Dexamethasone-based regimens versus melphalan-prednisone for elderly multiple myeloma patients ineligible for high-dose therapy.
Dexamethasone alone increases life expectancy in patients with relapsed multiple myeloma (MM); however, no large randomized study has compared dexamethasone and dexamethasone-based regimens with standard melphalan-prednisone in newly diagnosed MM patients ineligible for high-dose therapy. In the Intergroupe Francophone du Myélome (IFM) 95-01 trial, 488 patients aged 65 to 75 years were randomized between 4 regimens of treatment: melphalan-prednisone, dexamethasone alone, melphalan-dexamethasone, and dexamethasone-interferon alpha. Response rates at 6 months (except for complete response) were significantly higher among patients receiving melphalan-dexamethasone, and progression-free survival was significantly better among patients receiving melphalan (P < .001, for both comparisons), but there was no difference in overall survival between the 4 treatment groups. Moreover, the morbidity associated with dexamethasone-based regimens was significantly higher than with melphalan-prednisone, especially for severe pyogenic infections in the melphalan-dexamethasone arm and hemorrhage, severe diabetes, and gastrointestinal and psychiatric complications in the dexamethasone arms. Overall, these results indicated that dexamethasone should not be routinely recommended as first-line treatment in elderly patients with MM. In the context of the IFM 95-01 trial, the standard melphalan-prednisone remained the best treatment choice when efficacy and patient comfort were both considered. These results might be useful in the context of future combinations with innovative drugs.
Facon
Thierry
T
Service des Maladies du Sang, Hôpital Huriez, CHU de Lille, rue Michel Polonovski, 59037 Lille, France. t-facon@chru-lille.fr
Mary
Jean-Yves
JY
Pégourie
Brigitte
B
Attal
Michel
M
Renaud
Marc
M
Sadoun
Alain
A
Voillat
Laurent
L
Dorvaux
Véronique
V
Hulin
Cyrille
C
Lepeu
Gérard
G
Harousseau
Jean-Luc
JL
Eschard
Jean-Paul
JP
Ferrant
Augustin
A
Blanc
Michel
M
Maloisel
Frédéric
F
Orfeuvre
Hubert
H
Rossi
Jean-François
JF
Azaïs
Isabelle
I
Monconduit
Mathieu
M
Collet
Philippe
P
Anglaret
Bruno
B
Yakoub-Agha
Ibrahim
I
Wetterwald
Marc
M
Eghbali
Houchingue
H
Vekemans
Marie-Christine
MC
Maisonneuve
Hervé
H
Troncy
Jacques
J
Grosbois
Bernard
B
Doyen
Chantal
C
Thyss
Antoine
A
Jaubert
Jérome
J
Casassus
Philippe
P
Thielemans
Béatrice
B
Bataille
Régis
R
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007239:Infections / Q000453:epidemiology; D016898:Interferon-alpha / Q000008:administration & dosage; D008297:Male; D008558:Melphalan / Q000008:administration & dosage* / Q000009:adverse effects; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D018579:Patient Selection; D011241:Prednisone / Q000008:administration & dosage; D016019:Survival Analysis; D016896:Treatment Outcome
D016898:Interferon-alpha; D003907:Dexamethasone; D008558:Melphalan; D011241:Prednisone