Posted on March 8th, 2009 by
According to the results of two Phase III clinical trials, the addition of Rituxan® (rituximab) to chemotherapy improves progression-free survival among patients with chronic lymphocytic leukemia (CLL). These results were presented at the 50th Annual Meeting of the American Society of Hematology.
CLL is a disease characterized by high numbers of circulating abnormal lymphocytes (B-cells) in the peripheral blood. The disease often involves enlargement of lymph nodes in various parts of the body as well as enlargement of the spleen. It typically occurs in individuals between 65 and 70 years of age.
CLL is the most common adult leukemia with over 15,000 new cases per year in the United States and more than 4,000 deaths. CLL is not a rapidly growing cancer, but the abnormal cells accumulate in blood, bone marrow, lymph nodes and spleen, resulting in enlargement of these organs and decreased bone marrow and immune function. This disease interferes with the normal production of antibodies and immunoglobulins, so the body cannot properly fight infections.
Rituxan is a targeted therapy that binds to a marker known as CD20 on the surface of B-cells. This binding prompts the immune system to destroy the cell, and may also have direct anticancer effects on the cell.
The effect of Rituxan in combination with chemotherapy for the treatment of CLL was evaluated in two Phase III clinical trials. Both studies compared chemotherapy alone (with fludarabine and cyclophosphamide) to chemotherapy plus Rituxan.
The first study, known as the CLL8 study, assessed 817 previously untreated patients with advanced, CD20-positive CLL. Patients treated with chemotherapy plus Rituxan remained free of cancer progression for a median of 42.8 months, compared with 32.3 months among patients treated with chemotherapy alone. Severe side effects that were more common in the Rituxan group included low white blood cell counts (neutropenia and leukocytopenia).
The second study, known as the REACH study, assessed 552 previously treated patients with relapsed or refractory, CD20-positive CLL. Patients treated with chemotherapy plus Rituxan remained free of cancer progression for a median of 30.6 months, compared with 20.6 months among patients treated with chemotherapy alone.
These studies suggest that the addition of Rituxan to chemotherapy delays cancer progression among patients with CLL.
 Hallek M, Fingerle-Rowson G, Fink A-M et al. Immunochemotherapy with fludarabine (F), cyclophosphamide (C), and rituximab (R) (FCR) versus fludarabine and cyclophosphamide (FC) improves response rates and progression-free survival (PFS) of previously untreated patients (pts) with advanced chronic lymphocytic leukemia (CLL). Presented at the 50th Annual Meeting of the American Society of Hematology. San Francisco, CA, December 6-9, 2008. Abstract 325.
 Robak T, Moiseev SI, Dmoszynska A et al. Rituximab, fludarabine, and cyclophosphamide (R-FC) prolongs progression free survival in relapsed or refractory chronic lymphocytic leukemia (CLL) compared with FC alone: final results from the international randomized Phase III REACH trial. Presented at the 50th Annual Meeting of the American Society of Hematology. San Francisco, CA, December 6-9, 2008. Abstract LBA-1.
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