The 5‐year follow‐up of a real‐world observational study of patients in the United Kingdom and Ireland receiving ibrutinib for relapsed/refractory mantle cell lymphoma

Abstract

Summary This is a 5‐year real‐world study of 65 patients treated with ibrutinib for relapsed/refractory mantle cell lymphoma across the UK and Ireland. Ibrutinib was well tolerated with no fatal adverse events. The median progression‐free survival and overall survival (OS) was 12 and 18·5 months, respectively. Overall, 80% of patients discontinued treatment, predominantly for progressive disease. On discontinuation, 20% received alternative immunochemotherapy with a median OS of 24 months. Ibrutinib was used as a bridge to transplant in 8% (median OS not reached). These observations are comparable with trial outcomes with encouraging responses to immunochemotherapy at relapse.

IBRORS-MCL study: a Spanish retrospective and observational study of relapsed/refractory mantle-cell lymphoma treated with ibrutinib in routine clinical practice

“…The main reason for discontinuing ibrutinib was disease progression in nearly 50% of patients, a slightly lower discontinuation rate than that observed in the pooled analysis (59%) [ 10 ] and in other real-world analyses (55–69%) [ 13 , 15 , 16 , 20 ], which is likely explained by the shorter follow-up in our study. The risk of disease progression with ibrutinib increases with adverse prognostic features such as the presence of del(17p) mutation, high sMIPI score, high Ki67 level, blastoid morphology, and primary refractory disease [ 10 , 13 , 21 ].…”

“…This is probably due to a larger proportion of patients in our study receiving 1–2 prior lines, which supports previous evidence showing better outcomes when ibrutinib is used in earlier lines of therapy [ 6 , 16 ] as well as the increased presence of poor prognostic factors with increasing lines of therapy [ 17 ]. Lower-risk disease (76% with low-intermediate sMIPI) and better performance in our patients (94% with an ECOG PS 0–1) compared to other real-world cohorts [ 11 , 13 , 15 ] may have also contributed to these observations. Conversely, the proportion of patients with blastoid variant (24%), a well-known adverse prognostic factor, was higher in our cohort than in the clinical trial setting (12%) [ 10 ], and real-life Korean (3.4%) [ 16 ], Italian (3.9%) [ 11 ], and UK cohorts (14–18%) [ 14 , 15 ].…”

“…Lower-risk disease (76% with low-intermediate sMIPI) and better performance in our patients (94% with an ECOG PS 0–1) compared to other real-world cohorts [ 11 , 13 , 15 ] may have also contributed to these observations. Conversely, the proportion of patients with blastoid variant (24%), a well-known adverse prognostic factor, was higher in our cohort than in the clinical trial setting (12%) [ 10 ], and real-life Korean (3.4%) [ 16 ], Italian (3.9%) [ 11 ], and UK cohorts (14–18%) [ 14 , 15 ].…”

“…Our series mainly included MCL patients with advanced disease, with more than one extranodal site affected, who had been moderately pre-treated (77% of patients had received 1–2 prior lines of therapy) compared with the patients receiving 2 prior lines of therapy or less in phase II SPARK (52.5%) and phase III RAY (68%) studies [ 8 , 9 ] and other real-world cohorts including more heavily pre-treated patients (ranging from 55 to 70%) [ 11 , 13 , 15 ].…”

Tackling Mantle Cell Lymphoma in Europe

“…UK data support the now established use of ibrutinib as a bridge to consolidation with allo-SCT in younger fitter patients. Chimeric antigen receptor-T cell therapy trials after BTKi failure are also showing promising results [ 63 ]. The Fondazione Italiana Linfomi develops research projects in the lymphoma field, independently or in collaboration with major study groups conducting international projects, enrolling more than 1000 patients a year in some 90 clinical studies at the network of 90 onco-hematology research centers, benefiting from advice from 12 scientific boards covering different lymphoma aspects.…”