(Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras)
(Department of Hematology. Hôpital Haut-Lévêque)
Data: |
2023 |
Resum: |
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). |
Nota: |
The authors declare that this study received funding from Celgene, a Bristol-Myers Squibb Company. Author MG was employed by the funder and involved in study design, collection, analysis, or interpretation of data and writing the article and deciding to submit the article for publication. |
Nota: |
The authors thank Valerie Lauwers-Cances and Laure Devlamynck (Unité de Soutien Méthodologique à la Recherche, Centre Hospitalier et Universitaire de Toulouse, France), Pascale Olivier-Abbal (Service de Pharmacologie Médicale et Clinique, Centre Hospitalier et Universitaire de Toulouse, France), and Catherine Payen and Sandrine Rollet (Service d'Hématologie, Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France) for their assistance with the study. The authors thank Guang Chen for statistical support performed while employed at Celgene, a Bristol-Myers Squibb Company, and thank Peter J. Simon, PhD, CMPP, from MediTech Media, Ltd, and Martin Haschak, PhD from SciMentum, The Nucleus Group Holdings, Inc, for medical writing assistance, which was sponsored by Bristol Myers Squibb. The authors are fully responsible for all content and editorial decisions of this manuscript. |
Drets: |
Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original. |
Llengua: |
Anglès |
Document: |
Article ; recerca ; Versió publicada |
Matèria: |
multiple myeloma ;
ortezomib ;
lenalidomide ;
dexamethasone ;
thalidomide |
Publicat a: |
Frontiers in Oncology, Vol. 13 (2023) , p. 1197340, ISSN 2234-943X |