Bortezomib-melphalan-prednisone and continuous lenalidomide-dexamethasone represent the standard treatment of transplant-ineligible, newly diagnosed, multiple myeloma patients. To date, no randomized trial has compared bortezomib-melphalan-prednisone to lenalidomide-dexamethasone, and there is no evidence of the optimal treatment for newly diagnosed multiple myeloma, particularly in high-risk cytogenetic patients (del(17p), t(4;14) or t(14;16)). We pooled together data from newly diagnosed myeloma patients treated with bortezomib-melphalan-prednisone or lenalidomide-dexamethasone induction followed by lenalidomide maintenance 10 mg enrolled in the GIMEMA-MM-03-05 and EMN01 trials, to evaluate their efficacy in different patient subgroups, focusing on standard and high-risk cytogenetics. Overall, 474 patients were analyzed (bortezomib-melphalan-prednisone: 257 patients; lenalidomide-dexamethasone followed by lenalidomide maintenance: 217 patients). No difference in progression-free survival (Hazard Ratio: 0.96) and overall survival (Hazard Ratio: 1.08) was observed between bortezomib-melphalan-prednisone and lenalidomide-dexamethasone followed by lenalidomide in standard-risk, while a reduction in the risk of progression (Hazard Ratio: 0.54) and death (Hazard Ratio: 0.73) was seen in high-risk patients treated with bortezomib-melphalan-prednisone vs. lenalidomide-dexamethasone followed by lenalidomide. In particular, standard risk patients >75years benefited less from bortezomib-melphalan-prednisone than lenalidomide-dexamethasone followed by lenalidomide (Hazard Ratio for progression-free survival: 0.96; Hazard Ratio for overall survival: 1.81). In this non-randomized analysis, bortezomib-melphalan-prednisone and lenalidomide-dexamethasone followed by lenalidomide were equally effective in younger (≤75years), standard-risk patients, while older ones (>75years) benefited more from lenalidomide-dexamethasone followed by lenalidomide. In high-risk patients, bortezomib-melphalan-prednisone improved progression-free survival and overall survival irrespective of age. The source trials are registered at ClinicalTrials.gov (NCT01063179 and NCT01093196).

First-line therapy with either bortezomib-melphalan-prednisone or lenalidomide-dexamethasone followed by lenalidomide for transplant-ineligible multiple myeloma patients: a pooled analysis of two randomized trials

Larocca, Alessandra
First
;
Mina, Roberto;Evangelista, Andrea;Spada, Stefano;Oddolo, Daniela;Palumbo, Antonio;Boccadoro, Mario;Bringhen, Sara
Last
2020-01-01

Abstract

Bortezomib-melphalan-prednisone and continuous lenalidomide-dexamethasone represent the standard treatment of transplant-ineligible, newly diagnosed, multiple myeloma patients. To date, no randomized trial has compared bortezomib-melphalan-prednisone to lenalidomide-dexamethasone, and there is no evidence of the optimal treatment for newly diagnosed multiple myeloma, particularly in high-risk cytogenetic patients (del(17p), t(4;14) or t(14;16)). We pooled together data from newly diagnosed myeloma patients treated with bortezomib-melphalan-prednisone or lenalidomide-dexamethasone induction followed by lenalidomide maintenance 10 mg enrolled in the GIMEMA-MM-03-05 and EMN01 trials, to evaluate their efficacy in different patient subgroups, focusing on standard and high-risk cytogenetics. Overall, 474 patients were analyzed (bortezomib-melphalan-prednisone: 257 patients; lenalidomide-dexamethasone followed by lenalidomide maintenance: 217 patients). No difference in progression-free survival (Hazard Ratio: 0.96) and overall survival (Hazard Ratio: 1.08) was observed between bortezomib-melphalan-prednisone and lenalidomide-dexamethasone followed by lenalidomide in standard-risk, while a reduction in the risk of progression (Hazard Ratio: 0.54) and death (Hazard Ratio: 0.73) was seen in high-risk patients treated with bortezomib-melphalan-prednisone vs. lenalidomide-dexamethasone followed by lenalidomide. In particular, standard risk patients >75years benefited less from bortezomib-melphalan-prednisone than lenalidomide-dexamethasone followed by lenalidomide (Hazard Ratio for progression-free survival: 0.96; Hazard Ratio for overall survival: 1.81). In this non-randomized analysis, bortezomib-melphalan-prednisone and lenalidomide-dexamethasone followed by lenalidomide were equally effective in younger (≤75years), standard-risk patients, while older ones (>75years) benefited more from lenalidomide-dexamethasone followed by lenalidomide. In high-risk patients, bortezomib-melphalan-prednisone improved progression-free survival and overall survival irrespective of age. The source trials are registered at ClinicalTrials.gov (NCT01063179 and NCT01093196).
2020
105
4
1074
1080
https://haematologica.org/article/view/9342
https://doi.org/10.3324/haematol.2019.220657
bortezomib; elderly; lenalidomide; multiple myeloma; newly diagnosed
Larocca, Alessandra; Mina, Roberto; Offidani, Massimo; Liberati, Anna Marina; Ledda, Antonio; Patriarca, Francesca; Evangelista, Andrea; Spada, Stefan...espandi
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Descrizione: [PUBLISHED Vsn.] Larocca et al. Haematologica . 2020 Apr;105(4):1074-1080. doi: 10.3324/haematol.2019.220657. Epub 2019 Jun 27. © 2020 Ferrata Storti Foundation. Available at: https://haematologica.org/article/view/9342 | https://doi.org/10.3324/haematol.2019.220657
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2318/1732727
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