European researchers have found that patients with multiple myeloma (stages II or III) may have an advantage surviving, when thalidomide (Thalomid) is added to the standard therapy treatment. Two research studies seem to confirm these findings.
One of them led by Thierry Facon, M.D., of Hôpital Claude Huriez at the Centre Hospitalier Universitaire, and colleagues, was published in the Oct. 6 issue of The Lancet.
Multiple myeloma is a type of cancer of plasma cells. Plasma cells are the immune system cells in bone marrow that produce antibodies. Myeloma has many possible symptoms.
According to the International Myeloma Working Group common symptoms of MM are calcium elevated, renal failure, anemia, and bone lesions. Bone pain is a common issue with Multiple Myeloma cancer.
According to Facon’s study, when compared to standard treatment (melphalan (Alkeran) and prednisone) the addition of thalidomide (Thalomid) increased survival rate to 51.5 months. This is about 18 months longer and 13.3 months longer than a melphalan-based stem cell infusion standard therapy.
A second study, led by Antonio Palumbo, M.D., and Mario Boccadoro, M.D., both of the Università di Torino in Italy (published in the Lancet, too), agreed with Facon’s findings
Facon study was a large clinical trial involving 447 participants with newly diagnosed multiple myeloma patients. Participants were 65 to 75 years old.
Patients were assigned (randomly) to 12-week treatment groups. One group received a standard treatment of 0.25 mg/kg of melphalan and 2 mg/kg of prednisone. A second group received thalidomide daily at 400 mg per day continuously during the 12 cycles in addition to the standard treatment. A third group received autologous stem cell transplantation with two 100 mg/m² doses of melphalan.
Data analysis revealed that after 51.5 months of follow-up survival rates were better for the group who received thalidomide than the group that received melphalan and prednisone alone (51.6 versus 33.2 months) or stem cell transplantation with melphalan (51.6 versus 38.3 months). These results were statistically significant.
In regard to adverse effects of thalidomide researchers found:
* The drug thalidomide exhibited a higher degree of toxicity than the standard treatment and that of the stem cell transplantation
* The tahlidomide group had more Neutropenia than expected. However, vevere infections were not common with thalidomide
* Thromboembolism was significantly higher within the thalidomide group when compared to the standard treatment group and similar to that with stem cell treatment
* Peripheral neuropathy and constipation were “a concern” with thalidomide
Both Facon and Palumbo’s studies refer to the use of thalidomide for multiple myeloma as “a new standard of care” for multiple myeloma, However, Drs. Palumbo and Boccadoro caution, “the optimum dose of thalidomide, the number of cycles, and the need for maintenance therapy still need to be investigated.”
Facon T, et al “Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): A randomized trial” Lancet 2007; 370:1209-18. URL: http://www.thelancet.com/journals/lancet/article/PIIS0140673607615372/abstract
Palumbo A, Boccadoro M “A new standard of care for elderly patients with myeloma” Lancet 2007; 370:1191-2. (available by subscription only).
International Myeloma Working Group. Criteria for the classification of monoclonal gammopathies, multiple myeloma and related disorders: a report of the International Myeloma Working Group. Br J Haematol 2003;121:749-57