Treatment patterns and outcomes among mantle cell lymphoma patients treated with ibrutinib in the United States: a retrospective electronic medical record database and chart review study

Abstract

Summary The experience of patients with mantle cell lymphoma (MCL) in community oncology practices, including reasons for treatment discontinuation, is sparse. This retrospective study sought to elucidate treatment patterns and outcomes of patients with MCL treated with ibrutinib in the community setting. Patients were identified from the US Oncology Network electronic medical records database, iKnowMedTM, between 1 November 2013 and 31 October 2016. Descriptive analysis was performed to describe the demographic and clinical characteristics of the population. Kaplan–Meier estimates were performed to determine clinical outcomes. A Cox proportional hazards model was used to identify predictors of survival. Of the 1914 patients identified with MCL, 159 were treated with ibrutinib. The median age was 71 years and the majority were male (76%) and Caucasian (89%). The overall discontinuation rate was 83·6%; the most common reasons were progression (35%) and toxicities (25·6%). The median overall survival and progression‐free survival was 25·82 months (95% confidence interval [CI] 19·94, NR) and 19·55 months (95% CI 16·52, 24·28) respectively. In multivariate modelling, patient age was predictive of survival (hazard ratio 1·041, P = 0·0186). Ibrutinib was temporarily reduced in 16·4% (n = 26) and held in 30·2% (n = 48), primarily due to toxicity 66·7% (n = 32). Survival data showed similarities between community oncology practices and clinical trials.

Ibrutinib for mantle cell lymphoma at first relapse: a United Kingdom real‐world analysis of outcomes in 211 patients

“…Despite an older patient population tolerance to ibrutinib appears good, with discontinuation linked to drug‐related adverse events similar to those reported in clinical trials. This is in contrast to real‐world evidence from the United States where 21% of patients stopped ibrutinib due to drug‐related adverse events 14 . The difference may relate to the restricted availability of effective alternative therapy in the UK, particularly other BTK inhibitors, which encourages clinicians to manage toxicity without stopping ibrutinib.…”

“…This is in contrast to real-world evidence from the United States where 21% of patients stopped ibrutinib due to drug-related adverse events. 14 The difference may relate to the restricted availability of effective alternative therapy in the UK, particularly other BTK inhibitors, which encourages clinicians to manage toxicity without stopping ibrutinib. The death rate during ibrutinib therapy was high relative to trials but similar to real-world data for ibrutinib in chronic lymphocytic leukaemia and likely relates to competing risks of death, with advanced age and poor performance status noted in many affected patients.…”

Mantle cell lymphoma treatment options for elderly/unfit patients: A systematic review

“…Following removal of duplicate papers, 901 papers remained; of these 805 articles were removed after the titles and abstracts were screened, leaving 66 articles for full screening. From these papers, 16 articles met all the inclusion criteria, and were taken forward for qualitative synthesis ( Table 2 [ 13 , 23 , 24 , 32 , 54 , 55 , 56 , 57 , 58 , 59 – 61 , 63 , 64 , 65 , 67 ]).…”

Safety Profile of Ibrutinib: An Analysis of the WHO Pharmacovigilance Database

“…Discrepancies in discontinuation rates due to toxicity have been highlighted between initial pivotal clinical trials and realworld studies, where adverse drug reactions (ADRs) were responsible for 51, 29, and 21% of ibrutinib discontinuations in CLL, WM and MCL respectively (Gustine et al, 2018;Mato et al, 2018;Sharman et al, 2020). Higher treatment discontinuation for safety reasons in real-world settings is likely due to differences in patient characteristics.…”