CLINICAL NEWS
Reduction in Spleen Volume (pacritinib vs. best available
treatment), According to Baseline Cytopenia Level
TABLE.
<100,000 μ/L
50,000 μ/L
Pacritinib
BAT
p Value
Pacritinib
BAT
p Value
Intent-to-treat population
16.7%
0%
0.009
22.9%
0%
0.045
Evaluable population
23.5%
0%
0.007
33.3%
0%
0.037
that patients had no limitations on pre-existing
platelet counts before entering the study,” Dr.
Mesa said. While efficacy was seen in all of the
subgroups analyzed in the study – regardless of
platelet count – he also noted that there was significant treatment effect present in the highestrisk subset of patients (TABLE).
More red blood cell–dependent pa-
tients in the pacritinib arm also became
transfusion-independent (25.7% vs. 0% of BAT
patients; p=0.043).
Rates of adverse events were similar among
all treatment types, with diarrhea, nausea, and
vomiting as the most commonly reported adverse events among patients taking pacritinib.
“[The findings represent] an incremental
CLL-IPI: A New and Improved Staging
System for CLL?
In a recent study examining the validity of
prognostic markers for patients with chronic
lymphocytic leukemia (CLL), researchers
believe they have developed an internationally
applicable prognostic index for patients with
CLL. Called CLL-IPI (International Prognostic
Index), the newly developed scoring system
represents a collaboration among multiple
international study groups.
Nadine Kutsch, MD, from the University
Hospital of Cologne, in Germany, presented
the new CLL-IPI system at the 2015 American Society of Clinical Oncology Annual
Meeting. “In times of novel therapies and
improved prognosis for patients with CLL, the
traditional staging system developed by Rai
and Binet more than 30 years ago no longer
discriminates enough,” Dr. Kutsch said. “In
order to allow better information on survival, a
number of new prognostic markers have been
introduced, but there is no broadly applicable system integrating all of these markers.”
Furthermore, many of these prognostic tests
rely on complex (and costly) molecular and
biologic assays and are not available to all
patients with CLL.
The CLL-IPI, which was developed based on
analyses of 26 prognostic factors, could serve as
a simple, reliable, and easily applicable method
of risk stratification for patients with CLL.
The international group of researchers col-
benefit over our current landscape with [pacritinib] maintaining improvement in splenomegaly symptoms, which has been shown across
the JAK2 inhibitor class, but also incremental
benefit in improvement in cytopenias,” Dr. Mesa
told ASH Clinical News.
Other trials to help identify the ideal
patient population for pacritinib are currently
underway, Dr. Mesa added, including the
PERSIST-2 trial, which will examine the drug’s
safety and efficacy exclusively in patients with
thrombocytopenia. ●
Mesa RA, Egyed M, Szoke A, et al. Results of the PERSIST-1 phase III study of
pacritinib (PAC) versus best available therapy (BAT) in primary myelofibrosis
(PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential
thrombocythemia-myelofibrosis (PET-MF). Abstract LBA7006. Presented at the
2015 American Society of Clinical Oncology Annual Meeting, Chicago, IL, May
30, 2015.
• Low-risk patients (n=340): 93.2 percent
• Intermediate risk (n=464): 79.4 percent
lected data from eight phase III clinical trials
from France, Germany, the United Kingdom,
the United States, and Poland. The studies
included 3,472 treatment-naïve patients at
both early and advanced CLL stages (median
age, 61 years; range, 27-86 years). Patients were
followed for a median of 80 months.
The full analysis set was randomly divided
into training and internal validation datasets
(training: n=2,308, 67%; internal validation:
n=1,164, 33%). The study’s model was externally
validated in a third dataset that included 845
newly diagnosed CLL patients from the Mayo
Clinic in Rochester, Minnesota; these patients
had a median age of 62 years (range, 25-89 years)
and were observed for a median of 63 months.
Of the 1,192 patients from the training
dataset (52%), five independent predictors
for overall survival (OS) were identified: age,
clinical stage, del(17p) and/or TP53 mutation
status, IGHV mutation status, and ß2-microglobulin (B2M) level. Each variable was then
assigned an individual weighted grade (TABLE).
Adding all of these factors together results
in a prognostic score ranging from 0-10, with
four different risk groups: low (score 0-1),
intermediate (score 2-3), high (score 4-6), and
very high (score 7-10). Patients in these four
groups had significantly different rates of fiveyear OS (95% CI 0.69-0.76; p<0.001):
• High risk (n=326): 63.6 percent
• Very high risk (n=62): 23.3 percent
The results “were nicely confirmed” by the
internal validation dataset as well \