VTD is superior to VCD prior to intensive therapy in multiple myeloma: results of the prospective IFM2013-04 trial
Philippe Moreau, Cyrille Hulin, Margaret Macro, Denis Caillot, Carine Chaleteix, Murielle Roussel, Laurent Garderet, Bruno Royer, Sabine Brechignac, Mourad Tiab, Mathieu Puyade, Martine Escoffre, Anne-Marie Stoppa, Thierry Facon, Brigitte Pegourie, Driss Chaoui, Arnaud Jaccard, Borhane Slama, Gerald Marit, Karim Laribi, Pascal Godmer, Odile Luycx, Jean-Claude Eisenmann, Olivier Allangba, Mamoun Dib, Carla Araujo, Jean Fontan, Karim Belhadj, Marc Wetterwald, Véronique Dorvaux, Jean-Paul Fermand, Philippe Rodon, Brigitte Kolb, Sylvie Glaisner, Jean-Valere Malfuson, Pascal Lenain, Laetitia Biron, Lucie Planche, Helene Caillon, Herve Avet-Loiseau, Thomas Dejoie, Michel Attal, Philippe Moreau, Cyrille Hulin, Margaret Macro, Denis Caillot, Carine Chaleteix, Murielle Roussel, Laurent Garderet, Bruno Royer, Sabine Brechignac, Mourad Tiab, Mathieu Puyade, Martine Escoffre, Anne-Marie Stoppa, Thierry Facon, Brigitte Pegourie, Driss Chaoui, Arnaud Jaccard, Borhane Slama, Gerald Marit, Karim Laribi, Pascal Godmer, Odile Luycx, Jean-Claude Eisenmann, Olivier Allangba, Mamoun Dib, Carla Araujo, Jean Fontan, Karim Belhadj, Marc Wetterwald, Véronique Dorvaux, Jean-Paul Fermand, Philippe Rodon, Brigitte Kolb, Sylvie Glaisner, Jean-Valere Malfuson, Pascal Lenain, Laetitia Biron, Lucie Planche, Helene Caillon, Herve Avet-Loiseau, Thomas Dejoie, Michel Attal
Abstract
The Intergroupe Francophone du Myélome conducted a randomized trial to compare bortezomib-thalidomide-dexamethasone (VTD) with bortezomib-cyclophosphamide-dexamethasone (VCD) as induction before high-dose therapy and autologous stem cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma. Overall, a total of 340 patients were centrally randomly assigned to receive VTD or VCD. After 4 cycles, on an intent-to-treat basis, 66.3% of the patients in the VTD arm achieved at least a very good partial response (primary end point) vs 56.2% in the VCD arm (P = .05). In addition, the overall response rate was significantly higher in the VTD arm (92.3% vs 83.4% in the VCD arm; P = .01). Hematologic toxicity was higher in the VCD arm, with significantly increased rates of grade 3 and 4 anemia, thrombocytopenia, and neutropenia. On the other hand, the rate of peripheral neuropathy (PN) was significantly higher in the VTD arm. With the exception of hematologic adverse events and PN, other grade 3 or 4 toxicities were rare, with no significant differences between the VTD and VCD arms. Our data support the preferential use of VTD rather than VCD in preparation for ASCT. This trial was registered at www.clinicaltrials.gov as #NCT01564537 and at EudraCT as #2013-003174-27.
© 2016 by The American Society of Hematology.
Source: PubMed