title: Results of the PETHEMA ALL-96 trial in elderly patients with Philadelphia chromosome-negative acute lymphoblastic leukemia.
abstract: OBJECTIVE
  Only 20-30% of elderly patients with acute lymphoblastic leukemia (ALL) are enrolled in clinical trials because of co-morbid disorders or poor performance status. We present the results of treatment of Philadelphia chromosome-negative (Ph-) ALL patients over 55 yr treated in the PETHEMA ALL-96 trial.
  
  
  METHODS
  From 1996 to 2006, 33 patients > or = 55 yr with Ph- ALL were included. Induction therapy was vincristine, daunorubicin, prednisone, asparaginase, and cyclophosphamide over 5 weeks. Central nervous system (CNS) prophylaxis involved triple intrathecal (IT) therapy, 14 doses over the first year. Consolidation-1 included mercaptopurine, methotrexate, teniposide and cytarabine, followed by one consolidation-2 cycle similar to the induction cycle. Maintenance consisted of mercaptopurine and methotrexate up to 2 yr in complete remission (CR) with monthly reinduction cycles (vincristine, prednisone and asparaginase) during the first year.
  
  
  RESULTS
  Median (range) age was 65 yr (56-77). Phenotype (30 patients): early-pre-B 7, common/pre-B 18, T 5. Cytogenetics (28 patients): normal 12, complex 10, t(4;11) 2 and other 4. CR was achieved in 19/33 (57.6%) patients, early death occurred in 12 (36.4%) and 2 (6%) were resistant. Overall survival and disease-free survival probabilities (2 yr, 95% CI) were 39% (21%-57%) and 46% (22%-70%), respectively (median follow up of 24 months). Removal of asparaginase and cyclophosphamide from the induction decreased induction death (OR 0.119, CI 95% 0.022-0.637, P = 0.013) and increased survival (20% vs. 52%, P = 0.05).
  
  
  CONCLUSIONS
  The prognosis of elderly Ph- ALL patients is poor. In this study, less intensive induction decreased toxic death, allowing delivery of planned consolidation therapy and increased survival probability.
authors.affiliation: Clinical Hematology Department, Institut Catalá d'Oncologia-Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
authors.forename: Juan-Manuel
authors.initials: JM
authors.lastname: Sancho
authors.forename: Josep-Maria
authors.initials: JM
authors.lastname: Ribera
authors.forename: Blanca
authors.initials: B
authors.lastname: Xicoy
authors.forename: Mireia
authors.initials: M
authors.lastname: Morgades
authors.forename: Albert
authors.initials: A
authors.lastname: Oriol
authors.forename: Mar
authors.initials: M
authors.lastname: Tormo
authors.forename: Eloy
authors.initials: E
authors.lastname: del Potro
authors.forename: Guillermo
authors.initials: G
authors.lastname: Debén
authors.forename: Eugenia
authors.initials: E
authors.lastname: Abella
authors.forename: Concepción
authors.initials: C
authors.lastname: Bethencourt
authors.forename: Xavier
authors.initials: X
authors.lastname: Ortín
authors.forename: Salut
authors.initials: S
authors.lastname: Brunet
authors.forename: Fernando
authors.initials: F
authors.lastname: Ortega-Rivas
authors.forename: Andrés
authors.initials: A
authors.lastname: Novo
authors.forename: Ramón
authors.initials: R
authors.lastname: López
authors.forename: Jesús-María
authors.initials: JM
authors.lastname: Hernández-Rivas
authors.forename: Miguel-Angel
authors.initials: MA
authors.lastname: Sanz
authors.forename: Evarist
authors.initials: E
authors.lastname: Feliu
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001215:Asparaginase / Q000008:administration & dosage / Q000009:adverse effects; D015897:Comorbidity; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects; D003630:Daunorubicin / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D015122:Mercaptopurine / Q000008:administration & dosage / Q000009:adverse effects; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy*; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D011379:Prognosis; D012074:Remission Induction; D012720:Severity of Illness Index; D016019:Survival Analysis; D013713:Teniposide / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D003561:Cytarabine; D016179:Granulocyte Colony-Stimulating Factor; D014750:Vincristine; D003907:Dexamethasone; D003520:Cyclophosphamide; D013713:Teniposide; D015122:Mercaptopurine; D001215:Asparaginase; D011241:Prednisone; D008727:Methotrexate; D003630:Daunorubicin