Abstract
BackgroundMedian age at diagnosis of patients with chronic lymphocytic leukemia (CLL) is > 70 years. However, the majority of clinical trials do not reflect the demographics of CLL patients treated in the community. We examined treatment patterns, outcomes, and disease-related mortality in patients ≥ 75 years with CLL (E-CLL) in a real-world setting.MethodsThe Connect® CLL registry is a multicenter, prospective observational cohort study, which enrolled 1494 adult patients between 2010–2014, at 199 US sites. Patients with CLL were enrolled within 2 months of initiating first line of therapy (LOT1) or a subsequent LOT (LOT ≥ 2). Kaplan–Meier methods were used to evaluate overall survival. CLL- and infection-related mortality were assessed using cumulative incidence functions (CIF) and cause-specific hazards. Logistic regression was used to develop a classification model.ResultsA total of 455 E-CLL patients were enrolled; 259 were enrolled in LOT1 and 196 in LOT ≥ 2. E-CLL patients were more likely to receive rituximab monotherapy (19.3 vs. 8.6%; p < 0.0001) and chemotherapy-alone regimens (p < 0.0001) than younger patients. Overall and complete responses were lower in E-CLL patients than younger patients when given similar regimens. With a median follow-up of 3 years, CLL-related deaths were higher in E-CLL patients than younger patients in LOT1 (12.6 vs. 5.1% p = 0.0005) and LOT ≥ 2 (31.3 vs. 21.5%; p = 0.0277). Infection-related deaths were also higher in E-CLL patients than younger patients in LOT1 (7.4 vs. 2.7%; p = 0.0033) and in LOT ≥ 2 (16.2 vs. 11.2%; p = 0.0786). A prognostic score for E-CLL patients was developed: time from diagnosis to treatment < 3 months, enrollment therapy other than bendamustine/rituximab, and anemia, identified patients at higher risk of inferior survival. Furthermore, higher-risk patients experienced an increased risk of CLL- or infection-related death (30.6 vs 10.3%; p = 0.0006).ConclusionCLL- and infection-related mortality are higher in CLL patients aged ≥ 75 years than younger patients, underscoring the urgent need for alternative treatment strategies for these understudied patients.Trial RegistrationThe Connect CLL registry was registered at clinicaltrials.gov: NCT01081015 on March 4, 2010.
Highlights
Median age at diagnosis of patients with chronic lymphocytic leukemia (CLL) is > 70 years
While incremental improvements in treating CLL have been observed in the past decade [2], the majority of clinical trials leading to these treatment approaches have largely enrolled younger, fitter patients who do not accurately reflect the demographics of CLL patients seen in the community [3,4,5,6]
Patient demographics and disease characteristics were largely similar between patients enrolled in LOT1 and line of therapy (LOT) ≥ 2, with the exception of duration of CLL from diagnosis to enrollment (1.8 vs 7.2 years at LOT ≥ 2)
Summary
Median age at diagnosis of patients with chronic lymphocytic leukemia (CLL) is > 70 years. The majority of clinical trials do not reflect the demographics of CLL patients treated in the community. While incremental improvements in treating CLL have been observed in the past decade [2], the majority of clinical trials leading to these treatment approaches have largely enrolled younger, fitter patients who do not accurately reflect the demographics of CLL patients seen in the community [3,4,5,6]. A populationbased analysis of 28 590 US patients diagnosed with CLL (1992–2009) showed that the improvement in overall survival (OS) noted in younger patients was less pronounced in the elderly [11]. Brenner et al [12] showed that improved survival for CLL has not been observed in older patients
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