Phase III study of the value of thalidomide added to melphalan plus prednisone in elderly patients with newly diagnosed multiple myeloma: the HOVON 49 Study.
OBJECTIVE
For several decades, the treatment of elderly patients with multiple myeloma (MM) has consisted of melphalan and prednisone (MP). The Dutch-Belgium Hemato-Oncology Cooperative Group (HOVON) investigated the efficacy of thalidomide added to MP (MP-T) in a randomized phase III trial. The objective of this study was to investigate the efficacy, toxicity, and effects on quality of life of MP-T.


METHODS
A randomized phase III trial compared standard MP with MP-T (thalidomide 200 mg/d) in newly diagnosed patients with multiple myeloma older than age 65 years. Maintenance therapy with thalidomide 50 mg/d was administered to patients after MP-T until relapse. The primary end point was event-free survival (EFS); response rate, overall survival (OS), and progression-free survival (PFS) were secondary end points.


RESULTS
An intent-to-treat analysis of 333 evaluable patients showed significantly higher response rates in MP-T-treated patients compared with MP-treated patients a response (> or = partial response: 66% v 45%, respectively; P < .001; and > or = very good partial response [VGPR]: 27% v 10%, respectively; P < .001). EFS was 13 months with MP-T versus 9 months with MP (P < .001). OS was 40 months with MP-T versus 31 months with MP (P = .05).


CONCLUSIONS
This study demonstrates that thalidomide improves the response rate and VGPR in elderly patients with newly diagnosed MM. MP-T also results in a better EFS, PFS, and OS.
Haga Hospital, Leyweg 275, the Hague, the Netherlands. p.wijermans@hagaziekenhuis.nl
Pierre
P
Wijermans
Martijn
M
Schaafsma
Fabian
F
Termorshuizen
Rianne
R
Ammerlaan
Shulamiet
S
Wittebol
Harm
H
Sinnige
Sonja
S
Zweegman
Marinus
M
van Marwijk Kooy
René
R
van der Griend
Henk
H
Lokhorst
Pieter
P
Sonneveld
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000473:pathology; D015999:Multivariate Analysis; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D010146:Pain / Q000139:chemically induced; D011241:Prednisone / Q000008:administration & dosage; D011788:Quality of Life; D012044:Regression Analysis; D013792:Thalidomide / Q000008:administration & dosage; D016896:Treatment Outcome
D013792:Thalidomide; D008558:Melphalan; D011241:Prednisone