title: Effect of abiraterone acetate on fatigue in patients with metastatic castration-resistant prostate cancer after docetaxel chemotherapy.
abstract: BACKGROUND
  Fatigue is a common, debilitating side-effect of prostate cancer and its treatment. Patient-reported fatigue was evaluated as part of COU-AA-301, a randomized, placebo-controlled, phase III trial of abiraterone acetate and prednisone versus placebo and prednisone in metastatic castration-resistant prostate cancer (mCRPC) patients after docetaxel chemotherapy. This is the first phase III study in advanced prostate cancer to evaluate fatigue outcomes using a validated fatigue-specific instrument.
  
  
  METHODS
  The Brief Fatigue Inventory (BFI) questionnaire was used to measure patient-reported fatigue intensity and fatigue interference with activities of daily life. All analyses were conducted using prespecified responder definitions of clinically meaningful changes.
  
  
  RESULTS
  A total of 797 patients were randomized to abiraterone acetate and prednisone, and 398 were randomized to placebo and prednisone. Compared with prednisone alone, in patients with clinically significant fatigue at baseline, abiraterone acetate and prednisone significantly increased the proportion of patients reporting improvement in fatigue intensity (58.1% versus 40.3%, P = 0.0001), improved fatigue interference (55.0% versus 38.0%, P = 0.0075), and accelerated improvement in fatigue intensity (median 59 days versus 194 days, P = 0.0155).
  
  
  CONCLUSIONS
  In patients with mCRPC progressing after docetaxel chemotherapy, abiraterone acetate and prednisone yielded clinically meaningful improvements in patient-reported fatigue compared with prednisone alone.
authors.affiliation: Department of Medical Oncology, San Camillo and Forlanini Hospitals, Rome, Italy. cstern@mclink.it
authors.forename: C N
authors.initials: CN
authors.lastname: Sternberg
authors.forename: A
authors.initials: A
authors.lastname: Molina
authors.forename: S
authors.initials: S
authors.lastname: North
authors.forename: P
authors.initials: P
authors.lastname: Mainwaring
authors.forename: K
authors.initials: K
authors.lastname: Fizazi
authors.forename: Y
authors.initials: Y
authors.lastname: Hao
authors.forename: M
authors.initials: M
authors.lastname: Rothman
authors.forename: D D
authors.initials: DD
authors.lastname: Gagnon
authors.forename: T
authors.initials: T
authors.lastname: Kheoh
authors.forename: C M
authors.initials: CM
authors.lastname: Haqq
authors.forename: C
authors.initials: C
authors.lastname: Cleeland
authors.forename: J S
authors.initials: JS
authors.lastname: de Bono
authors.forename: H I
authors.initials: HI
authors.lastname: Scher
mesh_terms: D000069501:Abiraterone Acetate; D000730:Androstadienes / Q000008:administration & dosage*; D002369:Castration; D000077143:Docetaxel; D005221:Fatigue / Q000139:chemically induced / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D006801:Humans; D008297:Male; D009362:Neoplasm Metastasis / Q000188:drug therapy; D009367:Neoplasm Staging; D011241:Prednisone / Q000008:administration & dosage; D011471:Prostatic Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D011795:Surveys and Questionnaires; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000730:Androstadienes; D043823:Taxoids; D000077143:Docetaxel; D000069501:Abiraterone Acetate; D011241:Prednisone