title: Improved relapse-free survival after autologous stem cell transplantation does not translate into better quality of life in chronic lymphocytic leukemia: lessons from the randomized European Society for Blood and Marrow Transplantation-Intergroup study.
abstract: In chronic lymphocytic leukemia (CLL) medical progress is driven by clinical studies with relapse-free survival (RFS) as the primary endpoint. The randomized EBMT-Intergroup trial compared high-dose therapy and autologous stem cell transplantation (ASCT) to observation and demonstrated a substantial improvement of RFS without showing improved overall survival for the transplant arm. Here we report quality of life (QoL) information of the first 3 years following randomization from that study. The main objective was to assess the impact of treatment on QoL over time. Two secondary analyses were performed to further investigate the impact of ASCT and relapse on QoL. In the primary analysis, we demonstrate an adverse impact of ASCT on QoL which was largest at 4 months and continued throughout the first year after randomization. Further, we demonstrated a sustained adverse impact of relapse on QoL which worsened over time. Despite better disease control by ASCT the side effects thus turned the net effect towards inferior QoL in the first year and comparable QoL in the following 2 years after randomization. This study emphasizes the importance of information concerning QoL impacts when patients are counseled about treatments aimed at improving RFS in the absence of a survival benefit.
authors.affiliation: EBMT/Dept of Medical Statistics & Bioinformatics LUMC, Leiden, The Netherlands.
authors.forename: Liesbeth C
authors.initials: LC
authors.lastname: de Wreede
authors.forename: Maggie
authors.initials: M
authors.lastname: Watson
authors.forename: Marleen
authors.initials: M
authors.lastname: van Os
authors.forename: Donald
authors.initials: D
authors.lastname: Milligan
authors.forename: Michel
authors.initials: M
authors.lastname: van Gelder
authors.forename: Mauricette
authors.initials: M
authors.lastname: Michallet
authors.forename: Peter
authors.initials: P
authors.lastname: Dreger
authors.forename: Claire E
authors.initials: CE
authors.lastname: Dearden
authors.forename: Janis
authors.initials: J
authors.lastname: Homewood
authors.forename: Jehan
authors.initials: J
authors.lastname: Dupuis
authors.forename: Michel
authors.initials: M
authors.lastname: Leporrier
authors.forename: Michal
authors.initials: M
authors.lastname: Karas
authors.forename: Bernadette
authors.initials: B
authors.lastname: Corront
authors.forename: Gabriela M
authors.initials: GM
authors.lastname: Baerlocher
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Herr
authors.forename: Sylvain
authors.initials: S
authors.lastname: Choquet
authors.forename: Dietger W
authors.initials: DW
authors.lastname: Niederwieser
authors.forename: Laurent
authors.initials: L
authors.lastname: Sutton
authors.forename: Nicolaus
authors.initials: N
authors.lastname: Kröger
authors.forename: Theo M
authors.initials: TM
authors.lastname: de Witte
authors.forename: Johannes
authors.initials: J
authors.lastname: Schetelig On Behalf Of The Chronic Malignancies Working Party Of The Ebmt And The Uk Medical Research Council
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000401:mortality / Q000523:psychology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012008:Recurrence; D011795:Surveys and Questionnaires; D019172:Transplantation Conditioning; D014182:Transplantation, Autologous