Validation of the International Myeloma Working Group standard response criteria in the PETHEMA/GEM2012MENOS65 study: are these times of change?
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SUBMITTER: Jimenez-Ubieto A
PROVIDER: S-EPMC9642785 | biostudies-literature | 2021 Nov
REPOSITORIES: biostudies-literature
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Validation of the International Myeloma Working Group standard response criteria in the PETHEMA/GEM2012MENOS65 study: are these times of change?
Jiménez-Ubieto Ana A Paiva Bruno B Puig Noemi N Cedena Maria-Teresa MT Martínez-López Joaquín J Oriol Albert A Blanchard María-Jesús MJ Ríos Rafael R Martin Jesús J Martínez Rafael R Sureda Anna A Hernández Miguel-Teodoro MT de la Rubia Javier J Krnisk Isabel I Cabañas Valentín V Palomera Luis L Sánchez-Pina José María JM Bargay Joan J Mateos María-Victoria MV Rosiñol Laura L Blade Joan J San Miguel Jesús J Lahuerta Juan José JJ
Blood 20211101 19
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Project description:BackgroundCurrent recommendations for monitoring disease progression and response to treatment in humans with multiple myeloma include evaluation of serum paraprotein (M-protein) concentration. Densitometry, species-specific radial immunodiffusion (RID) and ELISA methods can be used to quantify M-proteins.ObjectiveRetrospectively evaluate use of the International Myeloma Working Group (IMWG) response criteria for humans in dogs with multiple myeloma.AnimalsSixteen dogs with a diagnosis of multiple myeloma, M-protein documented by serum protein electrophoresis (SPE) and immunofixation (IF) in an initial sample and subsequent electrophoretic evaluation of serial samples.MethodsRetrospectively, densitometric M-proteins, RID and globulins were measured and characterized according to IMWG criteria. Available clinical history was reviewed. Overall survival time (OST) was calculated from initial electrophoretic evaluation to death or last contact.ResultsAll cases received some form of nonstandardized chemotherapy. Complete response (CR), a lack of detectable M-protein by SPE and IF, was documented in 1 case. Median survival was longer for dogs that attained ≥90% densitometric M-protein reduction (630 days) than for those that did not attain at least 50% reduction in densitometric M-protein (284 days; log rank P = .006). Five dogs were defined as having progressive disease (M-protein increase of >25% and at least 0.5 g/dL from nadir), which correlated with concurrent or subsequent clinical deterioration. Response criteria categorized by serum globulins or RID was not correlated with OST or clinical findings.Conclusions and clinical importanceDensitometric M-protein characterized using IMWG response criteria correlated with OST and clinical findings. Densitometric M-protein detection should be used to monitor dogs with multiple myeloma.
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Project description:PurposeThe clinical outcome of multiple myeloma (MM) is heterogeneous. A simple and reliable tool is needed to stratify patients with MM. We combined the International Staging System (ISS) with chromosomal abnormalities (CA) detected by interphase fluorescent in situ hybridization after CD138 plasma cell purification and serum lactate dehydrogenase (LDH) to evaluate their prognostic value in newly diagnosed MM (NDMM).Patients and methodsClinical and laboratory data from 4,445 patients with NDMM enrolled onto 11 international trials were pooled together. The K-adaptive partitioning algorithm was used to define the most appropriate subgroups with homogeneous survival.ResultsISS, CA, and LDH data were simultaneously available in 3,060 of 4,445 patients. We defined the following three groups: revised ISS (R-ISS) I (n = 871), including ISS stage I (serum β2-microglobulin level < 3.5 mg/L and serum albumin level ≥ 3.5 g/dL), no high-risk CA [del(17p) and/or t(4;14) and/or t(14;16)], and normal LDH level (less than the upper limit of normal range); R-ISS III (n = 295), including ISS stage III (serum β2-microglobulin level > 5.5 mg/L) and high-risk CA or high LDH level; and R-ISS II (n = 1,894), including all the other possible combinations. At a median follow-up of 46 months, the 5-year OS rate was 82% in the R-ISS I, 62% in the R-ISS II, and 40% in the R-ISS III groups; the 5-year PFS rates were 55%, 36%, and 24%, respectively.ConclusionThe R-ISS is a simple and powerful prognostic staging system, and we recommend its use in future clinical studies to stratify patients with NDMM effectively with respect to the relative risk to their survival.
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