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Serum Free Light Chain Analysis for the Diagnosis, Management, and Prognosis of Plasma Cell Dyscrasias
Comparative Effectiveness Reviews, No. 73
Investigators: Madhumathi Rao, MD, PhD, Winifred W Yu, PhD, MS, RD, Jeffrey Chan, BS, Kamal Patel, MPH, MBA, Raymond Comenzo, MD, Jenny L Lamont, MS, Stanley Ip, MD, and Joseph Lau, MD.
Author Information and AffiliationsStructured Abstract
Objectives:
To summarize the literature regarding the role of the serum free light chain (SFLC) assay in diagnosis as an adjunct to traditional tests (defined as serum and urine electrophoresis or immunofixation electrophoresis), compared with traditional testing alone, and its role compared with traditional tests in the management of patients with plasma cell dyscrasias (PCDs).
Data Sources:
MEDLINE®, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews from January 2000 through January 2012.
Methods:
We used established systematic review methods, selecting only published, peer-reviewed, English-language articles on the basis of predetermined eligibility criteria. A standardized protocol was used to extract details on designs, diagnoses, interventions (diagnostic tests/disease monitoring), outcomes, and study methods. We considered studies of adults with suspected and diagnosed PCDs, specifically monoclonal gammopathy of undetermined significance (MGUS) or multiple myeloma (MM), which includes light chain MM, nonsecretory MM, and AL amyloidosis. The comparison and outcomes of interest were the role of the SFLC assay as an adjunct to traditional tests for diagnosis of PCDs, and the effectiveness of the SFLC assay versus traditional tests for studying progression to MM, treatment response, and prognosis.
Results:
The literature search yielded 3,036 citations, with 2,711 excluded at the abstract level. The remaining 325 articles were retrieved for full-text review, upon which 310 were excluded, most often because studies did not meet all the predefined eligibility criteria or were not comparative. A total of 15 studies were included. Three retrospective, fair-quality studies evaluated the SFLC assay as an adjunct to traditional testing in populations suspected of having a PCD. Three retrospective, poor-quality studies of AL amyloidosis, and eight studies (three of fair quality and five of poor quality) of MM, six of which were retrospective, evaluated either baseline or post-treatment concentrations of SFLC or monoclonal protein as predictors of clinical outcomes. Overall, because of the small number of studies and their poor methodological quality and considerable clinical heterogeneity, the strength of evidence was rated as insufficient regarding: (1) the value of adjunct SFLC testing on diagnostic accuracy in undiagnosed patients, (2) the role of the SFLC assay as a better predictor of outcome in PCDs or of progression of MGUS to MM, and (3) the role of the SFLC assay as a better indicator for therapeutic decisionmaking compared with traditional testing alone and as a substitute for other diagnostic tests.
Conclusions:
The role of the SFLC assay remains to be defined. The evidence was rated as insufficient to suggest that the assay may increase sensitivity when used as an adjunct to traditional testing for diagnosis of PCDs or that it was more effective for predicting and monitoring treatment response and for predicting patient survival. Methodological limitations of the studies reviewed preclude definitive conclusions regarding these potential uses. Future research should focus on standardization of diagnostic testing and monitoring algorithms in prespecified patient populations, with adherence to accepted definitions of outcomes and responses.
Contents
- Preface
- Key Informants
- Technical Expert Panel
- Peer Reviewers
- Executive Summary
- Introduction
- Methods
- Results
- Literature Search
- Study Quality Grade and Overall Strength of Evidence
- KQ1 Does adding the SFLC assay and the kappa/lambda ratio to traditional testing (serum/urine electrophoresis or IFE), compared with traditional testing alone, improve the diagnostic accuracy for PCDs (MGUS, MM, NSMM, or AL amyloidosis) in undiagnosed patients suspected of having a PCD?
- KQ2 As compared with traditional tests, how well does the SFLC assay independently predict progression to MM in patients with MGUS?
- KQ3 In patients with an existing diagnosis of PCD (MM, NSMM, or AL amyloidosis), does the use of the SFLC assay result in different treatment decisions as compared with traditional tests?
- KQ4 In patients with an existing diagnosis of PCD (MM, NSMM, or AL amyloidosis), is the SFLC assay better than traditional tests in indicating how the patient responds to treatment and of outcomes (overall survival, disease-free survival, remission, light chain escape, and quality of life)?
- KQ5 In patients with an existing diagnosis of PCD (MM, NSMM, or AL amyloidosis), does the use of the SFLC assay reduce the need for other diagnostic tests (e.g., bone marrow biopsy)?
- Discussion
- Acronyms
- Glossary
- References
- Appendix A Literature Search Strategy
- Appendix B Excluded Studies
- Appendix C Quality Criteria and Individual Study Grades
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2007-10055 I. Prepared by: Tufts Evidence-based Practice Center, Boston, MA
Suggested citation:
Rao M, Yu WW, Chan J, Patel K, Comenzo R, Lamont JL, Ip S, Lau J. Serum Free Light Chain Analysis for the Diagnosis, Management, and Prognosis of Plasma Cell Dyscrasias. Comparative Effectiveness Review No. 73. (Prepared by the Tufts Evidence-based Practice Center under Contract No. 290-2007-10055-I.) AHRQ Publication No. 12-EHC102-EF. Rockville, MD: Agency for Healthcare Research and Quality. August 2012. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the Tufts Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10055 I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
- 1
540 Gaither Road, Rockville, MD 20850; www
.ahrq.gov
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