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Prognostic biomarker testing of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) is low, indicating that many clinicians are not following clinical practice guideline recommendations, according to registry data presented at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.
“This prospective real-world registry is uniquely positioned to examine the impact of the dynamic CLL treatment landscape and changing guidelines observed in a routine clinical setting,” Anthony R. Mato, MD, of Memorial Sloan Kettering Cancer Center in New York City, and presenter of the study, said.
The prospective, observational, multicenter informCLL registry (ClinicalTrials.gov Identifier: NCT02582879) enrolled 1462 patients with CLL/SLL between 2015 and 2019. Among the cohort, 59% were previously untreated and 94% were treated in community-based practices.
The median age of the cohort was 71 years, and 65% were male. The majority of patients had an Eastern Cooperative Oncology Group performance status of 0 or 1, and 52% had a Rai stage of III/IV. The median follow-up was 14.9 and 15.3 months among patients who were treatment-naive and who had relapsed/refractory disease, respectively.
Rates of prognostic biomarker testing were low. Fluorescent in situ hybridization (FISH) testing was performed among 28% of patients, including 33% of previously-untreated and 21% of relapsed/refractory patients. Among patients tested by FISH, 24% had del(17p) and, of these patients, 28% were treated with chemoimmunotherapy (CIT). Of the patients who did not undergo FISH testing, 33% were treated with CIT.
Testing of other biomarkers occurred less frequently. TP53 mutations were evaluated among 11% of patients and 27% of whom were positive for a mutation. Among patients with a TP53 mutation, 19% were treated with CIT. Of the patients who did not undergo TP53 testing, 33% were treated with CIT.
IGHV was assessed among 12% of patients, and, of those, 70% had an unmutated gene. CIT was administered to 38% of patients with unmutated IGHV, and 34% of patients not tested for IGHV status received CIT.
Ibrutinib was the most commonly used therapy and was used among 46% of patients, followed by CIT at 33%, immunotherapy at 13%, other novel agents at 6%, and chemotherapy at 1%. Ibrutinib use has increased over time, from 14% and 57% among previously untreated and relapsed/refractory patients, respectively, in 2015, to 64% and 55%, respectively, in 2019.
The majority of patients initiated ibrutinib at the 420-mg dose (71%) and did not require dose modifications (75%). The proportion of patients who continued taking ibrutinib at 12 or 24 months was 77% and 68%, respectively.
Dr Mato concluded that the “data indicate a knowledge gap in terms of utility of prognostic marker interpretation and selection of therapies for patients with poor-risk disease.”
Disclosures: Some of the presenters disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the presentation abstract.
Mato AR, Barrientos JC, Sharman JP, et al. Real-world prognostic biomarker testing, treatment patterns and dosing among 1461 patients (pts) with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) from the informCLL Prospective Observational Registry. Presented at: the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition; December 5-9, 2020. Abstract 547.
This article originally appeared on Cancer Therapy Advisor