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According to results recently published in the Journal of Clinical Oncology, the chemotherapy treatment combination consisting of the agents Fludara (fludarabine) and Cytoxan (cyclophosphamide) plus the targeted agent Rituxan (rituximab) provides promising anticancer responses in patients with chronic lymphocytic leukemia (CLL) that has stopped responding to standard therapies.

CLL is a cancer involving the lymph (immune) system, which includes lymph nodes, blood and blood vessels found throughout the body, the spleen, thymus and tonsils. High quantities of this cancer are present 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 that exist in two forms: B and T-cells. These cells are produced in the bone marrow and each serves a specific function in fighting 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 and suppression of the formation and function of blood and immune cells. 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. Treatment options are limited for patients who have received several prior therapies or have stopped responding to standard therapies (refractory).

The chemotherapy agents Fludara and Cytoxan can be used alone as standard treatment for CLL. Results have also indicated 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 FDA approved for the treatment of relapsed or refractory low-grade or follicular, CD20+, B-cell non-Hodgkin’s lymphoma. Researchers have been evaluating Rituxan alone and in combination with other therapies for the treatment of CLL.

Researchers from the MD Anderson Cancer Center recently conducted a clinical trial to evaluate the treatment combination consisting of Fludara, Cytoxan and Rituxan in 177 patients with recurrent or refractory CLL. Patients had received an average of two prior therapies. Eighty-one percent of patients had received prior treatment with Fludara, and twelve percent had received prior treatment with Rituxan. Following treatment with Fludara/Cytoxan/Rituxan, anti-cancer responses were high-73 percent of patients had a partial response and 25 percent achieved a complete disappearance of detectable cancer (complete response). The average time to cancer progression was 28 months. The average survival time for patients who achieved an anti-cancer response following treatment has not yet been reached.

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The researchers concluded that the treatment combination consisting of Fludara, Cytoxan and Rituxan provides high anti-cancer activity in patients with recurrent or refractory CLL. Patients with recurrent or refractory CLL may wish to speak with their physician regarding their individual risks and benefits of treatment with this particular regimen.

Reference: Wierda W, O’Brien S, Wen S, et al.Chemoimmunotherapy with Fludarabine, Cyclophosphamide, and Rituximab for Relapsed and Refractory Chronic Lymphocytic Leukemia. Journal of Clinical Oncology2005;23:4070-4078.

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