Efficacy of single-agent bortezomib vs. single-agent thalidomide in patients with relapsed or refractory multiple myeloma: a systematic comparison.
OBJECTIVE
To conduct a systematic review of the efficacy of single-agent bortezomib vs. single-agent thalidomide in patients with relapsed/refractory multiple.


METHODS
Publications in English from 1966 to June 2005 (MEDLINE, EMBASE, Cochrane library), publication reference lists, Janssen-Cilag data-on-file and abstracts from recent multiple myeloma conferences were reviewed. Prospective studies containing at least a single arm of either treatment group with n> or =30 were included. Studies adding dexamethasone for non-responders were excluded. Statistical pooling was performed for response rate and overallsurvival.


RESULTS
One bortezomib study (n = 333, NEJM 2005, 352; 2487-98) and 15 thalidomide (n = 1007) studies met these criteria and were included. Patient baseline characteristics including age, gender, IgG : IgA, disease duration and beta-2 microglobulin were well matched except that 48% of bortezomib patients had received prior thalidomide. Response rate, defined as serum M-protein reduction > or =50%, was 53% for patients receiving bortezomib vs. 32% for thalidomide (P < 0.001, n = 10 studies). Response rate determined by European Group for Blood and Marrow Transplantation (EBMT) criteria was 41% for patients receiving bortezomib vs. 22% for thalidomide (P < 0.001, n = 4 studies).


CONCLUSIONS
Bortezomib was associated with a significantly higher response rate and complete remission rate using both M-protein and EBMT criteria.
Prince
H Miles
HM
Department of Haematology and Medical Oncology, Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, Vic., Australia.
Adena
Michael
M
Smith
Dell Kingsford
DK
Hertel
Judy
J
D000818:Animals; D001798:Blood Proteins; D001897:Boronic Acids / Q000627:therapeutic use*; D000069286:Bortezomib; D017690:Cell Transplantation; D006801:Humans; D007136:Immunoglobulins / Q000097:blood; D009101:Multiple Myeloma / Q000097:blood / Q000188:drug therapy* / Q000473:pathology* / Q000601:surgery; D011719:Pyrazines / Q000627:therapeutic use*; D012008:Recurrence; D013792:Thalidomide / Q000627:therapeutic use*
D001798:Blood Proteins; D001897:Boronic Acids; D007136:Immunoglobulins; C009823:M-proteins (Myeloma); D011719:Pyrazines; D013792:Thalidomide; D000069286:Bortezomib