Dataset Information

Outcomes in patients with chronic lymphocytic leukemia and TP53 aberration who received first-line ibrutinib: a nationwide registry study from the Italian Medicines Agency.

ABSTRACT: In this analysis we describe the effectiveness of first-line ibrutinib in 747 patients with chronic lymphocytic leukemia (CLL) and TP53 aberrations in a nationwide study with a 100% capture of patients who received the study drug. Median age was 71 years (range 32-95). An estimated treatment persistence rate of 63.4% (95% CI 60.0%-67.0%) and survival rate of 82.6% (95% CI 79.9-85.4%) were recorded at 24 months. Disease progression or death were the reasons for discontinuation in 182/397 patients (45.8%). A higher risk of treatment discontinuation was found to be associated with age, ECOG-PS and pre-existing heart disease, whereas ECOG ≥ 1, age ≥ 70 years and male sex were associated with an increased risk of death. Median post-progression overall survival (OS) was 12.2 months (95% CI 9.2-22.0). Post-discontinuation median OS in patients who discontinued ibrutinib for other reasons was not reached (95% CI 42.3 months - NA). Ibrutinib was an effective first-line treatment for CLL and TP53 aberrations in patients treated at large academic centers and community practice hospitals. Clinical characteristics at baseline may influence the effectiveness of ibrutinib, whereas the experience of prescribing centers and multi-hit or single-hit TP53 aberrations had no impact on outcome in this high-risk population.

SUBMITTER: Rigolin GM

PROVIDER: S-EPMC10307816 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Outcomes in patients with chronic lymphocytic leukemia and TP53 aberration who received first-line ibrutinib: a nationwide registry study from the Italian Medicines Agency.

Rigolin Gian Matteo GM Olimpieri Pier Paolo PP Summa Valentina V Celant Simone S Scarfò Lydia L Tognolo Lucia L Ballardini Maria Pia MP Urso Antonio A Sessa Mariarosaria M Gambara Silvia S Cura Francesca F Fortini Monica M Ghia Paolo P Cuneo Antonio A Russo Pierluigi P

Blood cancer journal 20230628 1

In this analysis we describe the effectiveness of first-line ibrutinib in 747 patients with chronic lymphocytic leukemia (CLL) and TP53 aberrations in a nationwide study with a 100% capture of patients who received the study drug. Median age was 71 years (range 32-95). An estimated treatment persistence rate of 63.4% (95% CI 60.0%-67.0%) and survival rate of 82.6% (95% CI 79.9-85.4%) were recorded at 24 months. Disease progression or death were the reasons for discontinuation in 182/397 patients ...[more]

PMID: 37380630

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Project description:ObjectiveTo investigate the education, knowledge and behaviour of Italian dentists regarding Silver Diamine Fluoride (SDF).MethodsA cross-sectional study was conducted from January to December 2022, through an online survey linked to an online continuing medical education (CME) course sent to Italian dentists. A priori power analysis estimated the necessary sample to be 1480 dentists with an anticipated frequency of 50% and a power of 99.99%. The questionnaire included 46 questions on participants ' demographic characteristics, training received, clinical knowledge of SDF, and attitudes and behaviours regarding its use. Descriptive statistics, bivariate, and mutlivariable regression analyses were performed to determine the association between the variables.ResultsThe response rate was 6.1% with 3876 respondents, evenly distributed geographically. Less than 10% of respondents had received training at undergraduate, postgraduate or masters level. A minority of dentists were familiar with the use of SDF for the treatment of dentine hypersensitivity (19.0%) and for the treatment of caries in children (22.2%) and adults (15.7%). The percentage of dentists who reported SDF use at least once was 20.6%. On mutlivariable analysis (χ2(11) = 995.9 p-value < 0.01), dentists who used SDF were positively associated with those who cared for patients with special needs, those who received good undergraduate or postgraduate training, and those who knew how to use SDF (p < 0.01). A second mutlivariable analysis (χ2(11) = 47.9 p-value < 0.01) revealed that younger respondents were associated with good training and knowledge of the use of SDF received during undergraduate studies, while older respondents were associated with good training received on managing hypersensitivity and caries in adults (p < 0.01).ConclusionsOverall, Italian dentists ' education, knowledge, and use of SDF were relatively poor. The majority of the sample 's responses were not consistent with scientific evidence. The use of SDF among Italian dentists is still far from being a reality. In Italy, it is necessary to increase training on SDF, primarily through the university, to hopefully increase its use, especially in non-invasive caries treatment.

Project description:BackgroundPatients with chronic lymphocytic leukaemia (CLL) with TP53 aberrations respond poorly to first-line chemoimmunotherapy, resulting in early relapse and short survival. We investigated the safety and activity of ibrutinib in previously untreated and relapsed or refractory CLL with TP53 aberrations.MethodsIn this investigator-initiated, single-arm phase 2 study, we enrolled eligible adult patients with active CLL with TP53 aberrations at the National Institutes of Health Clinical Center (Bethesda, MD, USA). Patients received 28-day cycles of ibrutinib 420 mg orally once daily until disease progression or the occurrence of limiting toxicities. The primary endpoint was overall response to treatment at 24 weeks in all evaluable patients. This study is registered with ClinicalTrials.gov, number NCT01500733, and is fully enrolled.FindingsBetween Dec 22, 2011, and Jan 2, 2014, we enrolled 51 patients; 47 had CLL with deletion 17p13.1 and four carried a TP53 mutation in the absence of deletion 17p13.1. All patients had active disease requiring therapy. 35 enrolled patients had previously untreated CLL and 16 had relapsed or refractory disease. Median follow-up was 24 months (IQR 12.9-27.0). 33 previously untreated patients and 15 patients with relapsed or refractory CLL were evaluable for response at 24 weeks. 32 (97%; 95% CI 86-100) of 33 previously untreated patients achieved an objective response, including partial response in 18 patients (55%) and partial response with lymphocytosis in 14 (42%). One patient had progressive disease at 0.4 months. 12 (80%; 95% CI 52-96) of the 15 patients with relapsed or refractory CLL had an objective response: six (40%) achieved a partial response and six (40%) a partial response with lymphocytosis; the remaining three (20%) patients had stable disease. Grade 3 or worse treatment-related adverse events were neutropenia in 12 (24%) patients (grade 4 in one [2%] patient), anaemia in seven (14%) patients, and thrombocytopenia in five (10%) patients (grade 4 in one [2%] patient). Grade 3 pneumonia occurred in three (6%) patients, and grade 3 rash in one (2%) patient.InterpretationThe activity and safety profile of single-agent ibrutinib in CLL with TP53 aberrations is encouraging and supports its consideration as a novel treatment option for patients with this high-risk disease in both first-line and second-line settings.FundingIntramural Research Program of the National Heart, Lung, and Blood Institute and the National Cancer Institute, Danish Cancer Society, Novo Nordisk Foundation, National Institutes of Health Medical Research Scholars Program, and Pharmacyclics Inc.

Dataset Information

Outcomes in patients with chronic lymphocytic leukemia and TP53 aberration who received first-line ibrutinib: a nationwide registry study from the Italian Medicines Agency.

Publications

Outcomes in patients with chronic lymphocytic leukemia and TP53 aberration who received first-line ibrutinib: a nationwide registry study from the Italian Medicines Agency.

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