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Incidence, outcomes, and risk factors of pleural effusion in patients receiving dasatinib therapy for Philadelphia chromosome-positive leukemia.

Hughes, Timothy P; Laneuville, Pierre; Rousselot, Philippe; Snyder, David S; Rea, Delphine; Shah, Neil P; Paar, David; Abruzzese, Elisabetta; Hochhaus, Andreas; Lipton, Jeffrey H; Cortes, Jorge E.
Haematologica; 2018 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-30093398
Dasatinib, a second-generation BCR-ABL1 tyrosine kinase inhibitor, is approved for the treatment of chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia, both as first-line therapy and after imatinib intolerance or resistance. While generally well tolerated, dasatinib has been associated with a higher risk for pleural effusions. Frequency, risk factors, and outcomes associated with pleural effusion were assessed in two phase 3 trials (DASISION and 034/Dose-optimization) and a pooled population of 11 trials that evaluated patients with chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia treated with dasatinib (including DASISION and 034/Dose-optimization). In this largest assessment of patients across the dasatinib clinical trial program (N=2712), pleural effusion developed in 6% to 9% of patients at risk annually in DASISION, and in 5% to 15% of patients at risk annually in 034/Dose-optimization. With a minimum follow-up of 5 and 7 years, drug-related pleural effusion occurred in 28% of patients in DASISION and in 33% of patients in 034/Dose-optimization, respectively. A significant risk factor identified for developing pleural effusion by a multivariate analysis was age. We found that overall responses to dasatinib, progression-free survival, and overall survival were similar in patients who developed pleural effusion and in patients who did not.
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