Comparison of Sebia Free Light Chain Assay With Freelite Assay for the Clinical Management of Diagnosis, Response, and Relapse Assessment in Multiple Myeloma.
Adolescent
Adult
Biomarkers, Tumor
/ blood
Bortezomib
/ therapeutic use
Female
Follow-Up Studies
Hematopoietic Stem Cell Transplantation
Humans
Immunoglobulin Light Chains
/ blood
Lenalidomide
/ therapeutic use
Male
Middle Aged
Multiple Myeloma
/ blood
Neoplasm Recurrence, Local
/ diagnosis
Reagent Kits, Diagnostic
Transplantation, Autologous
Treatment Outcome
Young Adult
IMWG
κ/λ ratio
Journal
Clinical lymphoma, myeloma & leukemia
ISSN: 2152-2669
Titre abrégé: Clin Lymphoma Myeloma Leuk
Pays: United States
ID NLM: 101525386
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
received:
19
12
2018
accepted:
17
01
2019
pubmed:
26
2
2019
medline:
7
7
2020
entrez:
26
2
2019
Statut:
ppublish
Résumé
Serum free light chain (FLC) measurement has become an important marker for the management of multiple myeloma (MM). However, several analytical challenges remain unresolved. We compared the clinical performances of the Sebia FLC assay in MM to the Freelite assay. A total of 177 patients from the IFM DFCI 2009 trial were enrolled onto this study, with a total of 368 samples analyzed. At baseline, concordance of the involved to noninvolved FLC ratio (iFLC/niFLC) was evaluated. During therapy, comparison of the disease response assessments according to International Myeloma Working Group criteria was performed. Compared to Freelite, the Sebia FLC assay demonstrated lower results, with a proportional bias with increased values. We demonstrated that the Sebia equivalent of the iFLC/niFLC ratio of 100 was 16. During follow-up, agreement in response assessment was moderate (for light chains MM) to good (for intact immunoglobulin MM). In the context of relapse, the concordance was moderate, but longitudinal follow-up showed a similar kinetics. The Sebia FLC assay provides inequivalent absolute results from the Freelite assay. Despite lower absolute FLC values, the kinetics of response and relapse is exactly the same. As with other FLC assays available, follow-up of MM with the same method is advisable.
Sections du résumé
BACKGROUND
Serum free light chain (FLC) measurement has become an important marker for the management of multiple myeloma (MM). However, several analytical challenges remain unresolved. We compared the clinical performances of the Sebia FLC assay in MM to the Freelite assay.
PATIENTS AND METHODS
A total of 177 patients from the IFM DFCI 2009 trial were enrolled onto this study, with a total of 368 samples analyzed. At baseline, concordance of the involved to noninvolved FLC ratio (iFLC/niFLC) was evaluated. During therapy, comparison of the disease response assessments according to International Myeloma Working Group criteria was performed.
RESULTS
Compared to Freelite, the Sebia FLC assay demonstrated lower results, with a proportional bias with increased values. We demonstrated that the Sebia equivalent of the iFLC/niFLC ratio of 100 was 16. During follow-up, agreement in response assessment was moderate (for light chains MM) to good (for intact immunoglobulin MM). In the context of relapse, the concordance was moderate, but longitudinal follow-up showed a similar kinetics.
CONCLUSION
The Sebia FLC assay provides inequivalent absolute results from the Freelite assay. Despite lower absolute FLC values, the kinetics of response and relapse is exactly the same. As with other FLC assays available, follow-up of MM with the same method is advisable.
Identifiants
pubmed: 30799237
pii: S2152-2650(18)31743-9
doi: 10.1016/j.clml.2019.01.007
pii:
doi:
Substances chimiques
Biomarkers, Tumor
0
Immunoglobulin Light Chains
0
Reagent Kits, Diagnostic
0
Bortezomib
69G8BD63PP
Lenalidomide
F0P408N6V4
Types de publication
Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
e228-e237Informations de copyright
Copyright © 2019 Elsevier Inc. All rights reserved.