxantrone group (18.3% vs 8.4%), he reported. The most frequent of these treatment-emergent adverse events were neutropenia (2.4%), hematuria (1.3%), diarrhea (1.1%) and fatigue (1.1%). Grade 3/4 peripheral neuropathy occurred in 0.5% of patients in the cabazitaxel arm vs 0.3% in the mitoxantrone arm.

Deaths due to adverse events were 4.9% in the cabazitaxel arm (predominantly due to neutropenia and its complications) vs 1.9% in the mitoxantrone arm.

The TROPIC (Treatment of Hormone-Refractory Metastatic Prostate Cancer Previously Treated with a Taxotere-Containing Regimen) study was conducted in 146 trial sites in 26 countries throughout the world, including the United States.

© 2010 Lippincott Williams & Wilkins, Inc.
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