In a recent publication in Blood Advances, researchers conducted a multicenter retrospective, observational study to evaluate the safety of bendamustine in a real-world setting that included patients with indolent B-cell non-Hodgkin lymphomas (iNHLs).
The authors wrote, “This multicenter, retrospective, observational study is one of the largest studies, to our knowledge, to date, evaluating the safety and toxicity profile of bendamustine for patients with iNHL treated outside of a clinical trial setting.”
The patients were treated between January 1, 2013, and December 31, 2016, and were identified from nine National Health Service (NHS) centers in the United Kingdom. The study was comprised of 323 eligible patients who received at least one dose of bendamustine with/without rituximab for untreated or relapsed/refractory iNHLs, including follicular lymphoma (FL), lymphoplasmacytic lymphoma, marginal zone, and mantle cell lymphomas (MCL). The patients with chronic lymphocytic leukemia/small lymphocytic lymphoma or transformed lymphoma or those enrolled in a clinical trial were excluded.
The average age of patients at iNHL diagnosis was 65 years (range, 20-92 years), and FL was the most common histology (54%). The primary endpoint of the study was the rate of treatment-related grade 3 to 5 serious adverse effects (SAEs).
The researchers measured and graded AE causality, according to common terminology criteria for AEs version 4.3. SAEs were defined as fatal or life-threatening, causing or prolonging hospital admission, or leading to significant disability. Other outcomes of interest involved grade 3 to 5 AE occurrence by treatment phase (induction, maintenance, and follow-up) and grade 3 to 5 infections, opportunistic infections, second cancers, the impact of AEs on dose reductions, postponements and treatment cessation, and mortalities related to bendamustine. The patients were followed up from the start date of bendamustine to the date of death or last hospital visit.
According to the authors, the results revealed, “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).”
Additionally, more SAEs per patient were reported in individuals with MCL, poor preinduction performance status (PS), poor premaintenance PS, abnormal preinduction total globulins, and in those receiving growth factors. The use of antimicrobial prophylaxis was variable, and despite prophylaxis, three of 10 opportunistic infections transpired. The authors also noted that infections and opportunistic infections were common and often occurred long after completion of treatment.
Based on their findings, the authors concluded that bendamustine-related deaths and treatment cessation in this real-world analysis were comparable with those of trial populations of younger, fitter patients. The researchers also noted that poor PS, mantle cell histology, and rituximab maintenance were identified as potential risk factors.
The authors also indicated that infections, including late-onset events, were the most frequent treatment-related SAEs reported and documented cause of mortality, necessitating prolonged antimicrobial prophylaxis and infectious surveillance, particularly for maintenance-treated patients.
Lastly, the authors wrote, “This multicenter, retrospective, observational study of bendamustine treatment for iNHL in routine practice demonstrates rates of bendamustine-related treatment discontinuation, dose delays, and reductions, hematological toxicity, and grade 5 events that are comparable with trial population outcomes despite including previously treated and untreated patients as well as patients who were older, frailer, and with more comorbidities.”
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