In a Phase II clinical trial published in the Journal of Clinical Oncology, researchers report that the combination of two antibody therapies, epratuzumab and Rituxan® (rituximab), offers promise for the treatment of non-Hodgkin’s lymphoma and should be further evaluated.

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 aiding the body fight infection. 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 the cells under a microscope indicates the growth rate. High-grade or aggressive NHL is the fastest growing, whereas low-grade or indolent lymphoma develops slowest. Lymphoma that has returned following therapy is classified as recurrent; refractory lymphoma is cancer that has stopped responding to standard therapies.

Newer treatments for NHL include targeted therapies such as Rituxan. These therapies are designed to target cancer cells specifically while causing minimal damage to normal, healthy cells. Rituxan is a monoclonal antibody that binds to B-cells in the body. The binding action is thought to stimulate the immune system to kill the cells to which Rituxan is bound, as well as to provide some direct killing effects itself. Epratuzumab, another monoclonal antibody being evaluated for treatment of NHL, also binds to B-cells. Since Rituxan and epratuzumab bind to different locations on B-cells, it’s possible that the combination of the two antibodies might be more effective than either alone. In a Phase II clinical trial, researchers in Italy evaluated the effect of treatment with epratuzumab and Rituxan on recurrent or refractory NHL.

The study evaluated 23 patients with recurrent or refractory B-cell lymphoma. Fifteen patients had indolent NHL and six had aggressive NHL. Patients were treated with epratuzumab and Rituxan over the course of four weeks. Results between indolent and aggressive forms of the disease were similar: 60% of patients with indolent NHL experienced a complete disappearance of detectable cancer after treatment, as did 50% of patients with aggressive NHL. The most common side effects of treatment were fever, shivering, and fatigue.

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The researchers concluded that combination antibody therapy with epratuzumab and Rituxan was well tolerated by patients and resulted in the disappearance or reduction of detectable cancer in a number of NHL patients. They recommend clinical trials comparing combination therapy to treatment with a single antibody therapy. Patients with recurrent or refractory NHL may wish to speak with their physician regarding their individual risks and benefits of participation in a clinical trial further evaluating antibody therapies or other promising therapeutic approaches. Two sources of information regarding ongoing clinical trials include the National Cancer Institute (www.cancer.gov) and www.cancerconsultants.com.

Reference: Leonard JP, Coleman M et al. Combination antibody therapy with epratuzumab and rituximab in relapsed or refractory non-Hodgkin’s lymphoma. Journal of Clinical Oncology. 2005;23:5044-5051.

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