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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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CLINICAL TRIALS AND OBSERVATIONS
Thalidomide-dexamethasone compared with melphalan-prednisolone in elderly patients with multiple myeloma
Heinz Ludwig1,
Roman Hajek2,
Elena Tóthová3,
Johannes Drach4,
Zdenek Adam2,
Boris Labar5,
Miklós Egyed6,
Ivan Spicka7,
Heinz Gisslinger8,
Richard Greil9,
Ingrid Kuhn10,
Niklas Zojer1, and
Axel Hinke11
1 Department of Medicine I, Wilhelminenspital Vienna, Vienna, Austria;
2 Internal Hematooncological Clinic, Faculty Hospital Brno and Faculty of Medicine MU, Brno, Czech Republic;
3 Clinic of Hematology, Faculty Hospital with Policlinic, Kosice, Slovakia;
4 Clinical Division of Oncology, Medical University of Vienna, Vienna, Austria;
5 Clinical Hospital "Rebro," Zagreb, Croatia;
6 Department of Internal Medicine, Kaposi Mór Teaching Hospital, Kaposvár, Hungary;
7 First Internal Clinic, Charles University, Prague, Czech Republic;
8 Department of Hematology, University Clinic, Vienna, Austria;
9 University Clinic, Salzburg, Austria;
10 Schering-Plough AESCA Pharma, Traiskirchen, Austria; and
11 Wissenschaftlicher Service Pharma Research Institute, Langenfeld, Germany
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  -2b thrice weekly or to 3 MU interferon -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
[ClinicalTrials.gov]
.
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