Real-World Analysis of the Therapeutic Management and Disease Burden in Chronic Myeloid Leukemia Patients with Later Lines in Italy

Abstract

Real world data are becoming a crucial tool to understand how cancer is treated in routine daily practice. This real-world analysis aims to describe the characteristics of patients with CML in 2nd or ≥3rd tyrosine kinase inhibitors (TKI) lines of therapy, to evaluate their treatment sequence and utilization in settings of Italian clinical practice in Italy. A retrospective analysis was performed using an administrative databases covering around 15.3 million cases. All adult patients prescribed with TKI as 2nd or ≥3rd lines (L) of therapy for CML during January 2015–December 2018 were included. A total of 491 patients in 2nd and 144 in ≥3rd L was included. In both cohorts, hypertension was the most reported comorbidity, followed by metabolic and blood count alterations. In each calendar inclusion year, an increment of 97.6% was observed in the number of patients treated in ≥3rd L. In the 2nd L cohort, 18.7% had a switch to 3rd L, while 26.4% of ≥3rd L patients switched to a subsequent line. Around 40% in both lines discontinued their treatment after a median time of 5.5 (2nd L) and 4.3 (≥3rd L) years. The results provided insights into CML management clinical practice, indicating a heavy disease burden for patients in later lines that showed an increasing complex management, and suggest that a need for novel treatment strategies might exists.

The Economic Burden of Chronic Myeloid Leukemia in Patients with Later Lines: Findings from a Real-World Analysis in Italy

“…1 b): 38 (26.4%) received imatinib, 32 (22.2%) ponatinib, 27 (18.8%) nilotinib, 24 (16.7%) bosutinib, and 23 (16.0%) dasatinib. Characteristics of patients were described elsewhere [ 13 ].

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“…Notably the most used TKI in the 3rd L cohort was imatinib. The sequence pattern of this subset of patients [ 13 ] shows that patients treated with first line imatinib, after receiving a different TKI in 2nd line, switched back to imatinib. Consistently, other real-world studies on patients with CML, have reported this trend, showing that a sizeable portion of patients in their later lines, at some point, switch back to imatinib [ 17 ].…”

“…The study population selection was already described [ 13 ]. Briefly, adult patients (≥ 18 years old) were screened for eligibility based on prescription for TKIs used to treat CML (identified by the ATC codes in force at the time of study period: bosutinib, ATC code L01XE14; dasatinib, ATC code L01XE06; imatinib, ATC code L01XE01; nilotinib, ATC code L01XE08; ponatinib, ATC code L01XE24) between January 1, 2010 and December 31, 2018 (inclusion period).…”

A Survey of Patient Experience in CML: American and Canadian Perspectives

“… 11 Further, a substantial proportion (30–50%) requires multiple lines of treatment before adequate disease management, 12–16 and this may be associated with a greater burden on aspects of daily life (e.g., psychosocial, physical, financial). 17 , 18 …”

“…11 Further, a substantial proportion (30-50%) requires multiple lines of treatment before adequate disease management, [12][13][14][15][16] and this may be associated with a greater burden on aspects of daily life (e.g., psychosocial, physical, financial). 17,18 Impacts on well-being result from any cancer diagnosis, and labelling a cancer as "good" is not helpful to individuals with the diagnosis. 19,20 While presumably used to promote feelings of reassurance at diagnosis, as time progresses, patients may feel misunderstood or isolated, and could feel that their health care provider (HCP) does not take their diagnosis seriously, leading to hesitation to share concerns with HCPs.…”