ALBERT

Description: Background: Chronic, low-grade adverse events (AEs) are common in CML patients (pts) treated with the BCR-ABL1 tyrosine kinase inhibitor (TKI) imatinib (IM) and may decrease quality of life (Efficace, Blood. 2011;118:4554) and adherence to therapy (Marin, J Clin Oncol. 2010;28:2381). These AEs may result in dose modifications and contribute to suboptimal response. Alternative TKIs are available with the potential to reduce AEs, improve tolerability, and support long-term treatment goals. The second-generation TKI dasatinib (DAS) has demonstrated efficacy in pts previously treated with IM in the CA180-034 trial (Shah, Blood. 2014;123:2317). We present the analysis of CA180-400 (NCT01660906), an open-label, multicenter phase 4 study designed to determine if chronic, low-grade nonhematologic AEs in IM-treated pts improve after switching to DAS. Methods: Adult CML-CP pts who had not failed previous IM therapy (complete hematologic response by 3 mo, partial cytogenetic response [PCyR] by 6 mo, or complete cytogenetic response [CCyR] by 12 mo [Baccarani, Blood. 2013;122:872]) and had a chronic, grade 1/2 nonhematologic IM-related AE persisting for ≥2 mo or recurring ≥3 times in the prior 12 mo, despite best supportive care, were switched to DAS 100 mg once daily until disease progression, treatment failure, unacceptable AE, withdrawal of consent, or study discontinuation at 12 mo. The primary endpoint was the frequency of chronic, grade 1/2 nonhematologic IM-related AEs that decreased in grade or resolved within 3 mo following DAS initiation. Treatment-emergent DAS-related AEs and pt-reported symptom burden using MD Anderson Symptom Inventory (MDASI)-CML symptom severity and interference scores (0-10 scale; 10=worst) were also evaluated 3 mo following the switch to DAS. Results: Thirty-nine pts were enrolled in the trial. Median age was 57 y (range 23-81 y), with 31% ≥65 y. Median duration of prior IM was 47 mo and 49% had received