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Subcutaneous rituximab in patients with diffuse large B cell lymphoma and follicular lymphoma: Final results of the non‐interventional study MabSCale

BACKGROUND: Rituximab has become a standard treatment for non‐Hodgkin lymphoma. Clinical studies have demonstrated the efficacy of rituximab in combination with standard chemotherapies in the treatment of follicular lymphoma (FL) and diffuse large B cell lymphoma (DLBCL) patients. This non‐intervent...

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Autores principales: Dürig, Jan, Uhlig, Jens, Gerhardt, Anke, Ritter, Markus, Hapke, Gunnar, Heßling, Jörg, Staib, Peter, Wolff, Frieder, Krumm, Katja, von Weikersthal, Ludwig Fischer
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/PMC9939131/
https://www.ncbi.nlm.nih.gov/pubmed/36017743
http://dx.doi.org/10.1002/cam4.5160
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author Dürig, Jan
Uhlig, Jens
Gerhardt, Anke
Ritter, Markus
Hapke, Gunnar
Heßling, Jörg
Staib, Peter
Wolff, Frieder
Krumm, Katja
von Weikersthal, Ludwig Fischer
author_facet Dürig, Jan
Uhlig, Jens
Gerhardt, Anke
Ritter, Markus
Hapke, Gunnar
Heßling, Jörg
Staib, Peter
Wolff, Frieder
Krumm, Katja
von Weikersthal, Ludwig Fischer
author_sort Dürig, Jan
collection PubMed
description BACKGROUND: Rituximab has become a standard treatment for non‐Hodgkin lymphoma. Clinical studies have demonstrated the efficacy of rituximab in combination with standard chemotherapies in the treatment of follicular lymphoma (FL) and diffuse large B cell lymphoma (DLBCL) patients. This non‐interventional study aimed to evaluate the effectiveness and safety of subcutaneous (SC) rituximab in routine clinical practice. METHODS: Adult patients with previously untreated CD20 positive DLBCL or FL who received rituximab SC and chemotherapy as first‐line treatment were observed between 07/2014 and 07/2019 at 99 institutions in Germany. Primary endpoint was the (unconfirmed) complete remission (CR/CRu) rate. Primary outcome was analyzed inferentially; other variables were evaluated descriptively. RESULTS: Overall 583 patients (247 FL; 336 DLBCL) were evaluated. CR/CRu rates were 51.4% (95% CI: 45.2; 57.6) in the FL set and 48.5% (95% CI: 43.2; 53.8) in the DLBCL set. Regarding progression‐free survival in the FL group, the probability of being event‐free was 94.2% in the first year and 86.2% in the second year. An overall response was achieved in 85.8% (FL) and 85.4% patients (DLBCL). Patient satisfaction at the end of study with the time saving simplification of the SC vs. intravenous route was 98% for FL and 97% for DLBCL. 45.3% of FL and 47.0% of DLBCL patients experienced an adverse event of grade ≥3. Serious adverse events of grade ≥3 occurred in 27.9% FL and 32.4% DLBCL patients, with the highest incidences for leucopenia, anemia, nausea, and fatigue. No new safety signals were detected. CONCLUSIONS: The results confirmed the effectiveness and safety of rituximab SC in both the FL and the DLBCL group. Satisfaction of patients and nurses with SC administration was high.
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spelling pubmed-99391312023-02-20 Subcutaneous rituximab in patients with diffuse large B cell lymphoma and follicular lymphoma: Final results of the non‐interventional study MabSCale Dürig, Jan Uhlig, Jens Gerhardt, Anke Ritter, Markus Hapke, Gunnar Heßling, Jörg Staib, Peter Wolff, Frieder Krumm, Katja von Weikersthal, Ludwig Fischer Cancer Med RESEARCH ARTICLES BACKGROUND: Rituximab has become a standard treatment for non‐Hodgkin lymphoma. Clinical studies have demonstrated the efficacy of rituximab in combination with standard chemotherapies in the treatment of follicular lymphoma (FL) and diffuse large B cell lymphoma (DLBCL) patients. This non‐interventional study aimed to evaluate the effectiveness and safety of subcutaneous (SC) rituximab in routine clinical practice. METHODS: Adult patients with previously untreated CD20 positive DLBCL or FL who received rituximab SC and chemotherapy as first‐line treatment were observed between 07/2014 and 07/2019 at 99 institutions in Germany. Primary endpoint was the (unconfirmed) complete remission (CR/CRu) rate. Primary outcome was analyzed inferentially; other variables were evaluated descriptively. RESULTS: Overall 583 patients (247 FL; 336 DLBCL) were evaluated. CR/CRu rates were 51.4% (95% CI: 45.2; 57.6) in the FL set and 48.5% (95% CI: 43.2; 53.8) in the DLBCL set. Regarding progression‐free survival in the FL group, the probability of being event‐free was 94.2% in the first year and 86.2% in the second year. An overall response was achieved in 85.8% (FL) and 85.4% patients (DLBCL). Patient satisfaction at the end of study with the time saving simplification of the SC vs. intravenous route was 98% for FL and 97% for DLBCL. 45.3% of FL and 47.0% of DLBCL patients experienced an adverse event of grade ≥3. Serious adverse events of grade ≥3 occurred in 27.9% FL and 32.4% DLBCL patients, with the highest incidences for leucopenia, anemia, nausea, and fatigue. No new safety signals were detected. CONCLUSIONS: The results confirmed the effectiveness and safety of rituximab SC in both the FL and the DLBCL group. Satisfaction of patients and nurses with SC administration was high. John Wiley and Sons Inc. 2022-08-26 /pmc/articles/PMC9939131/ /pubmed/36017743 http://dx.doi.org/10.1002/cam4.5160 Text en © 2022 The Authors. Cancer Medicine published by 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 RESEARCH ARTICLES
Dürig, Jan
Uhlig, Jens
Gerhardt, Anke
Ritter, Markus
Hapke, Gunnar
Heßling, Jörg
Staib, Peter
Wolff, Frieder
Krumm, Katja
von Weikersthal, Ludwig Fischer
Subcutaneous rituximab in patients with diffuse large B cell lymphoma and follicular lymphoma: Final results of the non‐interventional study MabSCale
title Subcutaneous rituximab in patients with diffuse large B cell lymphoma and follicular lymphoma: Final results of the non‐interventional study MabSCale
title_full Subcutaneous rituximab in patients with diffuse large B cell lymphoma and follicular lymphoma: Final results of the non‐interventional study MabSCale
title_fullStr Subcutaneous rituximab in patients with diffuse large B cell lymphoma and follicular lymphoma: Final results of the non‐interventional study MabSCale
title_full_unstemmed Subcutaneous rituximab in patients with diffuse large B cell lymphoma and follicular lymphoma: Final results of the non‐interventional study MabSCale
title_short Subcutaneous rituximab in patients with diffuse large B cell lymphoma and follicular lymphoma: Final results of the non‐interventional study MabSCale
title_sort subcutaneous rituximab in patients with diffuse large b cell lymphoma and follicular lymphoma: final results of the non‐interventional study mabscale
topic RESEARCH ARTICLES
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9939131/
https://www.ncbi.nlm.nih.gov/pubmed/36017743
http://dx.doi.org/10.1002/cam4.5160
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