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As a single agent for B-cell chronic lymphocytic leukemia (B-CLL) - Change Your Thinking: Campath First Line(1)
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Questions to Discuss With Your Doctor

 

Treatment of CLL

One of the first questions that patients with CLL ask is, "Can it be cured?" Currently, there is no cure for CLL, but it can be treated.4 However, in many cases it is not necessary to begin treatment immediately.9 This is because CLL often progresses so slowly that it poses little threat to the patient's well-being when first diagnosed. Physicians refer to this "treatment" strategy as "watchful waiting."3 Treatment is usually initiated when symptoms start to interfere with quality of life.9

Regular blood tests are an important part of this process so that the annual rate of the lymphocyte count can be monitored. If the lymphocyte count more than doubles in a 6-month period, this can indicate the need for anticancer treatment.11 Other signs of disease progression that prompt treatment are anemia, weight loss, enlarged lymph nodes, or presence of B-symptoms.4,9-11

There are a number of different treatments that the doctor can offer. While none of these treatments can cure CLL, they can delay the progress of the disease and improve the patient's quality of life considerably.4

Patients in more advanced stages are treated immediately.4,9 Many doctors are also studying the value of treating patients in less advanced Rai stages.5

The treatments offered are:

Chemotherapy

Chemotherapy means treatment with certain anticancer drugs. It is the standard treatment offered to CLL patients who have symptoms of their disease or are showing signs of progression, such as increasing anemia, painful lymph nodes, or a rapid increase in the lymphocyte count in the blood. Chemotherapy is intended to stop the progression of the disease and decrease any symptoms the patient may be experiencing.4,9-11

Some patients do not respond to their initial treatment or, having initially responded, fall back within 6 months. They are said to be resistant or refractory to this form of chemotherapy and they are offered an alternative treatment.4,9

The commonly used chemotherapy drugs are:

Alkylating agents—drug that interferes with the cell's DNA and inhibits cancer cell growth. Alkylating agents may be given as continuous therapy (tablets/infusions are given every day for an indefinite length of time) or as courses, or pulses, lasting 2 to 4 weeks. Treatment may be given on 1 or more days at the beginning of the pulse followed by a break in treatment for the rest of the cycle. Sometimes these agents are combined with other drugs.4,11

Purine analogs—anticancer drugs that interferes with cancer cell division and causes their death. Purine analogs may produce a higher response rate than alkylating agents when used either in previously untreated patients or those who have failed on other therapies.4,11

Fludara® (fludarabine phosphate) is a purine analog that is marketed by Bayer HealthCare Pharmaceuticals.15 Click to view Fludara Full Prescribing Information, including important safety information.

Corticosteroids—also known as glucocorticoids. They have an important role to play in the treatment of CLL and in patients who have a condition called autoimmune hemolytic anemia or thrombocytopenia. Corticosteroids make the patient feel better and reduce problems such as swollen lymph nodes and spleen. They also may be used in combination with other forms of chemotherapy.11

High doses of corticosteroids for short periods may be used in patients with advanced disease who do not respond to other treatments.

Biological therapy

Biological therapy uses biological preparations rather than synthetic chemicals to treat the disease. One type of biological therapy uses monoclonal antibodies, which are able to bind to specific proteins called CDs (or antigenic markers) on the surface of lymphocytes.4

Monoclonal antibody therapy offers another option for patients. Monoclonal antibodies may be used alone or in combination with chemotherapy.

Campath is a monoclonal antibody that is marketed by Bayer HealthCare Pharmaceuticals. Campath has been approved by the US Food and Drug Administration as a single medication for treating B-cell CLL, also known as B-CLL. It is the first and only monoclonal antibody that has been approved for this purpose. Campath is available only by prescription from your doctor.

Campath targets the CD52 molecule, an antigen that is found on the surface of many cells, including leukemia cells. This allows Campath to turn on the body's immune system to help attack the leukemia.

Click on the following links for more information about Campath, including Important Safety Information and Boxed Warning and full Prescribing Information [PDF].

Combination therapy

Some chemotherapeutic agents may be frequently used in combination. These combinations may often be more effective than their individual components because they attack the cancer cell at more than 1 stage during its division.11,12

Radiotherapy

Radiotherapy may relieve symptoms such as enlarged lymph nodes and/or spleen. Only those areas affected, such as painful lymph nodes, are irradiated.11 This involves bombarding cancerous tissue with high-energy x-rays, usually as a series of treatments of only a few minutes, over several days or weeks.

Surgery

The spleen may be removed when it is massively enlarged and painful, especially if this is the only or main symptom.4,11

Bone marrow transplantation

Bone marrow transplantation is usually carried out in young people with diseases such as acute lymphocytic leukemia for whom other treatments have not worked. Now it is available for some younger CLL patients who have achieved long periods of remission and who have a donor.4,11

Click here for more information on treatment responses.

Indications & Usage

Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).

Important safety information
WARNING: CYTOPENIAS, INFUSION REACTIONS, and INFECTIONS

Cytopenias: Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving Campath. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia.

Infusion Reactions: Campath administration can result in serious, including fatal, infusion reactions. Carefully monitor patients during infusions and withhold Campath for Grade 3 or 4 infusion reactions. Gradually escalate Campath to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days.

Infections: Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving Campath. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections.

In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. The following serious, including fatal, infusion reactions have been identified in post-marketing reports: syncope, pulmonary infiltrates, acute respiratory distress syndrome (ARDS), respiratory arrest, cardiac arrhythmias, myocardial infarction, acute cardiac insufficiency, cardiac arrest, angioedema, and anaphylactoid shock.

Prolonged myelosuppression have been reported in patients receiving Campath. Campath treatment results in severe and prolonged lymphopenia with a concomitant increased incidence of opportunistic infections. Assess CD4+ counts after treatment until recovery to ≥ 200 cells/µL. Obtain complete blood counts (CBC) at weekly intervals during Campath therapy and more frequently if worsening anemia, neutropenia, or thrombocytopenia occurs. Withhold Campath for severe cytopenias (except lymphopenia). Discontinue for autoimmune cytopenias or recurrent/persistent severe cytopenias (except lymphopenia).

Administer only irradiated blood products to avoid transfusion associated Graft versus Host Disease (TAGVHD), unless emergent circumstances dictate immediate transfusion.

Routinely monitor patients for CMV infection during Campath treatment and for at least 2 months following completion of treatment. Withhold Campath for serious infections and during antiviral treatment for CMV infection or confirmed CMV viremia. Initiate therapeutic ganciclovir (or equivalent) for CMV infection or confirmed CMV viremia.

Do not administer live viral vaccines to patients who have recently received Campath.

The most common adverse reactions (≥ 10%) were infusion reactions, cytopenias, cytomegalovirus (CMV) and other infections, nausea, emesis, diarrhea, and insomnia.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For important risk and use information, please see full Prescribing Information (PDF).