Updated Results: Velcade® Improves Survival Over Dexamethasone in Recurrent M.M.

Updated Results: Velcade® Improves Survival Over Dexamethasone in Recurrent Multiple Myeloma

According to updated results recently presented at the 2005 annual meeting of the American Society of Hematology (ASH), single-agent Velcade® (bortezomib) improves survival over dexamethasone by approximately 6 months in recurrent multiple myeloma.

Multiple myeloma is a cancer involving important immune (infection-fighting) cells called plasma cells. It is the second most common hematologic (blood) cancer in the U.S., where an estimated 50,000 individuals are currently living with multiple myeloma.

Plasma cells aid the body in fighting infection by producing specialized proteins called antibodies that target and kill foreign cells. In multiple myeloma, cancerous plasma cells produce abnormal and excessive antibodies that do not have the ability to properly fight infection. In addition, the cancerous plasma cells accumulate in the bone marrow, which suppresses the formation and function of other cells necessary for normal production of blood cells and immune functions. This excessive accumulation of cancer cells in the bone marrow ultimately leads to the formation of tumors in the bone and to the breakdown of bone.

If multiple myeloma returns following therapy, it is referred to as recurrent. Effective and easily tolerated treatment options are limited for patients with recurrent multiple myeloma.

Velcade is an agent approved for patients with multiple myeloma whose disease has progressed following one or more previous therapies. Velcade offers a new avenue for treatment: As a proteosome inhibitor, it interferes with the growth and survival of cancer cells responsible for recurrent multiple myeloma.

Proteosomes are proteins found in virtually all cells that are responsible for the breakdown and reuse of a cells other proteins. Proteosomes regulate several aspects of cellular activity, including survival.

Velcade has demonstrated an inhibitory effect on cellular survival through its effects on proteosomes. The drug also makes cancer cells more vulnerable to the killing effects of chemotherapy in refractory myeloma cells.

Evaluation of Velcade continues in the treatment of different stages of multiple myeloma, as well as in the treatment of other types of cancer.

Researchers affiliated with the Assessment of Proteosome Inhibition for Extending Remissions (APEX) Investigators conducted a large clinical trial directly comparing Velcade to high-dose dexamethasone (a steroid regimen that is routinely used in the treatment of multiple myeloma) in the treatment of recurrent multiple myeloma. This trial included 669 patients who had received one to three previous treatment regimens for their disease. Patients were then treated either with Velcade or high-dose dexamethasone.

Overall, treatment with Velcade improved anticancer responses, progression-free survival, and overall survival significantly more than high-dose dexamethasone. Results were published in the New England Journal of Medicine in June 2005, and the following updated results were presented at the 2005 ASH meeting:

  • The median overall survival was improved by 6 months for patients treated with Velcade (30 months), compared to those treated with dexamethasone (24 months).
  • At one year, 80% of patients treated with Velcade were still alive, compared with only 67% of patients treated with dexamethasone.
  • 62% of patients who were initially treated with dexamethasone crossed over for treatment with Velcade after their disease progressed while on dexamethasone; among these patients, outcomes remained significantly improved compared to those who stayed on dexamethasone.

The researchers concluded that Velcade improves survival over dexamethasone; this improvement remains superior even after long follow-up. Patients with recurrent multiple myeloma may wish to speak with their physician regarding their individual risks and benefits of treatment with Velcade.

Reference: Richardson P, Sonneveld P, Schuster M, et al. Bortezomib Continues to Demonstrate Superior Efficacy Compared with High-Dose Dexamethasone in Relapsed Multiple Myeloma: Updated Results of the APEX Trial. Proceedings from the 2005 annual meeting of the American Society of Hematology. December 2005. Abstract #2547.

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