title: A population-based study of chronic myeloid leukemia patients treated with imatinib in first line.
abstract: Chronic myeloid leukemia (CML) treatment is based on company-sponsored and academic trials testing different tyrosine kinase inhibitors (TKIs) as first-line therapy. These studies included patients selected according to many inclusion-exclusion criteria, particularly age and comorbidities, with specific treatment obligations. In daily clinical practice (real-life), inclusion-exclusion criteria do not exist, and the treatment outcome does not only depend on the choice of first-line TKI but also on second- and third-line TKIs. To investigate in a real-life setting the response and the outcome on first-line imatinib, with switch to second generation TKIs in case of unsatisfying response or intolerance, we analyzed all newly diagnosed patients (N = 236), living in two Italian regions, registered in a prospective study according to population-based criteria and treated front-line with imatinib. A switch from imatinib to second-generation TKIs was reported in 14% of patients for side effects and in 24% for failure or suboptimal response, with an improvement of molecular response in 57% of them. The 5-year overall survival (OS) and leukemia-related survival (LRS) were 85% and 93%, respectively; the 4-year rates of MR3.0and MR4.0were 75% and 48%, respectively. Cardiovascular complications were reported in 4% of patients treated with imatinib alone and in 6% of patients receiving nilotinib as second-line. Older age (≥70 years) affected OS, but not LRS. These data provide an unbiased reference on the CML management and on the results of TKI treatment in real-life, according to ELN recommendations, using imatinib as first-line treatment and second-generation TKIs as second-line therapy. Am. J. Hematol. 92:82-87, 2017. © 2016 Wiley Periodicals, Inc.
authors: Department of Oncology and Hematology, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.|Department of Experimental, Diagnostic and Specialty Medicine, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
authors: Fausto
authors: F
authors: Castagnetti
authors: Division of Hematology, A.O.U. Policlinico "Vittorio Emanuele,", University of Catania, Catania, Italy.
authors: Francesco
authors: F
authors: Di Raimondo
authors: Department of Oncology and Hematology, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.|Department of Experimental, Diagnostic and Specialty Medicine, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
authors: Antonio
authors: A
authors: De Vivo
authors: Division of Hematology, A.O.U. Policlinico "Vittorio Emanuele,", University of Catania, Catania, Italy.
authors: Antonio
authors: A
authors: Spitaleri
authors: Department of Oncology and Hematology, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.|Department of Experimental, Diagnostic and Specialty Medicine, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
authors: Gabriele
authors: G
authors: Gugliotta
authors: Division of Hematology and Bone Marrow Transplantation, Ospedali Riuniti Villa Sofia - Cervello, Palermo, Italy.
authors: Francesco
authors: F
authors: Fabbiano
authors: Division of Hematology, Arcispedale Santa Maria Nuova, IRCCS, Reggio Emilia, Italy.
authors: Isabella
authors: I
authors: Capodanno
authors: Division of Hematology, Ospedale Papardo, Messina, Italy.
authors: Donato
authors: D
authors: Mannina
authors: Division of Hematology, "Santa Maria delle Croci" Hospital, Ravenna, Italy.
authors: Marzia
authors: M
authors: Salvucci
authors: Service of Immunohematology and Transfusion Medicine, Azienda Ospedaliera Provinciale, Ragusa, Italy.
authors: Agostino
authors: A
authors: Antolino
authors: Division of Hematology, Modena University Hospital, University of Modena and Reggio Emilia, Modena, Italy.
authors: Roberto
authors: R
authors: Marasca
authors: Division of Hematology, Clinica La Maddalena, Palermo, Italy.
authors: Maurizio
authors: M
authors: Musso
authors: Division of Hematology and Bone Marrow Transplantation, University Hospital, Parma, Italy.
authors: Monica
authors: M
authors: Crugnola
authors: Division of Hematology, ARNAS Garibaldi, Catania, Italy.
authors: Stefana
authors: S
authors: Impera
authors: Division of Hematology and Bone Marrow Transplantation, "Guglielmo da Saliceto" Hospital, Piacenza, Italy.
authors: Elena
authors: E
authors: Trabacchi
authors: Division of Hematology, "G. Martino" University Hospital, University of Messina, Italy.
authors: Caterina
authors: C
authors: Musolino
authors: Division of Hematology, "Sant'Anna" University Hospital, University of Ferrara, Ferrara, Italy.
authors: Francesco
authors: F
authors: Cavazzini
authors: Division of Hematology, "S.Vincenzo" Hospital, Taormina, ME, Italy.
authors: Giuseppe
authors: G
authors: Mineo
authors: Division of Hematology, Ospedale degli Infermi, Rimini, Italy.
authors: Patrizia
authors: P
authors: Tosi
authors: Department of Oncology/Division of Hematology, Ospedale Civico, Palermo, Italy.
authors: Carmela
authors: C
authors: Tomaselli
authors: Division of Hematology, Ospedale S. Elia, Caltanissetta, Italy.
authors: Michele
authors: M
authors: Rizzo
authors: Division of Hematology and Bone Marrow Transplantation, Azienda Ospedaliera Universitaria Policlinico "P. Giaccone,", Palermo, Italy.
authors: Sergio
authors: S
authors: Siragusa
authors: Department of Oncology and Hematology, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.|Department of Experimental, Diagnostic and Specialty Medicine, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
authors: Miriam
authors: M
authors: Fogli
authors: Department of Oncology and Hematology, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.|Department of Experimental, Diagnostic and Specialty Medicine, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
authors: Riccardo
authors: R
authors: Ragionieri
authors: Department of Oncology and Hematology, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.|Department of Experimental, Diagnostic and Specialty Medicine, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
authors: Alessandro
authors: A
authors: Zironi
authors: Department of Oncology and Hematology, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.|Department of Experimental, Diagnostic and Specialty Medicine, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
authors: Simona
authors: S
authors: Soverini
authors: Department of Oncology and Hematology, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.|Department of Experimental, Diagnostic and Specialty Medicine, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
authors: Giovanni
authors: G
authors: Martinelli
authors: Department of Oncology and Hematology, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.|Department of Experimental, Diagnostic and Specialty Medicine, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
authors: Michele
authors: M
authors: Cavo
authors: Unit of Medical Oncology, A.O.U. Policlinico "Vittorio Emanuele," University of Catania, Catania, Italy.
authors: Paolo
authors: P
authors: Vigneri
authors: Division of Hematology, A.O.U. Policlinico "Vittorio Emanuele,", University of Catania, Catania, Italy.
authors: Fabio
authors: F
authors: Stagno
authors: Department of Oncology and Hematology, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.|Department of Experimental, Diagnostic and Specialty Medicine, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
authors: Gianantonio
authors: G
authors: Rosti
authors: Department of Hematology and Oncology "L. and A. Seràgnoli,", University of Bologna, Bologna, Italy.
authors: Michele
authors: M
authors: Baccarani
mesh_terms: D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D000068877:Imatinib Mesylate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D047428:Protein Kinase Inhibitors; D000068877:Imatinib Mesylate