Approximately 18,960 new cases of chronic lymphocytic leukemia (CLL) and 4660 deaths from CLL are estimated in the United States in 2016, with an overall estimated 5-year survival rate of 82.6%.1,2 Despite this, CLL patients with unfavorable genetic features such as del17p have relatively poor outcomes when treated with conventional chemoimmunotherapy (eg, fludarabine and cyclophosphamide, or bendamustine plus rituximab); however, several new treatments have been approved by the FDA for the treatment of previously untreated CLL in the past 3 years, including obinutuzumab with chlorambucil, and ibrutinib. Using a novel oncology electronic health record database, Arnieri and colleagues presented the results of an analysis to assess demographics and treatment patterns in patients with previously untreated CLL since the introduction of new treatment options.
A cohort of CLL patients was selected by identifying patients within Flatiron’s real-world oncology database. The Flatiron provider network comprises 230 clinics, 2000 clinicians, and more than 1 million cancer patients throughout the United States. Patients included in the cohort were required to meet the following criteria: ≥2 clinic encounters on different days occurring on or after January 1, 2011; ≥1 medication orders for an antineoplastic occurring on or after January 1, 2013; physician documentation of CLL; and evidence in unstructured documents (ie, information not organized in a preexisting data model, such as free text from a physician note/lab report) of having been treated specifically for CLL. The latter 2 criteria were assessed based on technology-enabled abstraction of unstructured data (eg, pathology reports, clinician notes). The cohort included patients of all ages treated between 2011 and 2015 from all 50 states of the United States.
As of June 2016, the cohort consisted of 1033 eligible CLL patients with a median age of 70 years. While distribution of first-line therapies initiated in 2011 to 2013 remained relatively constant by year, changes were observed during 2014 and 2015 following the introduction of obinutuzumab and ibrutinib; first-line obinutuzumab combination therapy increased from 7.2% in 2013 to 13.6% in 2015, and ibrutinib monotherapy or ibrutinib + rituximab increased from 9.8% in 2014 to 12.3% in 2015. Of note, fludarabine-containing regimens declined from 21.5% in 2011 to 8.4% in 2015. Decreases were also observed with rituximab monotherapy from 27.7% to 17.3%, bendamustine + rituximab from 36.1% to 31.6%, and rituximab + fludarabine + cyclophosphamide (RFC) from 4.6% to 2.2% from 2011 to 2015. Factors associated with chlorambucil treatment (as monotherapy or in combination) versus chemoimmunotherapy included older age (78.5 years vs 64 years and 62.6 years for chlorambucil and RFC, respectively) and Rai stage (78.1% of patients treated with chlorambucil had Rai stage 0-I disease vs 70.1% and 71.7% treated with bendamustine + rituximab and RFC, respectively). A fifth of patients with del17p were treated with ibrutinib.
The authors concluded that the real-world marked changes in first-line CLL treatments from 2011 to 2015 show increased utilization of newer agents, although no single standard of care for first-line therapy has been established. Second-line therapy reflects a similar degree of heterogeneity, and no uniform sequencing of agents has emerged. Further follow-up and analysis will contrast treatment patterns beyond randomized controlled trial data in a real-world setting and a cost-effectiveness analysis.
Arnieri B, et al. ASH 2016. Abstract 4787.
- Mato AR, et al. Blood. 2016;128:2199-2205.