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Medline ® Abstract for Reference 61

of 'Pulmonary toxicity associated with antineoplastic therapy: Molecularly targeted agents'

Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia Patients Trial.
Cortes JE, Saglio G, Kantarjian HM, Baccarani M, Mayer J, BoquéC, Shah NP, Chuah C, Casanova L, Bradley-Garelik B, Manos G, Hochhaus A
J Clin Oncol. 2016 Jul;34(20):2333-40. Epub 2016 May 23.
PURPOSE: 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 AND METHODS: 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).
RESULTS: 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.
CONCLUSION: 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.
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; JiříMayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Catalàd'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.