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.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.
Real-world cabazitaxel safety: the Italian early-access program in metastatic castration-resistant prostate cancer / S., Bracarda; A., Gernone; D., Gasparro; Marchetti, Paolo; M., Ronzoni; R., Bortolus; L., Fratino; U., Basso; R., Mazzanti; C., Messina; M., Tucci; F., Boccardo; G., Cartenì; C., Pinto; G., Fornarini; R., Mattioli; G., Procopio; V., Chiuri; T., Scotto; D., Dondi; G. D., Lorenzo. - In: FUTURE ONCOLOGY. - ISSN 1479-6694. - ELETTRONICO. - 10:(2014), pp. 975-983. [10.2217/fon.13.256]
Real-world cabazitaxel safety: the Italian early-access program in metastatic castration-resistant prostate cancer.
MARCHETTI, PAOLO;
2014
Abstract
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.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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
