© 2005-2012 American Society of Clinical Oncology (ASCO). All rights reserved worldwide.
Adding thalidomide (Thalomid) to the standard treatment of melphalan (Alkeran) and prednisone (MP, a class of drug similar to cortisone) significantly improves survival for newly-diagnosed patients age 65 and older with multiple myeloma, according to a new study. This is the first and only clinical trial to compare MP and thalidomide with either MP alone or a stem cell transplantation.
In this study, patients between the ages of 65 and 75 were assigned to three groups: 196 patients received MP, 125 received MP and thalidomide, and 126 patients received high doses of melphalan followed by autologous (using the patient's own stem cells) stem cell transplants, which is the standard treatment for younger patients.
Follow-up was measured at a median of 37 months. The cancer began to worsen after nearly 28 months for patients receiving MP and thalidomide, compared with 17 months for patients in the MP group and 19 months for patients in the transplant group. Overall survival for the patients receiving MP and thalidomide was 54 months, compared with 32 months for patients in the MP group and 39 months for patients in the transplant group.
"The results of MP plus thalidomide were so superior that enrollment in the study was stopped, and everyone who was receiving MP alone could have thalidomide added to their treatment," said Thierry Facon, MD, Professor of Hematology at the University of Lille, France, Chairman of the collaborative group Intergroupe Francophone du Myélome, and the study's lead author.
Patients receiving thalidomide experienced more side effects. For example, 12% of those patients experienced deep-vein thrombosis (potentially dangerous blood clots), compared with 5% in the standard therapy group and 7% in the transplant group. In addition, 30% of patients receiving thalidomide experienced neuropathy (numbness and tingling in the hands and feet), one of the drug's known side effects.
What This Means For Patients
Adding thalidomide to a standard treatment slows the development of multiple myeloma in older patients and helps them live longer. Thalidomide also causes more side effects. Patients should talk with their doctors to better understand the risks and benefits of thalidomide and ways to help manage side effects.