Written in Blood
compared with GHSG alone, suggesting that
“both functional parameters add a similar
level of predictive ability for FFP.”
They noted that GHSG groupings had
better predictive value when MTV t and TLG t
were incorporated into a model. “GHSG
grouping [alone] was not significantly
associated with outcome, but total MTV t
categorization of high (>268) versus low
(HR=2.20; 95% CI 0.92-5.25; p=0.076) and
TLG t categorization of high (>1,703) versus
low (HR=2.822; 95% CI 1.23-6.48; p=0.014)
correlated with worse FFP,” they reported.
Higher values of both MTV t and TLG t had
“worse FFP rates, [had] shorter FFP times,
and were more likely to have bulky disease
and IIB-advanced stage disease.”
FFP also was significantly worse for
patients with unfavorable disease and high
MTV or TLG, compared with those with
low MTV or TLG (p<0.001); a significant
difference was not observed in patients with
favorable HL. “This finding allows us to sub-
stratify patients with unfavorable [disease]
into two distinct categories: early-stage, low-
risk unfavorable and early-stage, high-risk
unfavorable,” the authors concluded, which
could better identify which patients would
benefit from treatment escalation.
The study is limited by its retrospective
design and small number of events. Most
patients were considered to have early-stage
unfavorable disease, so the results may not
VYXEOS™ (daunorubicin and cytarabine) liposome for injection,
for intravenous use
BRIEF SUMMARY OF PRESCRIBING INFORMATION: Consult
the Full Prescribing Information, including BOXED Warning,
for complete product information.
Initial U.S. Approval: 2017
WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN
AND/OR CYTARABINE-CONTAINING PRODUCTS
• VYXEOS has different dosage recommendations than
daunorubicin hydrochloride injection, cytarabine injection,
daunorubicin citrate liposome injection, and cytarabine
liposome injection. Verify drug name and dose prior to
preparation and administration to avoid dosing errors
[see Warnings and Precautions].
INDICATIONS AND USAGE
VYXEOS is indicated for the treatment of adults with newly-diagnosed
therapy-related acute myeloid leukemia (t-AML) or AML with
myelodysplasia-related changes (AML-MRC).
CONTRAINDICATIONS
The use of VYXEOS is contraindicated in patients with the following:
• History of serious hypersensitivity reaction to cytarabine,
daunorubicin, or any component of the formulation [see Warnings
and Precautions].
WARNINGS AND PRECAUTIONS
Do Not Interchange With Other Daunorubicin And/Or
Cytarabine-Containing Products
Due to substantial differences in the pharmacokinetic parameters,
the dose and schedule recommendations for VYXEOS are different
from those for daunorubicin hydrochloride injection, cytarabine injection,
daunorubicin citrate liposome injection, and cytarabine liposome
injection. Verify drug name and dose prior to preparation and
administration to avoid dosing errors. Do not substitute other
preparations of daunorubicin or cytarabine for VYXEOS.
Hemorrhage
Serious or fatal hemorrhage events, including fatal central nervous
system (CNS) hemorrhages, associated with prolonged severe
thrombocytopenia, have occurred in patients treated with VYXEOS.
In Study 1 (NCT01696084), the incidence of any grade hemorrhagic
events during the entire treatment period was 74% of patients on the
VYXEOS arm and 56% on the control arm. The most frequently reported
hemorrhagic event was epistaxis (36% in VYXEOS arm and 18% in control
arm). Grade 3 or greater events occurred in 12% of VYXEOS treated
patients and 8% of patients treated with 7+3. Fatal treatment-emergent
CNS hemorrhage not in the setting of progressive disease occurred in
2% of patients on the VYXEOS arm and in 0.7% of patients on the control
arm. Monitor blood counts regularly until recovery and administer
platelet transfusion support as required [see Adverse Reactions].
Cardiotoxi