CLL-185: Clinical Characteristics and Treatment Choices in Previously Untreated Elderly Patients (≥65 Years) With Chronic Lymphocytic Leukemia (CLL): Interim Analysis of the informCLL Real-World Registry

Abstract

Context Understanding clinical characteristics and treatment selection for elderly patients is essential in the era of novel agents. informCLL ( NCT02582879 , September 2015 initiation) is an ongoing, US-based, prospective, real-world observational registry of patients with CLL. Objective To characterize overall demographics of previously untreated elderly CLL patients and compare clinical factors and treatment choice of those aged 65-74 years (Group 1) versus ≥75 years (Group 2). Design/Patients An interim analysis (November 2018 data cut) of previously untreated patients from the informCLL registry who were aged ≥65 years and received single-agent ibrutinib, chemoimmunotherapy, or immunotherapy at enrollment. Association between age groups and treatment choice was assessed by multinomial logistic regression after adjusting for comprehensive demographic and clinical factors. Results Analysis included 449 elderly patients (Group 1: 238; Group 2: 211); median age was 74 years. Most patients were male (64.1%), white (92.4%), treated in community settings (94.9%), and Medicare/Medicaid-insured (88.4%). Median time from initial diagnosis to first treatment was 2.0 years. The majority had an Eastern Cooperative Oncology Group (ECOG) score ≤ 1 (87.1%) and Charlson Comorbidity Index (CCI) score ≤ 1 (62.0%). The most common comorbidities were hypertension (69.3%), other cardiovascular disorders (29.2%), non-CLL malignancies (26.3%), and connective tissue diseases (24.5%). Documented cytogenetic/molecular testing rates were low: TP53, 6.01%; IGHV, 5.35%; CLL FISH, 17.8%; any of the three, 18.7%. 202 (45.0%) patients received ibrutinib, 170 (37.9%) received chemoimmunotherapy, and 77 (17.1%) received immunotherapy. Group 2 (vs Group 1) had poorer performance status (ECOG scores ≥2, 12.9% vs 5.7%, p=0.01), more comorbidities (CCI scores ≥2, 45.5% vs 31.1%, p Conclusions Previously untreated real-world CLL patients aged ≥75 years (vs 65-74 years) had poorer performance status, more comorbidities, lower cytogenetic/molecular testing rates, and a higher likelihood of receiving ibrutinib versus chemoimmunotherapy as initial treatment.