title: CONIFER - Non-Interventional Study to Evaluate Therapy Monitoring During Deferasirox Treatment of Iron Toxicity in Myelodysplastic Syndrome Patients with Transfusional Iron Overload.
abstract: BACKGROUND
  The non-interventional study CONIFER was designed to assess the safety and clinical practicability of deferasirox for the treatment of transfusional iron overload in myelodysplastic syndrome (MDS) patients.
  
  
  METHODS
  Patients included in the study were diagnosed with MDS and received at least 1 treatment with deferasirox. The observation period covered the time from the initial visit until the last follow-up.
  
  
  RESULTS
  The data of 99 patients with MDS scored mainly as International Prognostic Scoring System (IPSS) low and intermediate 1 were evaluated. The mean age of the participants was 75 years and 58% of the patients were male. Iron overload was assessed by serum ferritin level (mean baseline serum ferritin 2,080 ± 1,244 µg/l). Patients were treated for a mean duration of 16 months (mean daily dose at baseline 11.8 ± 7.0 mg/kg). Stratification of serum ferritin levels by deferasirox dose showed a reduction at the higher but no reduction at the lower dose (< 15 mg/kg vs. ≥ 15 mg/kg and < 20 mg/kg vs. ≥ 20 mg/kg). The majority of patients (81%) were affected by at least 1 adverse event, with decreased renal creatinine clearance being the most frequent.
  
  
  CONCLUSIONS
  Higher doses (≥ 15 mg/kg) of deferasirox effectively and safely reduced serum ferritin levels in MDS patients with transfusional iron overload.
authors.affiliation: Onkologie Rheinland, Schwerpunktpraxis Bonn, Bonn, Germany.
authors.forename: Harald-Robert
authors.initials: HR
authors.lastname: Bruch
authors.forename: Yves
authors.initials: Y
authors.lastname: Dencausse
authors.forename: Jörg
authors.initials: J
authors.lastname: Heßling
authors.forename: Gerlinde
authors.initials: G
authors.lastname: Michl
authors.forename: Rudolf
authors.initials: R
authors.lastname: Schlag
authors.forename: Alexandra
authors.initials: A
authors.lastname: Skorupa
authors.forename: Cornelia
authors.initials: C
authors.lastname: Schneider-Schranz
authors.forename: Sebastian
authors.initials: S
authors.lastname: Wolf
authors.forename: Clemens
authors.initials: C
authors.lastname: Schulte
authors.forename: Hans
authors.initials: H
authors.lastname: Tesch
mesh_terms: D058186:Acute Kidney Injury / Q000139:chemically induced* / Q000517:prevention & control; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001565:Benzoates / Q000008:administration & dosage* / Q000009:adverse effects; D000077588:Deferasirox; D004305:Dose-Response Relationship, Drug; D016903:Drug Monitoring; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000517:prevention & control; D006801:Humans; D007502:Iron Chelating Agents / Q000008:administration & dosage / Q000009:adverse effects; D019190:Iron Overload / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D065227:Transfusion Reaction; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D001565:Benzoates; D007502:Iron Chelating Agents; D014230:Triazoles; D000077588:Deferasirox