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Real‐world clinical effectiveness and safety of CT‐P10 in patients with diffuse large B‐cell lymphoma: An observational study in Europe

The rituximab biosimilar CT‐P10 is approved for the treatment of non‐Hodgkin lymphoma. Previous studies have demonstrated clinical similarity between CT‐P10 and reference rituximab. However, real‐world data relating to treatment in patients with DLBCL with rituximab biosimilars are limited. This stu...

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Autores principales: Bishton, Mark J., Salles, Gilles, Golfier, Camille, Knauf, Wolfgang, Bocchia, Monica, Turner, Deborah, Slama, Borhane, Harchowal, Jatinder, Marshall, Scott, Bosi, Alberto, Lleonart, Juan José Bargay, Welslau, Manfred, Kim, SooKyoung, Lee, Young N., Zinzani, Pier L., Laribi, Kamel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9928637/
https://www.ncbi.nlm.nih.gov/pubmed/36819165
http://dx.doi.org/10.1002/jha2.593
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author Bishton, Mark J.
Salles, Gilles
Golfier, Camille
Knauf, Wolfgang
Bocchia, Monica
Turner, Deborah
Slama, Borhane
Harchowal, Jatinder
Marshall, Scott
Bosi, Alberto
Lleonart, Juan José Bargay
Welslau, Manfred
Kim, SooKyoung
Lee, Young N.
Zinzani, Pier L.
Laribi, Kamel
author_facet Bishton, Mark J.
Salles, Gilles
Golfier, Camille
Knauf, Wolfgang
Bocchia, Monica
Turner, Deborah
Slama, Borhane
Harchowal, Jatinder
Marshall, Scott
Bosi, Alberto
Lleonart, Juan José Bargay
Welslau, Manfred
Kim, SooKyoung
Lee, Young N.
Zinzani, Pier L.
Laribi, Kamel
author_sort Bishton, Mark J.
collection PubMed
description The rituximab biosimilar CT‐P10 is approved for the treatment of non‐Hodgkin lymphoma. Previous studies have demonstrated clinical similarity between CT‐P10 and reference rituximab. However, real‐world data relating to treatment in patients with DLBCL with rituximab biosimilars are limited. This study collected real‐world data relating to the effectiveness and safety of CT‐P10 treatment from the medical records of 389 patients with DLBCL (24 centers, five European countries). For the primary outcome (clinical effectiveness), overall survival (OS), progression‐free survival (PFS), and best response (BR) were assessed. The percentage (95% confidence interval [95% CI]) of patients alive at 12‐, 18‐, and 30 months postindex (initiation of CT‐P10) was 86% (82.4%–89.4%), 81% (76.9%–84.9%), and 76% (71.2%–80.1%), respectively. The PFS rate (percent, [95% CI]) at 12‐, 18‐, and 30 months postindex was 78% (74.2%–82.5%), 72% (67.9%–76.9%), and 67% (61.9%–71.7%), respectively. Median OS/PFS was not reached. For 82% (n = 312) of patients, the BR to CT‐P10 was a complete response. Adverse events were consistent with known effects of chemotherapy. This international, multicenter study provides real‐world data on the safety and effectiveness profile of CT‐P10 for DLBCL treatment and supports the adoption of CT‐P10 for the treatment of DLBCL.
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spelling pubmed-99286372023-02-16 Real‐world clinical effectiveness and safety of CT‐P10 in patients with diffuse large B‐cell lymphoma: An observational study in Europe Bishton, Mark J. Salles, Gilles Golfier, Camille Knauf, Wolfgang Bocchia, Monica Turner, Deborah Slama, Borhane Harchowal, Jatinder Marshall, Scott Bosi, Alberto Lleonart, Juan José Bargay Welslau, Manfred Kim, SooKyoung Lee, Young N. Zinzani, Pier L. Laribi, Kamel EJHaem Haematologic Malignancy ‐ Lymphoid The rituximab biosimilar CT‐P10 is approved for the treatment of non‐Hodgkin lymphoma. Previous studies have demonstrated clinical similarity between CT‐P10 and reference rituximab. However, real‐world data relating to treatment in patients with DLBCL with rituximab biosimilars are limited. This study collected real‐world data relating to the effectiveness and safety of CT‐P10 treatment from the medical records of 389 patients with DLBCL (24 centers, five European countries). For the primary outcome (clinical effectiveness), overall survival (OS), progression‐free survival (PFS), and best response (BR) were assessed. The percentage (95% confidence interval [95% CI]) of patients alive at 12‐, 18‐, and 30 months postindex (initiation of CT‐P10) was 86% (82.4%–89.4%), 81% (76.9%–84.9%), and 76% (71.2%–80.1%), respectively. The PFS rate (percent, [95% CI]) at 12‐, 18‐, and 30 months postindex was 78% (74.2%–82.5%), 72% (67.9%–76.9%), and 67% (61.9%–71.7%), respectively. Median OS/PFS was not reached. For 82% (n = 312) of patients, the BR to CT‐P10 was a complete response. Adverse events were consistent with known effects of chemotherapy. This international, multicenter study provides real‐world data on the safety and effectiveness profile of CT‐P10 for DLBCL treatment and supports the adoption of CT‐P10 for the treatment of DLBCL. John Wiley and Sons Inc. 2022-11-06 /pmc/articles/PMC9928637/ /pubmed/36819165 http://dx.doi.org/10.1002/jha2.593 Text en © 2022 The Authors. eJHaem published by British Society for Haematology and John Wiley & Sons Ltd. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Haematologic Malignancy ‐ Lymphoid
Bishton, Mark J.
Salles, Gilles
Golfier, Camille
Knauf, Wolfgang
Bocchia, Monica
Turner, Deborah
Slama, Borhane
Harchowal, Jatinder
Marshall, Scott
Bosi, Alberto
Lleonart, Juan José Bargay
Welslau, Manfred
Kim, SooKyoung
Lee, Young N.
Zinzani, Pier L.
Laribi, Kamel
Real‐world clinical effectiveness and safety of CT‐P10 in patients with diffuse large B‐cell lymphoma: An observational study in Europe
title Real‐world clinical effectiveness and safety of CT‐P10 in patients with diffuse large B‐cell lymphoma: An observational study in Europe
title_full Real‐world clinical effectiveness and safety of CT‐P10 in patients with diffuse large B‐cell lymphoma: An observational study in Europe
title_fullStr Real‐world clinical effectiveness and safety of CT‐P10 in patients with diffuse large B‐cell lymphoma: An observational study in Europe
title_full_unstemmed Real‐world clinical effectiveness and safety of CT‐P10 in patients with diffuse large B‐cell lymphoma: An observational study in Europe
title_short Real‐world clinical effectiveness and safety of CT‐P10 in patients with diffuse large B‐cell lymphoma: An observational study in Europe
title_sort real‐world clinical effectiveness and safety of ct‐p10 in patients with diffuse large b‐cell lymphoma: an observational study in europe
topic Haematologic Malignancy ‐ Lymphoid
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9928637/
https://www.ncbi.nlm.nih.gov/pubmed/36819165
http://dx.doi.org/10.1002/jha2.593
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