Short Course of Rituxan®/Chemotherapy Plus Maintenance Rituxan® Provides High Progression-Free Survival as Initial Treatment Diffuse B-Cell NHL Among Patients Ineligible for Standard R-CHOP

According to results presented at the 2006 annual meeting of the American Society for Clinical Oncology (ASCO), a short course of Rituxan® plus chemotherapy followed by Rituxan alone provides high rates of progression-free survival among patients with diffuse B-cell non-Hodgkin’s lymphoma who are not able to tolerate standard therapy.

Non-Hodgkin’s lymphoma (NHL) is a form of cancer that begins in the cells of the lymph system, which includes the spleen, thymus, tonsils, bone marrow, lymph nodes, and circulating immune cells. Lymphocytes are the main cells in the lymph system and exist in two forms: B and T-cells. Each of these cells serves a specific function in helping the body fight infection. B-cell NHL is the most common type of NHL; it involves cancer that originates in B-cells and affects their normal maturation.

In NHL, an excessive amount of atypical (cancerous) lymphocytes accumulates in the lymph system. These lymphocytes can crowd and suppress the formation and function of other immune and blood cells. NHL is categorized by the type of lymphocyte it involves and further defined by the rate at which the cancer grows. The appearance of cells under a microscope indicates the growth rate. High-grade or aggressive NHL is the fastest growing, whereas low-grade or indolent lymphoma develops more slowly. Lymphoma that has returned following therapy is classified as recurrent; refractory lymphoma is cancer that has stopped responding to standard therapies.

Rituxan is a monoclonal antibody that is FDA approved for the treatment of recurrent or refractory, low-grade or follicular B-cell NHL. Rituxan is designed to bind to a specific site on B-cells. This binding action stimulates the immune system to attack the cell to which Rituxan is bound. In addition, Rituxan may possess some direct anticancer activity and actually kill the cell to which it is bound.

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Diffuse large B-cell NHL (DLBCL) is a common type of NHL among elderly patients. Standard treatment for DLBCL consists of the chemotherapy combination known as CHOP plus Rituxan (R-CHOP). Unfortunately, patients with heart complications, the elderly, or those with other existing medical problems are often not candidates for treatment with R-CHOP as they are not able to safely tolerate the standard six to eight courses of therapy.

Researchers affiliated with the Minnie Pearl Cancer Research Network recently conducted a trial to evaluate the use of a short course of Rituxan plus chemotherapy with regimens referred to as CNOP or CVP, followed by further treatment with just Rituxan (maintenance Rituxan). Maintenance therapy is often used in an attempt to kill remaining cancer cells following initial therapy and/or delay the progression of cancer. This trial included 35 patients who were not considered appropriate candidates for R-CHOP. Patients were treated with R-CNOP (Rituxan, cyclophosphamide, mitoxantrone, vincristine, and prednisone), or R-CVP (Rituxan, cyclophosphamide, vincristine and prednisone) for only three cycles, followed by Rituxan given every six months.

• 31% of patients achieved a complete disappearance of detectable cancer (complete response).

• 38% of patients achieved a partial regression of their cancer (partial response).

• Disease stabilization was achieved in 31% of patients.

• No patient experienced disease progression.

• Progression-free survival at both one and two years was 92%.

• Treatment was well tolerated among these patients, with low levels of immune cells being the most common side effect.

The researchers concluded that only three courses of R-CNOP or R-CVP followed by maintenance Rituxan provides impressive progression-free survival at two years for patients with DLBCL who are not able to tolerate standard R-CHOP. Follow-up of these results will further confirm this treatment regimen’s effectiveness in these patients.

Reference: Raefsky E, Greco F, Spigel D, et al. Brief Duration Rituximab/Chemotherapy (CNOP or CVP) Followed by Maintenance Rituximab in Elderly/Poor Performance Status Patients with Diffuse Large B-Cell lymphoma (DLBCL): A Phase II Trial of the Minnie Pearl Cancer Research Network. Proceedings from the 42nd annual meeting of the American Society of Clinical Oncology. June 2006. Atlanta, GA. Abstract #7577.

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