title: Phase II study of single-agent arsenic trioxide for the front-line therapy of acute promyelocytic leukemia.
abstract: OBJECTIVE
  The long-term follow-up results of patients with acute promyelocytic leukemia (APL) treated with all-trans retinoic acid and chemotherapy show high cure rates. Several studies have shown high efficacy of single-agent arsenic trioxide in newly diagnosed APL. However, long-term follow-up results are needed.
  
  
  METHODS
  One hundred ninety-seven patients with newly diagnosed APL were treated with arsenic trioxide 0.15 mg/kg daily intravenous infusion until complete remission (CR). After achieving CR, the patients received one to four more courses of therapy with arsenic trioxide as consolidation and were observed with reverse-transcriptase polymerase chain reaction studies from peripheral blood (to detect of minimal residual disease) every 3 months or until relapse or death.
  
  
  RESULTS
  The morphologic CR rate was 85.8%. The most common cause of remission failure was early death owing to APL differentiation syndrome (13.2%). The most important prognostic factor for early mortality was a high WBC count at presentation. The 5-year disease-free survival (DFS) rate was 66.7% ± 4% (SE). Relapse after 5 years in CR was rare. The 5-year overall survival (OS) rate by intention-to-treat analysis was 64.4% ± 4%. In patients who achieved CR, OS and DFS were identical.
  
  
  CONCLUSIONS
  The long-term follow-up of newly diagnosed patients with APL treated with single-agent arsenic trioxide shows high rates of DFS and OS.
authors.affiliation: Hematology, Oncology, and Stem Cell Transplantation Research Center, Tehran University of Medical Sciences, Kargar Ave, Tehran, Iran.
authors.forename: Ardeshir
authors.initials: A
authors.lastname: Ghavamzadeh
authors.forename: Kamran
authors.initials: K
authors.lastname: Alimoghaddam
authors.forename: Shahrbano
authors.initials: S
authors.lastname: Rostami
authors.forename: Seyed Hamidolah
authors.initials: SH
authors.lastname: Ghaffari
authors.forename: Mohamad
authors.initials: M
authors.lastname: Jahani
authors.forename: Massoud
authors.initials: M
authors.lastname: Iravani
authors.forename: Seyed Asadollah
authors.initials: SA
authors.lastname: Mousavi
authors.forename: Babak
authors.initials: B
authors.lastname: Bahar
authors.forename: Mahdi
authors.initials: M
authors.lastname: Jalili
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000077237:Arsenic Trioxide; D001152:Arsenicals / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007492:Iran; D015473:Leukemia, Promyelocytic, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010087:Oxides / Q000009:adverse effects / Q000627:therapeutic use*; D012074:Remission Induction; D016019:Survival Analysis
chemical_list: D000970:Antineoplastic Agents; D001152:Arsenicals; D010087:Oxides; D000077237:Arsenic Trioxide