title: Additional cytogenetic changes do not influence the outcome of patients with newly diagnosed acute promyelocytic leukemia treated with an ATRA plus anthracyclin based protocol. A report of the Spanish group PETHEMA.
abstract: OBJECTIVE
  To analyze in patients with de novo acute promyelocytic leukemia (APL) treated with an ATRA plus anthracyclin-based protocol if the presence of additional cytogenetic aberrations to the t(15;17) influences: 1. clinical and biological presenting features; 2. disease outcome.
  
  
  METHODS
  One hundred and thirteen patients with newly diagnosed APL enrolled in the APL-96 protocol of the Spanish PETHEMA group were studied by conventional karyotyping, FISH and RT-PCR for the PML-RARa fusion. Treatment was homogeneous in all cases and consisted of anthracyclines and ATRA.
  
  
  RESULTS
  Additional chromosome aberrations were observed in 30% of cases. The most frequent secondary changes were +8 (14 cases), and abnormalities of chromosomes 9 or 3 (4 patients each), and of chromosomes 1 and 8 (3 cases each). No clinical, biological, morphological, immunophenotypic or molecular differences were observed between the group of APLs with t(15;17) alone and the group of patients with additional changes. Patients with additional changes had a higher rates of complete remission (CR) and 4-year disease-free survival (DFS) (97%, and 97%, respectively) than patients with t(15;17) alone (CR, 70% and DFS, 84%) but these differences were not statistically significant.
  
  
  CONCLUSIONS
  Patients with APL and additional cytogenetic abnormalities do not show different clinical, biological, morphological or molecular features as compared to patients with t(15;17) alone. The prognosis of patients with APL and t(15;17) alone and those with additional changes is similar in both groups. This study indicates that there is no rationale for administering more intensive treatment in APL patients with additional cytogenetic abnormalities receiving ATRA plus anthracycline-based chemotherapy.
authors.affiliation: Servicio de Hematología, Hospital Universitario de Salamanca, Paseo San Vicente 58-182, 37007 Salamanca, Spain. jmhernandezr@aehh.org
authors.forename: J M
authors.initials: JM
authors.lastname: Hernández
authors.forename: G
authors.initials: G
authors.lastname: Martín
authors.forename: N C
authors.initials: NC
authors.lastname: Gutiérrez
authors.forename: J
authors.initials: J
authors.lastname: Cervera
authors.forename: M T
authors.initials: MT
authors.lastname: Ferro
authors.forename: M J
authors.initials: MJ
authors.lastname: Calasanz
authors.forename: J A
authors.initials: JA
authors.lastname: Martínez-Climent
authors.forename: E
authors.initials: E
authors.lastname: Luño
authors.forename: M
authors.initials: M
authors.lastname: Tormo
authors.forename: C
authors.initials: C
authors.lastname: Rayón
authors.forename: J
authors.initials: J
authors.lastname: Díaz-Mediavilla
authors.forename: M
authors.initials: M
authors.lastname: González
authors.forename: J D
authors.initials: JD
authors.lastname: González-San Miguel
authors.forename: K
authors.initials: K
authors.lastname: Pérez-Equiza
authors.forename: C
authors.initials: C
authors.lastname: Rivas
authors.forename: J
authors.initials: J
authors.lastname: Esteve
authors.forename: M del C
authors.initials: Mdel C
authors.lastname: Alvarez
authors.forename: J
authors.initials: J
authors.lastname: Odriozola
authors.forename: J M
authors.initials: JM
authors.lastname: Ribera
authors.forename: M A
authors.initials: MA
authors.lastname: Sanz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002648:Child; D002869:Chromosome Aberrations; D020732:Cytogenetic Analysis; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015473:Leukemia, Promyelocytic, Acute / Q000175:diagnosis / Q000188:drug therapy / Q000235:genetics*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage
chemical_list: D000903:Antibiotics, Antineoplastic; D014212:Tretinoin