TY - JOUR
T1 - Thalidomide for previously untreated elderly patients with multiple myeloma
T2 - Meta-analysis of 1685 individual patient data from 6 randomized clinical trials
AU - Fayers, Peter M.
AU - Palumbo, Antonio
AU - Hulin, Cyrille
AU - Waage, Anders
AU - Wijermans, Pierre
AU - Beksaç, Meral
AU - Bringhen, Sara
AU - Mary, Jean Yves
AU - Gimsing, Peter
AU - Termorshuizen, Fabian
AU - Haznedar, Rauf
AU - Caravita, Tommaso
AU - Moreau, Philippe
AU - Turesson, Ingemar
AU - Musto, Pellegrino
AU - Benboubker, Lotfi
AU - Schaafsma, Martijn
AU - Sonneveld, Pieter
AU - Facon, Thierry
PY - 2011/8/4
Y1 - 2011/8/4
N2 - The role of thalidomide for previously untreated elderly patients with multiple myeloma remains unclear. Six randomized controlled trials, launched in or after 2000, compared melphalan and prednisone alone (MP) and with thalidomide (MPT). The effect on overall survival (OS) varied across trials. We carried out a meta-analysis of the 1685 individual patients in these trials. The primary endpoint was OS, and progression-free survival (PFS) and 1-year response rates were secondary endpoints. There was a highly significant benefit to OS from adding thalidomide to MP (hazard ratio = 0.83; 95% confidence interval 0.73-0.94, P = .004), representing increased median OS time of 6.6 months, from 32.7 months (MP) to 39.3 months (MPT). The thalidomide regimen was also associated with superior PFS (hazard ratio = 0.68, 95% confidence interval 0.61-0.76, P <.0001) and better 1-year response rates (partial response or better was 59% on MPT and 37% on MP). Although the trials differed in terms of patient baseline characteristics and thalidomide regimens, there was no evidence that treatment affected OS differently according to levels of the prognostic factors. We conclude that thalidomide added to MP improves OS and PFS in previously untreated elderly patients with multiple myeloma, extending the median survival time by on average 20%.
AB - The role of thalidomide for previously untreated elderly patients with multiple myeloma remains unclear. Six randomized controlled trials, launched in or after 2000, compared melphalan and prednisone alone (MP) and with thalidomide (MPT). The effect on overall survival (OS) varied across trials. We carried out a meta-analysis of the 1685 individual patients in these trials. The primary endpoint was OS, and progression-free survival (PFS) and 1-year response rates were secondary endpoints. There was a highly significant benefit to OS from adding thalidomide to MP (hazard ratio = 0.83; 95% confidence interval 0.73-0.94, P = .004), representing increased median OS time of 6.6 months, from 32.7 months (MP) to 39.3 months (MPT). The thalidomide regimen was also associated with superior PFS (hazard ratio = 0.68, 95% confidence interval 0.61-0.76, P <.0001) and better 1-year response rates (partial response or better was 59% on MPT and 37% on MP). Although the trials differed in terms of patient baseline characteristics and thalidomide regimens, there was no evidence that treatment affected OS differently according to levels of the prognostic factors. We conclude that thalidomide added to MP improves OS and PFS in previously untreated elderly patients with multiple myeloma, extending the median survival time by on average 20%.
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U2 - 10.1182/blood-2011-03-341669
DO - 10.1182/blood-2011-03-341669
M3 - Article
C2 - 21670471
AN - SCOPUS:80051570906
VL - 118
SP - 1239
EP - 1247
JO - Blood
JF - Blood
SN - 0006-4971
IS - 5
ER -