Frequently asked questions about APL
As a patient living with acute promyelocytic leukemia (APL), you may have questions
about your condition. Here, you can find the answers to some common questions about
APL. Knowledge is power. The more you know about APL, the more empowered you will
be in your fight against it.
- What is leukemia?
- Is there more than one type of leukemia?
- What is APL?
- What are the symptoms of APL?
- How is APL diagnosed?
- How is APL initially treated?
Answers to Frequently Asked Questions about APL:
- Leukemia is cancer that forms in the blood and bone marrow
- Leukemia occurs when the body produces too many immature blood cells that cannot
carry out their normal functions and that block the production of normal mature
blood cells
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There are four main types of leukemia:
- Chronic lymphoid leukemia (CLL)
- Acute lymphoid leukemia (ALL)
- Chronic myelogenous leukemia (CML)
- Acute myelogenous leukemia (AML)
Chronic leukemias typically progress more slowly than acute leukemias.
Doctors may also perform tests to classify leukemias into smaller groups, or subtypes,
to devise a unique treatment plan that will work best for a particular leukemia.
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- Acute promyelocytic leukemia (APL) is a subtype of acute myelogenous leukemia (AML)
- It occurs when the body produces too many immature blood cells known as promyelocytes,
which cannot carry out their normal functions and which block the production of
normal mature blood cells
- APL is diagnosed in about 1,500 patients each year, up to 30% of whom relapse after
initial therapy
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The symptoms of APL include:
- Feeling tired or short of breath
- Pale complexion from anemia
- Mild fever or swollen gums
- Slow healing of cuts or frequent minor infections
- Discomfort in bones or joints
- Bruising easily and bleeding
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- A doctor examines blood cells with a test called a complete blood count
- If the results are abnormal, the doctor or nurse may talk to you about a bone marrow
biopsy
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For most patients, the initial course of treatment for APL is a form of vitamin
A called all-
trans retinoic acid (ATRA) combined with chemotherapy.
- Up to 90% of patients typically respond to ATRA-based chemotherapy
- Up to 30% of patients who respond to ATRA-based chemotherapy still may experience
a relapse
For these patients who do not respond or experience a relapse, there is another
option. TRISENOX
® (arsenic trioxide) injection is an anticancer drug
proven effective in patients with relapsed or refractory APL.
>> Click here to learn more about TRISENOX including related saftey information and full BOXED WARNING
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TRISENOX is indicated for induction of remission and consolidation in patients with APL who
are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose
APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
Serious adverse events, grade 3 or 4, were common. Those events attributable to TRISENOX in the Phase 2
study of 40 patients with refractory or relapsed APL included APL differentiation syndrome (n=3), hyperleukocytosis (n=3), QTc
interval prolongation (n=16), atrial dysrhythmias (n=2), hyperglycemia (n=2), and torsades de pointes (n=1).
In addition to QT interval prolongation, the most common drug-related side effects included leukocytosis, gastrointestinal events (nausea, vomiting, diarrhea, and abdominal pain), fatigue, swelling, hyperglycemia (an abnormal increased content of sugar in the blood), shortness of breath, cough, rash or itching, headache, and dizziness. Have your doctor review side effects with you.
In clinical trials, most patients taking TRISENOX experienced some drug-related toxicity, most commonly leukocytosis, gastrointestinal (nausea, vomiting, diarrhea, and abdominal pain), fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching, headache, and dizziness. These adverse effects have not been observed to be permanent or irreversible, nor do they usually require interruption of therapy.
It is important to call your doctor if you experience any treatment side effects.
WARNING
Experienced Physician and Institution:
TRISENOX® (arsenic trioxide) injection should be administered under the supervision
of a physician who is experienced in the management of patients with acute leukemia.
APL Differentiation Syndrome:
Some patients with APL treated with TRISENOX have experienced symptoms similar to a syndrome called
the retinoic-acid-acute promyelocytic leukemia (RA-APL) or APL differentiation syndrome, characterized
by fever, dyspnea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or
without leukocytosis. This syndrome can be fatal. The management of the syndrome has not been fully
studied, but high-dose steroids have been used at the first suspicion of the APL differentiation
syndrome and appear to mitigate signs and symptoms. At the first signs that could suggest the syndrome
(unexplained fever, dyspnea and/or weight gain, abnormal chest auscultatory findings or radiographic
abnormalities), high-dose steroids (dexamethasone 10 mg intravenously BID) should be immediately
initiated, irrespective of the leukocyte count, and continued for at least 3 days or longer until
signs and symptoms have abated. The majority of patients do not require termination of TRISENOX therapy
during treatment of the APL differentiation syndrome.
ECG Abnormalities:
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can
lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal. The risk of torsade de pointes
is related to the extent of QT prolongation, concomitant administration of QT prolonging drugs, a history of
torsade de pointes, pre-existing QT interval prolongation, congestive heart failure, administration of
potassium-wasting diuretics, or other conditions that result in hypokalemia or hypomagnesemia. One patient
(also receiving amphotericin B) had torsade de pointes during induction therapy for relapsed APL with arsenic
trioxide.
ECG and Electrolyte Monitoring Recommendations:
Prior to initiating therapy with TRISENOX, a 12-lead ECG should be performed and serum electrolytes (potassium,
calcium, and magnesium) and creatinine should be assessed; pre-existing electrolyte abnormalities should be
corrected and, if possible, drugs that are known to prolong the QT interval should be discontinued. For QTc
greater than 500 msec, corrective measures should be completed and the QTc reassessed with serial ECGs prior
to considering using TRISENOX. During therapy with TRISENOX, potassium concentrations should be kept above 4 mEq/L
and magnesium concentrations should be kept above 1.8 mg/dL. Patients who reach an absolute QT interval value > 500
msec should be reassessed and immediate action should be taken to correct concomitant risk factors, if any, while
the risk/benefit of continuing versus suspending TRISENOX therapy should be considered. If syncope, rapid or irregular
heartbeat develops, the patient should be hospitalized for monitoring, serum electrolytes should be assessed, TRISENOX
therapy should be temporarily discontinued until the QTc interval regresses to below 460 msec, electrolyte abnormalities
are corrected, and the syncope and irregular heartbeat cease. There are no data on the effect of TRISENOX on the QTc
interval during the infusion.