According to results presented at the 2002 annual meeting of the American Society of Hematology, Velcade™ (bortezomide, PS-341) appears to be an effective treatment for patients with recurrent, low-grade non-Hodgkin’s lymphoma.

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. Once NHL recurs following initial therapy or stops responding to standard therapies, patients are left with limited options.

Velcade™ is classified as a proteosome inhibitor and has been granted “fast-track” status with the United States Food and Drug Administration (FDA). It is currently in its last phases of clinical trials for treatment of multiple myeloma prior to the FDA approval process. Proteosomes are proteins existent in virtually every cell that are responsible for the breakdown and re-use of other proteins in a cell. In addition, Velcade™ has demonstrated an effect on several proteins that regulate cellular growth and replication by either inhibiting or facilitating progression of numerous biological pathways.

Researchers from Memorial Sloan-Kettering Cancer Center and the National Cancer Institute recently conducted a clinical trial evaluating Velcade™ in the treatment of recurrent low-grade NHL. This trial involved 13 patients who had stopped responding to previous therapies and had either follicular lymphoma, mantle-cell lymphoma or chronic lymphocytic leukemia. Five patients achieved an anti-cancer response following treatment with Velcade™ and an additional 4 patients achieved a stabilization of their disease. Side effects were reported as modest, with low white blood cell levels and low platelet levels being the most common.

These researchers concluded that Velcade™ may present an effective and well tolerated treatment option for patients with low-grade NHL that has recurred or stopped responding to standard therapies. However, this trial was small and follow-up was only approximately 11 months, so further clinical trials are warranted to truly determine the clinical efficacy of Velcade™ for treatment of NHL. Patients with low-grade NHL that has recurred or stopped responding to standard therapies may wish to speak with their physician about the risks and benefits of participating in a clinical trial further evaluating Velcade™ or other promising therapeutic approaches. Two sources of information regarding ongoing clinical trials include the National Cancer Institute (cancer.gov) and www.eCancerTrials.com eCancerTrials.com also provides personalized clinical trial searches on behalf of patients.

Reference: O’Connor O, Moskowitz C, Wright J, et al. Phase II clinical experience with the proteasome inhibitor PS-341 in patients with indolent lymphomas. Proceedings of the 2002 Meeting of the American Society of Hematology.

Blood. 2002;100:774a, abstract number 3063.

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