Search

Background: Ibrutinib is a Bruton's tyrosine kinase inhibitor indicated for the first-line treatment and relapse of chronic lymphocytic leukaemia (CLL), Waldenström's macroglobulinemia (WM) and mantle cell lymphoma (MCL). This study aimed to describe the characteristics of CLL patients treated with ibrutinib and its effectiveness, safety, and treatment pattern in real life., Methods: All patients covered by the general health scheme (approximately 80% of the French population) with a first ibrutinib dispensation from August 1, 2017 (date of reimbursement in France) to December 31, 2020, were identified in the French National Health Insurance database (SNDS). An algorithm was developed to identify the disease (CLL, MCL or WM) for which ibrutinib was prescribed. This article focused on CLL patients. The time to next treatment (TTNT) was plotted using Kaplan‒Meier curves., Results: During this period, 6,083 patients initiated ibrutinib, among whom 2,771 (45.6%) patients had CLL (mean age of 74 years; 61% of men). At ibrutinib initiation, 46.6% of patients had a cardiovascular comorbidity. Most patients (91.7%) were not hospitalized during the exposure period for one of the cardiovascular or bleeding events studied. Hospitalizations were more frequent in patients with a cardiovascular comorbidity (5.9% versus 11.0%, p-value < 0.0001) and aged over 70 (5.9% versus 9.4%, p-value < 0.0001). The median TTNT was not reached., Conclusion: This is one of the largest cohorts of ibrutinib-treated patients in the world. The profile of CLL patients treated with ibrutinib was in accordance with the marketing authorization and reimbursement. This study confirmed effectiveness and safety data., (© 2024. The Author(s).)

The introduction of single-agent rituximab has markedly changed the approach to therapy of patients with post-transplantation lymphoproliferative disorder (PTLD), but response to treatment varies substantially between patients. In the current report, we analyze long-term efficacy of single-agent rituximab in 60 patients and present factors predictive of progression-free and overall survival. Twelve months after completing first-line treatment, 34 of 60 patients (57%) had progressive disease, resulting in a median progression-free survival of 6.0 months at a median follow-up of 16.3 months. Using multivariate Cox regression analysis, the following factors were identified as significantly predictive of overall survival: age at diagnosis, performance status, lactate dehydrogenase (LDH), and time from transplantation to PTLD. Stage of disease and Epstein-Barr virus association of PTLD did not influence overall survival. LDH and time from transplantation to PTLD were also predictive of progression-free survival. The international prognostic index was shown to be of limited predictive value in these patients, but a PTLD-specific prognostic index separated low-, intermediate-, and high-risk patients with high significance: 2-year overall survival rates after first-line treatment with single-agent rituximab were 88, 50, and 0%, respectively. Thus, prognostic indices can be useful tools for prediction of treatment outcome and for the development of risk-adapted treatment strategies in patients with PTLD and may also provide the basis for interstudy comparisons.