TY - JOUR AU - Timothy P. Hughes, AU - Pierre Laneuville, AU - Philippe Rousselot, AU - David S. Snyder, AU - Delphine Rea, AU - Neil P. Shah, AU - David Paar, AU - Elisabetta Abruzzese, AU - Andreas Hochhaus, AU - Jeffrey H. Lipton, AU - Jorge E. Cortes, PY - 2018/12/31 Y2 - 2024/03/29 TI - Incidence, outcomes, and risk factors of pleural effusion in patients receiving dasatinib therapy for Philadelphia chromosome-positive leukemia JF - Haematologica JA - haematol VL - 104 IS - 1 SE - Articles DO - 10.3324/haematol.2018.188987 UR - https://haematologica.org/article/view/8745 SP - 93-101 AB - 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 6-9% of patients at risk annually in DASISION, and in 5-15% 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. clinicaltrials.gov identifier 00481247; 00123474. ER -