Abstract

Objective: To evaluate how treatment regimens in informCLL aligned with NCCN Guidelines®-recommended regimens for CLL/SLL. Patients: Patients receiving approved CLL treatment were categorized by del(17p)/TP53 mutation status, line of therapy, and age/comorbidity. Significant comorbidities (SC) were defined as Charlson Comorbidity Index (CCI) ≥3. Age/comorbidity groups for patients without del(17p)/TP53mut: frail (≥65 years)+SC; elderly (≥65) without SC or younger (<65)+SC; and younger (<65) without SC. NCCN Guidelines for CLL/SLL V.2.2017 were used, given 74% informCLL enrollment ≥2017. Results: In informCLL (N=1462; previously untreated [1L], 58%; relapsed/refractory [R/R], 42%), community-based practices enrolled 93%. Median age: 71 years (34–95); median CCI: 1.0 (0–11); CCI ≥3: 16%. 27% of patients (n=389) had del(17p)/TP53mut data available. 59%–64% with del(17p)/TP53mut and 68%–100% without del(17p)/TP53mut received NCCN-recommended regimens. For patients with del(17p)/TP53mut, 62% 1L and 44% R/R received recommended category-2A ibrutinib; 24% 1L and 21% R/R had non-recommended CIT (BR/FCR). For patients without del(17p)/TP53mut and frail+SC, 60% 1L had category-1 ibrutinib or obinutuzumab+chlorambucil, but 24% received non-recommended BR; all R/R patients had category-1 ibrutinib or idelalisib+rituximab. For patients without del(17p)/TP53mut and elderly/younger+SC, 69% 1L and 58% R/R patients had category-1 ibrutinib or category-2A BR. For patients without del(17p)/TP53mut and younger without SC, 87% 1L and 82% R/R had BR (category-2A), FCR (1L: category-1; R/R: category-2A), or ibrutinib (1L: category-2A; R/R: category-1). For patients without del(17p)/TP53mut data available (73%, n=1073), ibrutinib (44%), CIT (32%), and anti-CD20 monotherapy (14%) were the most common regimens. Conclusions: Of patients with del(17p)/TP53mut, one-third received non-NCCN-recommended regimens. Given most patients in informCLL lacked del(17p)/TP53mut data and may have received suboptimal therapy, there is a need for awareness of guidelines recommendations to better inform treatment decisions. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.2.2017 - February 21, 2017. © National Comprehensive Cancer Network, Inc. 2017. All rights reserved. Accessed 08/08/2017. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. To evaluate how treatment regimens in informCLL aligned with NCCN Guidelines®-recommended regimens for CLL/SLL. Patients receiving approved CLL treatment were categorized by del(17p)/TP53 mutation status, line of therapy, and age/comorbidity. Significant comorbidities (SC) were defined as Charlson Comorbidity Index (CCI) ≥3. Age/comorbidity groups for patients without del(17p)/TP53mut: frail (≥65 years)+SC; elderly (≥65) without SC or younger (<65)+SC; and younger (<65) without SC. NCCN Guidelines for CLL/SLL V.2.2017 were used, given 74% informCLL enrollment ≥2017. In informCLL (N=1462; previously untreated [1L], 58%; relapsed/refractory [R/R], 42%), community-based practices enrolled 93%. Median age: 71 years (34–95); median CCI: 1.0 (0–11); CCI ≥3: 16%. 27% of patients (n=389) had del(17p)/TP53mut data available. 59%–64% with del(17p)/TP53mut and 68%–100% without del(17p)/TP53mut received NCCN-recommended regimens. For patients with del(17p)/TP53mut, 62% 1L and 44% R/R received recommended category-2A ibrutinib; 24% 1L and 21% R/R had non-recommended CIT (BR/FCR). For patients without del(17p)/TP53mut and frail+SC, 60% 1L had category-1 ibrutinib or obinutuzumab+chlorambucil, but 24% received non-recommended BR; all R/R patients had category-1 ibrutinib or idelalisib+rituximab. For patients without del(17p)/TP53mut and elderly/younger+SC, 69% 1L and 58% R/R patients had category-1 ibrutinib or category-2A BR. For patients without del(17p)/TP53mut and younger without SC, 87% 1L and 82% R/R had BR (category-2A), FCR (1L: category-1; R/R: category-2A), or ibrutinib (1L: category-2A; R/R: category-1). For patients without del(17p)/TP53mut data available (73%, n=1073), ibrutinib (44%), CIT (32%), and anti-CD20 monotherapy (14%) were the most common regimens. Of patients with del(17p)/TP53mut, one-third received non-NCCN-recommended regimens. Given most patients in informCLL lacked del(17p)/TP53mut data and may have received suboptimal therapy, there is a need for awareness of guidelines recommendations to better inform treatment decisions. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.2.2017 - February 21, 2017. © National Comprehensive Cancer Network, Inc. 2017. All rights reserved. Accessed 08/08/2017. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

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