Incidence, Prevalence, and Real-World Treatment Patterns in Chronic Myeloid Leukemia: Results from a Population-Representative German Claims Data Analysis

Abstract

Introduction Real-world data on usage of 1st, 2nd and 3rd generation tyrosine kinase inhibitor (TKIs) in chronic myeloid leukemia (CML) is scarce. This study therefore aimed to analyze the use of different TKIs used in 1st- and 2nd-line treatment and the frequency of TKI switches in CML. Methods This observational study was based on the InGef research database, an anonymized representative claims dataset in Germany (n= 4 million). An incidence and prevalence patient CML cohort was followed for 5 and 3 years. Analyses regarding incidence, prevalence and therapy distribution were performed descriptively. Results 151 patients were included in the incidence and 636 patients in the prevalence cohort. This resulted in an incidence of 1.8 (95%-confidence interval [CI]: 1.34 – 2.20) and a prevalence of 14.9 (95%-CI 13.70 – 16.03) per 100,000 inhabitants. For the incidence cohort, data on 1st-line therapy was available for 124 patients and distributed across imatinib (N=52), nilotinib (N=44), dasatinib (N=12), chemotherapies as hydroxycarbamide (N=11) and ponatinib/bosutinib (N=5). 26% of patients switched TKI therapy at least once in three years. In the prevalence cohort, 423 patients (66.5%) had claims on existing or newly emerged cardiovascular diseases (CD). No significant differences (p=0.32) between TKIs in patients with CD were found. Discussion Every fourth patient switched TKI therapy within the first three years after treatment initiation. Switches were more likely when hints of disease progression or intolerability were observable in the database.

A Multicenter Retrospective Chart Review Study of Treatment and Disease Patterns and Clinical Outcomes of Patients with Chronic-Phase Chronic Myeloid Leukemia in Third-Line Treatment or with T315I Mutation

“…To gain insight into the disease burden of these patient populations in France, this retrospective multicenter chart review study examined the characteristics, treatment patterns, and outcomes of real-world CP-CML patients who failed multiple lines of treatment with TKIs or who harbored the T315I mutation. Consistent with previous reports [11][12][13][14][15][16][17][18], we found that a large proportion of patients switched to another treatment (after a median time of 17 and 11 months in the 3L+ and T315I cohorts, respectively) or discontinued treatment altogether (50% and 65%, respectively), mainly due to intolerance, resistance, and signs of ineffectiveness. Additionally, less than half of patients with documented responses had MR 4.0 or MR 4.5 , and most patients experienced AEs.…”

“…All are indicated for patients with previous TKI exposure, and imatinib, dasatinib, nilotinib, and bosutinib are also indicated in the frontline setting [ 6 , 7 , 8 , 9 , 10 ]. Despite the survival benefits conferred by TKIs, high rates of switching between TKIs—mainly due to intolerance or the development of resistance—have been reported in both clinical trials [ 11 , 12 , 13 ] and real-world studies [ 14 , 15 , 16 , 17 , 18 ]. In a retrospective study examining the treatment patterns of patients with CML in the United Kingdom (UK) between January 2013 and June 2018, 44% of patients had at least one TKI switch during the study period and 21% switched three or more times [ 17 ]; moreover, in an administrative database study conducted in Italy (January 2015–December 2018), treatment switching was observed in 26% of patients with three or more lines of treatment [ 14 ].…”

Prognosis in Chronic Myeloid Leukemia: Baseline Factors, Dynamic Risk Assessment and Novel Insights

“…In real-life experiences, about 25–45% of imatinib-treated patients switch to a 2G-TKI, and in 65–80% of cases the change is due to resistance [ 158 , 159 , 160 ]. Use of 2G-TKIs is associated with lower rates of resistance than imatinib, but still relevant: the reason for the switch after a frontline 2G-TKI, in clinical trial or real-life setting is treatment failure in about 10–40% of cases [ 15 , 161 , 162 , 163 , 164 , 165 , 166 ].…”