title: Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia Patients Trial.
abstract: We report the 5-year analysis from the phase III Dasatinib Versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia Patients (DASISION) trial, evaluating long-term efficacy and safety outcomes of patients with chronic myeloid leukemia (CML) in chronic phase (CP) treated with dasatinib or imatinib.
  
  
  
  Patients with newly diagnosed CML-CP were randomly assigned to receive dasatinib 100 mg once daily (n = 259) or imatinib 400 mg once daily (n = 260).
  
  
  
  At the time of study closure, 61% and 63% of dasatinib- and imatinib-treated patients remained on initial therapy, respectively. Cumulative rates of major molecular response and molecular responses with a 4.0- or 4.5-log reduction in BCR-ABL1 transcripts from baseline by 5 years remained statistically significantly higher for dasatinib compared with imatinib. Rates for progression-free and overall survival at 5 years remained high and similar across treatment arms. In patients who achieved BCR-ABL1 ≤ 10% at 3 months (dasatinib, 84%; imatinib, 64%), improvements in progression-free and overall survival and lower rates of transformation to accelerated/blast phase were reported compared with patients with BCR-ABL1 greater than 10% at 3 months. Transformation to accelerated/blast phase occurred in 5% and 7% of patients in the dasatinib and imatinib arms, respectively. Fifteen dasatinib-treated and 19 imatinib-treated patients had BCR-ABL1 mutations identified at discontinuation. There were no new or unexpected adverse events identified in either treatment arm, and pleural effusion was the only drug-related, nonhematologic adverse event reported more frequently with dasatinib (28% v 0.8% with imatinib). First occurrences of pleural effusion were reported with dasatinib, with the highest incidence in year 1. Arterial ischemic events were uncommon in both treatment arms.
  
  
  
  These final results from the DASISION trial continue to support dasatinib 100 mg once daily as a safe and effective first-line therapy for the long-term treatment of CML-CP.
authors.affiliation: Jorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany. jcortes@mdanderson.org.
authors.forename: Jorge E
authors.initials: JE
authors.lastname: Cortes
authors.affiliation: Jorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Saglio
authors.affiliation: Jorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
authors.forename: Hagop M
authors.initials: HM
authors.lastname: Kantarjian
authors.affiliation: Jorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
authors.forename: Michele
authors.initials: M
authors.lastname: Baccarani
authors.affiliation: Jorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
authors.forename: Jiří
authors.initials: J
authors.lastname: Mayer
authors.affiliation: Jorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
authors.forename: Concepción
authors.initials: C
authors.lastname: Boqué
authors.affiliation: Jorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
authors.forename: Neil P
authors.initials: NP
authors.lastname: Shah
authors.affiliation: Jorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
authors.forename: Charles
authors.initials: C
authors.lastname: Chuah
authors.affiliation: Jorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
authors.forename: Luis
authors.initials: L
authors.lastname: Casanova
authors.affiliation: Jorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
authors.forename: Brigid
authors.initials: B
authors.lastname: Bradley-Garelik
authors.affiliation: Jorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
authors.forename: George
authors.initials: G
authors.lastname: Manos
authors.affiliation: Jorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Hochhaus
mesh_terms: D000328:Adult; D000368:Aged; D000069439:Dasatinib / Q000009:adverse effects / Q000627:therapeutic use*; D016044:Fusion Proteins, bcr-abl / Q000235:genetics; D006801:Humans; D000068877:Imatinib Mesylate / Q000009:adverse effects / Q000627:therapeutic use*; D015466:Leukemia, Myeloid, Chronic-Phase / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D008875:Middle Aged; D009154:Mutation
chemical_list: C581634:BCR-ABL1 fusion protein, human; D000068877:Imatinib Mesylate; D016044:Fusion Proteins, bcr-abl; D000069439:Dasatinib