title: PSA flare with abiraterone in patients with metastatic castration-resistant prostate cancer.
abstract: BACKGROUND
  The aim of this study was to assess early serum prostate-specific antigen (PSA) changes in patients treated with abiraterone and to correlate those changes with clinical outcome.
  
  
  METHODS
  We retrospectively evaluated 103 patients with castrate-resistant prostate cancer (CRPC) treated with compassionate use of abiraterone in Romagna, Italy. In these patients, serum PSA levels were monitored every 4 weeks, and a time course of serum PSA levels was obtained. The PSA flare phenomenon was evaluated. The log-rank test was applied to compare survival between groups of patients according to early PSA level changes.
  
  
  RESULTS
  Of 103 patients, 43 (41.7%) had an immediate PSA response, whereas 9 (8.7%) had an initial PSA flare. Of the 9 patients with PSA flare, 5 attained a subsequent PSA response. The temporary PSA flare exceeded baseline values by a median of 19.7% (range, 5%-62.9%). The median PFS of the 9 patients in the PSA-flare group was higher compared with patients without the PSA flare (10.5 vs. 6.4 months; P = .0999) but was similar to the subgroup of patients with immediate PSA response (10.5 vs. 10.7 months; P = .7019). In the multivariate analysis, only the PSA response remained as a predictor of progression-free survival (PFS) (P < .0001) and overall survival (OS) (P = .0003), respectively.
  
  
  CONCLUSIONS
  PSA flare occurs not infrequently in patients with CRPC who respond to abiraterone. Patients should be informed of this possible PSA flare phenomenon.
authors.affiliation: Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
authors.forename: Salvatore L
authors.initials: SL
authors.lastname: Burgio
authors.affiliation: Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
authors.forename: Vincenza
authors.initials: V
authors.lastname: Conteduca
authors.affiliation: Biostatistic and Clinical Trials Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
authors.forename: Britt
authors.initials: B
authors.lastname: Rudnas
authors.affiliation: Oncology Unit, City Hospital, Faenza, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Carrozza
authors.affiliation: Oncology Unit, Umberto I Hospital, Lugo di Romagna, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Campadelli
authors.affiliation: Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Bianchi
authors.affiliation: Oncology Unit, Cervesi Hospital, Cattolica, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Fabbri
authors.affiliation: Oncology Unit, Santa Maria delle Croci Hospital, Ravenna, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Montanari
authors.affiliation: Biostatistic and Clinical Trials Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Carretta
authors.affiliation: Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Menna
authors.affiliation: Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy. Electronic address: ugo.degiorgi@irst.emr.it.
authors.forename: Ugo
authors.initials: U
authors.lastname: De Giorgi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000736:Androstenes / Q000627:therapeutic use*; D018572:Disease-Free Survival; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017430:Prostate-Specific Antigen / Q000097:blood*; D064129:Prostatic Neoplasms, Castration-Resistant / Q000097:blood* / Q000188:drug therapy*; D012189:Retrospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000736:Androstenes; D017430:Prostate-Specific Antigen; C089740:abiraterone
keywords: Abiraterone; Castration-resistant prostate cancer; Outcome; PSA flare; Progression; Survival