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CIT photo_spacer-02.jpgReal-world evidence supports NCCN guidelines recommending against first-line use of chemoimmunotherapy (CIT) in high-risk chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients

First-line use of CIT for patients with genetic abnormalities in CLL/SLL, a cancer of the blood and bone marrow, resulted in significantly higher risk of treatment failure, next line of treatment initiation, and higher costs. Cytogenetic testing examining changes in chromosomes/DNA can help to inform optimal clinical decisions for these individuals.

Enterprise Analytics Core domain(s): oncology, cost of care, quality of care, policy guidance

Summary

Background
In patients with CLL/SLL, high-risk genetic abnormalities are associated with inferior responses to CIT, and the economic burden of this remains uncertain. This study aimed to compare real-world clinical and economic outcomes in high-risk and perceived non-high-risk patients initiating first-line CIT.

Methods

This study linked patients’ administrative claims with medical charts and Cancer Care Quality Program data.


Results

  • In real-world clinical management of CLL/SLL, we found high-risk patients initiating first-line CIT had significantly higher risks of treatment failure, next line of treatment initiation, and incurred higher costs compared with perceived non-high-risk patients.
  • The results of this study support National Comprehensive Cancer Network (NCCN) Guidelines (version 2.2020) recommendation of NOT using CIT as first-line treatment for the high-risk patients (present of del(17p) or TP53 mutation).
  • This also highlights the crucial role of cytogenetic risk status assessment, a test examining any changes in chromosomes/DNA, as recommended by NCCN Guidelines.
  • While the use of cytogenetic testing for initiating first-line CIT has been increasing in recent years (2017-2019), the extent of testing is still far from optimal (less than 50%).
CIT Figure.jpg

Key takeaways

This presents several opportunities for Elevance Health:

  • Promote cytogenetic test assessment prior to first-line CIT treatment to guide appropriate treatment
  • Limit/restrict first-line CIT use among high-risk CLL patients

Publication

Leslie LA, Gangan N, Tan H, Huang Q. Clinical and economic burden among patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) receiving first-line (1L) chemoimmunotherapy (CIT) by risk status: A chart-linked claims analysis. J Clin Oncol, 2021. 39(S15).

Carelon Research project team: Jason Tan, Nilesh Gangan, Jessica Malenfant*

*Carelon Research Associate at the time of the study.  



For more information on a specific study or to connect with the Actionable Insights Committee, contact us at [email protected].

This study was conducted by Carelon Research (formerly HealthCore, Inc.), a subsidiary of Elevance Health and funded by Janssen Pharmaceuticals. Dissemination and sharing of the Newsletter is limited to Elevance Health and its subsidiaries and included findings and implications are for Elevance Health and its affiliates’ internal use only.


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Teams at Carelon Research

The clinical research team at Carelon Research coordinates and conducts a broad range of clinical trials and registries – from small studies focused on rare and orphan diseases to large studies of complex and chronic conditions. We work with projects across the research spectrum, including life sciences, biotech, medical device, diagnostics, the government (National Institutes of Health, CDC, etc.) and academic institutions. For more information, visit our clinical research page.
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The safety & epidemiology research team at Carelon Research uncovers vital evidence on the utilization, safety, and effectiveness of biopharmaceuticals and devices in large, real-world patient populations. Our researchers provide a broad range of expertise and operational experience to the timely and accurate execution of epidemiologic studies in the pre- and post-marketing settings. For more information, visit our safety and epidemiology research page.