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Blood, 15 February 2006, Vol. 107, No. 4, pp. 1292-1298.
Prepublished online as a Blood First Edition Paper on September 20, 2005; DOI 10.1182/blood-2005-04-1588.
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CLINICAL TRIALS AND OBSERVATIONS
Dexamethasone-based regimens versus melphalan-prednisone for elderly multiple myeloma patients ineligible for high-dose therapy
Thierry Facon,
Jean-Yves Mary,
Brigitte Pégourie,
Michel Attal,
Marc Renaud,
Alain Sadoun,
Laurent Voillat,
Véronique Dorvaux,
Cyrille Hulin,
Gérard Lepeu,
Jean-Luc Harousseau,
Jean-Paul Eschard,
Augustin Ferrant,
Michel Blanc,
Frédéric Maloisel,
Hubert Orfeuvre,
Jean-François Rossi,
Isabelle Azaïs,
Mathieu Monconduit,
Philippe Collet,
Bruno Anglaret,
Ibrahim Yakoub-Agha,
Marc Wetterwald,
Houchingue Eghbali,
Marie-Christine Vekemans,
Hervé Maisonneuve,
Jacques Troncy,
Bernard Grosbois,
Chantal Doyen,
Antoine Thyss,
Jérome Jaubert,
Philippe Casassus,
Béatrice Thielemans,
Régis Bataille, for the Intergroupe Francophone du Myélome (IFM) group
From the Service d'Hématologie, Centre Hospitalier Universitaire (CHU) Lille, France; Département de Biostatistique et Informatique Médicale, Institut National de la Santé et de la Recherche Médicale (INSERM) Erm0321, Hopital Saint-Louis, Université Paris VII, France; Service d'Hématologie, CHU Grenoble, CHU Toulouse, CHU Poitiers, CHU Besançon, Centre Hospitalier (CH) Metz, CHU Nancy, CH Avignon, CHU Nantes, France; Service de Rhumatologie, CHU Reims, France; Service d'Hématologie, UCL, Bruxelles, Belgique; Service d'Hématologie, CH Chambery, CHU Strasbourg, CH Bourgen-Bresse, CHU Montpellier, France; Service de Rhumatologie, CH Poitiers, France; Service d'Hématologie, Centre Henri Becquerel, Rouen, France; Service de Rhumatologie, CHU St Etienne, France; Service d'Hématologie, CH Valence, CH Saint Brieuc, CH Dunkerque, France; Service d'Hématologie, Institut Bergonié, Bordeaux, France; Service d'Hématologie, Hornu, Belgique; Service de Médecine, CH La Roche/Yon, France; Service d'Hématologie, Hôpital E. Herriot, Lyon, France; Service de Médecine Interne, CHU Rennes, France; Service d'Hématologie, UCL, Yvoir, Belgique; Service d'Hématologie, Centre Lacassagne, Nice, France; Service d'Hématologie, CHU St Etienne, CHU Bobigny, France; Pharmacie centrale, CHU Lille, France; and Centre A. Gauducheau, Nantes, France.
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.
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