Addition of Rituxan to Fludara May Improve Survival in Chronic Lymphocytic Leukemia
According to results recently presented at the 45th annual meeting of the American Society of Hematology (ASH), the addition of Rituxan® to Fludara® may improve survival as initial therapy for chronic lymphocytic leukemia (CLL). However, this was not a clinical trial directly comparing regimens, and further research is necessary to compare sequential therapy with Rituxan and Fludara to the combination of Rituxan and Fludara in order to establish clinical effectiveness of this combination as initial treatment of CLL.
CLL is a cancer involving the lymph (immune) system, which includes lymph nodes, blood and blood vessels found throughout the body, as well as the spleen, thymus and tonsils. This cancer is found in high quantities throughout circulating blood and in bone marrow (spongy material inside large bones that produces blood forming cells). CLL is characterized by the production of atypical lymphocytes. Lymphocytes are specialized immune cells, of which there are two types: B and T-cells.
These cells are produced in the bone marrow and each has a very specific function in aiding the body to fight infection. The large majority of CLL cases involve mature B-lymphocytes that tend to live much longer than normal, accumulating in the blood, bone marrow, lymph nodes and spleen. This results in overcrowding of these areas, suppressing the formation and function of blood and immune cells that are normally present. Additionally, the cancerous lymphocytes themselves do not function normally, leading to a further decrease in the ability of the body to fight infection. CLL is considered a slow-growing or low-grade cancer. Treatment for CLL may include chemotherapy, radiation therapy, biological therapy and/or stem cell transplantation.
The chemotherapy agent Fludara used alone is a standard treatment option for CLL, and results have indicated that Rituxan has anti-cancer activity in the treatment of CLL. In addition, research has demonstrated that the combination of Fludara and Rituxan is active in the treatment of CLL.
Rituxan is a monoclonal antibody that is produced through laboratory processes to bind to a portion (CD20) of B-cells, the most common cancerous type of cells in CLL. The binding action stimulates the immune system to attack the cell to which Rituxan is bound. Rituxan is approved by the U.S. Food and Drug Administration for the treatment of relapsed or refractory low-grade or follicular, CD20+, B-cell non-Hodgkin lymphoma. Researchers have been evaluating Rituxan alone and in combination with other therapies for the treatment of CLL.
Recently, researchers associated with the Cancer and Leukemia Group B (CALGB) analyzed data from two different studies. One study included 104 patients who were treated with the combination of Fludara and Rituxan for the treatment of CLL, and the second study included 179 patients who were treated with Fludara alone. Patients in the two trials had similar disease characteristics, and eligibility criteria for the two trials were virtually identical.
Two years following therapy, patients in the trial involving treatment with Rituxan plus Fludara had progression-free and overall survival rates of 67 percent and 93 percent, respectively. Patients in the trial involving treatment with Fludara alone had progression-free and overall survival rates of 45 percent and 81 percent, respectively, at two years following therapy. Researchers could not find any clinical variables besides treatment regimens that may have altered treatment outcomes between the two groups of patients.
The researchers concluded that the addition of Rituxan to Fludara appears to improve survival when used as initial therapy for CLL. However, further trials are necessary to compare the combination of Fludara plus Rituxan as initial therapy to sequential administration of Fludara and Rituxan (meaning a patient is treated with one agent after a recurrence following the initial agent) to truly determine the clinical benefit of Fludara plus Rituxan.
Patients with CLL may wish to discuss the risks and benefits of treatment with Fludara and Rituxan or the participation in a clinical trial evaluating different scheduling of Fludara/Rituxan or other promising therapeutic approaches.
CLL is a cancer involving the lymph (immune) system, which includes lymph nodes, blood and blood vessels found throughout the body, as well as the spleen, thymus and tonsils. This cancer is found in high quantities throughout circulating blood and in bone marrow (spongy material inside large bones that produces blood forming cells). CLL is characterized by the production of atypical lymphocytes. Lymphocytes are specialized immune cells, of which there are two types: B and T-cells.
These cells are produced in the bone marrow and each has a very specific function in aiding the body to fight infection. The large majority of CLL cases involve mature B-lymphocytes that tend to live much longer than normal, accumulating in the blood, bone marrow, lymph nodes and spleen. This results in overcrowding of these areas, suppressing the formation and function of blood and immune cells that are normally present. Additionally, the cancerous lymphocytes themselves do not function normally, leading to a further decrease in the ability of the body to fight infection. CLL is considered a slow-growing or low-grade cancer. Treatment for CLL may include chemotherapy, radiation therapy, biological therapy and/or stem cell transplantation.
The chemotherapy agent Fludara used alone is a standard treatment option for CLL, and results have indicated that Rituxan has anti-cancer activity in the treatment of CLL. In addition, research has demonstrated that the combination of Fludara and Rituxan is active in the treatment of CLL.
Rituxan is a monoclonal antibody that is produced through laboratory processes to bind to a portion (CD20) of B-cells, the most common cancerous type of cells in CLL. The binding action stimulates the immune system to attack the cell to which Rituxan is bound. Rituxan is approved by the U.S. Food and Drug Administration for the treatment of relapsed or refractory low-grade or follicular, CD20+, B-cell non-Hodgkin lymphoma. Researchers have been evaluating Rituxan alone and in combination with other therapies for the treatment of CLL.
Recently, researchers associated with the Cancer and Leukemia Group B (CALGB) analyzed data from two different studies. One study included 104 patients who were treated with the combination of Fludara and Rituxan for the treatment of CLL, and the second study included 179 patients who were treated with Fludara alone. Patients in the two trials had similar disease characteristics, and eligibility criteria for the two trials were virtually identical.
Two years following therapy, patients in the trial involving treatment with Rituxan plus Fludara had progression-free and overall survival rates of 67 percent and 93 percent, respectively. Patients in the trial involving treatment with Fludara alone had progression-free and overall survival rates of 45 percent and 81 percent, respectively, at two years following therapy. Researchers could not find any clinical variables besides treatment regimens that may have altered treatment outcomes between the two groups of patients.
The researchers concluded that the addition of Rituxan to Fludara appears to improve survival when used as initial therapy for CLL. However, further trials are necessary to compare the combination of Fludara plus Rituxan as initial therapy to sequential administration of Fludara and Rituxan (meaning a patient is treated with one agent after a recurrence following the initial agent) to truly determine the clinical benefit of Fludara plus Rituxan.
Patients with CLL may wish to discuss the risks and benefits of treatment with Fludara and Rituxan or the participation in a clinical trial evaluating different scheduling of Fludara/Rituxan or other promising therapeutic approaches.
posted by TM at 8:34 AM
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