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270 Anticoagulation Therapy
https://t.me/med1917
• Increasing the prophylactic doses of LMWH may
be appropriate in morbidly obese patients (body
mass index 40 kg/m
•
Laboratory monitoring of LMWH could be
considered in patients with morbid obesity
(weight >190 kg). Peak anti-Xa levels should
be drawn 4 hours after sub-Q injection of
LMWH; however, the efficacy and safety of dose
adjustments have not been established.
Be aware of syringe size of LMWH when
•
choosing a dose in obese patients. Using
once-daily enoxaparin may not be practical in
patients >100 kg due to available doses and
required number of syringes to use, and it did not
appear as efficacious as twice-daily dosing in the
Merli study that led to market approval.
2
).
60
Patients with Malignancy
•
VTE in patients with malignancy is secondary to a hypercoagulable state, and
patients with cancer have an increased risk of VTE especially in the first few
months after diagnosis. Although not all malignancies are associated with throm
bosis, the overall risk of VTE is increased 7-fold in patients with a malignancy
and up to 28-fold in certain malignancies.
•
VTE is the second most common cause of mortality in patients with cancer.
•
Treatment guidelines for VTE in patients with cancer are available through
multiple national organizations (National Comprehensive Cancer Network
[NCCN]/American Society of Clinical Oncology [ASCO]/American College of
Chest Physicians [ACCP]). The guidelines generally recommend LMWH for the
initial treatment of VTE in patients with cancer.
•
Extended duration of therapies are generally preferred over shorter durations
of therapy at least until cancer is in remission or surgically removed.
61-67
-
CONSIDERATIONS IN SPECIAL POPULATIONS 271
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TABLE 11-14: Treatment Guidelines for the Management of VTE
in Patients with Cancer
Category NCCN ASCO ACCP
Initial treatment LMWH is preferred
therapy.
Recommended
agents:
•
•
•
•
Long-term treatment LMWH is preferred
for the first 6 months
as monotherapy
without VKA.
VKA therapy with INR
value targeted at 2–3.
63-65
Dalteparin
Enoxaparin
Fondaparinux
UFH
LMWH is preferred
over UFH for the
initial 5–10 days in
newly diagnosed
VTE in patients with
cancer.
Recommended
agents:
•
UFH
Dalteparin
•
•
Enoxaparin
Tinzaparin
•
•
Fondaparinux
LMWH for at least 6
months is preferred
over VKAs.
VKAs are acceptable
alternatives if LMWH
is not available.
Use of novel oral
anticoagulants is not
recommended at this
time.
LMWH over
VKA therapy is
recommended in
patients with DVT
or PE.
No preference of
VKA over DOACs in
patients not receiving
LMWH.
Extended
anticoagulation is
recommended if the
risk of bleeding is not
high in patients with
DVT or PE.
Duration Minimum of 3 months
ACCP: American College of Chest Physicians, ASCO: American Society of Clinical Oncology,
DOAC: direct-acting oral anticoagulant, DVT: deep vein thrombosis, LMWH: low molecular
weight heparin, NCCN: National Comprehensive Cancer Network, PE: pulmonary embolism,
UFH: unfractionated heparin, VKA: vitamin K antagonist
Indefinite
anticoagulation if
active cancer or
persistent risk factors.
Recommended
agents:
• Dalteparin
• Enoxaparin
• Tinzaparin
• VKA
At least 6 months
Therapy beyond 6
months considered
in patients with
metastatic disease
or receiving
chemotherapy.
Recommend
extended
anticoagulant therapy
over 3 months of
therapy in patients
with DVT or PE.
272 Anticoagulation Therapy
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TABLE 11-15: Cancer-Related Thromboembolism
Two-Year Cumulative Incidence Relative Risk (95% CI)
Prostate
Localized (1%)
•
• Regional (1.3%)
•
Remote (1.2%)
Breast
•
Localized (0.8%)
Regional (1.3%)
•
•
Remote (2.6%)
Lung
Localized (1.3%)
•
Regional (2.2%)
•
•
Remote (2.6%)
Colon/Rectum
Localized (1%)
•
•
Regional (2.4%)
Remote (2.9%)
•
Melanoma
•
Localized (0.3%)
Regional (0.9%)
•
•
Remote (2.9%)
Non-Hodgkin Lymphoma
Localized (1.5%)
•
Regional (3.2%)
•
•
Remote (2.1%)
Uterus
Localized (1.2%)
•
• Regional (2.2%)
•
Remote (4.8%)
Bladder
Localized (0.9%)
•
•
Regional (2%)
Remote (4.3%)
•
Pancreas
Localized (3.2%)
•
•
Regional (3%)
Remote (5.4%)
•
Stomach
•
Localized (2.3%)
Regional (3.4%)
•
•
Remote (4.4%)
Ovary
Localized (2.3%)
•
•
Regional (3.4%)
Remote (4.4%)
•
Kidney
Localized (1.3%)
•
•
Regional (3.8%)
•
Remote (3.5%)
Noncancer in patients: (1)
patients without cancer
Head/Neck—0.29 (0.2– 0.4)
Bladder—0.42 (0.36– 0.49)
Breast—0.44 (0.40– 0.48)
Esophagus—0.76 (0.58–0.97)
Cervix—0.90 (0.68–1.18)
Liver—0.92 (0.076–1.10)
Prostate—0.98 (0.93–1.04)
Rectum—1.11 (1–1.22)
Lung—1.13 (1.07–1.19)
Colon—1.36 (1.29–1.44)
Renal—1.41 (1.25–1.59)
Stomach—1.49 (1.33–1.68)
Lymphomas—1.80 (1.65–1.96)
Pancreas—2.05 (1.87–2.4)
Ovary—2.16 (1.93–2.41)
Leukemia—2.18 (2.01–2.37)
Brain—2.37 (2.04–2.74)
Uterus—3.4 (2.97–3.87)
68,69
*Patients without cancers, but with other medical conditions, were assumed to have a risk of 1 for
venous thromboembolism.
TABLE 11-16: Khorana Scale (Predictive Model for
Chemotherapy-Associated VTE)
Patient Characteristic Risk Score*
• Site of cancer
• Very high risk (stomach, pancreas)
• High risk (lung, lymphoma, gynecologic, bladder, testicular)
•
Prechemotherapy platelet count ≥350 x 10
• Hemoglobin level <10 g/dL or use of red cell growth factors 1
• Prechemotherapy leukocyte count >11 x 10
• BMI ≥35 kg/m
*Low risk, score = 0; Intermediate risk, score = 1–2; High risk, score = ≥3
BMI: body mass index, VTE: venous thromboembolism, x: times
70
2
1
9
/L 1
9
/L 1
2
1
CONSIDERATIONS IN SPECIAL POPULATIONS 273
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Caveats for Consideration
•
Patients with malignancy are at high risk for developing VTE with a score of ≥3
based on collection of simple variables.
therapy initiation and periodically thereafter.
TABLE 11-17: Dosing of LMWH in Patients with VTE and
Malignancy
Agent Dalteparin Enoxaparin Tinzaparin Fondaparinux
Dose 200 units/kg x 1
LMWH: low molecular weight heparin, units: International Units, VTE: venous thromboembolism
71-79
month
150 units/kg daily
thereafter
1 mg/kg q12h x 1
month
1.5 mg/kg once
daily thereafter is
an option
175 units/kg once
daily
5 mg (wt <50 kg)
7.5 mg (wt 50–100
kg)
10 mg (wt >100
kg) once daily
Caveats for Consideration
•
Dalteparin has demonstrated significant reductions in VTE.
•
LMWH trials have showed varying results in bleeding rates and mortality.
•
The trial for enoxaparin in cancer was stopped for enrollment reasons. Several
trials have demonstrated inferior performance of once-daily enoxaparin for
acute VTE treatment, so the dosing regimen above is extrapolated from the
dalteparin trials.
•
Subset analysis of DOACs has demonstrated lower rates of VTE and bleeding
compared to VKA; however, these have been nonsignificant changes.
•
The Hokusai VTE Cancer trial assessing edoxaban and dalteparin showed
non-inferiority in the composite outcome, but the edoxaban group failed to
show a significant reduction in VTE while leading to a significant increase in
bleeding, especially GI bleeding.
80
• LMWH are the recommended agents to treat
VTE in patients with malignancy, as they have
demonstrated reductions in VTE compared to VKA.
• Patients who receive PEG asparaginase may
experience a severe drop in antithrombin. If
they develop a VTE, they may not respond to
an antithrombin dependent anticoagulant until
antithrombin recovers. In such situations, a
DOAC may need to be considered.
• In patients with Trousseau syndrome
(spontaneous or recurrent venous thrombosis),
274 Anticoagulation Therapy
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heparin is the preferred anticoagulant of choice
(not VKA or DOACs) and should be continued
indefinitely because stopping for even 1 day can
result in recurrence of thrombosis.
•
The use of VKAs in patients with malignancy
may have several limitations including drug
interactions with chemotherapeutic medications,
altered absorption and pharmacokinetics,
inability to take secondary to nausea, and need
for increased monitoring in patients with liver
metastasis.
• Practical issues in the long-term use of LMWH
include cost of the medication, ability of the
patient to administer parenteral or subcutaneous
medications, possible need for monitoring of
medication in certain patients, and the patient’s
quality of life.
DOAC agents have not been directly compared
•
to LMWH or to VKA specifically in patients
with malignancy, however, subset analysis of
several DOAC trials have assessed their role in
this patient population. In general, DOACs have
demonstrated similar rates in VTE recurrence
and bleeding compared to VKA; however, many
clinicians feel cancer-specific studies are needed
and that comparisons to long-term LMWH are
needed. In addition, the effects of the DOACs
on the chemotherapy regimen should also be
considered.
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