title: The clinical safety of ibrutinib in chronic lymphocytic leukemia.
abstract: BACKGROUND
  Ibrutinib , a targeted inhibitor of B-cell receptor signaling, achieved impressive clinical results for patients with chronic lymphocytic leukemia (CLL). These results allowed the approval of ibrutinib for the treatment of patients with CLL who have received at least one prior therapy and those with a 17p deletion regardless of line of therapy.
  
  
  METHODS
  Comprehensive data from either Phase I-II or randomized Phase III studies are analyzed in this article. In addition, we reviewed data on the prevalence and the clinical management of some peculiar toxicities ibrutinib related such as lymphocytosis, major bleeding and atrial fibrillation.
  
  
  CONCLUSIONS
  Ibrutinib has radically changed the scenery of relapsed/refractory CLL treatment and established an important paradigm in the molecularly targeted approach of this disease. Discontinuation of ibrutinib is rarely due to adverse events related to the drug. Patients who discontinue treatment represent a challenge to the physicians because treatment options are very limited.
authors.affiliation: a Azienda Ospedaliera Pugliese-Ciaccio, Department Hematology-Oncology , Catanzaro, Italy +39 0 961 883 001 ; +39 0 961 883 467 ; smolica@libero.it.
authors.forename: Stefano
authors.initials: S
authors.lastname: Molica
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives; D000818:Animals; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000473:pathology; D058990:Molecular Targeted Therapy; D010880:Piperidines; D011720:Pyrazoles / Q000009:adverse effects* / Q000627:therapeutic use; D011743:Pyrimidines / Q000009:adverse effects* / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic
chemical_list: D000970:Antineoplastic Agents; D010880:Piperidines; D011720:Pyrazoles; D011743:Pyrimidines; C551803:ibrutinib; D000225:Adenine
keywords: chronic lymphocytic leukemia; clinical use; ibrutinib; ibrutinib-association; management toxicities; safety; toxicities