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      Estudio de terapia secuencial en mieloma múltiple en recaída Translated title: Sequential therapy study in relapsed multiple myeloma

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          Abstract

          Resumen Objetivo: Evaluar la efectividad y la seguridad de dos secuencias de tratamiento diferentes utilizadas en pacientes diagnosticados de mieloma múltiple no candidatos a trasplante de médula ósea según la práctica clínica habitual. Material y métodos: Se trata de un estudio post-autorización observacional no intervencionista de seguimiento retrospectivo/prospectivo, unicéntrico realizado en un hospital de tercer nivel desde enero de 2015 hasta octubre de 2019. El estudio se realizó en dos fases: Una retrospectiva donde se analizaron los pacientes que habían recibido bortezomib como retratamiento en primera recaída y lenalidomida en segunda recaída, tras haber recibido una primera línea con bortezomib; y una prospectiva donde se analizaron los pacientes que iban a recibir lenalidomida en primera recaída, seguido de bortezomib en segunda recaída. La variable principal del estudio fue el tiempo hasta progresión (TTP) de cada secuencia y las variables secundarias fueron supervivencia global (SG), reacciones adversas más frecuentes y otras. Resultados: Se incluyeron 110 pacientes, 55 en la fase retrospectiva y 55 en la prospectiva. El tiempo mediano libre de progresión por serie fue de 29,0 meses para los pacientes de la serie retrospectiva y de 31,0 meses para los de la serie prospectiva. La mediana de supervivencia global fue de 61,0 meses para los pacientes de la serie retrospectiva y de 64,0 meses para los de la prospectiva. Conclusiones: En términos de resultados en salud, la secuencia 2 que utilizó la lenalidomida en primera recaída resultó más efectiva y segura que la secuencia 1 que utilizó el bortezomib como retratamiento.

          Translated abstract

          Abstract Objective: To evaluate the effectiveness and safety of two different treatment sequences used in patients diagnosed with multiple myeloma who are not candidates for bone marrow transplantation according to usual clinical practice. Material and methods: Retrospective/ prospective follow-up non-interventional post-authorization observational study, conducted at a third level hospital from January 2015 to October 2019. The study was conducted in two phases: A retrospective phase where patients who had received bortezomib as retreatment in first relapse and lenalidomide in the second relapse, after having received a first-line with bortezomib, were analyzed; and a prospective phase where patients who were going to receive lenalidomide in the first relapse, followed by bortezomib in second relapse, were analyzed. The primary variable of the study was the time to progression (TTP) of each treatment sequence, and the secondary variables were global survival (SG), more frequent adverse reactions and others defined in the statistical analysis. Results: 110 patients were included, 55 in the retrospective phase and 55 in the prospective phase. The median time free of progression per series was 29.0 months for patients in the retrospective series and 31.0 months for patients in the prospective series. The median overall survival was 61.0 months for patients in the retrospective series and 64.0 months for those in the prospective series. Conclusions: In terms of health outcomes, treatment sequence 2 using lenalidomide at first relapse was more effective and safe than treatment sequence 1 using bortezomib as retreatment.

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          Most cited references27

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          Multiple Myeloma

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            The proteasome inhibitor PS-341 inhibits growth, induces apoptosis, and overcomes drug resistance in human multiple myeloma cells.

            Human multiple myeloma (MM) is a presently incurable hematological malignancy, and novel biologically based therapies are urgently needed. Proteasome inhibitors represent a novel potential anticancer therapy. In this study, we demonstrate that the proteasome inhibitor PS-341 directly inhibits proliferation and induces apoptosis of human MM cell lines and freshly isolated patient MM cells; inhibits mitogen-activated protein kinase growth signaling in MM cells; induces apoptosis despite induction of p21 and p27 in both p53 wild-type and p53 mutant MM cells; overcomes drug resistance; adds to the anti-MM activity of dexamethasone; and overcomes the resistance to apoptosis in MM cells conferred by interleukin-6. PS-341 also inhibits the paracrine growth of human MM cells by decreasing their adherence to bone marrow stromal cells (BMSCs) and related nuclear factor kappaB-dependent induction of interleukin-6 secretion in BMSCs, as well as inhibiting proliferation and growth signaling of residual adherent MM cells. These data, therefore, demonstrate that PS-341 both acts directly on MM cells and alters cellular interactions and cytokine secretion in the BM millieu to inhibit tumor cell growth, induce apoptosis, and overcome drug resistance. Given the acceptable animal and human toxicity profile of PS-341, these studies provide the framework for clinical evaluation of PS-341 to improve outcome for patients with this universally fatal hematological malignancy.
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              Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1.

              It is essential that there be consistency in the conduct, analysis, and reporting of clinical trial results in myeloma. The goal of the International Myeloma Workshop Consensus Panel 1 was to develop a set of guidelines for the uniform reporting of clinical trial results in myeloma. This paper provides a summary of the current response criteria in myeloma, detailed definitions for patient populations, lines of therapy, and specific endpoints. We propose that future clinical trials in myeloma follow the guidelines for reporting results proposed in this manuscript.
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                Author and article information

                Journal
                ofil
                Revista de la OFIL
                Rev. OFIL·ILAPHAR
                Organización de Farmacéuticos Ibero-Latinoamericanos (Madrid, Madrid, Spain )
                1131-9429
                1699-714X
                September 2022
                : 32
                : 3
                : 283-290
                Affiliations
                [1] Jaén orgnameHospital Universitario de Jaén orgdiv1Servicio de Farmacia España carolina.alarcon.sspa@ 123456juntadeandalucia.es
                [2] Granada orgnameHospital Universitario Virgen de las Nieves orgdiv1Servicio de Farmacia España
                [3] Granada orgnameHospital Universitario Virgen de las Nieves orgdiv1Servicio de Hematología y Hemoterapia España
                [4] Sevilla orgnameHospital Universitario Virgen Macarena orgdiv1Servicio de Farmacia España
                Article
                S1699-714X2022000300012 S1699-714X(22)03200300012
                10.4321/s1699-714x20220003000012
                a74a9a63-be23-4554-912c-a66eb832374f

                This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

                History
                : 01 February 2021
                : 26 February 2021
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 27, Pages: 8
                Product

                SciELO Spain

                Categories
                Originales

                Multiple myeloma,Mieloma múltiple,resultados en salud,terapia secuencial,health outcomes,sequential therapy

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