{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T09:21:45Z","timestamp":1787563305364,"version":"build-2736575974"},"reference-count":54,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2024,3,20]],"date-time":"2024-03-20T00:00:00Z","timestamp":1710892800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Johnson &amp; Johnson"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Real-world data in clinical practice are needed to confirm the efficacy and safety that ibrutinib has demonstrated in clinical trials of patients with chronic lymphocytic leukemia (CLL). We described the real-world persistence rate, patterns of use, and clinical outcomes in 309 patients with CLL receiving single-agent ibrutinib in first line (1L, n = 118), 2L (n = 127) and \u22653L (n = 64) in the prospective, real-world, Italian EVIdeNCE study. After a median follow-up of 23.9 months, 29.8% of patients discontinued ibrutinib (1L: 24.6%, 2L: 29.9%, \u22653L: 39.1%), mainly owing to adverse events (AEs)\/toxicity (14.2%). The most common AEs leading to discontinuation were infections (1L, \u22653L) and cardiac events (2L). The 2-year retention rate was 70.2% in the whole cohort (1L: 75.4%, 2L: 70.1%, \u22653L: 60.9%). The 2-year PFS and OS were, respectively, 85.4% and 91.7% in 1L, 80.0% and 86.2% in 2L, and 70.1% and 80.0% in \u22653L. Cardiovascular conditions did not impact patients\u2019 clinical outcomes. The most common AEs were infections (30.7%), bleeding (12.9%), fatigue (10.0%), and neutropenia (9.7%), while grade 3\u20134 atrial fibrillation occurred in 3.9% of patients. No new safety signals were detected. These results strongly support ibrutinib as a valuable treatment option for CLL.<\/jats:p>","DOI":"10.3390\/cancers16061228","type":"journal-article","created":{"date-parts":[[2024,3,20]],"date-time":"2024-03-20T13:09:36Z","timestamp":1710940176000},"page":"1228","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Real-World Outcome of Treatment with Single-Agent Ibrutinib in Italian Patients with Chronic Lymphocytic Leukemia: Final Results of the EVIdeNCE Study"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2425-9474","authenticated-orcid":false,"given":"Francesca Romana","family":"Mauro","sequence":"first","affiliation":[{"name":"Ematologia, Sapienza Universit\u00e0 di Roma, 00185 Roma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Potito Rosario","family":"Scalzulli","sequence":"additional","affiliation":[{"name":"Ospedale \u201cCasa Sollievo della Sofferenza\u201d, 71013 San Giovanni Rotondo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lydia","family":"Scarf\u00f2","sequence":"additional","affiliation":[{"name":"Universit\u00e0 Vita-Salute San Raffaele, 20132 Milano, Italy"},{"name":"IRCCS Ospedale San Raffaele, 20132 Milano, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carla","family":"Minoia","sequence":"additional","affiliation":[{"name":"Hematology Unit, IRCCS Istituto Tumori \u201cGiovanni Paolo II\u201d, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9792-9542","authenticated-orcid":false,"given":"Roberta","family":"Murru","sequence":"additional","affiliation":[{"name":"Hematology and Stem Cell Transplantation Unit, Ospedale Oncologico A. 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Brotzu, 09134 Cagliari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5630-9862","authenticated-orcid":false,"given":"Paolo","family":"Sportoletti","sequence":"additional","affiliation":[{"name":"Sezione di Ematologia, Universit\u00e0 degli Studi di Perugia, 06123 Perugia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ferdinando","family":"Frigeri","sequence":"additional","affiliation":[{"name":"AORN \u201cSant\u2019Anna e San Sebastiano\u201d, 81100 Caserta, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7926-6052","authenticated-orcid":false,"given":"Francesco","family":"Albano","sequence":"additional","affiliation":[{"name":"Hematology and Stem Cell Transplantation Unit, Department of Precision and Regenerative Medicine and Ionian Area (DiMePRe-J), University of Bari \u201cAldo Moro\u201d, 70121 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola","family":"Di Renzo","sequence":"additional","affiliation":[{"name":"UOC Ematologia e Trapianto di Cellule Staminali-PO \u201cVito Fazzi\u201d ASL Lecce, 73100 Lecce, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Sanna","sequence":"additional","affiliation":[{"name":"AOU Careggi, 50121 Firenze, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8327-1396","authenticated-orcid":false,"given":"Luca","family":"Laurenti","sequence":"additional","affiliation":[{"name":"Policlinico A. 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