Abstract
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%.
Original language | English |
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Pages (from-to) | 1239-1247 |
Number of pages | 9 |
Journal | Blood |
Volume | 118 |
Issue number | 5 |
Early online date | 4 Aug 2011 |
DOIs | |
Publication status | Published - 4 Aug 2011 |
Bibliographical note
AuthorshipContribution: P.M.F. was responsible for the data analysis and wrote the manuscript; and all authors were the principal investigators and major contributors or statisticians for respective trials, participated in the elaboration of the meta-analysis statistical plan, and made important contribution to the preparation and revision of the manuscript.
Conflict-of-interest disclosure: A.P. has honoraria and an advisory role for Celgene. S.B. has honoraria from Celgene. C.H., P. Moreau, and T.F. have honoraria or an advisory role for Celgene, Pharmion, and Janssen Cilag. A.W. and P.G. have an advisory role for Janssen Cilag, Celgene, and Mundipharma. M.B. has honoraria
from and is a member of the Speakers Bureau for Celgene and
Ortho Biotech. The remaining authors declare no competing
financial interests