Impact of Ibrutinib Dose Reduction on Treatment Outcomes in CLL: Real-World Insights

By Patrick Daly - September 15, 2023

Oncology nurses play a pivotal role in the care of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma, particularly when it comes to understanding treatment options and their effects. Recent trials have examined the use of first-line ibrutinib monotherapy in treatment-naïve patients and found that those who required a dose reduction due to adverse events (AEs) achieved efficacy outcomes similar to those without reductions.

However, medical understanding of real-world dosing patterns and related outcomes with ibrutinib remains limited. To bridge this gap, investigators delved into a US insurance claims database to identify such patterns and assess the time to next treatment (TTNT) in patients with dose reductions compared to those without. Their research findings were presented at the 2023 Society of Hematologic Oncology Annual Meeting.

Dr. Mazyar Shadman, the lead author of the study, revealed that patients who had a dose reduction due to AEs actually experienced a longer TTNT compared to those who did not undergo a reduction. It is important to note that the study did not establish causal associations between specific AEs and subsequent dose reductions.

Starting in February 2014, the analysis focused on 658 patients who received first-line single-agent ibrutinib at a dose of 420 mg and encountered an AE during treatment, with a follow-up period of at least 90 days post-initiation of treatment. Patients who discontinued ibrutinib were considered in both groups. TTNT was defined as the time from the AE occurrence to either the initiation of another treatment or death.

Among the patients, 95 (14%) had an ibrutinib dose reduction, while 563 (86%) did not require such an adjustment. Here are the key treatment patterns identified for patients with or without a dose reduction:

With Dose Reduction:

  • Mean ibrutinib treatment duration: 922 days (median, 842)
  • Mean time to first AE: 161 days (median, 51)
  • Mean time from AE to end of therapy: 760 days (median, 725)

Without Dose Reduction:

  • Mean ibrutinib treatment duration: 735 days (median, 606)
  • Mean time to first AE: 227 days (median, 119)
  • Mean time from AE to end of therapy: 508 days (median, 352)

Patients with a dose reduction exhibited a lower occurrence of the next treatment or death (31%) compared to patients without a reduction (39%). The median TTNT was significantly longer in patients with dose reductions, measuring 59.5 months versus 30.6 months in those without reductions (unadjusted hazard ratio [HR], 0.56; P=.003; adjusted HR, 0.62; P=.017). The study authors noted that these patterns were consistent across both cardiac and noncardiac AE subgroups.

In conclusion, the study suggests that managing adverse events with ibrutinib dose reduction can be an effective strategy for oncology nurses and clinicians. It not only addresses AEs but also appears to delay disease progression, as indicated by the extended TTNT. This real-world insight provides valuable information for healthcare providers, helping them optimize treatment approaches and improve patient outcomes in CLL.


Shadman M, Srivastava BP, Patel S, et al. Real-World Dosing Patterns and Time to Next Treatment for Previously Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma With or Without Ibrutinib Dose Reduction Following an Adverse Event. Abstract CLL-403. Presented at the 11th Annual Meeting of the Society of Hematologic Oncology; September 6-9, 2023; Houston, Texas.

Post Tags:SOHO 2023: CLL