CLINICAL NEWS
and cytogenetic prognosis than those
who received all their care at our center,”
Ms. Hershenfeld noted. Patients receiving shared-care had a median age of 57
years (range: 21.7-78.6) and 40 (54.8%)
were male. Seven (9.6%) had favorable, 42
(57.5%) had intermediate, six (8.2%) had
poor, and 18 (24.7%) had indeterminate
cytogenetic profiles.
Patients in the shared-care model
travelled a mean distance of 99.5 ± 57.8 km
(median = 87.8; range = 28.4-266
km) each way to the quaternary
care center, compared with 26.3
± 33.6 km (median = 14.5; range
= 0.55-211 km) each way to their
local treatment center (p <0.001
for difference).
The estimated mean travel
time was also reduced (p<0.001 for
difference):
Age, Sex, and Timing of Treatment Response
Predict Avascular Necrosis in Children with ALL
Avascular necrosis (AVN), a disorder resulting from
a temporary or permanent loss of blood supply to the
bone, is one of the most serious late complications of
therapy in children with acute lymphocytic leukemia
(ALL). Currently, there is no consensus on how osteonecrosis in ALL develops.
LET HIM EXPLORE
• Travel time from home to the
quaternary center was 71.6
± 38 minutes (median = 62;
range = 29-170)
WITH ELOCTATE, THE
FIRST AND ONLY rFVIII WITH
A PROLONGED HALF-LIFE
• Travel time from home to
their local center was 23.3 ±
21.9 minutes (median = 18;
range = 2-137)
By receiving post-consolidation
care locally, then, patients were
able to save 146.5 ± 99.6 km in
round-trip distance and 96.7 ±
63.4 minutes of round-trip travel
time, per visit, compared with travelling to the quaternary care center.
Patients in the shared-care
model had similar rates of overall
survival to those who received all
of their care at Princess Margaret
(p>0.05). Thirty-, 60-, and 90-day
survival from the start of consolidation chemotherapy was: 98.6,
97.2, and 95.9 percent (shared-care
model) and 98.8, 97.1, and 95.3
percent (quaternary center).
“Multivariate Cox proportional hazards models revealed no
significant increase in hazard of
death for the shared-care patients
compared to control when controlling for age, gender, AML versus
APL, and cytogenetic prognosis
(p>0.05),” Dr. Hershenfeld and her
co-authors wrote.
Though the shared-care model
“is still in its infancy, it does work,”
Ms. Hershenfeld said. “The results
are encouraging to be able to
expand this model at more centers
across the country.” ●
REFERENCE
Hershenfeld SA, Maki K, Rothfels L, et al. Sharing postAML consolidation supportive therapy with local centers
reduces patient travel burden without compromising
safety and efficacy. Abstract #27. Presented at the 2015
ASH Annual Meeting on Hematologic Malignancies;
September 19, 2015; Chicago, IL.
Selected Important Safety Information
• ELOCTATE is contraindicated in patients who have had life-threatening
hypersensitivity reactions to ELOCTATE, including anaphylaxis
GET TO KNOW ELOCTATE
ABR
BLEED CONTROL
Median overall
annualized
bleed rate (ABR) of
†
1.6
(0.0, 4.69)‡
*
0
BLEEDS
in
45%
of subjects*†
DOSING
Routine
prophylaxis
starting interval of
4
EVERY
DAYS§
rFVIII=recombinant Factor VIII.
*A-LONG, a multicenter, prospective, open-label, Phase 3 study (N=165) evaluating the safety and efficacy of ELOCTATE in previously treated male patients (aged
12-65 years) with severe hemophilia A (<1% endogenous FVIII activity or a genetic mutation consistent with severe hemophilia A) that compared the efficacy of
each of 2 prophylactic treatment regimens (individualized interval [n=117] and fixed weekly [n=23]) to episodic (on-demand [n=23]) treatment. Hemostatic efficacy
was determined in treatment of bleeding episodes and during perioperative management in subjects undergoing major surgical procedures. 164 and 163 subjects
were evaluable for safety and efficacy, respectively. 146 and 23 subjects were treated for at least 26 weeks and 39 weeks, respectively.
†
In the individualized prophylaxis arm (n=117) of the A-LONG clinical trial.
‡
Median (interquartile range 25th-75th percentiles).
§
Recommended prophylaxis starting dose of 50 IU/kg every 4 days, with adjustments based on patient response in the range of 25-65 IU/kg at 3- to 5-day
intervals. More frequent or higher doses up to 80 IU/kg may be required in children <6 years of age.
Indications and Important Safety Information
INDICATIONS: ELOCTATE [Antihemophilic Factor (Recombinant),
Fc Fusion Protein] is a recombinant DNA derived, antihemophilic
factor indicated in adults and children with Hemophilia A
(congenital Factor VIII deficiency) for: control and prevention
of bleeding episodes, perioperative management (surgical
prophylaxis), and routine prophylaxis to prevent or reduce
the frequency of bleeding episodes. ELOCTATE is not
indicated for the treatment of von Willebrand disease.
CONTRAINDICATIONS: ELOCTATE is contraindicated in patients
who have had life-threatening hypersensitivity reactions to
ELOCTATE, including anaphylaxis.
discontinue ELOCTATE and initiate appropriate treatment if
hypersensitivity reactions occur. Formation of neutralizing
antibodies (inhibitors) to Factor VIII can occur following
administration of ELOCTATE. Patients using ELOCTATE should
be monitored for the development of Fa