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Real-world cabazitaxel safety: The Italian early-access program in metastatic castration-resistant prostate cancer

Bracarda S. Gernone A. Gasparro D. Marchetti P. Ronzoni M. Bortolus R. Fratino L. Basso U. Mazzanti R. Messina C. Tucci M. Boccardo F. Carteni G. Pinto C. Fornarini G. Mattioli R. Procopio G. Chiuri V. Scotto T. Dondi D. Di Lorenzo G.

Future Oncol. 2014 May;10(6):975-83. 



Cabazitaxel is a novel taxane that is approved for use in metastatic castration-resistant prostate cancer based on the Phase III TROPIC study, which showed improved overall survival with cabazitaxel/prednisone versus mitoxantrone/prednisone. A global early-access program was initiated in order to provide early access to cabazitaxel in docetaxel-pretreated patients and to obtain real-world data.

Patients & methods

We report interim safety results from an Italian prospective, single-arm, multicenter, open-label trial of 218 patients receiving cabazitaxel 25 mg/m2 every 3 weeks plus prednisolone 10 mg/day, until disease progression, unacceptable toxicity, investigator's decision or death.


Patients completing treatment received a median of six cabazitaxel cycles. The most common grade 3/4 adverse events were neutropenia (33.9%), leukopenia (15.6%), anemia (6%) and asthenia (6%). No peripheral neuropathy or nail disorders were observed.


These results confirm that cabazitaxel has a manageable safety profile in daily clinical practice and support its use in patients with prostate cancer who progress during or after a docetaxel-based therapy.



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