title: Feasibility and results of subtype-oriented protocols in older adults and fit elderly patients with acute lymphoblastic leukemia: Results of three prospective parallel trials from the PETHEMA group.
abstract: OBJECTIVE
  The prognosis of acute lymphoblastic leukemia (ALL) is poor in older adults and elderly patients, and subtype-oriented prospective trials are scarce in these patients. We present the results of three prospective parallel subtype-oriented protocols in fit patients older than 55 years.
  
  
  METHODS
  In 2008, three prospective phase II trials in patients older than 55 years were activated: ALLOLD07 for Philadephia (Ph) chromosome-negative ALL, ALLOPH07 for Ph-positive ALL, and BURKIMAB08 for mature B-ALL. Early death (ED), complete remission (CR), disease-free survival (DFS), overall survival (OS) and toxicity were analyzed.
  
  
  RESULTS
  56, 53 and 21 patients from the ALLOLD07, ALLOPH07 and BURKIMAB08 trials, respectively, were evaluable. CR was 74%, 87% and 70%, with an ED rate of 13%, 11% and 15%, respectively. The medians of DFS were 8 and 38 months for ALLOLD07 and ALLOPH07 protocols, not being achieved in the BURKIMAB08 trial (p=0.001), and the median OS was 12, 37 and 25 months, respectively (p=0.030). Neutropenia, thrombocytopenia and infections were less frequent in the ALLOPH07 trial vs. ALLOLD07 and BURKIMAB trials, and renal toxicity and mucositis were more frequent in the BURKIMAB08 trial vs. the ALLOLD07 and ALLOPH07 trials. ECOG score and WBC count had prognostic significance for OS in ALLOPH07 and BURKIMAB08 trials, whereas no prognostic factors were identified in ALLOLD07 protocol.
  
  
  CONCLUSIONS
  Subtype-oriented treatment had an impact in the outcome of older adults with ALL. The poorest outcome was observed in Ph-negative non-Mature B-cell ALL patients, for whom improvements in therapy are clearly needed.
authors.affiliation: Hematology Department of Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Josep Carreras Leukaemia Research Institute (IJC), Badalona, Universitat Autònoma de Barcelona, Spain. Electronic address: jribera@iconcologia.net.
authors.forename: Josep-Maria
authors.initials: JM
authors.lastname: Ribera
authors.affiliation: Hematology Department of Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Josep Carreras Leukaemia Research Institute (IJC), Badalona, Universitat Autònoma de Barcelona, Spain.
authors.forename: Olga
authors.initials: O
authors.lastname: García
authors.affiliation: Hematology Department of Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Josep Carreras Leukaemia Research Institute (IJC), Badalona, Universitat Autònoma de Barcelona, Spain.
authors.forename: Albert
authors.initials: A
authors.lastname: Oriol
authors.affiliation: Hematology Department of Hospital General Universitario de Alicante, Alicante, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Gil
authors.affiliation: Hematology Department of Hospital Universitario y Politécnico La Fe. Valencia, Spain.
authors.forename: Pau
authors.initials: P
authors.lastname: Montesinos
authors.affiliation: Hematology Department of Hospital Central de Asturias, Oviedo, Spain.
authors.forename: Teresa
authors.initials: T
authors.lastname: Bernal
authors.affiliation: Hematology Department of Hospital Universitario Virgen del Rocío, Sevilla, Spain.
authors.forename: José
authors.initials: J
authors.lastname: González-Campos
authors.affiliation: Hematology Department of Hospital Universitario Lucus Augusti, Lugo, Spain.
authors.forename: Esperanza
authors.initials: E
authors.lastname: Lavilla
authors.affiliation: Hematology Department of Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Josep Carreras Leukaemia Research Institute (IJC), Badalona, Universitat Autònoma de Barcelona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Ribera
authors.affiliation: Hematology Department of Hospital de Sant Pau, Barcelona, Spain.
authors.forename: Salut
authors.initials: S
authors.lastname: Brunet
authors.affiliation: Hematology Department of Hospital Doce de Octubre, Madrid, Spain.
authors.forename: María-Pilar
authors.initials: MP
authors.lastname: Martínez
authors.affiliation: Hematology Department of Hospital Clínico, Valencia, Spain.
authors.forename: Mar
authors.initials: M
authors.lastname: Tormo
authors.affiliation: Hematology Department of Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Josep Carreras Leukaemia Research Institute (IJC), Badalona, Universitat Autònoma de Barcelona, Spain.
authors.forename: Eulàlia
authors.initials: E
authors.lastname: Genescà
authors.affiliation: Hematology Department of Hospital Vall d'Hebron, Barcelona, Spain.
authors.forename: Pere
authors.initials: P
authors.lastname: Barba
authors.affiliation: Hematology Department of Institut Català d'Oncologia-Hospital Duran i Reynals, L'Hospitalet de Llobregat, Spain.
authors.forename: Josep
authors.initials: J
authors.lastname: Sarrà
authors.affiliation: Hematology Department of Hospital Universitario de Getafe, Getafe, Spain.
authors.forename: María-Carmen
authors.initials: MC
authors.lastname: Monteserín
authors.affiliation: Hematology Department of Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Soria
authors.affiliation: Hematology Department of Hospital Marqués de Valdecilla, Santander, Spain.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Colorado
authors.affiliation: Hematology Department of Hospital Son Llàtzer, Palma de Mallorca, Spain.
authors.forename: Antònia
authors.initials: A
authors.lastname: Cladera
authors.affiliation: Hematology Department of Hospital Arnau de Vilanova, Lleida, Spain.
authors.forename: Antoni
authors.initials: A
authors.lastname: García-Guiñón
authors.affiliation: Hematology Department of Hospital Ramón y Cajal, Madrid, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Calbacho
authors.affiliation: Hematology Department of Hospital Madrid Norte Sanchinarro, Madrid, Spain.
authors.forename: Alfons
authors.initials: A
authors.lastname: Serrano
authors.affiliation: Hematology Department of Hospital Verge de la Cinta, Tortosa, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Ortín
authors.affiliation: Hematology Department of Hospital Universitario Doctor Peset, Valencia, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Pedreño
authors.affiliation: Hematology Department of Hospital General Universitario Morales Meseguer, Murcia, Spain.
authors.forename: Maria-Luz
authors.initials: ML
authors.lastname: Amigo
authors.affiliation: Hematology Department of Institut Català d'Oncologia-Hospital Joan XXIII, Tarragona, Spain.
authors.forename: Lourdes
authors.initials: L
authors.lastname: Escoda
authors.affiliation: Hematology Department of Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Josep Carreras Leukaemia Research Institute (IJC), Badalona, Universitat Autònoma de Barcelona, Spain.
authors.forename: Evarist
authors.initials: E
authors.lastname: Feliu
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000401:mortality; D011379:Prognosis
keywords: Acute lymphoblastic leukemia; Elderly; Risk-adapted therapy