title: Cabazitaxel for metastatic castration-resistant prostate cancer: safety data from the Spanish expanded access program.
abstract: 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.
authors.affiliation: University Hospital 12 de Octubre, Medical Oncology Department, Urooncology Unit (I+12 Research Institute) , Avda. de Cordoba, s/n, 28041 Madrid , Spain.
authors.forename: Daniel
authors.initials: D
authors.lastname: Castellano
authors.forename: Luis M
authors.initials: LM
authors.lastname: Antón Aparicio
authors.forename: Emilio
authors.initials: E
authors.lastname: Esteban
authors.forename: Alfredo
authors.initials: A
authors.lastname: Sánchez-Hernández
authors.forename: Jose Ramón
authors.initials: JR
authors.lastname: Germà
authors.forename: Norberto
authors.initials: N
authors.lastname: Batista
authors.forename: Pablo
authors.initials: P
authors.lastname: Maroto
authors.forename: Begoña
authors.initials: B
authors.lastname: Pérez-Valderrama
authors.forename: Raquel
authors.initials: R
authors.lastname: Luque
authors.forename: María José
authors.initials: MJ
authors.lastname: Méndez-Vidal
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000077143:Docetaxel; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011239:Prednisolone / Q000008:administration & dosage; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000473:pathology; D013030:Spain; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D043823:Taxoids; D000077143:Docetaxel; C552428:cabazitaxel; D011239:Prednisolone
keywords: cabazitaxel; compassionate use studies; docetaxel; prostatic neoplasms; safety