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Early Ibrutinib Dose Modifications in CLL: A Post Hoc Analysis of the Real-World EVIdeNCE Study
Stefano Molica1, Potito Rosario Scalzulli2, Lydia Scarfò3,4
1Hull York Medical School, University of Hull, Hull HU6 7RX, UK.
Cancers
|March 28, 2026
Summary
Early dose adjustments for ibrutinib in chronic lymphocytic leukemia (CLL) are driven by patient health, but do not independently affect survival outcomes. Maintaining relative dose intensity (RDI) is generally feasible and confirms ibrutinib
Area of Science:
- Oncology
- Pharmacology
- Clinical Medicine
Background:
- Ibrutinib significantly improves outcomes in chronic lymphocytic leukemia (CLL).
- Real-world data on early dose modifications and relative dose intensity (RDI) impact on survival are limited.
Purpose of the Study:
- To evaluate the impact of dose reductions and RDI maintenance in the first 90 days of ibrutinib treatment on clinical outcomes in CLL patients.
Main Methods:
- Post hoc analysis of 275 CLL patients from the prospective observational EVIdeNCE study (NCT03720561).
- Analysis of baseline factors associated with early dose modifications and RDI.
- Cox proportional hazards models with landmark approach to assess associations with overall survival (OS) and progression-free survival (PFS).
Main Results:
- Higher comorbidity burden (Cumulative Illness Rating Scale, ECOG status) predicted early dose reductions.
- Most patients maintained ≥80% RDI over 90 days.
- Initially, 100% RDI at 90 days was associated with improved PFS, but this effect was not significant after adjusting for patient characteristics.
Conclusions:
- Baseline comorbidities and functional status influence early ibrutinib dose modifications.
- Dose adjustments and RDI variability do not independently impact survival outcomes in real-world CLL management.
- Confirms the overall tolerability of ibrutinib in routine clinical practice.
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