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Background: The first‐generation BTK inhibitor ibrutinib is a standard‐of‐care therapy in the treatment of chronic lymphocytic leukemia (CLL) despite potential side effects that often lead to discontinuation. Methods: This study used 2013–2019 claims data to describe the incidence rate of adverse events (AEs) among elderly Medicare beneficiaries newly initiating ibrutinib for CLL. Results: The final sample contained 11,870 Medicare beneficiaries with CLL (mean age 77.2) newly initiating ibrutinib, of whom 65.2% discontinued over mean follow‐up of 2.3 years. The overall incidence rate of AEs was 62.5 per 1000 patient‐months for all discontinuers and 32.9 per 1000 patient‐months for non‐discontinuers. Discontinuers had a higher incidence rate of AEs per 1000 patient‐months compared with non‐discontinuers for all AEs examined, including infection (22.8 vs. 14.5), atrial fibrillation (15.1 vs. 7.0), anemia (21.9 vs. 14.5), and arthralgia/myalgia (19.5 vs. 13.6). Conclusion: In this first real‐world study of a national sample of elderly US patients treated with ibrutinib, we found a clear unmet need for improved management of ibrutinib‐related AEs and/or new treatments to improve real‐world outcomes in patients with CLL. [ABSTRACT FROM AUTHOR]

Prior studies evaluating ibrutinib discontinuation are limited to clinical trials and selected medical centers and hence may not reflect real-world practice. This study used Medicare claims (2013–2019) to examine ibrutinib discontinuation and associated factors among elderly patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Over a median follow-up of 2.1years, two-thirds (65.2%) of the 11,870 new ibrutinib initiators were discontinued, with half (45.1%) of patients discontinuing within 12months of initiation. Factors such as advanced age, lack of Part D low-income subsidy, evidence of prior CLL/SLL treatment, and cardiovascular comorbidities (e.g. atrial fibrillation) were associated with higher risk of discontinuation. Over a median of 1.2years from discontinuation, 40% of discontinuers initiated another CLL/SLL treatment after ibrutinib discontinuation; 25% of patients restarted ibrutinib treatment at some point over follow-up. Our findings point to a large unmet need with the widely used BTKi ibrutinib and underscore the importance of ongoing development of efficacious and well-tolerated CLL/SLL therapies. [ABSTRACT FROM AUTHOR]

Background: The majority of patients with acute myeloid leukemia (AML) are aged >65 years at the time of diagnosis and are not actively treated. The objective of the current study was to determine the prevalence, temporal trends, and factors associated with no active treatment (NAT) among older patients with AML in the United States.Methods: A retrospective analysis was performed of Surveillance, Epidemiology, and End Results (SEER)-Medicare data from 14,089 patients with AML residing in the United States who were diagnosed with AML at age ≥66 years during 2001 through 2013. NAT was defined as not receiving any chemotherapy, including hypomethylating agents. Multivariable logistic regression models were used to analyze sociodemographic, clinical, and provider characteristics associated with NAT.Results: The percentage of patients with NAT decreased over time from 59.7% among patients diagnosed in 2001 to 42.8% among those diagnosed in 2013. The median overall survival for the entire cohort was 82 days from the time of diagnosis. Patients treated with NAT had worse survival compared with those receiving active treatment. Variables found to be associated with higher odds of NAT included older age, certain sociodemographic characteristics (household income within the lowest quartile, residence outside the Northeast region of the United States, and being unmarried), and clinical factors (≥3 comorbidities, the presence of mental disorders, recent hospitalization, and disability).Conclusions: Greater than one-half of older patients with AML residing in the United States do not receive any active leukemia-directed therapy despite the availability of lower intensity therapies such as hypomethylating agents. Lack of active therapy receipt is associated with inferior survival. Identifying predictors of NAT might improve the quality of care and survival in this patient population, especially as novel therapeutic options with lower toxicity are becoming available. [ABSTRACT FROM AUTHOR]