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Blood, 9 April 2009, Vol. 113, No. 15, pp. 3435-3442.
Prepublished online as a Blood First Edition Paper on October 27, 2008; DOI 10.1182/blood-2008-07-169565.
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Submitted July 18, 2008
Accepted October 13, 2008
Thalidomide-dexamethasone compared to melphalan-prednisolone in elderly patients with multiple myeloma
Heinz Ludwig*, Roman Hajek, Elena Tothova, Johannes Drach, Zdenek Adam, Boris Labar, Miklos Egyed, Ivan Spicka, Heinz Gisslinger, Richard Greil, Ingrid Kuhn, Niklas Zojer, and Axel Hinke
Department of Medicine I, Wilhelminenspital, Vienna, Austria
Internal Hematooncological Clinic, Faculty Hospital Brno and Faculty of Medicine MU Brno, Brno, Czech Republic
Clinic of Hematology, Faculty Hospital with Policlinic, Kosice, Slovakia
Department of Oncology, University Clinic Vienna, Vienna, Austria
Clinical Hospital "Rebro", Zagreb, Croatia
Department of Internal Medicine, Kaposi Mor Teaching Hospital, Kaposvar, Hungary
1st Internal Clinic, Charles University, Prague, Czech Republic
Department of Hematology, University Clinic Vienna, Vienna, Austria
University Clinic Salzburg, Salzburg, Austria
Schering-Plough Inc., Traiskirchen, Austria
WISP Research Institute, Langenfeld, Germany
* Corresponding author; email: heinz.ludwig{at}wienkav.at.
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  -2b TIW or to 3 MU interferon -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.
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