Bortezomib plus dexamethasone versus reduced-dose bortezomib, thalidomide plus dexamethasone as induction treatment before autologous stem cell transplantation in newly diagnosed multiple myeloma
Philippe Moreau, Herve Avet-Loiseau, Thierry Facon, Michel Attal, Mourad Tiab, Cyrille Hulin, Chantal Doyen, Laurent Garderet, Edouard Randriamalala, Carla Araujo, Gérard Lepeu, Gerald Marit, Denis Caillot, Martine Escoffre, Bruno Lioure, Lotfi Benboubker, Brigitte Pégourié, Brigitte Kolb, Anne Marie Stoppa, Jean-Gabriel Fuzibet, Olivier Decaux, Mamoun Dib, Christian Berthou, Carine Chaleteix, Catherine Sebban, Catherine Traullé, Jean Fontan, Marc Wetterwald, Pascal Lenain, Claire Mathiot, Jean-Luc Harousseau, Philippe Moreau, Herve Avet-Loiseau, Thierry Facon, Michel Attal, Mourad Tiab, Cyrille Hulin, Chantal Doyen, Laurent Garderet, Edouard Randriamalala, Carla Araujo, Gérard Lepeu, Gerald Marit, Denis Caillot, Martine Escoffre, Bruno Lioure, Lotfi Benboubker, Brigitte Pégourié, Brigitte Kolb, Anne Marie Stoppa, Jean-Gabriel Fuzibet, Olivier Decaux, Mamoun Dib, Christian Berthou, Carine Chaleteix, Catherine Sebban, Catherine Traullé, Jean Fontan, Marc Wetterwald, Pascal Lenain, Claire Mathiot, Jean-Luc Harousseau
Abstract
The Intergroupe Francophone du Myelome conducted a randomized trial to compare bortezomib-dexamethasone (VD) as induction before high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) to a combination consisting of reduced doses of bortezomib and thalidomide plus dexamethasone (vtD) in patients with multiple myeloma. Overall, a total of 199 patients were centrally randomly assigned to receive VD or vtD. After 4 cycles, the complete response (CR) rate was the same in both groups (13% in the vtD arm, 12% in the VD arm, P = .74). However, the CR plus very good partial response (VGPR) rate was significantly higher in the vtD arm (49% vs 36%, P = .05). After ASCT, the CR plus VGPR rate was significantly higher in the vtD arm (74% vs 58%, P = .02). The reduced doses of bortezomib and thalidomide translated into a reduced incidence of peripheral neuropathy (PN): grade ≥ 2 PN were reported in 34% in the VD arm versus 14% in the vtD arm (P = .001). vtD, including reduced doses of bortezomib and thalidomide, yields higher VGPR rates compared with VD and can be considered a new effective triplet combination before HDT/ASCT.
Trial registration: ClinicalTrials.gov NCT00910897.
Source: PubMed