TY - JOUR

T1 - Real-world outcomes upon second-line treatment in patients with chronic lymphocytic leukaemia

AU - Vainer, Noomi

AU - Aarup, Kathrine

AU - Andersen, Michael Asger

AU - Wind-Hansen, Lise

AU - Nielsen, Tine

AU - Frederiksen, Henrik

AU - Enggaard, Lisbeth

AU - Poulsen, Christian Bjorn

AU - Niemann, Carsten U.

AU - Rotbain, Emelie C.

PY - 2023

Y1 - 2023

N2 - 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.

AB - 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.

KW - adverse events

KW - chronic lymphocytic leukaemia

KW - survival

KW - targeted treatment

KW - treatment effect

KW - OPEN-LABEL

KW - CLL-IPI

KW - IBRUTINIB

KW - VENETOCLAX

KW - RITUXIMAB

KW - THERAPY

KW - METAANALYSIS

KW - 1ST-LINE

KW - PHASE-2

KW - OLDER

U2 - 10.1111/bjh.18715

DO - 10.1111/bjh.18715

M3 - Journal article

C2 - 36896699

VL - 201

SP - 874

EP - 886

JO - British Journal of Haematology

JF - British Journal of Haematology

SN - 0007-1048

IS - 5

ER -