Publicaciones científicas

Integrated analysis of randomized controlled trials evaluating bortezomib + lenalidomide + dexamethasone or bortezomib + thalidomide + dexamethasone induction in transplant-eligible newly diagnosed multiple myeloma

12-nov-2023 | Revista: Frontiers in Oncology

Laura Rosiñol 1, Benjamin Hebraud 2, Albert Oriol 3, Anne-Laurène Colin 4, Rafael Ríos Tamayo 5, Cyrille Hulin 6, María Jesús Blanchard 7, Denis Caillot 8, Anna Sureda 9, Miguel Teodoro Hernández 10, Bertrand Arnulf 11, Maria-Victoria Mateos 12, Margaret Macro 13, Jesús San-Miguel 14, Karim Belhadj 15, Juan José Lahuerta 14, M Brigid Garelik 16, Joan Bladé 1, Philippe Moreau 17


Abstract

Objective: Providing the most efficacious frontline treatment for newly diagnosed multiple myeloma (NDMM) is critical for patient outcomes. No direct comparisons have been made between bortezomib + lenalidomide + dexamethasone (VRD) and bortezomib + thalidomide + dexamethasone (VTD) induction regimens in transplant-eligible NDMM.

Methods: An integrated analysis was performed using patient data from four trials meeting prespecified eligibility criteria: two using VRD (PETHEMA GEM2012 and IFM 2009) and two using VTD (PETHEMA GEM2005 and IFM 2013-04).

Results: The primary endpoint was met, with VRD demonstrating a noninferior rate of at least very good partial response (≥ VGPR) after induction vs VTD. GEM comparison demonstrated improvement in the ≥ VGPR rate after induction for VRD vs VTD (66.3% vs 51.2%; P = .00281) that increased after transplant (74.4% vs 53.5%). Undetectable minimal residual disease rates post induction (46.7% vs 34.9%) and post transplant (62.4% vs 47.3%) support the benefit of VRD vs VTD. Treatment-emergent adverse events leading to study and/or treatment discontinuation were less frequent with VRD (3%, GEM2012; 6%, IFM 2009) vs VTD (11%, IFM 2013-04).

Conclusion: These results supported the benefit of VRD over VTD for induction in transplant-eligible patients with NDMM. The trials included are registered with ClinicalTrials.gov (NCT01916252, NCT01191060, NCT00461747, and NCT01971658).

CITA DEL ARTÍCULO Front Oncol. 2023 Nov 2:13:1197340. doi: 10.3389/fonc.2023.1197340. eCollection 2023.