respectively, Rucaparib of which only 1 patient experienced a grade 4 ALT or AST elevation. The median time to first elevated laboratory value of ALT and AST was 21.5 and 29.0 days, respectively, and the median duration of a reported increase of ALT and AST AEs was 15.0 and 9.0 days. ALT and AST elevations rarely led to treatment discontinuation. Recovery from grade 3/4 laboratory elevations of ALT and AST to grade 0/1 severity took a median duration of 29.0 and 21.5 days, respectively. Dose interruptions and reductions, respectively, due to AEs were required for 63% and 48% of patients. Twenty four patients discontinued bosutinib treatment because of AEs, including 16% of dasatinib resistant, 30% of dasatinib intolerant, and 11% of nilotinibresistant patients.
AEs most frequently leading to discontinuation included thrombocytopenia, neutropenia, and elevated ALT. Of note, 6 patients were in MCyR at the time that they discontinued treatment due to an AE. Retrospective evaluation of cross intolerance between bosutinib and dasatinib found that 11 of 50 patients with dasatinib intolerance experienced the same small molecule Bcr-Abl inhibitor AE on bosutinib as a grade3/4 event and 4 of 50 patients discontinued bosutinib due to the same AE. The most common cross intolerance events on bosutinib were hematologic events, with 8 of 20 patients with dasatinib intolerance related to myelosuppression experiencing grade 3/4 myelosuppression on bosutinib and 2 of 20 patients discontinuing bosutinib due to myelosuppression.
Of the 19 patients with pleural effusions as the reason for dasatinib intolerance, only 2 patients experienced grade 3/4 pleural effusions on bosutinib and neither patient discontinued bosutinib due to a pleural effusion. No patient with dasatinib intolerance related to cardiovascular events, gastrointestinal events, musculoskeletal events, or skin disorders experienced the Rocuronium structure same toxicity as a grade 3/4 AE on bosutinib.Bosutinib demonstrated clinical activity and an acceptable safety profile in this study subpopulation of patients with CP CML who were previously treated with imatinib and dasatinib and/or nilotinib. This patient population has limited treatment options and clearly represents an area of unmet medical need for new approved therapies. There have been few published articles with dasatinib or nilotinib after failure of 2 prior TKIs in CML,16 18 and the current analysis represents the largest analysis of a TKI following the failure of multiple prior TKIs in CML.
Newer therapies, such as bosutinib, may represent a valid treatment option for some patients who have previously been treated with multiple TKIs for CML. In this study, the rate of MCyR was 32% and the rate of confirmed CHR was 73% after a median follow up time of 28.5 months. An additional 6% of evaluable patients achieved a minor cytogenetic response, which has Idarubicin solubility been associated with prolonged survival in the second line and greater settings.19 Further, responses were durable for most patient subpopulations, with overall median durations of MCyR and CHR not yet reached. The MCyR rate with bosutinib is similar, yet with longer median duration, when compared with historical results from smaller studies of dasatinib or nilotinib used as third line therapies. In a small study of 23 patients who prequel received.
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