ABSTRACT
BACKGROUND: Ibrutinib demonstrated remarkable efficacy and favorable tolerability in patients with untreated or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), including those with high-risk genetic alterations. The IBRORS-CLL study assessed the characteristics, clinical management and outcome of CLL patients receiving ibrutinib in routine clinical practice in Spain. PATIENTS: Observational, retrospective, multicenter study in CLL patients who started single-agent ibrutinib as first-line treatment or at first or second relapse between January 2016 and January 2019. RESULTS: A total of 269 patients were included (median age: 70.9 years; cardiovascular comorbidity: 55.4%, including hypertension [47.6%] and atrial fibrillation [AF] [7.1%]). Overall, 96.7% and 69% of patients underwent molecular testing for del(17p)/TP53 mutation and IGHV mutation status. High-risk genetic features included unmutated IGHV (79%) and del(17p)/TP53 mutation (first-line: 66.3%; second-line: 23.1%). Overall, 84 (31.2%) patients received ibrutinib as first-line treatment, and it was used as second- and third-line therapy in 121 (45.0%) and 64 (23.8%) patients. The median progression-free survival and overall survival were not reached irrespective of del(17p)/TP53, or unmutated IGHV. Common grade ≥3 adverse events were infections (12.2%) and bleeding (3%). Grade ≥3 AF occurred in 1.5% of patients. CONCLUSION: This real-world study shows that single-agent ibrutinib is an effective therapy for CLL, regardless of age and high-risk molecular features, consistent with clinical trials. Additionally, single-agent ibrutinib was well tolerated, with a low rate of cardiovascular events. This study also emphasized a high molecular testing rate of del(17p)/TP53 mutation and IGHV mutation status in clinical practice according to guideline recommendations.
Subject(s)
Leukemia, Lymphocytic, Chronic, B-Cell , Adenine/analogs & derivatives , Aged , Humans , Piperidines , Pyrazoles/adverse effects , Pyrimidines/adverse effects , Retrospective Studies , Spain/epidemiologyABSTRACT
The differential diagnosis between primary cutaneous diffuse large B-cell lymphoma and cutaneous follicular lymphoma is one of the most difficult aspects of dermatopathology, even though morphological criteria are well established and a wide panel of antibodies is available to every laboratory. Such diagnosis is, however, not trivial because it has important prognostic and therapeutic implications. Nevertheless, when the literature is reviewed, there is a feeling that the diagnostic deficits from the past could perhaps be responsible for the differences observed in the therapeutic results with less aggressive treatments, such as rituximab. The current report briefly revises some cases of primary cutaneous diffuse large B-cell lymphoma treated with rituximab, which have been reported in the literature. It also presents an additional case emphasizing the current approach to the differential diagnosis.
