TY - JOUR
T1 - Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma
T2 - Updated results of a randomized controlled trial
AU - Palumbo, Antonio
AU - Bringhen, Sara
AU - Liberati, Anna M.
AU - Caravita, Tommaso
AU - Falcone, Antonietta
AU - Callea, Vincenzo
AU - Montanaro, Marco
AU - Ria, Roberto
AU - Capaldi, Antonio
AU - Zambello, Renato
AU - Benevolo, Giulia
AU - Derudas, Daniele
AU - Dore, Fausto
AU - Cavallo, Federica
AU - Gay, Francesca
AU - Falco, Patrizia
AU - Ciccone, Giovannino
AU - Musto, Pellegrino
AU - Cavo, Michele
AU - Boccadoro, Mario
PY - 2008/10/15
Y1 - 2008/10/15
N2 - The initial analysis of the oral combination melphalan, prednisone, and thalidomide (MPT) in newly diagnosed patients with myeloma showed significantly higher response rate and longer progression-free survival (PFS) than did the standard melphalan and prednisone (MP) combination and suggested a survival advantage. In this updated analysis, efficacy and safety end points were updated. Patients were randomly assigned to receive oral MPT or MP alone. Updated analysis was by intention to treat and included PFS, overall survival (OS), and survival after progression. After a median follow-up of 38.1 months, the median PFS was 21.8 months for MPT and 14.5 months for MP (P=.004). The median OS was 45.0 months for MPT and 47.6 months for MP (P=.79). In different patient subgroups, MPT improved PFS irrespective of age, serum concentrations of β 2-microglobulin, or high International Staging System. Thalidomide or bortezomib administration as salvage regimens significantly improved survival after progression in the MP group (P=.002) but not in the MPT group (P=.34). These data confirm activity of MPT for PFS but failed to show any survival advantage. New agents in the management of relapsed disease could explain this finding. The study is registered at www.clinicaltrials.gov as #NCT00232934.
AB - The initial analysis of the oral combination melphalan, prednisone, and thalidomide (MPT) in newly diagnosed patients with myeloma showed significantly higher response rate and longer progression-free survival (PFS) than did the standard melphalan and prednisone (MP) combination and suggested a survival advantage. In this updated analysis, efficacy and safety end points were updated. Patients were randomly assigned to receive oral MPT or MP alone. Updated analysis was by intention to treat and included PFS, overall survival (OS), and survival after progression. After a median follow-up of 38.1 months, the median PFS was 21.8 months for MPT and 14.5 months for MP (P=.004). The median OS was 45.0 months for MPT and 47.6 months for MP (P=.79). In different patient subgroups, MPT improved PFS irrespective of age, serum concentrations of β 2-microglobulin, or high International Staging System. Thalidomide or bortezomib administration as salvage regimens significantly improved survival after progression in the MP group (P=.002) but not in the MPT group (P=.34). These data confirm activity of MPT for PFS but failed to show any survival advantage. New agents in the management of relapsed disease could explain this finding. The study is registered at www.clinicaltrials.gov as #NCT00232934.
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U2 - 10.1182/blood-2008-04-149427
DO - 10.1182/blood-2008-04-149427
M3 - Article
C2 - 18505783
AN - SCOPUS:54049135250
VL - 112
SP - 3107
EP - 3114
JO - Blood
JF - Blood
SN - 0006-4971
IS - 8
ER -