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DOI 10.1182/blood-2016-01-693580

Медицинская библиотека · Blood · 2016

VTD is superior to VCD prior to intensive therapy in multiple myeloma: results of the prospective IFM2013-04 trial.

Moreau Philippe, Hulin Cyrille, Macro Margaret, Caillot Denis, Chaleteix Carine, Roussel Murielle, Garderet Laurent, Royer Bruno, Brechignac Sabine, Tiab Mourad, Puyade Mathieu, Escoffre Martine, Stoppa Anne-Marie, Facon Thierry, Pegourie Brigitte, Chaoui Driss, Jaccard Arnaud, Slama Borhane, Marit Gerald, Laribi Karim, Godmer Pascal, Luycx Odile, Eisenmann Jean-Claude, Allangba Olivier, Dib Mamoun, Araujo Carla, Fontan Jean, Belhadj Karim, Wetterwald Marc, Dorvaux Véronique, Fermand Jean-Paul, Rodon Philippe, Kolb Brigitte, Glaisner Sylvie, Malfuson Jean-Valere, Lenain Pascal, Biron Laetitia, Planche Lucie, Caillon Helene, Avet-Loiseau Herve, Dejoie Thomas, Attal Michel

Клиническое исследование III фазыСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПеревод пока не подготовлен

Аннотация

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.

Для цитирования: Moreau Philippe, Hulin Cyrille, Macro Margaret, Caillot Denis, Chaleteix Carine, Roussel Murielle, Garderet Laurent, Royer Bruno, Brechignac Sabine, Tiab Mourad, Puyade Mathieu, Escoffre Martine, Stoppa Anne-Marie, Facon Thierry, Pegourie Brigitte, Chaoui Driss, Jaccard Arnaud, Slama Borhane, Marit Gerald, Laribi Karim, Godmer Pascal, Luycx Odile, Eisenmann Jean-Claude, Allangba Olivier, Dib Mamoun, Araujo Carla, Fontan Jean, Belhadj Karim, Wetterwald Marc, Dorvaux Véronique, Fermand Jean-Paul, Rodon Philippe, Kolb Brigitte, Glaisner Sylvie, Malfuson Jean-Valere, Lenain Pascal, Biron Laetitia, Planche Lucie, Caillon Helene, Avet-Loiseau Herve, Dejoie Thomas, Attal Michel. VTD is superior to VCD prior to intensive therapy in multiple myeloma: results of the prospective IFM2013-04 trial.. Blood. 2016. DOI: 10.1182/blood-2016-01-693580.

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