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. 2023 Jun;201(5):874-886.
doi: 10.1111/bjh.18715. Epub 2023 Mar 10.

Real-world outcomes upon second-line treatment in patients with chronic lymphocytic leukaemia

Noomi Vainer  1 , Kathrine Aarup  1 , Michael Asger Andersen  1   2 , Lise Wind-Hansen  3 , Tine Nielsen  3 , Henrik Frederiksen  3   4   5 , Lisbeth Enggaard  1 , Christian Bjørn Poulsen  6 , Carsten U Niemann  1   7 , Emelie C Rotbain  1   3   4   8
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Real-world outcomes upon second-line treatment in patients with chronic lymphocytic leukaemia

Noomi Vainer et al. Br J Haematol. 2023 Jun.

Abstract

For chronic lymphocytic leukaemia (CLL), targeted drugs have become the standard of care, in particular for second-line treatment. In this study, overall survival (OS), treatment-free survival (TFS) and adverse events (AE) were registered retrospectively in a Danish population-based cohort upon second-line treatment for CLL. Data were collected from medical records and the Danish National CLL register. For 286 patients receiving second-line treatment, three-year TFS was higher upon targeted treatment (ibrutinib/venetoclax/idelalisib) [63%, 95% confidence interval (CI) 50%-76%] compared with fludarabine, cyclophosphamide and rituximab or bendamustine and rituximab (FCR/BR) (37%, CI: 26%-48%) and chlorambucil+/-CD20-antibody (CD20Clb/Clb) (22%, CI: 10%-33%). Upon targeted treatment, three-year OS estimates were higher for targeted treatment (79%, CI: 68%-91%) compared with FCR/BR (70%, CI: 60%-81%) or CD20Clb/Clb (60%, CI: 47%-74%). The most common AEs were infections and haematological AEs; 92% of patients treated with targeted drugs had AEs, 53% of which were severe. Upon FCR/BR and CD20Clb/Clb, AEs were present for 75% and 53% respectively, of which 63% and 31% were severe. These real-world data demonstrate higher TFS and a tendency towards higher OS following targeted second-line treatment for CLL compared to chemoimmunotherapy, also for patients who may be frailer and more comorbid.

Keywords: adverse events; chronic lymphocytic leukaemia; survival; targeted treatment; treatment effect.

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