Thalidomide: new indication. For elderly myeloma patients: some improvement in first-line treatment
Prescrire International 18(100): 49-52
2009
ISSN/ISBN: 1167-7422 PMID: 19585712 Document Number: 637703
(1) First-line treatment with the melphalan-prednisone combination increases median overall survival time by at least 3 years in half of myeloma patients over 65 years of age; (2) Thalidomide, an immunodepressant, is now approved in the European Union as an adjunct to this treatment in elderly myeloma patients; (3) Clinical evaluation is based on 5 trials. One unblinded controlled trial included 447 patients. The addition of thalidomide to the melphalan-prednisone combination increased survival time by at least 1.5 years in half of the patients (median survival time: 51.6 months versus 33.2 months). Another trial in 255 patients that was published in detail showed an increase in progression-free survival, but did not show an overall survival advantage, after more than 3 years of follow-up. Three similar trials have been reported as conference abstracts. One trial showed a survival advantage of 1.5 years, but the other two did not. These 3 trials also showed an increase in progression-free survival; (4) Thalidomide has frequent and sometimes severe adverse effects, including neuropathy, venous thrombosis and pulmonary embolism, cutaneous disorders and bradycardia; (5) Thalidomide is highly teratogenic. As it enters semen, men who have partners of child-bearing age must use very effective methods of birth control; (6) In practice, provided treatment is closely monitored, thalidomide can be added to the melphalan-prednisone combination as first-line treatment for myeloma patients over 65 years of age.