Thalomid® – Prolongs Survival in Multiple Myeloma

Posted on April 27th, 2009 by

One year of treatment with Thalomid® (thalidomide) and prednisone after a single autologous stem cell transplant prolongs survival in patients with newly diagnosed multiple myeloma, according to the results of a study published in the Journal of Clinical Oncology.[1]

Multiple myeloma is a cancer of the blood that affects the plasma cells, which are an important part of the immune system that produce antibodies to help fight infection and disease. Multiple myeloma is characterized by an excess production of abnormal plasma cells. Symptoms include increased risk of bacterial infections and impaired immune responses.

High-dose therapy followed by autologous stem cell transplant (ASCT) is a standard approach to treating patients with Stage II or III multiple myeloma. High doses of chemotherapy are more effective at killing cancer cells than lower doses. However, high-dose therapy destroys many other cells in the body. A dangerous side effect of administering high-dose therapy is damage to the stem cells in the bone marrow that develop into mature blood cells. Without functioning stem cells in the bone marrow, the body cannot produce red blood cells, white blood cells, or platelets, which leaves patients vulnerable to infection and bleeding and unable to supply adequate oxygen to their tissues. However, bone marrow function can be restored after high-dose therapy by replacing the damaged stem cells with healthy ones. This is a procedure known as a stem cell transplant. A stem cell transplant that utilizes the patient’s own cells is called an autologous stem cell transplant.

Relapse is inevitable in multiple myeloma, so strategies to prolong the duration of response after high-dose therapy and ASCT are important. Thalomid is an oral agent that helps block angiogenesis, an action called anti-angiogenesis. Anti-angiogenesis inhibits blood vessel formation so that cancer growth is limited by lack of blood supply. 

Researchers conducted a study in 269 patients with newly diagnosed multiple myeloma. After undergoing a single ASCT, 129 patients were randomly assigned to receive indefinite prednisone and 114 were assigned to receive one year of Thalomid in addition to indefinite prednisone. After a median follow-up of three years, the overall survival for the Thalomid group was 86% compared with 75% for the control group and the progression-free survival was 42% for the Thalomid group and 23% for the control group. The results are summarized in Table 1.

Table 1: Prednisone Versus Prednisone plus Thalomid in Multiple Myeloma

  Prednisone Prednisone plus Thalomid
Number of patients 129 12
CR plus VGPR 40% 65%
Median time to progression 560 days 931 days
3-year progression-free survival 23% 42%
3-year overall survival 75% 86%
Survival 12 months after progression 79% 77%

CR=complete response, VGPR=very good partial response

The researchers concluded that one year of consolidation therapy with Thalomid and prednisone prolongs survival after ASCT in patients with newly diagnosed multiple myeloma. Although the neurological toxicity was higher in the Thalomid group, there were no differences between the two groups for thromboembolic events.

Reference:


[1] Spencer A, Prince HM, Roberts AW, et al. Consolidation therapy with low-dose thalidomide and prednisolone prolongs the survival of multiple myeloma patients undergoing a single autologous stem-cell transplantation procedure. Journal of Clinical Oncology. 2009; 27: 1788-1793.

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