According to results from an interim analysis of a recent clinical trial, the addition of Rituxan® to chemotherapy proves superior to chemotherapy alone in patients under the age of 60 years with aggressive non-Hodgkin’s lymphoma. The results from this interim analysis resulted in halting of the trial two years prior to its intended finish date.

Non-Hodgkin’s lymphoma (NHL) is a form of cancer that begins in the cells of the lymph system. The lymph system includes the spleen, thymus, tonsils, bone marrow, lymph nodes and circulating immune cells. The main cells in the lymph system are lymphocytes, of which there are two types: B and T-cells. Each of these cells has a very specific function in aiding the body to fight infection. NHL is characterized by the excessive accumulation of atypical (cancerous) lymphocytes. These lymphocytes can crowd the lymph system and suppress the formation and function of other immune and blood cells. While NHL is categorized by the type of lymphocyte it involves, it is also further defined by the rate at which the cancer grows, based on the appearance of the cells under a microscope. High-grade or aggressive NHL is the fastest growing and low-grade or indolent lymphoma is the slowest growing.

Rituxan® (rituximab) is a type of biologic therapy that is approved for the treatment of low-grade B-cell NHL that has recurred following previous therapy. Rituxan® is a monoclonal antibody, which is a protein that is made through laboratory processes to target and bind to specific components of specific cells. Rituxan® is targeted against the CD20 antigen, which is found on B-cells, the most common type of cancerous cell in NHL. When Rituxan® binds to the B-cell, it stimulates the immune system to mount an attack against the cell. Rituxan® is typically well tolerated and researchers continue to evaluate Rituxan® in various types of NHL in combination with several types of therapy.

A recent international clinical trial was conducted to evaluate Rituxan® as treatment in aggressive NHL in patients under the age of 60. This trial included patients who had not received prior therapy; half of the patients were treated with Rituxan® plus chemotherapy, and the other half were treated with chemotherapy alone. At the time of a pre-planned analysis, the duration of time before patients stopped responding to treatment was significantly longer in those treated with Rituxan® and chemotherapy, compared to those treated with chemotherapy alone. Although results have not yet been released, the trial was halted due to the significant difference in outcomes between the two groups of patients.

Patients who are younger than 60 years of age and diagnosed with aggressive non-Hodgkin’s lymphoma may wish to speak with their physician about the risks and benefits of adding Rituxan® to their treatment regimen.

Reference: Roche. Study of MabThera in aggressive non-Hodgkin's lymphoma in patients less than 60 years old halted two years early due to significant efficacy benefits. Available at: http://www.roche.com/med-corp-detail-2003?id=1096&media-language=e. Accessed December 2003.

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