Dexamethasone-based regimens versus melphalan-prednisone for elderly multiple myeloma patients ineligible for high-dose therapy.

Facon, Thierry;Mary, Jean-Yves;Pégourie, Brigitte;Attal, Michel;Bataille, Régis;et.al.
(2006) Blood — Vol. 107, n° 4, p. 1292-1298 (2006)

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Authors
  • Facon, Thierry
    Author
  • Mary, Jean-Yves
    Author
  • Pégourie, Brigitte
    Author
  • Attal, Michel
    Author
  • Ferrant, AugustinUCLouvain
    Author
  • Collet, PhilippeUCLouvain
    Author
  • Doyen, ChantalUCLouvain
    Author
  • Bataille, Régis
    Author
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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.
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Facon, T., Mary, J.-Y., Pégourie, B., Attal, M., Renaud, M., Sadoun, A., Voillat, L., Dorvaux, V., Hulin, C., Lepeu, G., Harousseau, J.-L., Eschard, J.-P., Ferrant, A., Blanc, M., Maloisel, F., Orfeuvre, H., Rossi, J.-F., Azaïs, I., Monconduit, M., et al. (2006). Dexamethasone-based regimens versus melphalan-prednisone for elderly multiple myeloma patients ineligible for high-dose therapy. Blood, 107(4), 1292-1298. https://doi.org/10.1182/blood-2005-04-1588 (Original work published 2006)