Literature Scan
The study is limited by the retrospective data collection for certain patients
and its small patient population, which
did not allow the researchers to compare
recurrence rates between patients with
distal versus proximal UEDVT or among
those whose UEDVT was related or not
related to CVC. In addition, the centers
participating in the trial were specialized
in the diagnosis and management of VTE,
thus treatment strategies captured in
this study may not be generalizable to
daily practice in other settings.
“Further studies are needed to
inform physicians on the best management strategies for this disease,
particularly in high-risk subgroups,
such as cancer patients,” Dr. Bleker told ASH Clinical News. “Our
results should ideally be confirmed
in a prospective registry study with
standardized treatment strategies, a
large sample size, a long follow-up
duration, and central adjudication of
outcomes.”
or exposure to previous therapy.
“Midostaurin showed clinical activity in the most advanced form of SM, mast cell leukemia, with eight of the
16 patients with this highly fatal variant of SM responding,” Jason Gotlib, MD, MS, first author of the study, told
ASH Clinical News. “Historically, the survival of these
patients typically has been less than six months. In our
study, the median duration of response had not yet been
reached for patients with aggressive SM.”
Dr. Gotlib, from the Hematology Division at the StanS:6.75”
In the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy
Everyone has a distinct profile
Consider your patient.Consider BOSULIF.
Bleker SM, Van Es N, Kleinjan A, et al. Current management
strategies and long-term clinical outcomes of upper extremity
venous thrombosis. J Thromb Haemost. 2016;14:973-81.
( b o s u t inib)
Midostaurin:
A Promising
New Option
for Patients
With Advanced
Systemic
Mastocytosis
42
ASH Clinical News
Bosutinib (BOSULIF®) is recommended by the NCCN Clinical Practice Guidelines in
Oncology (NCCN Guidelines®) as a treatment option for patients with CML in need
of 2nd- or later-line TKI therapy.1
Study design: BOSULIF 500 mg once-daily treatment was studied in a single-arm, Phase 1/2, open-label, multicenter
trial (N=546) in patients with CP, AP, or BP CML in second line (after imatinib) or in third line (after imatinib followed by
dasatinib and/or nilotinib). Of the 546 patients enrolled, 73% were imatinib resistant and 27% were imatinib intolerant.2
AP=accelerated phase; BP=blast phase; CP=chronic phase.
IMPORTANT SAFETY INFORMATION
Contraindication: History of hypersensitivity to BOSULIF. Reactions have
included anaphylaxis. Anaphylactic shock occurred in less than 0.2% of treated
patients in clinical trials.
Gastrointestinal Toxicity: Diarrhea, nausea, vomiting, and abdominal pain
can occur. In the clinical trial, median time to onset for diarrhea was 2 days,
median duration was 1 day, and median number of episodes per patient was 3
(range 1-221). Monitor and manage patients using standards of care, including
antidiarrheals, antiemetics, and/or fluid replacement. Withhold, dose reduce,
or discontinue BOSULIF as necessary.
Myelosuppression: Thrombocytopenia, anemia, and neutropenia can occur.
Perform complete blood counts weekly for the first month and then monthly
or as clinically indicated. Withhold, dose reduce, or discontinue BOSULIF
as necessary.
Hepatic Toxicity: Twenty percent of patients experienced an increase in either
ALT or AST. Liver enzyme elevation usually occurs early in treatment. Perform
B:15.5”
T:15.25”
G:.5”
BOSULIF is indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia
chromosome–positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.
REFERENCE
Advanced systemic mastocytosis
(SM) is a rare myeloproliferative
neoplasm associated with poor
prognosis and a lack of effective treatment options. The oral, multitarget
protein kinase inhibitor midostaurin
is known to inhibit KIT D816V, a
mutation present in about 90 percent
of patients with SM.
In a multicenter, open-label,
phase II study published in The
New England Journal of Medicine,
researchers evaluated the efficacy,
safety, and patient-reported outcomes
of twice-daily midostaurin 100 mg in
patients with advanced SM, finding
that the drug led to an overall response rate (ORR) of 60 percent, and
similar response rates regardless of
disease subtype, KIT mutation status,
ford University School of Medicine – Stanford Cancer
Institute in Stanford, California, and authors enrolled
patients with aggressive SM, SM with an associated
hematologic neoplasm, or mast-cell leukemia (according
to the World Health organization criteria) into the study.
Patients were excluded if they had received ≥3 prior treatments for mastocytosis or had a cardiac ejection fraction
<50 percent.
Between January 2009 and July 2012, 116 patients
were enrolled from 29 sites, with 89 patients eligible for
hepatic enzyme tests monthly for the first 3 months and as clinically indicated.
In patients with transaminase elevations, monitor liver enzymes more
frequently. Drug-induced liver injury has occurred. Withhold, dose reduce, or
discontinue BOSULIF as necessary. In patients with mild, moderate, or severe
hepatic impairment, the recommended starting dose is 200 mg daily.
Renal Toxicity: An on-treatment decline in estimated glomerular filtration
rate has occurred in patients treated with BOSULIF. Monitor renal function
at baseline and during therapy, with particular attention to patients with
preexisting renal impairment or risk factors. Consider dose adjustment
in patients with baseline and treatment emergent renal impairment. The
recommended starting doses for patients with severe renal impairment
(CrCL <30 mL/min) or moderate renal impairment (CrCL 30-50 mL/min)
are 300 mg and 400 mg daily, respectively.
Fluid Retention: Fluid retention can occur and may cause pericardial effusion,
pleural effusion, pulmonary edema, and/or peripheral edema. Monitor
and manage patients using standards of care. Interrupt, dose reduce, or
discontinue BOSULIF as necessary.