title: Idarubicin oral: new formulation. No proven benefit over 60.
abstract: (1) Oral idarubicin is marketed in France for the treatment of acute myeloblastic leukaemia in patients over 60 who are ineligible for intensive intravenous treatment.  (2) The clinical file on oral idarubicin is limited.  (3) In non comparative trials the median survival time after starting treatment with oral idarubicin, alone or combined with other cytotoxic agents, did not exceed 12 months.  (4) The only comparative trial of single-agent idarubicin in this indication gave unfavourable results.  Another comparative trial tested a combination comprising idarubicin, but the role of idarubicin alone cannot be determined from the results.  (5) In the palliative care setting the clinical efficacy of oral idarubicin has not yet been demonstrated.  (6) The main adverse events observed during oral idarubicin therapy are neutropenia, thrombocytopenia, nausea and vomiting, diarrhoea and hair loss.  Their impact on patients' quality of life has not been adequately assessed.
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D017277:Drug Approval; D005602:France; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality; D008875:Middle Aged; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D015255:Idarubicin