Cabazitaxel for metastatic castration-resistant prostate cancer: safety data from the Spanish expanded access program
Por:
Castellano, D, Aparicio, LMA, Esteban, E, Sanchez-Hernandez, A, Germa, JR, Batista, N, Maroto, P, Perez-Valderrama, B, Luque, R, Mendez-Vidal, MJ
Publicada:
1 sep 2014
Resumen:
Background: Based on the TROPIC study results, cabazitaxel was approved for the management of metastatic castration-resistant prostate cancer (mCRPC) progressing on or after docetaxel.
Methods: This multi-centre program provided early access to cabazitaxel to patients with mCRPC before its commercialization. Safety data from 153 Spanish patients receiving cabazitaxel 25 mg/m(2) i.v. Q3W, plus oral prednisone/prednisolone 10 mg daily, are reported.
Results: Median age of patients was 70 years (26.8% >= 75 years), 94.1 and 26.8% had bone and visceral metastasis, respectively. Most had an Eastern Cooperative Oncology Group <= 1 (88.9%) and had received a median of 8.0 cycles of last docetaxel treatment. The median of cabazitaxel cycles and cumulative dose were 6.0 (Interquartile range [IQR]: 4.0; 8.0) and 148.9 (IQR: 98.2; 201.4) mg/m(2), respectively. Adverse events (AEs) possibly related to cabazitaxel occurred in 143 (93.5%) patients. The most frequent grade >= 3 AEs were neutropenia (n = 25, 16.3%) and asthenia (n = 17, 11.1%). Febrile neutropenia and grade >= 3 diarrhea occurred in 5.2% of the patients each. There were five (3.3%) possibly treatment-related deaths, mainly infection-related. G-CSFs were used in 114 (74.5%) patients, generally as prophylaxis (n = 107; 69.9%). Grade >= 3 peripheral neuropathy and nail disorders were uncommon.
Conclusions: Cabazitaxel administration, in a real-world setting, is tolerated by Spanish patients with mCRPC, and the AEs are manageable.
Filiaciones:
Castellano, D:
Univ Hosp 12 Octubre, Res Inst I 12, Dept Med Oncol, Urooncol Unit, Madrid 28041, Spain
Aparicio, LMA:
Hosp Juan Canalejo, Dept Med Oncol, La Coruna 15006, Spain
Esteban, E:
Hosp Gen Asturias, Dept Med Oncol, E-33006 Oviedo, Spain
Sanchez-Hernandez, A:
Hosp Prov Castellon, Dept Med Oncol, Castellon De La Plana 12002, Spain
Germa, JR:
Hosp Duran & Reynals, ICO, Dept Med Oncol, Barcelona 08908, Spain
Batista, N:
Hosp Univ Canarias, Dept Med Oncol, Tenerife 38320, Spain
Maroto, P:
Hosp Santa Creu & Sant Pau, Dept Med Oncol, Barcelona 08026, Spain
Perez-Valderrama, B:
Hosp Univ Virgen Roci, Dept Med Oncol, Seville 41013, Spain
Luque, R:
Hosp Virgen Nieves, Dept Med Oncol, Granada 18014, Spain
Mendez-Vidal, MJ:
Medical Oncology Department, Hospital Univ. Reina Sofia, E-14004-Córdoba, Avda. Menéndez Pidal, s/n, Spain
Green Accepted
|