Metastatic Melanoma Patients Undergoing Treatment with Dacarbazine and Interferon May Benefit from the Addition of Thymosin α 1

Posted on April 16th, 2010 by

The addition of thymosin Metastatic Melanoma Patients Undergoing Treatment with Dacarbazine and Interferon May Benefit from the Addition of Thymosin α 1 (Tα1) to dacarbazine and interferon improved overall survival and progression-free survival compared with dacarbazine and interferon alone in patients with metastatic melanoma. These results were recently published in the Journal of Clinical Oncology.[1]

The administration of chemotherapy combined with immunotherapy appears to be the most promising currently available therapy for metastatic melanoma. Interferon-alpha and thymosin α 1 are both synthetically produced agents that simulate naturally occurring substances produced by the body that stimulate the immune system. Interferon-alpha has been shown to produce anticancer effects in the treatment of melanoma. Thymosin α 1 has been studied extensively in the treatment of hepatitis, AIDS, and cancer. Thymosin is produced by the thymus gland and stimulates the initiation of a cascade of immune events including the maturation of T-cells (immune cells involved in the direct attack of foreign cells). Dacarbazine is the standard chemotherapy agent for the treatment of metastatic melanoma, with an overall response rate of approximately 10-15%.

In this large European study, researchers evaluated 488 melanoma patients with Stage IV, unresectable disease. Patients were randomly selected to one of the following treatment arms:

  • Thymosin α 1 (1.6 mg), dacarbazine, interferon
  • Thymosin α 1 (3.2 mg), dacarbazine, interferon
  • Thymosin α 1 (6.4 mg), dacarbazine, interferon
  • Thymosin α 1 (3.2 mg) and dacarbazine
  • Dacarbazine and interferon (control group)

The addition of thymosin α 1 was well tolerated with no additional side effects reported. For patients receiving treatment that included thymosin a 1, median overall survival was 9.4 months versus 6.6 months in the control arm. One-year survival ranged from 37.1% to 45.5% in patients treated with a regimen that included thymosin α 1 versus 34.2% in the control group. A recent review of 42 Phase II trials reported a 25.5% one-year survival rate for Stage IV melanoma patients.

The researchers concluded that thymosin α1 is well tolerated and active in advanced melanoma. Further studies are warranted.

Reference:


[1] Maio M, Mackiewicz A, Testori A, et al. Large Randomized Study of Thymosin a 1, Interferon Alfa, or Both in Combination With Dacarbazine in Patients With Metastatic Melanoma. Journal of Clinical Oncology. 2010;28: 1780-1787.

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