title: Comparison of intensive chemotherapy, allogeneic or autologous stem cell transplantation as post-remission treatment for adult patients with high-risk acute lymphoblastic leukemia. Results of the PETHEMA ALL-93 trial.
abstract: OBJECTIVE
  The optimal post-remission therapy for adults with high-risk acute lymphoblastic leukemia (ALL) is not well established. This multicenter randomized trial by the Spanish PETHEMA Group was addressed to compare three options of post-remission therapy in adults with high-risk ALL: chemotherapy, allogeneic stem cell transplantation (SCT) and autologous SCT.
  
  
  METHODS
  A total of 222 valid high-risk ALL patients entered the trial. All received a standard five-drug/five-week induction course. Patients in complete remission with an HLA-identical family donor were assigned to allogeneic SCT (n=84) and the remaining were randomized to autologous SCT (n=50) or to delayed intensification followed by maintenance chemotherapy up to 2 years in complete remission (n=48).
  
  
  RESULTS
  Overall, 183 patients achieved complete remission (82%). With a median follow-up of 70 months, the median disease-free survival and overall survival were 17 and 23 months, respectively. The 5-year disease-free survival and overall survival were 35% (95% CI, 30%-41%) and 34% (95% CI, 28%-39%), respectively. Patients allocated to the chemotherapy, allogeneic and autologous SCT were comparable in the main pre-treatment ALL characteristics and the rate of response to therapy. Intention-to-treat analysis showed no differences between patients according to whether they had or did not have a donor in disease-free survival (39%, 95% CI 30-48% vs. 33%, 95% CI 23-41%) and overall survival (44%, 95% CI 35-52% vs. 35%, 95% CI 25-44%), as well as for autologous SCT vs. chemotherapy comparisons (disease-free survival: 40%, 95% CI 28-52% vs. 51%, 95% CI 37-67%; overall survival: 43%, 95% CI 29-58% vs. 52%, 95% CI 39-65%). No differences were observed when the analysis was made on the basis of the treatment actually performed.
  
  
  CONCLUSIONS
  This study failed to prove that, when a family donor is available, allogeneic SCT produces a better outcome than autologous SCT or chemotherapy in adults with high-risk ALL.
authors.affiliation: Servicio de Hematología Clínica, Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol, C/ Canyet S/N, 08916 Badalona, Spain. jmribera@ns.hugtip.scs.es
authors.forename: Josep-María
authors.initials: JM
authors.lastname: Ribera
authors.forename: Albert
authors.initials: A
authors.lastname: Oriol
authors.forename: Concepción
authors.initials: C
authors.lastname: Bethencourt
authors.forename: Ricardo
authors.initials: R
authors.lastname: Parody
authors.forename: Jesús-María
authors.initials: JM
authors.lastname: Hernández-Rivas
authors.forename: María-José
authors.initials: MJ
authors.lastname: Moreno
authors.forename: Eloy
authors.initials: E
authors.lastname: del Potro
authors.forename: Mar
authors.initials: M
authors.lastname: Torm
authors.forename: Concepción
authors.initials: C
authors.lastname: Rivas
authors.forename: Joan
authors.initials: J
authors.lastname: Besalduch
authors.forename: Miguel-Angel
authors.initials: MA
authors.lastname: Sanz
authors.forename: Juan-José
authors.initials: JJ
authors.lastname: Ortega
mesh_terms: D000293:Adolescent; D000328:Adult; D000970:Antineoplastic Agents / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000453:epidemiology / Q000601:surgery*; D012074:Remission Induction; D012307:Risk Factors; D033581:Stem Cell Transplantation / Q000379:methods*; D014182:Transplantation, Autologous; D014184:Transplantation, Homologous
chemical_list: D000970:Antineoplastic Agents