Liver tests increase on abiraterone acetate in men with metastatic prostate cancer: Natural history, management and outcome

Eur J Cancer. 2020 Apr:129:117-122. doi: 10.1016/j.ejca.2020.01.017. Epub 2020 Mar 6.


Background: Abiraterone acetate (abiraterone) combined with prednisone is a standard of care in metastatic castration-resistant prostate cancer. Recently, benefit in overall survival was reported in metastatic castration-sensitive prostate cancer also, and an extension of indication has been granted. Abiraterone is seldom associated with liver toxicity. The clinical management and the outcome of patients with transaminase increase while on abiraterone have not been described.

Patients and method: We identified 25 men with metastatic prostate cancer and liver function test disorders occurring while on abiraterone treatment from December 2009 to September 2017 in three oncology centres in France.

Results: Forty-six liver disorder events occurred in 25 patients while on abiraterone treatment. The median age at liver function test increase was 67 (55-85) years. The incidence of aspartate aminotransférase (AST) (24 events) and that of alanine aminotransférase (ALT) (22 events) increases were similar. Liver toxicity was of grade 1, 2 and 3 (Common Terminology Criteria for Adverse Events. version 4) in 7 (32%), 6 (27%) and 9 (41%) patients for ALT, and in 12 (50%), 6 (25%) and 6 (25%) for AST, respectively. The median time from abiraterone initiation to the detection of liver toxicity was 7.1 (4-95) weeks. The median time from highest ALT/AST increase to normalisation was 6.2 [2-14] weeks. In 13 patients (52%), liver tests spontaneously returned to baseline values, while abiraterone was continued at full dose.

Conclusion: Liver function test increase is a rare event that typically occurs within the first two months on abiraterone. Most patients experience normalisation of the tests, either spontaneously or after dose reduction/discontinuation.

Keywords: Abiraterone acetate; Liver toxicity; Prostate cancer.

MeSH terms

  • Abiraterone Acetate / administration & dosage
  • Abiraterone Acetate / adverse effects*
  • Administration, Oral
  • Aged
  • Aged, 80 and over
  • Alanine Transaminase / blood
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects*
  • Aspartate Aminotransferases / blood
  • Bone Neoplasms / drug therapy*
  • Bone Neoplasms / secondary
  • Chemical and Drug Induced Liver Injury / blood
  • Chemical and Drug Induced Liver Injury / diagnosis
  • Chemical and Drug Induced Liver Injury / epidemiology*
  • Chemical and Drug Induced Liver Injury / prevention & control
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Humans
  • Incidence
  • Liver Function Tests / statistics & numerical data
  • Liver Neoplasms / drug therapy*
  • Liver Neoplasms / secondary
  • Lymphatic Metastasis / drug therapy
  • Lymphatic Metastasis / pathology
  • Male
  • Middle Aged
  • Prednisone / administration & dosage
  • Prednisone / adverse effects
  • Prostatic Neoplasms, Castration-Resistant / blood
  • Prostatic Neoplasms, Castration-Resistant / drug therapy*
  • Remission, Spontaneous


  • Aspartate Aminotransferases
  • Alanine Transaminase
  • Abiraterone Acetate
  • Prednisone