title: Dexamethasone-based regimens versus melphalan-prednisone for elderly multiple myeloma patients ineligible for high-dose therapy.
abstract: 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.
authors.affiliation: Service des Maladies du Sang, Hôpital Huriez, CHU de Lille, rue Michel Polonovski, 59037 Lille, France. t-facon@chru-lille.fr
authors.forename: Thierry
authors.initials: T
authors.lastname: Facon
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Mary
authors.forename: Brigitte
authors.initials: B
authors.lastname: Pégourie
authors.forename: Michel
authors.initials: M
authors.lastname: Attal
authors.forename: Marc
authors.initials: M
authors.lastname: Renaud
authors.forename: Alain
authors.initials: A
authors.lastname: Sadoun
authors.forename: Laurent
authors.initials: L
authors.lastname: Voillat
authors.forename: Véronique
authors.initials: V
authors.lastname: Dorvaux
authors.forename: Cyrille
authors.initials: C
authors.lastname: Hulin
authors.forename: Gérard
authors.initials: G
authors.lastname: Lepeu
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Harousseau
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Eschard
authors.forename: Augustin
authors.initials: A
authors.lastname: Ferrant
authors.forename: Michel
authors.initials: M
authors.lastname: Blanc
authors.forename: Frédéric
authors.initials: F
authors.lastname: Maloisel
authors.forename: Hubert
authors.initials: H
authors.lastname: Orfeuvre
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Rossi
authors.forename: Isabelle
authors.initials: I
authors.lastname: Azaïs
authors.forename: Mathieu
authors.initials: M
authors.lastname: Monconduit
authors.forename: Philippe
authors.initials: P
authors.lastname: Collet
authors.forename: Bruno
authors.initials: B
authors.lastname: Anglaret
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Yakoub-Agha
authors.forename: Marc
authors.initials: M
authors.lastname: Wetterwald
authors.forename: Houchingue
authors.initials: H
authors.lastname: Eghbali
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Vekemans
authors.forename: Hervé
authors.initials: H
authors.lastname: Maisonneuve
authors.forename: Jacques
authors.initials: J
authors.lastname: Troncy
authors.forename: Bernard
authors.initials: B
authors.lastname: Grosbois
authors.forename: Chantal
authors.initials: C
authors.lastname: Doyen
authors.forename: Antoine
authors.initials: A
authors.lastname: Thyss
authors.forename: Jérome
authors.initials: J
authors.lastname: Jaubert
authors.forename: Philippe
authors.initials: P
authors.lastname: Casassus
authors.forename: Béatrice
authors.initials: B
authors.lastname: Thielemans
authors.forename: Régis
authors.initials: R
authors.lastname: Bataille
mesh_terms: 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
chemical_list: D016898:Interferon-alpha; D003907:Dexamethasone; D008558:Melphalan; D011241:Prednisone