Real‐world clinical effectiveness and safety of CT‐P10 in patients with diffuse large B‐cell lymphoma: An observational study in Europe
Abstract 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....
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2023-02-01
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| Series: | eJHaem |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/jha2.593 |
| _version_ | 1797263300057104384 |
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| author | Mark J. Bishton Gilles Salles Camille Golfier Wolfgang Knauf Monica Bocchia Deborah Turner Borhane Slama Jatinder Harchowal Scott Marshall Alberto Bosi Juan José Bargay Lleonart Manfred Welslau SooKyoung Kim Young N. Lee Pier L. Zinzani Kamel Laribi |
| author_facet | Mark J. Bishton Gilles Salles Camille Golfier Wolfgang Knauf Monica Bocchia Deborah Turner Borhane Slama Jatinder Harchowal Scott Marshall Alberto Bosi Juan José Bargay Lleonart Manfred Welslau SooKyoung Kim Young N. Lee Pier L. Zinzani Kamel Laribi |
| author_sort | Mark J. Bishton |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-03-12T14:07:15Z |
| format | Article |
| id | doaj.art-fe50306f84f445cd873e4e8c3079f682 |
| institution | Directory Open Access Journal |
| issn | 2688-6146 |
| language | English |
| last_indexed | 2024-04-25T00:10:49Z |
| publishDate | 2023-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | eJHaem |
| spelling | doaj.art-fe50306f84f445cd873e4e8c3079f6822024-03-13T13:30:47ZengWileyeJHaem2688-61462023-02-0141455410.1002/jha2.593Real‐world clinical effectiveness and safety of CT‐P10 in patients with diffuse large B‐cell lymphoma: An observational study in EuropeMark J. Bishton0Gilles Salles1Camille Golfier2Wolfgang Knauf3Monica Bocchia4Deborah Turner5Borhane Slama6Jatinder Harchowal7Scott Marshall8Alberto Bosi9Juan José Bargay Lleonart10Manfred Welslau11SooKyoung Kim12Young N. Lee13Pier L. Zinzani14Kamel Laribi15Nottingham City HospitalNottingham University Hospitals NHS Trust NottinghamUKCentre Hospitalier Lyon Sud ‐ Service d'Hématologie Clinique LyonFranceCentre Hospitalier Lyon Sud ‐ Service d'Hématologie Clinique LyonFranceCentrum Für Hämatologie und Onkologie Bethanien Frankfurt am MainGermanyHematology UnitAzienda Ospedaliero Universitaria Senese, University of Siena SienaItalyTorbay and South Devon NHS Foundation Trust DevonUKCentre Hospitalier d'Avignon AvignonFranceUniversity College London Hospitals NHS Foundation Trust LondonUKSouth Tyneside and Sunderland NHS Foundation TrustSunderland Royal Hospital SunderlandUKDepartment of Clinical and Experimental MedicineUniversity of Florence FlorenceItalySon Llatzer University Hospital‐ Institut Investigació Sanitaria Illes Balear (IdIsBa) Palma de MallorcaSpainOnkologie Aschaffenburg, Klinikum Aschaffenburg AschaffenburgGermanyCelltrion Healthcare Co. Ltd. IncheonRepublic of KoreaCelltrion Healthcare Co. Ltd. IncheonRepublic of KoreaIRCCS Azienda Ospedaliero‐Universitaria di BolognaIstituto di Ematologia “Seràgnoli” BolognaItalyDepartment of HematologyCentre Hospitalier du Mans Le MansFranceAbstract 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.https://doi.org/10.1002/jha2.593biosimilarDLBCLNHLrituximab |
| spellingShingle | Mark J. Bishton Gilles Salles Camille Golfier Wolfgang Knauf Monica Bocchia Deborah Turner Borhane Slama Jatinder Harchowal Scott Marshall Alberto Bosi Juan José Bargay Lleonart Manfred Welslau SooKyoung Kim Young N. Lee Pier L. Zinzani Kamel Laribi Real‐world clinical effectiveness and safety of CT‐P10 in patients with diffuse large B‐cell lymphoma: An observational study in Europe eJHaem biosimilar DLBCL NHL rituximab |
| 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 | biosimilar DLBCL NHL rituximab |
| url | https://doi.org/10.1002/jha2.593 |
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