title: Impact of exclusion criteria for the DASISION and ENESTnd trials in the front-line treatment of a 'real-life' patient population with chronic myeloid leukaemia.
abstract: Both Dasision and ENESTnd trials had many exclusion criteria, with a possible selection bias compared with the real-life. To address the impact of this bias on the first-line treatment in the current clinical practice, we revised 207 unselected newly diagnosed chronic phase chronic myeloid leukaemia (CML) patients [M/F 108/99, median age 58.8 years, interquartile range 42.3-70.2] treated with front-line imatinib from June 2002 to June 2013 at our Institution, and evaluated how many of them would have been excluded from enrolment in the two trials. Twenty-eight patients (13.5%) should have been excluded by both trials because of polycomorbidities (12), severe cardiomyopathy (five), age > 80 with frailty (three), drug abuse (two) or other severe concomitant diseases (six). In addition, eight patients should have been excluded by Dasision due to isolated chronic obstructive broncopulmonar disease, and 19 patients should have been excluded by ENESTnd due to isolated diabetes (10), arrhythmia (four), acute myocardial infarction > 6 months before CML diagnosis (two), chronic pancreatic disease (two) and peripheral arterial obstructive disease (one). On the whole, 36 patients (17.4%) would have been excluded by Dasision trial and 47 (22.7%) by ENESTnd trial. The patients potentially not eligible for both trials were significantly older and with imatinib had a worse outcome compared with patients potentially eligible. Our data highlight that an automatic transposition of results available in clinical controlled trials into the frontline real-life management of CML patients should be regarded with caution. Copyright © 2015 John Wiley & Sons, Ltd.
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Latagliata
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy.
authors.forename: Ida
authors.initials: I
authors.lastname: Carmosino
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Vozella
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Volpicelli
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: De Angelis
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy.
authors.forename: Maria Giovanna
authors.initials: MG
authors.lastname: Loglisci
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy.
authors.forename: Adriano
authors.initials: A
authors.lastname: Salaroli
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy.
authors.forename: Maria Lucia
authors.initials: ML
authors.lastname: De Luca
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Montagna
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Serrao
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Molica
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Diverio
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Nanni
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Mancini
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Breccia
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy.
authors.forename: Giuliana
authors.initials: G
authors.lastname: Alimena
mesh_terms: D000328:Adult; D000368:Aged; D018849:Controlled Clinical Trials as Topic; D005260:Female; D006801:Humans; D000068877:Imatinib Mesylate / Q000009:adverse effects / Q000627:therapeutic use; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged
chemical_list: D000068877:Imatinib Mesylate
keywords: chronic myeloid leukaemia; dasatinib; imatinib; nilotinib; real-life