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Rhodes, J.1; Sail, K.2; Yazdy, Sarraf M.3; Hill, B.4; Shadman, M.5; Tuncer, H.6; Winter, A.4; Kennard, K.1; Allan, J.7; Ujjani, C.5; Brander, D.8; Cho, S.2; Sharmokh, S.2; Jiang, Dingfeng D.2; Nabhan, C.9; Barr, P.10; Brown, J.11; Fox, C.12; Schuh, A.13; Eyre, T.13; Lamanna, N.14; Wierda, W.15; Skarbnik, A.16; Roeker, L.17; Bannerji, R.18; Evens, A.18; Pauff, J.2; Schuster, S.1; Follows, G.19; Cheson, B.3; Eichhorst, B.20; Mato, A.17

doi: 10.1097/01.HS9.0000559736.57279.87
Poster Session I: Chronic lymphocytic leukemia and related disorders - Clinical

1University of Pennsylvania, Philadelphia

2AbbVie Inc., North Chicago

3Georgetown University Hospital, Washington DC

4Cleveland Clinic, Cleveland

5Fred Hutchinson Cancer Research Center, Seattle

6The Cancer Center at Lowell General Hospita, Lowell

7Cornell University Medical Center, New York

8Duke Cancer Institute, Durham

9Aptitude Health, Atlanta

10Wilmot Cancer Institute, Rochester

11Dana-Farber Cancer Institute, Boston, United States

12Nottingham University Hospitals, Nottingham

13Churchill Hospital, Oxford University, Oxford, United Kingdom

14Columbia University, New York

15MD Anderson Cancer Center, Houston

16Novant Health, Charlotte

17Memorial Sloan Kettering Cancer Center, New York

18Rutgers Cancer Institute of New Jersey, New Brunswick, United States

19Cambridge University Hospitals, Cambridge, United Kingdom

20University of Cologne, Cologne, Germany

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The approval of novel targeted agents (TA) has revolutionized the treatment landscape for patients (pts) with chronic lymphocytic leukemia (CLL). Guidelines suggest that treatment selection between chemo-immunotherapy (CIT) and TA is driven by several factors including age, disease stage, patient's fitness, comorbid conditions, IGHV mutation status, del(17p) and/or TP53 mutation, CLL-associated symptoms and patient preference. However, it is not well understood to what extent other external factors influence treatment selection in real-world clinical practice.

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To identify characteristics (clinical, demographic, and socioeconomic) associated with treatment selection between CIT and TA in first-line CLL based on real-world data collected from multiple cancer centers in the US.

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The CLL Collaborative Study of Real-World Evidence (CORE) is a large multicenter retrospective observational study of CLL pts treated at either community or academic centers in the US. Pts were eligible for inclusion in this analysis if they started first-line CLL therapy after January 1st, 2016 (post-approval of novel TA in the first-line). Descriptive statistics were used to compare sociodemographic and clinical characteristics (collected prior to initiation of treatment) between pts on CIT and TA. Clinical and sociodemographic covariates were included in multivariable logistic regression model to evaluate factors associated with first-line treatment selection.

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Of the 386 treatment-naïve pts with CLL, 39% received CIT and 61% received TA. Approximately 46% of the pts receiving TA were younger than 65 years of age, and 44% had commercial insurance. More than half of the pts (59%) receiving CIT were younger than 65 years of age and only 36% had commercial insurance. Majority (82%) of pts receiving TA were initiated on Ibrutinib monotherapy. BR (45%) and FCR (27%) were the most commonly administered CIT regimens. About 93% and 80% of all pts underwent testing for chromosomal abnormalities and IGHV mutation status, respectively. Del(17)p/TP53 mutation status was observed in 5% (n = 8) and 26% (n = 60) of pts initiating CIT and TA, respectively. Complex karyotype (3+) was observed in 1% of CIT versus (vs) 7% of TA pts. In addition, 36% of CIT pts and 50% of TA pts had creatinine clearance <80 mL/min. Results from multivariable logistic regression model showed that pts (age >65yrs) were two times more likely to receive TA than pts younger than 65 (OR: 1.95; 95%CI: 1.04-3.66). Clinical characteristics such as del(17p)/TP53 (OR: 7.28; 95%CI: 3.18-16.66) and creatinine clearance <80 ml/min (OR: 1.83; 95%CI: 1.07-3.11) were significantly associated with higher likelihood of TA treatment selection. Other clinical characteristics such as IGHV mutation status and ECOG score were not associated with treatment selection. Pts with commercial insurance (OR: 2.55; 95%Cl: 1.28-5.08) and pts having Medicare with supplemental plans (OR: 2.84; 95%Cl: 1.19-6.77) were more likely to receive TA versus those with Medicare only.

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Findings from this study demonstrated that older age, insurance coverage, del(17p)/TP53 mutation status, and creatinine clearance were associated with treatment selection preferences in real-world clinical practice. As TAs and novel combinations continue to change the treatment paradigm in first-line CLL, their utilization patterns and associated outcomes need to be continuously evaluated.

Copyright © 2019 The Authors. Published by Wolters Kluwer Health Inc., on behalf of the European Hematology Association.