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A novel prednisone premedication protocol significantly decreases infusion‑related reactions of rituximab in newly diagnosed diffuse large B‑cell lymphoma

Rituximab is a widely used anti-CD20 monoclonal antibody with a high incidence of infusion-related reactions (IRRs) during administration. Reducing the incidence of IRRs remains problematic in hematological practices. In the present study, a novel strategy of a prednisone pretreatment regimen was de...

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Autores principales: Ding, Jianghua, Leng, Zhaohui, Gu, Hong, Jing, Xiang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: D.A. Spandidos 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10189846/
https://www.ncbi.nlm.nih.gov/pubmed/37205922
http://dx.doi.org/10.3892/ol.2023.13844
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author Ding, Jianghua
Leng, Zhaohui
Gu, Hong
Jing, Xiang
author_facet Ding, Jianghua
Leng, Zhaohui
Gu, Hong
Jing, Xiang
author_sort Ding, Jianghua
collection PubMed
description Rituximab is a widely used anti-CD20 monoclonal antibody with a high incidence of infusion-related reactions (IRRs) during administration. Reducing the incidence of IRRs remains problematic in hematological practices. In the present study, a novel strategy of a prednisone pretreatment regimen was designed similar to the combination of rituximab, cyclophosphamide, epirubicin, vincristine and prednisone (R-CHOP) with the aim of exploring the effect on the incidence of IRRs to rituximab in patients with diffuse large B-cell lymphoma (DLBCL). A prospective, randomized (1:1) and controlled study was conducted in three regional hospitals in two groups (n=44 for each group): i) A control group treated with standard R-CHOP-like regimen; and ii) a group receiving a prednisone-pretreatment, modified R-CHOP-like protocol for newly diagnosed patients with DLBCL. The primary endpoint was to assess the incidence of IRRs to rituximab, as well as the association of IRRs with the efficacy of treatment. The second endpoint involved clinical outcomes. The total incidence of IRRs to rituximab in the treatment group was significantly lower compared with that in the control group (15.9 vs. 43.2%; P=0.0051). The different grade incidence of IRRs was lower in the treatment group compared with that in the control group (P=0.0053). In total, 29.5% of patients (26/88) experienced >1 IRR episode. The incidence of IRRs in the pre-treatment group was decreased compared with that in the control group in the 1st cycle (15.9 vs. 43.2%; P=0.0051) and 2nd cycle (6.8 vs. 27.3%; P=0.0107). The overall response rate was similar between the two groups (P>0.05). Median progression-free survival and median overall survival time were not statistically distinct between the two groups (P=0.5244 and P=0.5778, respectively). Grade ≥III toxicities mainly included vomiting and nausea (<20%), leukopenia and granulocytopenia (<20%), and alopecia (<25%). No death events were reported. Apart from IRRs to rituximab, the incidence of other adverse events was similar in both groups. The novel prednisone-pretreatment R-CHOP-like protocol in the present study significantly decreased the total and different grade incidences of IRRs to rituximab among newly diagnosed patients with DLBCL. This clinical trial was retrospectively registered with the Chinese Clinical Trial Registry (registration number, ChiCTR2300070327; date of registration, 10 April 2023).
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spelling pubmed-101898462023-05-18 A novel prednisone premedication protocol significantly decreases infusion‑related reactions of rituximab in newly diagnosed diffuse large B‑cell lymphoma Ding, Jianghua Leng, Zhaohui Gu, Hong Jing, Xiang Oncol Lett Articles Rituximab is a widely used anti-CD20 monoclonal antibody with a high incidence of infusion-related reactions (IRRs) during administration. Reducing the incidence of IRRs remains problematic in hematological practices. In the present study, a novel strategy of a prednisone pretreatment regimen was designed similar to the combination of rituximab, cyclophosphamide, epirubicin, vincristine and prednisone (R-CHOP) with the aim of exploring the effect on the incidence of IRRs to rituximab in patients with diffuse large B-cell lymphoma (DLBCL). A prospective, randomized (1:1) and controlled study was conducted in three regional hospitals in two groups (n=44 for each group): i) A control group treated with standard R-CHOP-like regimen; and ii) a group receiving a prednisone-pretreatment, modified R-CHOP-like protocol for newly diagnosed patients with DLBCL. The primary endpoint was to assess the incidence of IRRs to rituximab, as well as the association of IRRs with the efficacy of treatment. The second endpoint involved clinical outcomes. The total incidence of IRRs to rituximab in the treatment group was significantly lower compared with that in the control group (15.9 vs. 43.2%; P=0.0051). The different grade incidence of IRRs was lower in the treatment group compared with that in the control group (P=0.0053). In total, 29.5% of patients (26/88) experienced >1 IRR episode. The incidence of IRRs in the pre-treatment group was decreased compared with that in the control group in the 1st cycle (15.9 vs. 43.2%; P=0.0051) and 2nd cycle (6.8 vs. 27.3%; P=0.0107). The overall response rate was similar between the two groups (P>0.05). Median progression-free survival and median overall survival time were not statistically distinct between the two groups (P=0.5244 and P=0.5778, respectively). Grade ≥III toxicities mainly included vomiting and nausea (<20%), leukopenia and granulocytopenia (<20%), and alopecia (<25%). No death events were reported. Apart from IRRs to rituximab, the incidence of other adverse events was similar in both groups. The novel prednisone-pretreatment R-CHOP-like protocol in the present study significantly decreased the total and different grade incidences of IRRs to rituximab among newly diagnosed patients with DLBCL. This clinical trial was retrospectively registered with the Chinese Clinical Trial Registry (registration number, ChiCTR2300070327; date of registration, 10 April 2023). D.A. Spandidos 2023-04-28 /pmc/articles/PMC10189846/ /pubmed/37205922 http://dx.doi.org/10.3892/ol.2023.13844 Text en Copyright: © Ding et al. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License (https://creativecommons.org/licenses/by-nc-nd/4.0/) , which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
spellingShingle Articles
Ding, Jianghua
Leng, Zhaohui
Gu, Hong
Jing, Xiang
A novel prednisone premedication protocol significantly decreases infusion‑related reactions of rituximab in newly diagnosed diffuse large B‑cell lymphoma
title A novel prednisone premedication protocol significantly decreases infusion‑related reactions of rituximab in newly diagnosed diffuse large B‑cell lymphoma
title_full A novel prednisone premedication protocol significantly decreases infusion‑related reactions of rituximab in newly diagnosed diffuse large B‑cell lymphoma
title_fullStr A novel prednisone premedication protocol significantly decreases infusion‑related reactions of rituximab in newly diagnosed diffuse large B‑cell lymphoma
title_full_unstemmed A novel prednisone premedication protocol significantly decreases infusion‑related reactions of rituximab in newly diagnosed diffuse large B‑cell lymphoma
title_short A novel prednisone premedication protocol significantly decreases infusion‑related reactions of rituximab in newly diagnosed diffuse large B‑cell lymphoma
title_sort novel prednisone premedication protocol significantly decreases infusion‑related reactions of rituximab in newly diagnosed diffuse large b‑cell lymphoma
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10189846/
https://www.ncbi.nlm.nih.gov/pubmed/37205922
http://dx.doi.org/10.3892/ol.2023.13844
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