title: Thalidomide for previously untreated elderly patients with multiple myeloma: meta-analysis of 1685 individual patient data from 6 randomized clinical trials.
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%.
authors.affiliation: Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, United Kingdom. p.fayers@abdn.ac.uk
authors.forename: Peter M
authors.initials: PM
authors.lastname: Fayers
authors.forename: Antonio
authors.initials: A
authors.lastname: Palumbo
authors.forename: Cyrille
authors.initials: C
authors.lastname: Hulin
authors.forename: Anders
authors.initials: A
authors.lastname: Waage
authors.forename: Pierre
authors.initials: P
authors.lastname: Wijermans
authors.forename: Meral
authors.initials: M
authors.lastname: Beksaç
authors.forename: Sara
authors.initials: S
authors.lastname: Bringhen
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Mary
authors.forename: Peter
authors.initials: P
authors.lastname: Gimsing
authors.forename: Fabian
authors.initials: F
authors.lastname: Termorshuizen
authors.forename: Rauf
authors.initials: R
authors.lastname: Haznedar
authors.forename: Tommaso
authors.initials: T
authors.lastname: Caravita
authors.forename: Philippe
authors.initials: P
authors.lastname: Moreau
authors.forename: Ingemar
authors.initials: I
authors.lastname: Turesson
authors.forename: Pellegrino
authors.initials: P
authors.lastname: Musto
authors.forename: Lotfi
authors.initials: L
authors.lastname: Benboubker
authors.forename: Martijn
authors.initials: M
authors.lastname: Schaafsma
authors.forename: Pieter
authors.initials: P
authors.lastname: Sonneveld
authors.forename: Thierry
authors.initials: T
authors.lastname: Facon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008297:Male; D008558:Melphalan / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D020360:Neoadjuvant Therapy; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic; D016019:Survival Analysis; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D013792:Thalidomide; D008558:Melphalan; D011241:Prednisone