Toxicities and outcomes of 621 ibrutinib-treated chronic lymphocytic leukemia patients in the United States: a real-world analysis.

We examined demographics, dosing, discontinuation rates and reasons, toxicities, and outcomes. The primary endpoint was progression-free survival. 621 ibrutinib-treated patients were identified. A total of 546 (88%) patients were treated with commercial drug. Clinical trial patients were younger (mean age 58 versus 61 years, p=0.01) and had a similar time from diagnosis to treatment with ibrutinib (mean 85 versus 87 months, p=0.8). With a median follow-up of 17 months, an estimated 42% of patients discontinued ibrutinib (median time to ibrutinib discontinuation was 7 months). Notably, ibrutinib toxicity was the most common reason for discontinuation in all settings. Median progression free survival and overall survival for the entire cohort were 35 months and not reached (median follow-up 17 months), respectively. In the largest reported series on ibrutinib-treated chronic lymphocytic leukemia patients, we show that 42% of patients discontinued ibrutinib. Intolerance as opposed to chronic lymphocytic leukemia progression was the most common reason for discontinuation. Outcomes remain excellent and were not impacted by line of therapy and whether patients were treated on clinical studies or commercially. These data strongly argue to find strategies to minimize ibrutinib intolerance so that efficacy can be further maximized. Future clinical trials should consider time-limited therapy approaches, particularly in patients achieving a complete response, in order to minimize ibruti...
Source: Haematologica - Category: Hematology Authors: Tags: Haematologica Source Type: research