TY - JOUR
T1 - Safety of bendamustine for the treatment of indolent non-Hodgkin lymphoma
T2 - a UK real-world experience
AU - Shotton, Rohan
AU - Broadbent, Rachel
AU - Alchawaf, Alia
AU - Mohamed, Mohamed Bakri
AU - Gibb, Adam
AU - Martinez-Calle, Nicolás
AU - Fox, Christopher P
AU - Bishton, Mark
AU - Pender, Alexandra
AU - Gleeson, Mary
AU - Cunningham, David
AU - Davies, Andrew
AU - Yadollahi, Sina
AU - Eyre, Toby A
AU - Collins, Graham
AU - Djebbari, Faouzi
AU - Kassam, Shireen
AU - Garland, Paula
AU - Watts, Emily
AU - Osborne, Wendy
AU - Townsend, William
AU - Pocock, Rachael
AU - Ahearne, Matthew J
AU - Miall, Fiona
AU - Wang, Xin
AU - Linton, Kim M
N1 - © 2024 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.
PY - 2024/2/27
Y1 - 2024/2/27
N2 - Bendamustine is among the most effective chemotherapeutics for indolent B-cell non-Hodgkin lymphomas (iNHL), but trial reports of significant toxicity, including opportunistic infections and excess deaths, led to prescriber warnings. We conducted a multicenter observational study evaluating bendamustine toxicity in real-world practice. Patients receiving at least 1 dose of bendamustine with/without rituximab (R) for iNHL were included. Demographics, lymphoma and treatment details, and grade 3 to 5 adverse events (AEs) were analyzed and correlated. In total, 323 patients were enrolled from 9 National Health Service hospitals. Most patients (96%) received bendamustine-R, and 46%, R maintenance. Overall, 21.7% experienced serious AEs (SAE) related to treatment, including infections in 12%, with absolute risk highest during induction (63%), maintenance (20%), and follow-up (17%) and the relative risk highest during maintenance (54%), induction (34%), and follow-up (28%). Toxicity led to permanent treatment discontinuation for 13% of patients, and 2.8% died of bendamustine-related infections (n = 5), myelodysplastic syndrome (n = 3), and cardiac disease (n = 1). More SAEs per patient were reported in patients with mantle cell lymphoma, poor preinduction performance status (PS), poor premaintenance PS, and abnormal preinduction total globulins and in those receiving growth factors. Use of antimicrobial prophylaxis was variable, and 3 of 10 opportunistic infections occurred despite prophylaxis. In this real-world analysis, bendamustine-related deaths and treatment discontinuation were similar to those of trial populations of younger, fitter patients. Poor PS, mantle cell histology, and maintenance R were potential risk factors. Infections, including late onset events, were the most common treatment-related SAE and cause of death, warranting extended antimicrobial prophylaxis and infectious surveillance, especially for maintenance-treated patients.
AB - Bendamustine is among the most effective chemotherapeutics for indolent B-cell non-Hodgkin lymphomas (iNHL), but trial reports of significant toxicity, including opportunistic infections and excess deaths, led to prescriber warnings. We conducted a multicenter observational study evaluating bendamustine toxicity in real-world practice. Patients receiving at least 1 dose of bendamustine with/without rituximab (R) for iNHL were included. Demographics, lymphoma and treatment details, and grade 3 to 5 adverse events (AEs) were analyzed and correlated. In total, 323 patients were enrolled from 9 National Health Service hospitals. Most patients (96%) received bendamustine-R, and 46%, R maintenance. Overall, 21.7% experienced serious AEs (SAE) related to treatment, including infections in 12%, with absolute risk highest during induction (63%), maintenance (20%), and follow-up (17%) and the relative risk highest during maintenance (54%), induction (34%), and follow-up (28%). Toxicity led to permanent treatment discontinuation for 13% of patients, and 2.8% died of bendamustine-related infections (n = 5), myelodysplastic syndrome (n = 3), and cardiac disease (n = 1). More SAEs per patient were reported in patients with mantle cell lymphoma, poor preinduction performance status (PS), poor premaintenance PS, and abnormal preinduction total globulins and in those receiving growth factors. Use of antimicrobial prophylaxis was variable, and 3 of 10 opportunistic infections occurred despite prophylaxis. In this real-world analysis, bendamustine-related deaths and treatment discontinuation were similar to those of trial populations of younger, fitter patients. Poor PS, mantle cell histology, and maintenance R were potential risk factors. Infections, including late onset events, were the most common treatment-related SAE and cause of death, warranting extended antimicrobial prophylaxis and infectious surveillance, especially for maintenance-treated patients.
KW - Humans
KW - Adult
KW - Bendamustine Hydrochloride/adverse effects
KW - State Medicine
KW - Lymphoma, Non-Hodgkin/drug therapy
KW - Lymphoma, Mantle-Cell/drug therapy
KW - Lymphoma, B-Cell/drug therapy
KW - Anti-Infective Agents/therapeutic use
KW - Opportunistic Infections/chemically induced
KW - United Kingdom
UR - https://www.scopus.com/pages/publications/85186751897
UR - https://www.mendeley.com/catalogue/1895232c-c9ed-3b10-8fb2-4eb1a9ccfe18/
U2 - 10.1182/bloodadvances.2023011305
DO - 10.1182/bloodadvances.2023011305
M3 - Article
C2 - 37967358
SN - 2473-9537
VL - 8
SP - 878
EP - 888
JO - Blood Advances
JF - Blood Advances
IS - 4
ER -
