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Pomalidomide Plus Low-Dose Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients: Results of the Real-World “POWERFUL” Study

The “POWERFUL” multicenter, retrospective, and prospective study investigated the effectiveness of pomalidomide plus low-dose dexamethasone (POM/LoDex) therapy in relapsed/refractory multiple myeloma in routine care in Greece. Ninety-nine eligible adult patients treated with POM/LoDex according to t...

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Autores principales: Terpos, Evangelos, Repousis, Panagiotis, Lalayanni, Chrysavgi, Hatjiharissi, Evdoxia, Assimakopoulou, Theodora, Vassilopoulos, Georgios, Pouli, Anastasia, Spanoudakis, Emmanouil, Michalis, Eurydiki, Pangalis, Gerassimos, Ntanasis-Stathopoulos, Ioannis, Poziopoulos, Christos, Kyrtsonis, Marie-Christine, Pappa, Vasiliki, Symeonidis, Argiris, Georgopoulos, Christos, Zikos, Panagiotis M., Gavriatopoulou, Maria, Papadaki, Helen A., Dadakaridou, Magdalini, Karvounis-Marolachakis, Kiki, Katodritou, Eirini
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8038613/
https://www.ncbi.nlm.nih.gov/pubmed/33916376
http://dx.doi.org/10.3390/jcm10071509
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author Terpos, Evangelos
Repousis, Panagiotis
Lalayanni, Chrysavgi
Hatjiharissi, Evdoxia
Assimakopoulou, Theodora
Vassilopoulos, Georgios
Pouli, Anastasia
Spanoudakis, Emmanouil
Michalis, Eurydiki
Pangalis, Gerassimos
Ntanasis-Stathopoulos, Ioannis
Poziopoulos, Christos
Kyrtsonis, Marie-Christine
Pappa, Vasiliki
Symeonidis, Argiris
Georgopoulos, Christos
Zikos, Panagiotis M.
Gavriatopoulou, Maria
Papadaki, Helen A.
Dadakaridou, Magdalini
Karvounis-Marolachakis, Kiki
Katodritou, Eirini
author_facet Terpos, Evangelos
Repousis, Panagiotis
Lalayanni, Chrysavgi
Hatjiharissi, Evdoxia
Assimakopoulou, Theodora
Vassilopoulos, Georgios
Pouli, Anastasia
Spanoudakis, Emmanouil
Michalis, Eurydiki
Pangalis, Gerassimos
Ntanasis-Stathopoulos, Ioannis
Poziopoulos, Christos
Kyrtsonis, Marie-Christine
Pappa, Vasiliki
Symeonidis, Argiris
Georgopoulos, Christos
Zikos, Panagiotis M.
Gavriatopoulou, Maria
Papadaki, Helen A.
Dadakaridou, Magdalini
Karvounis-Marolachakis, Kiki
Katodritou, Eirini
author_sort Terpos, Evangelos
collection PubMed
description The “POWERFUL” multicenter, retrospective, and prospective study investigated the effectiveness of pomalidomide plus low-dose dexamethasone (POM/LoDex) therapy in relapsed/refractory multiple myeloma in routine care in Greece. Ninety-nine eligible adult patients treated with POM/LoDex according to the approved label after having received ≥2 prior therapies, including lenalidomide and bortezomib, were consecutively enrolled between 16 November 2017 and 21 February 2019 in 18 hematology departments. Fifty patients (50.5%) started POM/LoDex as third-line treatment. During the treatment period (median: 8.3 months; range: 0.3–47.6 months), the median POM dose was 4 mg/day, and 31.3% of the patients received additional antimyeloma agents. The overall response rate was 32.3%. During a median follow-up period of 13.8 months (Kaplan–Meier estimate), the median progression-free survival (PFS) was 10.5 months (95% CI: 7.4–14.4). The PFS was not significantly different between patients receiving POM/LoDex in the third versus later line of therapy, nor between patients receiving concomitant antimyeloma therapy versus POM/LoDEx doublet. During the prospective safety data collection period (median: 7.6 months) among patients with prospective follow-up (N = 75), POM-related adverse event incidence rate was 42.7% (serious: 18.7%; grade  ≥  3 hematological POM-related adverse events: 8.0%). Only neutropenia (13.3%) was reported at a frequency ≥10%. In conclusion, in this real-world study, POM/LoDex displayed a long PFS with no new safety signals emerging.
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spelling pubmed-80386132021-04-12 Pomalidomide Plus Low-Dose Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients: Results of the Real-World “POWERFUL” Study Terpos, Evangelos Repousis, Panagiotis Lalayanni, Chrysavgi Hatjiharissi, Evdoxia Assimakopoulou, Theodora Vassilopoulos, Georgios Pouli, Anastasia Spanoudakis, Emmanouil Michalis, Eurydiki Pangalis, Gerassimos Ntanasis-Stathopoulos, Ioannis Poziopoulos, Christos Kyrtsonis, Marie-Christine Pappa, Vasiliki Symeonidis, Argiris Georgopoulos, Christos Zikos, Panagiotis M. Gavriatopoulou, Maria Papadaki, Helen A. Dadakaridou, Magdalini Karvounis-Marolachakis, Kiki Katodritou, Eirini J Clin Med Article The “POWERFUL” multicenter, retrospective, and prospective study investigated the effectiveness of pomalidomide plus low-dose dexamethasone (POM/LoDex) therapy in relapsed/refractory multiple myeloma in routine care in Greece. Ninety-nine eligible adult patients treated with POM/LoDex according to the approved label after having received ≥2 prior therapies, including lenalidomide and bortezomib, were consecutively enrolled between 16 November 2017 and 21 February 2019 in 18 hematology departments. Fifty patients (50.5%) started POM/LoDex as third-line treatment. During the treatment period (median: 8.3 months; range: 0.3–47.6 months), the median POM dose was 4 mg/day, and 31.3% of the patients received additional antimyeloma agents. The overall response rate was 32.3%. During a median follow-up period of 13.8 months (Kaplan–Meier estimate), the median progression-free survival (PFS) was 10.5 months (95% CI: 7.4–14.4). The PFS was not significantly different between patients receiving POM/LoDex in the third versus later line of therapy, nor between patients receiving concomitant antimyeloma therapy versus POM/LoDEx doublet. During the prospective safety data collection period (median: 7.6 months) among patients with prospective follow-up (N = 75), POM-related adverse event incidence rate was 42.7% (serious: 18.7%; grade  ≥  3 hematological POM-related adverse events: 8.0%). Only neutropenia (13.3%) was reported at a frequency ≥10%. In conclusion, in this real-world study, POM/LoDex displayed a long PFS with no new safety signals emerging. MDPI 2021-04-05 /pmc/articles/PMC8038613/ /pubmed/33916376 http://dx.doi.org/10.3390/jcm10071509 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Terpos, Evangelos
Repousis, Panagiotis
Lalayanni, Chrysavgi
Hatjiharissi, Evdoxia
Assimakopoulou, Theodora
Vassilopoulos, Georgios
Pouli, Anastasia
Spanoudakis, Emmanouil
Michalis, Eurydiki
Pangalis, Gerassimos
Ntanasis-Stathopoulos, Ioannis
Poziopoulos, Christos
Kyrtsonis, Marie-Christine
Pappa, Vasiliki
Symeonidis, Argiris
Georgopoulos, Christos
Zikos, Panagiotis M.
Gavriatopoulou, Maria
Papadaki, Helen A.
Dadakaridou, Magdalini
Karvounis-Marolachakis, Kiki
Katodritou, Eirini
Pomalidomide Plus Low-Dose Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients: Results of the Real-World “POWERFUL” Study
title Pomalidomide Plus Low-Dose Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients: Results of the Real-World “POWERFUL” Study
title_full Pomalidomide Plus Low-Dose Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients: Results of the Real-World “POWERFUL” Study
title_fullStr Pomalidomide Plus Low-Dose Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients: Results of the Real-World “POWERFUL” Study
title_full_unstemmed Pomalidomide Plus Low-Dose Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients: Results of the Real-World “POWERFUL” Study
title_short Pomalidomide Plus Low-Dose Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients: Results of the Real-World “POWERFUL” Study
title_sort pomalidomide plus low-dose dexamethasone in relapsed/refractory multiple myeloma patients: results of the real-world “powerful” study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8038613/
https://www.ncbi.nlm.nih.gov/pubmed/33916376
http://dx.doi.org/10.3390/jcm10071509
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