On Location
American Society of Hematology’s
57TH ANNUAL MEETING & EXPOSITION
eaturing more than 4,500 abstract
presentations and a jam-packed
Education Program, the 2015
ASH Annual Meeting & Exposition
featured practice-changing research from
across the spectrum of hematologic malignancies and blood disorders.
Here, ASH Clinical News presents highlights from the meeting, including new
advances for the treatment of betathalassemia major, a discussion of the role of
transplant in myeloma, and new treatments
that lengthen the survival for patients with
chronic lymphocytic leukemia.
For more cov erage of the 2015 ASH
Annual Meeting, take a look at the supplement to our January issue and visit
ashclinicalnews.org/on-location for our
complete coverage.
ASH Clinical News was also on-site to
speak with presenters and moderators
about the groundbreaking research that
was shared at the meeting. Check out all
of the interviews at ashclinicalnews.org/
multimedia/exclusive-videos.
38
ASH Clinical News
For FLT3-Mutated AML
Patients, Midostaurin Added to
Chemotherapy Improved Survival
Patients with FLT3-mutated acute myeloid
leukemia (AML) have poor prognosis, a high
chance of relapse, and a limited number of treatment options. Research presented at this year’s
ASH Annual Meeting suggests that adding the
investigational FLT3 inhibitor midostaurin to
standard, “7+3” chemotherapy, followed by one
year of maintenance therapy, improves event-free
survival (EFS) and overall survival (OS), compared with standard chemotherapy alone.
“This trial is the first step in applying the
theories of personalized medicine to patients
with AML,” said Richard M. Stone, MD, from
the Department of Medical Oncology at DanaFarber Cancer Institute in Boston, Massachusetts.
Patients with the FLT3 mutation, he added, “are
likely to benefit from the addition of this targeted
agent, midostaurin, to standard chemotherapy.”
In the randomized, phase III RATIFY trial
(the largest clinical trial in FLT3-mutated AML
conducted to date), 717 patients (median age =
48 years; range = 18-60 years) were randomized
to receive either midostaurin (n=360) or placebo
(n=357). There were no significant differences between the two groups in terms of age, race, FLT3
subtype, or baseline complete blood cell count.
The induction therapy protocol was: daunorubicin (60 mg/m2) on days 1-3, cytarabine (200
mg/m2) on days 1-7, and either midostaurin or
placebo administered orally at a dose of 50 mg
twice-daily on days 8-22.
Re-treatment with a second course was allowed if residual AML was noted on a marrow
exam performed on day 21, and patients achieving complete remission (CR) received up to four
cycles of cytarabine (3 g/m2) every 12 hours on
days 1, 3, and 5 plus midostaurin or placebo (50
mg) twice-daily on days eight through 22. Patients
then received one year of maintenance therapy
with midostaurin or placebo (50 mg) twice-daily.
“The final analysis was to occur after 509
deaths, but given the slow rate of events (359
January 2016