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

eJHaem

article

Mark J. Bishton¹  Gilles Salles³  Camille Golfier³  Wolfgang Knauf⁵  Monica Bocchia⁶  Deborah Turner⁷  Borhane Slama⁸  Jatinder Harchowal⁹  Scott Marshall^1,11  Alberto Bosi^1,12  Juan José Bargay Lleonart^1,13  Manfred Welslau^1,14  SooKyoung Kim^1,15  Young N. Lee^1,15  Pier L. Zinzani^1,16  Kamel Laribi^1,18 

[1] Nottingham City Hospital, Nottingham University Hospitals NHS Trust;Translational Medical Sciences, University of Nottingham;Centre Hospitalier Lyon Sud - Service d'Hématologie Clinique;This work was completed when at Memorial Sloan Kettering Cancer Center New York;Centrum Für Hämatologie und Onkologie Bethanien;Hematology Unit, Azienda Ospedaliero Universitaria Senese, University of Siena;Torbay and South Devon NHS Foundation Trust;Centre Hospitalier d'Avignon;University College London Hospitals NHS Foundation Trust;This work was completed when at The Royal Marsden NHS Foundation Trust;South Tyneside and Sunderland NHS Foundation Trust, Sunderland Royal Hospital;Department of Clinical and Experimental Medicine, University of Florence;Son Llatzer University Hospital- Institut Investigació Sanitaria Illes Balear;Onkologie Aschaffenburg;Celltrion Healthcare Co. Ltd., Incheon;IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia “Seràgnoli”;Dipartimento di Medicina Specialistica e Sperimentale, Università di Bologna;Department of Hematology, Centre Hospitalier du Mans

关键词: biosimilar;    DLBCL;    NHL;    rituximab;   

DOI  :  10.1002/jha2.593

来源: Wiley

【 摘 要 】

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.

【 授权许可】

Unknown