REAL-WORLD DEL(17P), TP53, AND IGHV BASELINE TESTING PATTERNS IN CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITHIN A LARGE NETWORK OF US COMMUNITY ONCOLOGY PRACTICES
Author(s)
Lisa Herms, PhD1, Deepak Adhikari, MS1, Heather Neuhalfen, MBA1, Celena Williams, BSN1, Aaron Peevyhouse, MSBA1, Neeharika Srivastava Makani, MD2, Christian A. Thomas, MD, FACP, FASCO3, Mark S. Walker, PhD1;
1ONCare Alliance, Tacoma, WA, USA, 2Comprehensive Hematology Oncology, St. Petersburg, FL, USA, 3New England Cancer Specialists, Westbrook, ME, USA
1ONCare Alliance, Tacoma, WA, USA, 2Comprehensive Hematology Oncology, St. Petersburg, FL, USA, 3New England Cancer Specialists, Westbrook, ME, USA
OBJECTIVES: Biomarker testing is essential for evidence-based CLL management. Guidelines recommend assessing del(17p), TP53, and IGHV status to inform prognosis and treatment. Historically, adoption has been inconsistent, particularly in community settings where most patients receive care. This study evaluated real-world biomarker testing rates across a large network of 31 community practices serving over 4 million patients.
METHODS: This retrospective cohort study used electronic medical records from adults with CLL initiating frontline therapy between 1/1/2022 and 6/30/2024 within ONCare Alliance. Patient characteristics were summarized overall and by biomarker status; logistic regression identified predictors of del(17p) or TP53 testing.
RESULTS: Of 450 patients, 379 (84.2%) were tested for del(17p) or TP53; of those tested, 35 (9.2%) were positive and 344 (90.8%) were negative. Most (297/379, 78.4%) had a single test—nearly all for del(17p) (281/297, 94.6%). IGHV testing occurred in 212 patients (47.1%) with 135 unmutated and 77 mutated (63.7% and 36.3% of those tested, respectively). Ten patients (2.2%) were both IGHV-unmutated and del(17p)/TP53-positive. Mean age was 70.5 years; 35.6% were female, 88.9% White, and 5.3% Black/African American. Del(17p)/TP53-negative patients were younger (69.4 years; p=0.0003) and less often female (32.3%; p=0.0318); IGHV groups showed no demographic differences. Stage at diagnosis varied by IGHV (p = 0.0090), with mutated patients more often stage IV (24.7%). High-risk classification was more common among del(17p)/TP53-positive (31.4%; p<0.0001) and IGHV-unmutated (15.6%; p=0.0047) patients. Overall, 76.2% had ≥1 comorbidity, with nominally lower rates in del(17p)/TP53-negative (73.5%) and IGHV-mutated (66.2%) groups. Testing was predicted by younger age (p=0.0050), male sex (p=0.0158), and better performance status (p=0.0306); hypertension suggested lower testing (p=0.0561).
CONCLUSIONS: Testing rates exceeded prior real-world reports, demonstrating strong guideline adherence in community settings. These findings suggest that standardized biomarker testing is achievable in routine community practice and can support equitable, evidence-based care which can result in better patient care and outcomes.
METHODS: This retrospective cohort study used electronic medical records from adults with CLL initiating frontline therapy between 1/1/2022 and 6/30/2024 within ONCare Alliance. Patient characteristics were summarized overall and by biomarker status; logistic regression identified predictors of del(17p) or TP53 testing.
RESULTS: Of 450 patients, 379 (84.2%) were tested for del(17p) or TP53; of those tested, 35 (9.2%) were positive and 344 (90.8%) were negative. Most (297/379, 78.4%) had a single test—nearly all for del(17p) (281/297, 94.6%). IGHV testing occurred in 212 patients (47.1%) with 135 unmutated and 77 mutated (63.7% and 36.3% of those tested, respectively). Ten patients (2.2%) were both IGHV-unmutated and del(17p)/TP53-positive. Mean age was 70.5 years; 35.6% were female, 88.9% White, and 5.3% Black/African American. Del(17p)/TP53-negative patients were younger (69.4 years; p=0.0003) and less often female (32.3%; p=0.0318); IGHV groups showed no demographic differences. Stage at diagnosis varied by IGHV (p = 0.0090), with mutated patients more often stage IV (24.7%). High-risk classification was more common among del(17p)/TP53-positive (31.4%; p<0.0001) and IGHV-unmutated (15.6%; p=0.0047) patients. Overall, 76.2% had ≥1 comorbidity, with nominally lower rates in del(17p)/TP53-negative (73.5%) and IGHV-mutated (66.2%) groups. Testing was predicted by younger age (p=0.0050), male sex (p=0.0158), and better performance status (p=0.0306); hypertension suggested lower testing (p=0.0561).
CONCLUSIONS: Testing rates exceeded prior real-world reports, demonstrating strong guideline adherence in community settings. These findings suggest that standardized biomarker testing is achievable in routine community practice and can support equitable, evidence-based care which can result in better patient care and outcomes.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
SA30
Topic
Study Approaches
Disease
SDC: Oncology