Written in Blood
demonstrated that immunoglobulin (Ig)
levels and CD4+ T cells were recovered by
one year post-AHCT. Median IgG, IgA,
and IgM levels recovered to 1,090 mg/
dL (range = 270.0-2331.0), 123 mg/dL
(range = 6-534), and 48.5 mg/dL (range
= 24-254), respectively; median CD4+
T-cell count recovered to 280.3/µL (range
= 28.8-1148.0).
When the results from the HIVpositive population were compared
with a matched population of 151
non-HIV transplant recipients from
the Center for International Blood
and Marrow Transplant Research
database, the outcomes did not
differ statistically between the two
patient populations. The probability
of one-year OS in the control group
was 87.7 percent (95% CI 80.9-92.2),
and the probability of PFS was 69.5
percent (95% CI 61.1-76.4). And,
as seen in TABLE 1 (page 21), hazard
ratios for mortality and other endpoints were similar.
“Together, these trials validate the
concept that controlled HIV-infection
should not preclude consideration
of AHCT for patients who otherwise
meet standard transplant eligibility criteria,” the authors concluded.
“Patients with HIV-related lymphoma
should also be considered appropriate potential participants for future
AHCT clinic trials.”
While these results are encouraging, Dr. Alvarnas and colleagues noted
some important HIV-related clinical
issues that should govern the care of
patients with HIV-related lymphoma,
including monitoring any potential
drug-drug interactions between
anti-HIV therapy and AHCT-related
regimens, and carefully deciding when
to continue or discontinue anti-HIV
therapy to avoid the risk of increasing
HIV resistance.
lymphocytic leukemia (ALL) found that
96 percent of patients treated with a
combination of low-intensity chemotherapy and dasatinib (a second-generation
multi-targeted tyrosine kinase inhibitor of
the BCR-ABL1 and SRC family kinases)
achieved complete remission (CR). In
addition, 58 percent of patients remained
relapse-free at 12 months.
“Elderly patients can be successfully
treated with the combination of dasatinib
and low-intensity chemotherapy without
excessive toxicity, with the expectation
of a 41 percent overall survival at three
years outside allogeneic hematopoietic
cell transplantation (alloHCT),” Philippe
Rousselot, MD, PhD, lead author of the
study, told ASH Clinical News. Dr. Rousselot, from the Hemato-Oncology Unit at
the Hôpital André Mignot in Le Chesnay,
France, and colleagues conducted the
prospective, phase II study of 71 patients
(median age = 69 years; range = 59-83
years) who were treated between August
2007 and July 2010 in Belgium, Germany,
Italy, and France.
Patients had newly diagnosed Ph+
and/or BCR-ABL1-positive ALL, with
or without documented central nervous
system involvement, and had not received
S:6.75”
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.
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.
( b o s u t inib)
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
REFERENCE
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
Alvarnas JC, Rademacher JL, Wang Y, et al. Autologous hematopoietic cell transplantation for HIV-related lymphoma:
results of the (BMT CTN) 0803/AIDS malignancy consortium
(AMC) 071 trial. Blood. 2016. [Epub ahead of print]
AP=accelerated phase; BP=blast phase; CP=chronic phase.
Dasatinib Plus
Low-Intensity
Chemotherapy
Results in LongTerm Survival for
Older Patients
with Ph+ ALL
A long-term study focusing on
older patients with Philadelphia
chromosome-positive (Ph+) acute
22
ASH Clinical News
IMPORTANT SAFETY INFORMATION
Contraindication: Hypersensitivity to BOSULIF. Anaphylactic shock occurred in
less than 0.2% of treated patients.
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
hepatic enzyme tests monthly for the first 3 months and as clinically indicated.
B:15
T:15.
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 m L/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.