title: Translating Clinical Evidence-Based Medicine into the Real World: Single-Center Experience with Cabazitaxel in Metastatic Prostate Cancer Patients.
abstract: BACKGROUND
  We studied the efficacy and safety of cabazitaxel in unselected real-life patients.
  
  
  METHODS
  We retrospectively investigated all patients with metastatic prostate cancer (mPC) treated with cabazitaxel 25 mg/m2 i.v. every 3 weeks combined with oral prednisolone (10 mg once daily) after first-line docetaxel chemotherapy. Study issues were to report patient characteristics and cabazitaxel data in terms of tolerance and efficacy. Overall survival (OS) and progression-free survival (PFS) were evaluated using the Kaplan-Meier method. All data were compared with TROPIC results.
  
  
  RESULTS
  From 2011 to 2014, 41 patients received cabazitaxel; 15 patients (37%) had a performance status (PS) ≥2 versus 7% (p < 0.0001) in TROPIC, and 38 patients (93%) presented a Gleason score ≥7 at baseline (vs. 60%; p < 0.0001). All patients had metastatic disease at baseline. Previous therapies were radiotherapy in 17 patients (41 vs. 61%; p = 0.01) and surgery in 24 patients (59 vs. 52%; p = 0.4). The median number of cabazitaxel cycles was 5 (1-10) versus 6 (3-10) in TROPIC. Five patients completed 10 cycles of cabazitaxel (12%) versus 28% in TROPIC (p = 0.03). Toxicities were anemia (12 patients, 29%), diarrhea (9 patients, 22%), nausea (7 patients, 17%), pain (6 patients, 15%), sepsis (4 patients, 10%), neutropenia (3 patients, 7%) and urinary tract infection (1 patient, 2%). The tumor response rate was 19.5 versus 14.4% in TROPIC (nonsignificant). PFS was 4.5 months (95% CI 3.3-6.4) in our analysis and 2.8 months (95% CI 2.4-3.0) in TROPIC. OS was 12.1 months (95% CI 9.2 to not reached) and 15.1 months (95% CI 14.1-16.3), respectively.
  
  
  CONCLUSIONS
  In our unselected mPC patients with poorer baseline clinical conditions and aggressive disease, cabazitaxel seems efficient and not more toxic than in the TROPIC study.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Moriceau
authors.forename: Aline
authors.initials: A
authors.lastname: Guillot
authors.forename: Cécile
authors.initials: C
authors.lastname: Pacaut
authors.forename: Benoîte
authors.initials: B
authors.lastname: Méry
authors.forename: Alexander Tuan
authors.initials: AT
authors.lastname: Falk
authors.forename: Jane-Chloé
authors.initials: JC
authors.lastname: Trone
authors.forename: Olivier
authors.initials: O
authors.lastname: Collard
authors.forename: Guy
authors.initials: G
authors.lastname: De Laroche
authors.forename: Pierre
authors.initials: P
authors.lastname: Fournel
authors.forename: Yacine
authors.initials: Y
authors.lastname: Merrouche
authors.forename: Nicolas
authors.initials: N
authors.lastname: Magné
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D000077143:Docetaxel; D019317:Evidence-Based Medicine; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D009362:Neoplasm Metastasis; D011239:Prednisolone / Q000008:administration & dosage; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D012189:Retrospective Studies; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; C552428:cabazitaxel; D011239:Prednisolone