CLINICAL NEWS
denosumab and 23.98 months with ZA
(HR=0.98, 95% CI 0.85-1.14; p value for
non-inferiority = 0.01). However, deno-
sumab did not demonstrate superiority
in delaying time to first SRE and delaying
time to first-and-subsequent SREs (second-
ary endpoints).
Overall survival (OS) was comparable
for denosumab and ZA (HR=0.90; 95%
CI 0.70-1.16; p value for non-inferiority =
0.41). Median PFS was 10.7 months longer
in the denosumab group than the ZA
group (46.1 months [range = 34.3
months to not estimable] and 35.4
months [range = 30.2 months to not
estimable]; HR=0.82 [95% CI 0.68-
0.99]; p=0.036).
The most common AEs (occur-
ring in ≥10% of patients) associated
with denosumab were diarrhea (34%),
nausea (32%), anemia (22%), back
pain (21%), thrombocytopenia (19%),
peripheral edema (17%), hypocalce-
mia (16%), upper respiratory tract
infection (15%), rash (14%), and
headache (11%). Patients discontinued
denosumab most commonly because
of osteonecrosis of the jaw. This AE
occurred more often in the denosum-
ab group than in the ZA cohort (4.1%
vs. 2.8%; p values not reported).
The median treatment exposure
was 16 months (range = 1-50 months)
with denosumab and 15 months
(range = 1-45 months) with ZA.
Source: Amgen press release, January 5, 2018.
IV Bag Shortage
Making Flu Season
Worse
Supplies of intravenous (IV) saline
and nutrient solutions were already
tight before hurricanes hit Puerto
Rico in September of last year and cut
power to manufacturing plants. Now,
as Puerto Rico continues its recovery
efforts, the U.S. supply of IV bags used
to deliver sterile solutions is dropping
to crisis levels.
An aggressive flu season has
further hampered hospitals. “If we
can’t support patients coming [into]
emergency rooms who have the flu,
more people are going to die,” predicts
Deborah Pasko, PharmD, MHA,
director of medication safety and qual-
ity at the American Society of Health-
System Pharmacists. “I see it as a crisis.”
Hospital officials, pharmacists, and
other staff have been devising alterna-
tives and workarounds: substituting
pills for IV-administered drugs when
possible and changing dosing schedules
or injecting drugs directly into a vein.
They’ve also been changing some
procedures, such as discontinuing IV
bags as soon as possible and not starting
ASHClinicalNews.org
patients on IV drips during surgery until it’s
certain they are needed.
The FDA said it believes shortages will
start to ease by spring 2018, but stressed “the
production situation in Puerto Rico remains
fragile.” Puerto Rico’s power grid is being
slowly restored and the last of three Baxter
International factories there that make saline
bags and nutrient solutions was reconnected
in December 2017.
Source: AP News, January 9, 2018.
FDA Approves Firstline
Arsenic Trioxide for
Acute Promyelocytic
Leukemia
The FDA approved arsenic trioxide in
combination with the all-trans retinoic acid
(ATRA) tretinoin for firstline treatment
of adults with newly diagnosed, low-risk
acute promyelocytic leukemia (APL) and
t(15;17) or PML-RARA gene expression.
The decision was based on a global
safety database for arsenic trioxide, as well
as results from a randomized, phase III trial
that enrolled 156 patients between October
2007 and September 2010. Participants
received ATRA plus arsenic trioxide (n=77;
median age = 44.6 years; range = 19.1-70.2
years) or ATRA plus chemotherapy (n=79;
IT TAKES
BOLD ACTION
TO REDUCE
CANCER IN
KENTUCKY
MARKEY CANCER CENTER
See how at ukhealthcare.com/lesscancer