THALIDOMIDE NOT FOR PATIENTS OVER 75

Blood. 2008 Oct 27. [Epub ahead of print]

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Thalidomide-dexamethasone compared to melphalan-prednisolone in elderly patients with multiple myeloma.

Ludwig H, Hajek R, Tothova E, Drach J, Adam Z, Labar B, Egyed M, Spicka I, Gisslinger H, Greil R, Kuhn I, Zojer N, Hinke A.

Department of Medicine I, Wilhelminenspital, Vienna, Austria.

Thalidomide-dexamethasone (TD) has successfully been used for treatment of young patients with multiple myeloma (MM). We compared TD with melphalan-prednisolone (MP) as first line treatment in 289 elderly patients with MM. Patients were randomized to either thalidomide 200mg plus dexamethasone 40mg, days 1-4, and 15-18 on even cycles and on days 1-4 on odd cycles, during a 28-day cycle or to melphalan 0.25mg/kg and prednisolone 2mg/kg orally on days 1-4 during a 28 to 42 day cycle. For maintenance, patients achieving stable disease or better were randomized to either thalidomide 100mg daily and 3 MU interferon alpha-2b TIW or to 3 MU interferon alpha-2b TIW only, but results on this phase will only be presented after longer follow up. TD resulted in a higher proportion of complete and very good remissions (26% vs. 13%, P=0.0066) and overall responses (68% vs. 50%, P=0.0023) compared to MP. Time to progression (21.2 vs. 29.1 months, P=0.2), and progression-free survival was similar (16.7 vs. 20.7 months, P=0.1), but overall survival was significantly shorter in the TD group (41.5 vs. 49.4 months, P=0.024). Toxicity was higher with TD, particularly in patients above 75 years with poor performance status. TD yielded higher response rates, but was more toxic in older patients and was associated with shorter overall survival. The study is registered as NCT00205751 at ClinicalTrials.gov.