Safety Outcomes of Bendamustine Treatment Among Patients With Indolent Non-Hodgkin Lymphoma in Real-World Setting

Findings from a Real-World Analysis

According to a real-world, multicenter, observational trial and analysis published in Blood Advances, the safety outcomes of bendamustine treatment among patients with indolent non-Hodgkin lymphoma (iNHL) in routine practice were comparable to trial population outcomes, including rates of bendamustine-related treatment discontinuation, dose delays and reductions, hematological toxicity, and grade 5 events. These outcomes were similar despite including previously treated and untreated patients, as well as patients who were older, more frail, and had more comorbidities, as opposed to the trial population of younger, fitter patients. 

Rohan Shotton, MD, The Christie NHS Foundation Trust, Manchester, United Kingdom, and coauthors stated, “Bendamustine is among the most effective chemotherapeutics for indolent B-cell non-Hodgkin lymphomas, but trial reports of significant toxicity, including opportunistic infections and excess deaths, led to prescriber warnings.”

In this trial and analysis, the study authors aimed to assess the toxicity of bendamustine in real-world practice to compare results with those of prior studies. 
A total of 323 patients with iNHL who had received 1 or more dose(s) of bendamustine with or without rituximab were enrolled from 9 National Health Service hospitals. The majority of patients, 96%, received bendamustine plus rituximab, and 46% received rituximab as maintenance. 

Safety results indicated that 21.7% of patients had serious adverse events related to the treatment, including 12% who experienced infections. The absolute risk was highest during induction (63%), maintenance (20%), and follow-up (17%). The relative risk was highest during maintenance (54%), induction (34%), and follow-up (28%). 

Treatment discontinuation due to toxicity occurred for 13% of patients, and 2.8% died due to bendamustine-related infections (n = 5), myelodysplastic syndrome (n = 3), and cardiac arrest (n = 1). A higher number of serious adverse events per patient was reported among patients who had mantle cell lymphoma, poor pre-induction performance status (PS), poor pre-maintenance PS, abnormal pre-induction total globulins, and those receiving growth factors. Additionally, 3 of 10 opportunistic infections took place despite the use of antimicrobial 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 [rituximab] were potential risk factors,” Shotton et al concluded. 

They added, “Infections, including late onset events, were the most common treatment-related [serious adverse events] and cause of death, warranting extended antimicrobial prophylaxis and infectious surveillance, especially for maintenance-treated patients.”

Source:  

Shotton R, Broadbent R, Alchawaf A, et al. Safety of bendamustine for the treatment of indolent non-Hodgkin lymphoma: a UK real-world experience. Blood Adv. Published online: February 15, 2024. doi: 10.1182/bloodadvances.2023011305