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. 2024 Mar 20;16(6):1228.
doi: 10.3390/cancers16061228.

Real-World Outcome of Treatment with Single-Agent Ibrutinib in Italian Patients with Chronic Lymphocytic Leukemia: Final Results of the EVIdeNCE Study

Francesca Romana Mauro  1 , Potito Rosario Scalzulli  2 , Lydia Scarfò  3   4 , Carla Minoia  5 , Roberta Murru  6 , Paolo Sportoletti  7 , Ferdinando Frigeri  8 , Francesco Albano  9 , Nicola Di Renzo  10 , Alessandro Sanna  11 , Luca Laurenti  12 , Massimo Massaia  13   14 , Ramona Cassin  15 , Marta Coscia  14   16 , Caterina Patti  17 , Elsa Pennese  18 , Agostino Tafuri  19 , Annalisa Chiarenza  20 , Piero Galieni  21 , Omar Perbellini  22 , Carmine Selleri  23 , Catello Califano  24 , Felicetto Ferrara  25 , Antonio Cuneo  26 , Marco Murineddu  27 , Gaetano Palumbo  28 , Ilaria Scortechini  29 , Alessandra Tedeschi  30 , Livio Trentin  31 , Marzia Varettoni  32 , Fabrizio Pane  33 , Anna Marina Liberati  34 , Francesco Merli  35 , Lucia Morello  36 , Gerardo Musuraca  37 , Monica Tani  38 , Adalberto Ibatici  39 , Giulia Regazzoni  40 , Michele Di Candia  40 , Maria Palma  40 , Danilo Arienti  40 , Stefano Molica  41   42
Affiliations

Real-World Outcome of Treatment with Single-Agent Ibrutinib in Italian Patients with Chronic Lymphocytic Leukemia: Final Results of the EVIdeNCE Study

Francesca Romana Mauro et al. Cancers (Basel). .

Abstract

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 ≥3L (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%, ≥3L: 39.1%), mainly owing to adverse events (AEs)/toxicity (14.2%). The most common AEs leading to discontinuation were infections (1L, ≥3L) and cardiac events (2L). The 2-year retention rate was 70.2% in the whole cohort (1L: 75.4%, 2L: 70.1%, ≥3L: 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 ≥3L. Cardiovascular conditions did not impact patients' clinical outcomes. The most common AEs were infections (30.7%), bleeding (12.9%), fatigue (10.0%), and neutropenia (9.7%), while grade 3-4 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.

Keywords: chronic lymphocytic leukemia; clinical outcomes; effectiveness; ibrutinib; real-world evidence; retention.

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Conflict of interest statement

A. Cuneo has received honoraria for speaking from AbbVie, AstraZeneca, BeiGene, and Janssen; and has served on advisory boards for AbbVie, AstraZeneca, BeiGene, Janssen, and Lilly. A. Tedeschi has received honoraria for speaking from AstraZeneca, Lilly, AbbVie, BeiGene, and Janssen; and has served on advisory boards for AstraZeneca, Lilly, AbbVie, BeiGene, and Janssen. F. Frigeri has received honoraria for speaking and served on the advisory board for Celgene, Janssen-Cilag, BMS, GSK, AbbVie, Eusapharma, Novartis, AstraZeneca, Sobi, Incyte, and Gilead. F.M. has served on advisory boards for Takeda, Janssen, Novartis, Gilead, Incyte, and Roche. F.R.M. has received research grants from AbbVie and Takeda; has received honoraria for speaking from Janssen, AbbVie, Astra Zeneca, and BeiGene; has served on advisory boards for AbbVie, BeiGene, AstraZeneca, and Janssen; and has served as a consultant for Janssen, AbbVie, AstraZeneca, and BeiGene. G.M. has received honoraria for speaking from Janssen, AbbVie, AstraZeneca, Incyte, and Takeda; and has served on advisory boards for Janssen, AbbVie, AstraZeneca, Incyte, and Takeda. L.S. has received honoraria for speaking from Octapharma; and has served on advisory boards for AbbVie, AstraZeneca, BeiGene, Janssen, and Lilly. L.T. has served on advisory boards for BeiGene, Janssen, and Takeda. M.C. has received research grants from Janssen and AbbVie; has received honoraria for speaking from AstraZeneca; and has served on advisory boards for AbbVie, AstraZeneca, BeiGene, and Janssen. M. Massaia has received research grants from Sanofi and has served on advisory boards for AbbVie and Janssen. M.V. has received honoraria for speaking from AbbVie, AstraZeneca, and BeiGene; and has served on advisory boards for AbbVie, AstraZeneca, BeiGene, and Janssen. P.S. has received research grants from Gilead; has received honoraria for speaking from Janssen, AstraZeneca, and AbbVie; has served on advisory boards for Janssen, AstraZeneca, AbbVie, and BeiGene. R.M. has received honoraria for speaking from AbbVie, AstraZeneca, BeiGene, and Janssen; and has served on advisory boards for AstraZeneca and BeiGene. S.M. has received honoraria for speaking from AstraZeneca and AbbVie; and has served as consultant for Janssen and AstraZeneca. D.A., G.R., M.D.C., and M.P. are currently employed at Johnson & Johnson. A. Chiarenza, A.I., A.M.L., A.S., A. Tafuri, C.C., C.M., C.P., C.S., E.P., F.A., F. Ferrara, F.P., G.P., I.S., L.L., L.M., M. Murineddu, M.T., N.D.R., O.P., P.G., P.R.S. and R.C. declare no conflict of interest.

Figures

Figure 1
Figure 1
Ibrutinib retention rates at 1 and 2 years in patients with chronic lymphocytic leukemia by the line of treatment in which the drug was administered in the prospective real-world EVIdeNCE study. Vertical lines represent 95% confidence intervals.
Figure 2
Figure 2
Adverse events of any grade leading to ibrutinib discontinuation by the line of treatment in which the drug was administered in the prospective real-world EVIdeNCE study.
See this image and copyright information in PMC

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