Cargando…
Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy
After FDA and EMA approval of the regimen containing polatuzumab vedotin plus rituximab and bendamustine (PolaBR), eligible relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients in Italy were granted early access through a Named Patient Program. A multicentric observational retrospectiv...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9663137/ https://www.ncbi.nlm.nih.gov/pubmed/36398133 http://dx.doi.org/10.1097/HS9.0000000000000798 |
_version_ | 1784830804428324864 |
---|---|
author | Argnani, Lisa Broccoli, Alessandro Pellegrini, Cinzia Fabbri, Alberto Puccini, Benedetta Bruna, Riccardo Tisi, Maria Chiara Masia, Francesco Flenghi, Leonardo Nizzoli, Maria Elena Musso, Maurizio Salerno, Marilena Scalzulli, Potito Rosario Dessi’, Daniela Ferrarini, Isacco Pennese, Elsa Lucchini, Elisa Rossi, Francesca Gaia Minoia, Carla Gherlinzoni, Filippo Musto, Pellegrino Patti, Caterina Stefoni, Vittorio Zinzani, Pier Luigi |
author_facet | Argnani, Lisa Broccoli, Alessandro Pellegrini, Cinzia Fabbri, Alberto Puccini, Benedetta Bruna, Riccardo Tisi, Maria Chiara Masia, Francesco Flenghi, Leonardo Nizzoli, Maria Elena Musso, Maurizio Salerno, Marilena Scalzulli, Potito Rosario Dessi’, Daniela Ferrarini, Isacco Pennese, Elsa Lucchini, Elisa Rossi, Francesca Gaia Minoia, Carla Gherlinzoni, Filippo Musto, Pellegrino Patti, Caterina Stefoni, Vittorio Zinzani, Pier Luigi |
author_sort | Argnani, Lisa |
collection | PubMed |
description | After FDA and EMA approval of the regimen containing polatuzumab vedotin plus rituximab and bendamustine (PolaBR), eligible relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients in Italy were granted early access through a Named Patient Program. A multicentric observational retrospective study was conducted focusing on the effectiveness and safety of PolaBR in everyday clinical practice. Fifty-five patients were enrolled. There were 26 females (47.3%), 32 patients were primary refractory and 45 (81.8%) resulted refractory to their last therapy. The decision to add or not bendamustine was at physician’s discretion. Thirty-six patients underwent PolaBR, and 19 PolaR. The 2 groups did not differ in most of baseline characteristics. The final overall response rate was 32.7% (18.2% complete response rate), with a best response rate of 49.1%. Median disease-free survival was reached at 12 months, median progression-free survival at 4.9 months and median overall survival at 9 months, respectively. Overall, 88 adverse events (AEs) were registered during treatment in 31 patients, 22 of grade ≥3. Eight cases of neuropathy occurred, all of grades 1–2 and all related to polatuzumab. The two groups of treatment did not differ for effectiveness endpoints but presented statistically significant difference in AEs occurrence, especially in hematological AEs, in AEs of grade equal or greater than 3 and in incidence of neuropathy. Our data add useful information on the effectiveness of Pola(B)R in the setting of heavily pretreated DLBCL and may also suggest a better tolerability in absence of bendamustine without compromise of efficacy. |
format | Online Article Text |
id | pubmed-9663137 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-96631372022-11-16 Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy Argnani, Lisa Broccoli, Alessandro Pellegrini, Cinzia Fabbri, Alberto Puccini, Benedetta Bruna, Riccardo Tisi, Maria Chiara Masia, Francesco Flenghi, Leonardo Nizzoli, Maria Elena Musso, Maurizio Salerno, Marilena Scalzulli, Potito Rosario Dessi’, Daniela Ferrarini, Isacco Pennese, Elsa Lucchini, Elisa Rossi, Francesca Gaia Minoia, Carla Gherlinzoni, Filippo Musto, Pellegrino Patti, Caterina Stefoni, Vittorio Zinzani, Pier Luigi Hemasphere Article After FDA and EMA approval of the regimen containing polatuzumab vedotin plus rituximab and bendamustine (PolaBR), eligible relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients in Italy were granted early access through a Named Patient Program. A multicentric observational retrospective study was conducted focusing on the effectiveness and safety of PolaBR in everyday clinical practice. Fifty-five patients were enrolled. There were 26 females (47.3%), 32 patients were primary refractory and 45 (81.8%) resulted refractory to their last therapy. The decision to add or not bendamustine was at physician’s discretion. Thirty-six patients underwent PolaBR, and 19 PolaR. The 2 groups did not differ in most of baseline characteristics. The final overall response rate was 32.7% (18.2% complete response rate), with a best response rate of 49.1%. Median disease-free survival was reached at 12 months, median progression-free survival at 4.9 months and median overall survival at 9 months, respectively. Overall, 88 adverse events (AEs) were registered during treatment in 31 patients, 22 of grade ≥3. Eight cases of neuropathy occurred, all of grades 1–2 and all related to polatuzumab. The two groups of treatment did not differ for effectiveness endpoints but presented statistically significant difference in AEs occurrence, especially in hematological AEs, in AEs of grade equal or greater than 3 and in incidence of neuropathy. Our data add useful information on the effectiveness of Pola(B)R in the setting of heavily pretreated DLBCL and may also suggest a better tolerability in absence of bendamustine without compromise of efficacy. Lippincott Williams & Wilkins 2022-11-11 /pmc/articles/PMC9663137/ /pubmed/36398133 http://dx.doi.org/10.1097/HS9.0000000000000798 Text en Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Hematology Association. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. |
spellingShingle | Article Argnani, Lisa Broccoli, Alessandro Pellegrini, Cinzia Fabbri, Alberto Puccini, Benedetta Bruna, Riccardo Tisi, Maria Chiara Masia, Francesco Flenghi, Leonardo Nizzoli, Maria Elena Musso, Maurizio Salerno, Marilena Scalzulli, Potito Rosario Dessi’, Daniela Ferrarini, Isacco Pennese, Elsa Lucchini, Elisa Rossi, Francesca Gaia Minoia, Carla Gherlinzoni, Filippo Musto, Pellegrino Patti, Caterina Stefoni, Vittorio Zinzani, Pier Luigi Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy |
title | Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy |
title_full | Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy |
title_fullStr | Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy |
title_full_unstemmed | Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy |
title_short | Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy |
title_sort | real-world outcomes of relapsed/refractory diffuse large b-cell lymphoma treated with polatuzumab vedotin-based therapy |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9663137/ https://www.ncbi.nlm.nih.gov/pubmed/36398133 http://dx.doi.org/10.1097/HS9.0000000000000798 |
work_keys_str_mv | AT argnanilisa realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT broccolialessandro realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT pellegrinicinzia realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT fabbrialberto realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT puccinibenedetta realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT brunariccardo realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT tisimariachiara realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT masiafrancesco realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT flenghileonardo realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT nizzolimariaelena realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT mussomaurizio realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT salernomarilena realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT scalzullipotitorosario realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT dessidaniela realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT ferrariniisacco realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT penneseelsa realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT lucchinielisa realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT rossifrancescagaia realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT minoiacarla realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT gherlinzonifilippo realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT mustopellegrino realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT patticaterina realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT stefonivittorio realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy AT zinzanipierluigi realworldoutcomesofrelapsedrefractorydiffuselargebcelllymphomatreatedwithpolatuzumabvedotinbasedtherapy |