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Randomized study of reduced-intensity chemotherapy combined with imatinib in adults with Ph-positive acute lymphoblastic leukemia.

  • Chalandon Y Division of Hematology, Department of Medical Specialties, University Hospital and University of Geneva, Geneva, Switzerland; Swiss Group for Clinical Cancer Research, Bern, Switzerland;
  • Thomas X Division of Hematology, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Bénite, France;
  • Hayette S Division of Hematology, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Bénite, France;
  • Cayuela JM Division of Hematology, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, University Paris Diderot, Paris, France;
  • Abbal C Division of Hematology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland;
  • Huguet F Division of Hematology, Institut Universitaire de Cancérologie, Toulouse, France;
  • Raffoux E Division of Hematology, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, University Paris Diderot, Paris, France;
  • Leguay T Division of Hematology, Hôpital Haut-Levêque, Pessac, France;
  • Rousselot P Division of Hematology, Hôpital Mignot, Versailles, France;
  • Lepretre S Division of Hematology, Centre Henri Becquerel, Rouen, France;
  • Escoffre-Barbe M Division of Hematology, Hôpital Pontchailloux, Rennes, France;
  • Maury S Division of Hematology, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris, University Paris Est Créteil, Créteil, France;
  • Berthon C Division of Hematology, Hôpital Claude Huriez, Lille, France;
  • Tavernier E Division of Hematology, Institut de Cancérologie Lucien-Neuwirth, Saint-Priest-en-Jarez, France;
  • Lambert JF Swiss Group for Clinical Cancer Research, Bern, Switzerland; Division of Hematology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland;
  • Lafage-Pochitaloff M Division of Hematology, Hôpital de la Timone, Marseille, France;
  • Lhéritier V Group for Research on Adult Acute Lymphoblastic Leukemia, Lyon, France;
  • Chevret S Division of Biostatistics, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, University Paris Diderot, Paris, France; and.
  • Ifrah N Division of Hematology, Centre Hospitalier Universitaire d'Angers and INSERM U892/Centre National de la Recherche Scientifique 6299, Angers, France.
  • Dombret H Division of Hematology, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, University Paris Diderot, Paris, France;
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  • 2015-04-17
Published in:
  • Blood. - 2015
Adolescent
Adult
Antineoplastic Combined Chemotherapy Protocols
Benzamides
Disease-Free Survival
Female
Humans
Imatinib Mesylate
Male
Middle Aged
Philadelphia Chromosome
Piperazines
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Protein Kinase Inhibitors
Pyrimidines
Stem Cell Transplantation
Treatment Outcome
Young Adult
English In this study, we randomly compared high doses of the tyrosine kinase inhibitor imatinib combined with reduced-intensity chemotherapy (arm A) to standard imatinib/hyperCVAD (cyclophosphamide/vincristine/doxorubicin/dexamethasone) therapy (arm B) in 268 adults (median age, 47 years) with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). The primary objective was the major molecular response (MMolR) rate after cycle 2, patients being then eligible for allogeneic stem cell transplantation (SCT) if they had a donor, or autologous SCT if in MMolR and no donor. With fewer induction deaths, the complete remission (CR) rate was higher in arm A than in arm B (98% vs 91%; P = .006), whereas the MMolR rate was similar in both arms (66% vs 64%). With a median follow-up of 4.8 years, 5-year event-free survival and overall survival (OS) rates were estimated at 37.1% and 45.6%, respectively, without difference between the arms. Allogeneic transplantation was associated with a significant benefit in relapse-free survival (hazard ratio [HR], 0.69; P = .036) and OS (HR, 0.64; P = .02), with initial white blood cell count being the only factor significantly interacting with this SCT effect. In patients achieving MMolR, outcome was similar after autologous and allogeneic transplantation. This study validates an induction regimen combining reduced-intensity chemotherapy and imatinib in Ph+ ALL adult patients and suggests that SCT in first CR is still a good option for Ph+ ALL adult patients. This trial was registered at www.clinicaltrials.gov as #NCT00327678.
Language
  • English
Open access status
bronze
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https://folia.unifr.ch/global/documents/287553
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