Real-World Outcomes of Patients With CLL Treated With Common Therapy
A new study sought to better define real-world initiation, management, and outcomes of patients with chronic lymphocytic leukemia (CLL) treated with a standard-of-care therapy.
The study will be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (June 1-5, 2018; Chicago, IL).
In April 2016, the United States Food and Drug Administration (FDA) approved venetoclax—an oral bioavailable BCL-2 inhibitor—for the treatment of patients with CLL. However, data is limited for real-world initiation, management, and outcomes for patients with this disease treated with venetoclax.
Chadi Nabhan, MD, MBA, FACP, Cardinal Health Specialty Solutions (Dublin, OH), and colleagues conducted a retrospective cohort study involving 222 patients with CLL who initiated venetoclax. Investigators from 25 community centers provided patient-level data from medical records that included demographics, clinical characteristics, ramp up management, and outcomes. Tumor burden was assessed per FDA label. Tumor lysis syndrome (TLS) was defined by Howard criteria and response was based on iwCLL criteria.
Researchers noted the primary endpoint of the analysis was response, while characteristics and outcomes were summarized by descriptive statistics.
Among the total patient population, 22% used venetoclax in combination with ibrutinib (7%) or an anti-CD20 inhibitor (14%). At baseline, 11%, 49%, and 40% had low, medium, and high tumor burden, respectively. Twenty-seven percent of patients initiated venetoclax as an inpatient.
During ramp up, Dr Nabhan and colleagues reported that 6% of patients had a dose interruption, though no interruptions were due to hematologic abnormalities. TLS events occurred in 6% of patients. Maximum dose of venetoclax (400 mg) was achieved in 53% of patients and 46% were maintained at doses less than 400 mg following ramp up.
After a median follow-up of 6.1 months, the objective response rate was 75%. Median time to best response was 3 months. Among the 38 patients assessed for minimal residual disease during venetoclax, 23 patients were minimal residual disease negative. Resolution of baseline lymphadenopathy, lymphocytosis, or B symptoms were reported among 93%, 95%, and 96%, respectively, researchers added.
“Most venetoclax-treated patients with CLL completed the ramp up, few experienced a TLS/hematologic event, and responses were comparable to clinical trials,” Dr Nabhan and colleagues concluded. “Inpatient management deviated from the FDA label, suggesting opportunity to improve adherence to initiation guidance.”—Zachary Bessette