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

Autori
Ludwig, Heinz ; Hajek, Roman ; Tóthová, Elena ; Drach, Johannes ; Adam, Zdenek ; Labar, Boris ; Egyed, Miklós ; Spicka, Ivan ; Gisslinger, Heinz ; Greil, Richard ; Kuhn, Ingrid ; Zojer, Niklas ; Hinke, Axel

Izvornik
Blood (0006-4971) 113 (2009), 15; 3435-3442

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
Thalidomide/*administration & dosage/adverse effects; Multiple Myeloma/*drug therapy/immunology/mortality; Melphalan/*administration & dosage/adverse effects; Prednisolone/*administration & dosage/adverse effects

Sažetak
We compared thalidomide-dexamethasone (TD) with melphalan-prednisolone (MP) in 289 elderly patients with multiple myeloma (MM). Patients received either thalidomide 200 mg plus dexamethasone 40 mg, days 1 to 4 and 15 to 18 on even cycles and days 1 to 4 on odd cycles, during a 28-day cycle or to melphalan 0.25 mg/kg and prednisolone 2 mg/kg orally on days 1 to 4 during a 28- to 42-day cycle. Patients achieving stable disease or better were randomly assigned to maintenance therapy with either thalidomide 100 mg daily and 3 MU interferon alpha-2b thrice weekly or to 3 MU interferon alpha-2b thrice weekly only. TD resulted in a higher proportion of complete and very good remissions (26% vs 13% ; P= .006) and overall responses (68% vs 50% ; P= .002) compared with MP. Time to progression (21.2 vs 29.1 months ; P= .2), and progression-free survival was similar (16.7 vs 20.7 months ; P= .1), but overall survival was significantly shorter in the TD group (41.5 vs 49.4 months ; P= .024). Toxicity was higher with TD, particularly in patients older than 75 years with poor performance status. The study was registered at ClinicalTrials.gov as NCT00205751.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

POVEZANOST RADA