title: Real-world cabazitaxel safety: the Italian early-access program in metastatic castration-resistant prostate cancer.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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.
authors.forename: Sergio
authors.initials: S
authors.lastname: Bracarda
authors.forename: Angela
authors.initials: A
authors.lastname: Gernone
authors.forename: Donatello
authors.initials: D
authors.lastname: Gasparro
authors.forename: Paolo
authors.initials: P
authors.lastname: Marchetti
authors.forename: Monica
authors.initials: M
authors.lastname: Ronzoni
authors.forename: Roberto
authors.initials: R
authors.lastname: Bortolus
authors.forename: Lucia
authors.initials: L
authors.lastname: Fratino
authors.forename: Umberto
authors.initials: U
authors.lastname: Basso
authors.forename: Roberto
authors.initials: R
authors.lastname: Mazzanti
authors.forename: Caterina
authors.initials: C
authors.lastname: Messina
authors.forename: Marcello
authors.initials: M
authors.lastname: Tucci
authors.forename: Francesco
authors.initials: F
authors.lastname: Boccardo
authors.forename: Giacomo
authors.initials: G
authors.lastname: Cartenì
authors.forename: Carmine
authors.initials: C
authors.lastname: Pinto
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Fornarini
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Mattioli
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Procopio
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Chiuri
authors.forename: Tiziana
authors.initials: T
authors.lastname: Scotto
authors.forename: Davide
authors.initials: D
authors.lastname: Dondi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Di Lorenzo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; C552428:cabazitaxel
keywords: cabazitaxel; castrate resistant; docetaxel; prostate cancer; safety; taxane