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Future Oncol. 2014 May;10(6):975-83. doi: 10.2217/fon.13.256. Epub 2013 Dec 3.

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

Author information

1
Medical Oncology Unit, Department of Oncology, San Donato Hospital, 52100 Arezzo, Italy; Department of Oncology USL8, Istituto Toscano Tumori (ITT), San Donato Hospital, Via Pietro Nenni 20, 52100 Arezzo, Italy. sergio.bracarda@usl8.toscana.it.

Abstract

AIM:

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.

RESULTS:

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.

CONCLUSION:

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.

KEYWORDS:

cabazitaxel; castrate resistant; docetaxel; prostate cancer; safety; taxane

PMID:
24295376
DOI:
10.2217/fon.13.256
[Indexed for MEDLINE]
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