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Lifestyle issues for APL patients

As a patient with acute promyelocytic leukemia (APL), there are several lifestyle issues you may encounter — before, during, and after treatment.

Click on the links below for helpful information about the following lifestyle issues:
Physical concerns

Side effects of treatment
As you undergo treatment for APL, you may experience side effects. It is important to talk to your doctor about any symptoms you develop, even if they seem unrelated to APL or your treatment.

Some common side effects of cancer treatment may include: Again, be sure to talk to your doctor about any side effects you experience.

>> Click here for more information from the National Cancer Institute about coping with treatment side effects.

Fatigue
Fatigue is one of the most common symptoms experienced by cancer patients. A study by the Fatigue Coalition found that while the majority of patients experience fatigue, it is one of the most overlooked and undertreated side effects of cancer. Fatigue is complex, and has biological, psychological, and behavioral causes. It may be caused by the disease itself, treatments, medications, pain, nutritional deficits, anxiety and depression. Fatigue is difficult to describe and people with cancer may express it in different ways, such as saying they feel tired, weak, exhausted, weary, worn-out, heavy, or slow. If those words describe how you feel as you undergo treatment for APL, know that you are not alone.

>> Click here for more information from the National Cancer Institute about fatigue during cancer treatment.

Pain
People living with APL may experience pain caused by the cancer itself, or by treatments. Pain may be acute (severe and lasting for a short period of time) or chronic (severe or mild over a long period of time). If pain continues without treatment, it often leads to irritation, depression, and a lack of energy. It is important to know that you do not have to live in pain and your medical team can help control your pain.

>> Click here for more information from the National Cancer Institute about pain during cancer treatment.

Diet and exercise
Good nutrition is always vital for your body. This is especially true during cancer treatment. It is important to remember, however, that according to the National Cancer Institute, there is no evidence that any specific type of diet or food alone can either cure cancer or keep it from coming back. A good approach is to eat a variety of healthful foods every day. Ask your doctor, nurse, or registered dietician before changing your diet or taking any vitamin or mineral supplements. Your healthcare team can help you create an eating plan that is best for you.

>> Click here for more information from the National Cancer Institute about nutrition before, during, and after treatment.

Emotional concerns
Many patients confronting cancer ponder what is really important in life, relationships, spirituality and future direction. It is common to feel anxiety, depression, or fear as you face APL. Again, as with the experience of physical symptoms and side effects, you are not alone.

Coping with anxiety and depression
First of all, it is important to know that anxiety and depression are normal reactions to cancer. Being diagnosed with APL and undergoing treatment can be challenging both physically and emotionally.

Anxiety: You may experience anxiety while undergoing a cancer screening test, waiting for test results, receiving a diagnosis, undergoing treatment, or anticipating a relapse. Anxiety associated with cancer may increase feelings of pain, interfere with one's ability to sleep, cause nausea and vomiting, and interfere with quality of life. Most patients are able to reduce their anxiety by learning more about their cancer and the treatment they can expect to receive. On this site, for example, you can learn about APL, its causes, the signs and symptoms, diagnosis and testing procedures, treatments, and lifestyle issues.

>> Click here for more information from the National Cancer Institute about coping with anxiety.

Depression: Depression, like anxiety, can also interfere with your quality of life. Important issues in the life of any person with cancer that may trigger depression include: fear of death, interruption of life plans, changes in body image and self-esteem, changes in social role and lifestyle, and money and legal concerns. Signs of depression may include sleeping more or less than usual, lack of energy, crying or tearfulness, and an inability to concentrate. Help is available to you if you are experiencing symptoms of depression. You may wish to discuss how you’re feeling with your medical team.

>> Click here for more information from the National Cancer Institute about coping with depression.

Relationship issues
Your relationships with friends, family, and significant others may change as a result of your diagnosis. Some relationships may become strained as a result of your diagnosis, while others may become stronger. You might also find some of your own interests and desires changing as a result of your diagnosis and/or treatment, which can have an effect on your relationships. Furthermore, some patients would prefer not to talk about their diagnosis and/or treatment(s), while others relish the opportunity to have someone to talk to about their unique experience. Keeping the lines of communication open with those in your life can be beneficial to everyone involved. There are a variety of ways to let your loved ones know how you would prefer to handle your diagnosis and treatment, whether that is talking to them in person, over the phone, or even writing a letter or e-mail to them.

>> Click here for more information about dealing with changing family roles as you confront your APL.

>> Click here for helpful suggestions for sharing your feelings about cancer with your loved ones.

Financial concerns
Many APL patients face financial hardships as a result of their diagnosis and treatments. There are many resources available that can potentially assist you in meeting your financial needs at any point following diagnosis. These resources include: health insurance, government programs, disability benefits, services furnished by voluntary organizations, and living benefits from life insurance policies. If you have no medical insurance, other options are also available for you.

>> Click here for comprehensive information from the American Cancer Society about insurance and financial assistance.

Reimbursement assistance
Reimbursement assistance and support is available through a program called CORE (Cephalon Oncology Reimbursement Expertise). CORE information resources can be accessed online or with personalized support via a toll-free hotline. Both CORE resources are designed to help clarify the issues and facilitate the processes involved when submitting reimbursement claims for Cephalon Oncology products like TRISENOX® (arsenic trioxide) injection, a treatment option for APL patients whose cancer returns or does not respond to initial therapy.

CORE Hotline: Phone: 1-888-587-3263
Fax: 1-866-676-4073

>> Click here to visit the CORE website at www.CephalonOncologyCORE.com.


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.

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