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. 2020 Mar;20(3):174-183.e3.
doi: 10.1016/j.clml.2019.10.009. Epub 2019 Oct 21.

Prognostic Testing and Treatment Patterns in Chronic Lymphocytic Leukemia in the Era of Novel Targeted Therapies: Results From the informCLL Registry

Affiliations

Prognostic Testing and Treatment Patterns in Chronic Lymphocytic Leukemia in the Era of Novel Targeted Therapies: Results From the informCLL Registry

Anthony R Mato et al. Clin Lymphoma Myeloma Leuk. 2020 Mar.

Abstract

Introduction: The therapeutic landscape for chronic lymphocytic leukemia (CLL) has significantly shifted with the approval of novel agents. Understanding current prognostic testing and treatment practices in this new era is critical. Beginning enrollment in 2015, informCLL is the first United States-based real-world, prospective, observational registry that initiated enrollment after approval of novel agents.

Patients and methods: Eligible patients were age ≥ 18 years, started CLL treatment within 30 days of enrollment, and provided consent. For this planned interim analysis, treatments were classified into 5 groups: ibrutinib, chemoimmunotherapy, chemotherapy, immunotherapy, and other novel agents.

Results: Frequency of prognostic testing and treatment patterns are reported among 840 patients (459 previously untreated; 381 relapsed/refractory), enrolled largely (96%) from community practice settings. Testing for chromosomal abnormalities by fluorescence in situ hybridization, TP53 mutation, or IGHV mutation status occurred infrequently among all patients (31%, 11%, and 11%, respectively). Chemoimmunotherapy was the most common treatment in previously untreated patients (42%), whereas ibrutinib was the most common treatment among relapsed/refractory patients (51%). Of patients who tested positive for del(17p) or TP53 mutation, 34% and 26% received chemoimmunotherapy, respectively. Among patients who did not have fluorescence in situ hybridization or TP53 mutation testing prior to enrollment, 33% and 32% received chemoimmunotherapy, respectively.

Conclusion: Our findings indicate that prognostic testing rates were poor, and approximately one-third of high-risk patients (del[17p] and TP53) received chemoimmunotherapy, which is not aligned with current CLL treatment recommendations. This represents an opportunity to educate and alert health care professionals about the necessity of prognostic testing to guide optimal CLL treatment decisions.

Keywords: Chemoimmunotherapy; Ibrutinib; Novel agents; Prognostic marker; Real-world registry.

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Conflict of interest statement

The remaining authors have stated that they have no conflicts of interest.

Figures

Figure 1
Figure 1. Frequency of Prognostic Biomarker Testing for FISH (A), TP53 Mutational Status (B), and IGHV Mutational Status (C) Are Shown by Line of Therapy and All Patients
Abbreviations: FISH = fluorescence in situ hybridization; IGHV = immunoglobulin heavy-chain variable region gene; TP53 = tumor protein p53 gene.
Figure 2
Figure 2. Proportion of Tested Patients With Specific Genetic Abnormality and/or Molecular Mutations Are Shown by Line of Therapy and All Patients
n* represents the number of patients with available testing results. Abbreviations: del(17p) = chromosome 17p deletion; del(11q) = chromosome 11q deletion; del(13q) = chromosome 13q deletion; FISH = fluorescence in situ hybridization; IGHV = immunoglobulin heavy-chain variable region gene; TP53 = tumor protein p53 gene.
Figure 3
Figure 3. Percentage of Patients Receiving Specific Treatment Are Shown by Line of Therapy and All Patients for Prognostic Biomarker Status for del(17p) (A), TP53 Mutation (B), and IGHV Mutation (C)
Abbreviations: CIT = chemoimmunotherapy; CT = chemotherapy; del(17p) = chromosome 17p deletion; IGHV = immunoglobulin heavy-chain variable region gene; IT = immunotherapy; TP53 = tumor protein p53 gene.

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