| Addition of thalidomide to standard
chemotherapy improves survival for elderly patients with multiple myeloma The addition of thalidomide to standard chemotherapy with melphalan and prednisone improves survival for elderly patients with multiple myeloma compared with both standard treatment and stem cell transplant, according to a presentation at the annual meeting of the American Society of Clinical Oncology. The multicenter French study of patients age 65 to 75 years randomized 196 patients to standard chemotherapy, 125 to chemotherapy plus thalidomide, and 126 patients to high-dose melphalan followed by autologous stem cell transplant. After a median follow-up of about 37 months, researchers found that patients in the thalidomide group had significantly longer median progression-free survival: 27.6 months versus 17.1 months for standard care patients and 19.4 months for transplant patients. There was also a longer median overall survival time: 53.6 months for thalidomide patients versus 32.2 months for standard care patients and 38.6 months for the transplant group. Side effects were much higher in the thalidomide group?12 percent of patients experienced deep-vein thrombosis compared with 5 percent in the standard therapy group and 6.5 percent in the transplant group. About 30 percent of patients in the thalidomide group experienced peripheral neuropathy (tingling or numbness in the extremities), a side effect that was not observed at all in the other two arms and is commonly associated with thalidomide. “The results of melphalan-prednisone plus thalidomide were so superior that enrollment in the study was stopped so that everyone who was receiving melphalan-prednisone alone could have thalidomide added to their treatment,” said Thierry Facon, MD, Professor of Hematology at the University of Lille, Chairman of the collaborative group Intergroupe Francophone du Myelome, and the study’s lead author. Thalidomide has been used experimentally in the treatment of multiple myeloma since the late 1990s. The current standard first-line treatment for elderly patients (those 65 and older) with multiple myeloma is a combination of the drugs melphalan and prednisone (MP). For younger patients, the standard treatment is an intense dose of melphalan followed by a stem cell transplant. Researchers noted that while other studies have evaluated thalidomide in elderly patients, this study was the first trial to evaluate thalidomide in combination with standard therapy against both standard therapy alone and stem cell transplant. |