This document provides information on acute myeloid leukemia (AML) for nurses to answer common patient questions. It defines AML and how it develops from damaged stem cells in bone marrow. Symptoms include fatigue, infections, and blood-related issues like anemia and low platelet counts. Current AML treatments include chemotherapy, stem cell transplants, and newer targeted therapies. Novel therapies discussed include drugs that target FLT3, IDH1/2, BCL-2, and Hedgehog pathway mutations.
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Meeting the Many Challenges of AML: Oncology Nurse Tactics in an Era of Novel Therapies
1. Access the activity, “Meeting the Many Challenges of AML: Oncology Nurse
Tactics in an Era of Novel Therapies,” at PeerView.com/TZV40
A Guide for Nurses to Answering
Common Patient Questions on AML1
PRACTICE AID
What is AML
and how
does it
develop?
What are
some other
effects or
symptoms
of AML?
What are
some of the
blood-related
symptoms of
AML?
Acute myeloid leukemia (AML) is a cancer of the bone marrow and the blood that
can progress rapidly without treatment. For the most part, it affects cells that aren't
fully developed; these cells can't carry out their normal functions. More specifically,
AML develops when the DNA (genetic material) of a developing stem cell in the
bone marrow is damaged—a process called an “acquired mutation.” The damaged
stem cell then becomes a leukemic cell and multiplies into billions of cells called
leukemic blasts.
Leukemic blasts do not function normally, and they block the production of normal
cells. Blasts typically grow and survive better than normal cells, and this can result in
a lower number of healthy blood cells (red cells, white cells, and platelets).
Often, patients with AML feel a loss of well-being because of the underproduction
of normal bone marrow cells. Symptoms may include fatigue or shortness of breath
during normal physical activities.
People with AML may also have the following: signs of bleeding caused by a very
low platelet count; the appearance of pinhead-sized red spots on the skin called
“petechiae”; mild fever; swollen gums; frequent minor infections; loss of appetite
and weight; bone or joint discomfort; and an enlarged spleen or liver.
There are several ways AML affects healthy blood cells. This disease can result in
anemia, a condition in which there is a low number of red cells in the blood,
which can cause fatigue and shortness of breath.
Neutropenia may also be present; this is a condition characterized by a low
number of white cells, which hampers the immune system so that it can't
effectively guard against infection.
Finally, AML can also result in thrombocytopenia, a condition defined by low
numbers of platelets, which can cause bleeding and easy bruising with no
apparent cause. If all three of these syndromes are present, we call that
pancytopenia.
2. Access the activity, “Meeting the Many Challenges of AML: Oncology Nurse
Tactics in an Era of Novel Therapies,” at PeerView.com/TZV40
A Guide for Nurses to Answering
Common Patient Questions on AML1
PRACTICE AID
1. Based on https://www.lls.org/leukemia/acute-myeloid-leukemia. Information current as of July 2020.
Is there anything about my AML
that can help the oncology team
choose the right therapy for me?
What are the current treatments
available for AML?
Yes, there are many factors that can influence
the choice of treatment. AML is a disease of
many subtypes, some more or less responsive
to therapy, and so the results of your disease’s
cytogenetic analysis will be one important
factor.
Other factors useful for selecting the right
therapy for you include the following
• Whether you have received chemotherapy in
the past to treat another type of cancer
• Whether you have had myelodysplastic
syndrome or another blood cancer
• Whether your disease has certain biologic
features that might make it more or less
difficult to treat
• Whether the AML is in your central nervous
system
• Whether your AML has not responded to
treatment or has relapsed
• The presence of systemic infection at
diagnosis
• Your age and general health or functional
status
There is a range of therapies we can choose
from, and we’ll do our best to make sure
we choose the best one for your needs.
Traditionally, initial treatment options have
focused on multi-agent chemotherapy
regimens. There are also less-intensive
treatments that might be useful for patients
who are older and/or unfit for intensive therapy.
Allogeneic stem cell transplant is also an option
for eligible patients with AML. Recently, you
might have seen or heard that there is a great
deal of excitement around newer therapies for
AML. For example, there are novel treatments
in development that target some subsets of
AML that are defined by specific mutations or
other molecular aspects of the disease. Some of
these agents include midostaurin, gilteritinib,
quizartinib, crenolanib, enasidenib, ivosidenib,
glasdegib, and venetoclax. Other agents,
such as CC-486, are being tested for use as
maintenance therapy—or a strategy that can
be used to keep patients in remission after they
respond to upfront treatment.
There are also new formulations of effective
chemotherapy regimens, such as CPX-351, that
are beneficial in secondary AML (ie, AML that
has developed after an earlier cancer or after
therapy associated with AML development,
or AML that has certain biologic features
suggestive of myelodysplasia).
We can discuss which of these strategies is right
for you—including through enrollment in a
clinical trial.
3. Tools for Patient Education in AML
PRACTICE AID
Access the activity, “Meeting the Many Challenges of AML: Oncology Nurse Tactics in an Era of Novel
Therapies,” at PeerView.com/TZV40
Calendars can be useful
tools for patients
because they can convey
treatment schedules
and dosing information
for modern
chemotherapy
platforms
Example of a calendar showing CPX-351 infusion schedule
for a patient with sAML/AML-MRC
Schedule and recovery time can be added to illustrate
treatment over time and work with a given patient’s schedule
x
Images courtesy of Brennan Sehrt, BSN, RN- 2 CC.
4. Tools for Patient Education in AML
PRACTICE AID
Access the activity, “Meeting the Many Challenges of AML: Oncology Nurse Tactics in an Era of Novel
Therapies,” at PeerView.com/TZV40
AML: acute myeloid leukemia; MRC: myelodysplasia-related changes; sAML: secondary AML.
SUN MON TUE
Blank Calendar for Download
WED THU FRI SAT
5. Access the activity, “Meeting the Many Challenges of AML: Oncology Nurse Tactics in an Era of Novel
Therapies,” at PeerView.com/TZV40
A Snapshot of Innovative Therapies in AML
Current Status, Dosing, and Other Considerations
PRACTICE AID
STATUS DOSEDRUG CONSIDERATIONSTARGET
Approved
Plus chemotherapy in adults with newly
diagnosed FLT3-mutation–positive AML
50 mg orally twice daily with food on
d 8-21 of each induction cycle with
cytarabine and daunorubicin and on
d 8-21 of each consolidation cycle with
high-dose cytarabine
Midostaurin4
q GI events most common
q Promote therapy adherence
q Be mindful of potential drug–drug interactions
FLT3
Approved
Adults with R/R
IDH2-mutation–positive AML
100 mg orally daily
Enasidenib10
Monitor for:
q IDH-differentiation syndrome
q GI events
IDH2 q Elevated bilirubin
q Leukocytosis
Approved
Adults with IDH1-mutation–positive newly
diagnosed AML who are ≥75 years or
who have comorbidities that preclude
the use of intensive induction
chemotherapy or R/R AML
500 mg orally daily
Ivosidenib11
Monitor for:
q IDH-differentiation syndrome
q Guillain-Barré syndrome
IDH1 q QT prolongation
q GI events, nausea,
leukocytosis
Phase 3 testing
Adults with newly diagnosed and R/R
FLT3-ITD–positive AML
60 mg used in phase 3 QuANTUM-R
study (30-mg lead-in)Quizartinib6-9
q Most common AEs in early studies included nausea,
prolonged QT interval, vomiting, and dysgeusia
FLT3
Approved
Adults with newly diagnosed
t-AML or AML-MRC
Induction: daunorubicin 44 mg/m2
and
cytarabine 100 mg/m2
liposome IV
over 90 min on d 1, 3, and 5a
CPX-3511-3
q Can cause prolongation of blood count suppression;
monitor blood counts regularly until recovery
q Not recommended in patients with decreased cardiac
function
Cytotoxic therapy
(liposomal cytarabine
+ daunorubicin
5:1 molar ratio)
Approved
Adults with FLT3-mutation–positive
R/R AML
120 mg orally daily
Gilteritinib5
q Most common AEs include myalgia/arthralgia,
transaminase increase, fatigue/malaise, noninfectious
diarrhea, dyspnea, edema, rash, pneumonia, nausea,
stomatitis, cough, headache, hypotension, dizziness,
and vomiting
FLT3
Approved
In combination with azacitidine or
decitabine or low-dose cytarabine for
newly diagnosed AML in adults
≥75 years or who have comorbidities
that preclude use of intensive
induction chemotherapy
BCL-2
Ramp-up phase: 100 mg orally on d 1,
200 mg on d 2, 400 mg on d 3;
d 4 and beyond: 400 mg (with HMA)
or 600 mg (with low-dose cytarabine)
q Most common AEs as part of combination therapy in
AML include nausea, diarrhea, thrombocytopenia,
constipation, neutropenia, febrile neutropenia, and
fatigue (among others)b
q Standard monitoring and prophylaxis measures for TLS
are recommended
Venetoclax12
6. a
For additional induction, use d 1 and 3 for subsequent cycles, if needed; for consolidation: daunorubicin 29 mg/m2
and cytarabine 65 mg/m2
liposome IV over 90 min on d 1 and 3. b
See prescribing information for a complete list of common AEs with venetoclax combinations in AML.12
AML: acute myeloid leukemia; AML-MRC: AML with myelodysplasia-related changes; BCL-2: B cell lymphoma 2; BM: bone marrow; CD: cluster of differentiation; FLT3: fms-like tyrosine kinase 3; FN: febrile neutropenia; HCT: hematopoietic cell transplantation; Hhp: hedgehog pathway; HMA: hypomethylating
agent; IDH: isocitrate dehydrogenase; ITD: internal tandem duplication; mAb: monoclonal antibody; MDS: myelodysplastic syndrome; RFS: relapse-free survival; R/R: relapsed or refractory; t-AML: therapy-related acute myeloid leukemia; TLS: tumor lysis syndrome; VOD: veno-occlusive disease.
1. Lancet JE et al. 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO 2016). Abstract 7000. 2. Lancet JE et al. 2017 Annual BMT Tandem Meetings (BMT Tandem 2017). Abstract 19. 3. Vyxeos (daunorubicin and cytarabine) Prescribing Information. http://pp.jazzpharma.com/pi/
vyxeos.en.USPI.pdf. 4. Rydapt (midostaurin) Prescribing Information. https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/rydapt.pdf. 5. Xospata (gilteritinib) Prescribing Information. https://astellas.us/docs/xospata.pdf. 6. https://clinicaltrials.gov/ct2/show/NCT02668653.
7. https://clinicaltrials.gov/ct2/show/NCT02039726. 8. Cortez J et al. 23rd Congress of the European Hematology Association (EHA 2018). Abstract LB2600. 9. https://pharmaphorum.com/market-access-2/fda-grants-leukaemia-drug-breakthrough-status/. 10. Idhifa (enasidenib) Prescribing Information.
https://media.celgene.com/content/uploads/idhifa-pi.pdf. 11. Tibsovo (ivosidenib) Prescribing Information. https://www.tibsovo.com/pdf/prescribinginformation.pdf. 12. Venclexta (venetoclax) Prescribing Information. https://www.rxabbvie.com/pdf/venclexta.pdf. 13. Mylotarg (gemtuzumab
ozogamicin) Prescribing Information. http://labeling.pfizer.com/ShowLabeling.aspx?id=9548. 14. https://www.fda.gov/drugs/fda-approves-glasdegib-aml-adults-age-75-or-older-or-who-have-comorbidities . 15. Daurismo (glasdegib) Prescribing Information. http://labeling.pfizer.com/ShowLabeling.
aspx?id=11336. 16. Agura E et al. 60th American Society of Hematology Annual Meeting and Exposition (ASH 2018). Abstract 1017. 17. Roboz GJ et al. FutureOncol. 2016;12:293-302. 18. Wei AH et al. 61st Annual Meeting and Exposition of the American Society of Hematology (ASH 2019). Abstract LBA-3.
Information current as of July 2020.
Access the activity, “Meeting the Many Challenges of AML: Oncology Nurse Tactics in an Era of Novel
Therapies,” at PeerView.com/TZV40
A Snapshot of Innovative Therapies in AML
Current Status, Dosing, and Other Considerations
PRACTICE AID
DRUG STATUS TARGET DOSE CONSIDERATIONS
Glasdegib14,15
Approved
In combination with low-dose cytarabine
for newly diagnosed AML in adults
≥75 years or who have comorbidities
that preclude use of intensive
induction chemotherapy
Hhp 100 mg orally daily
q Most common AEs include anemia, fatigue, hemorrhage,
FN, musculoskeletal pain, nausea, edema,
thrombocytopenia, changes in taste, and dyspnea
q See label for other common AEs and for information
on the potential for embryo-fetal toxicity and appropriate
management approaches
Gemtuzumab
ozogamicin13
Approved
Newly diagnosed CD33+ AML in adults,
R/R CD33+ AML in adults, and in
pediatric patients aged ≥2 years
CD33
Induction: 3 mg/m2
(up to one
4.5-mg vial) on d 1, 4, and 7 in
combination with daunorubicin
and cytarabine
q Infusion-related reactions
q Premedicate with corticosteroid, antihistamine,
and acetaminophen
q Monitor platelet counts frequently (hemorrhage) and
signs/symptoms of liver toxicity (VOD)
Phase 3 SIERRA study
Adults aged ≥55 years with active,
R/R AML, adequate organ function,
and related/unrelated matched donor
CD45
(BC8 mAb
linked to
radioisotope
iodine-131)
Dosimetry directed
(SIERRA study)
Iomab-B16
Phase 2 data as maintenance therapy
post-HCT in AML
Phase 3 QUAZAR study
Maintenance with oral azacitidine in
adults aged ≥55 years with AML in
first complete remission induced
substantial improvements in OS and
RFS following induction chemotherapy
+/- consolidation (non-HCT candidates)
300 mg orally daily for 14 d of 28-d
treatment cycles (QUAZAR study)Oral
azacitidine17,18
Epigenetic
modification
(novel oral
formulation
of HMA)
q Preliminary data from the ongoing phase 3 SIERRA
trial confirm the feasibility of targeted conditioning with
Iomab-B with near-universal and rapid engraftment of
older patients with active AML and high BM blast burden
q No nonrelapse mortality reported in the Iomab-B arm;
select nonhematologic AEs included stomatitis,
malnutrition, and epistaxis, among others
q In phase 3 testing, most common grade 3/4 AEs
included neutropenia, thrombocytopenia, and anemia