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Early M‐Protein Dynamics Predicts Progression‐Free Survival in Patients With Relapsed/Refractory Multiple Myeloma

Authors :
Steven Sun
Kevin Bellew
Katja Weisel
Xu Steven Xu
Pieter Sonneveld
Maria-Victoria Mateos
Nizar J. Bahlis
Xiaoyu Yan
Meletios A. Dimopoulos
Honghui Zhou
Saad Z. Usmani
Jon Ukropec
Thomas A. Puchalski
Qi Ming
Hematology
Business Economics
Source :
Clinical and Translational Science, 13(6), 1345-1354. Wiley-Blackwell Publishing Ltd, Clinical and Translational Science
Publication Year :
2020
Publisher :
Wiley, 2020.

Abstract

This study aimed to predict long-term progression-free survival (PFS) using early M-protein dynamic measurements in patients with relapsed/refractory multiple myeloma (MM). The PFS was modeled based on dynamic M-protein data from two phase III studies, POLLUX and CASTOR, which included 569 and 498 patients with relapsed/refractory MM, respectively. Both studies compared active controls (lenalidomide and dexamethasone, and bortezomib and dexamethasone, respectively) alone vs. in combination with daratumumab. Three M-protein dynamic features from the longitudinal M-protein data were evaluated up to different time cutoffs (1, 2, 3, and 6 months). The abilities of early M-protein dynamic measurements to predict the PFS were evaluated using Cox proportional hazards survival models. Both univariate and multivariable analyses suggest that maximum reduction of M-protein (i.e., depth of response) was the most predictive of PFS. Despite the statistical significance, the baseline covariates provided very limited predictive value regarding the treatment effect of daratumumab. However, M-protein dynamic features obtained within the first 2 months reasonably predicted PFS and the associated treatment effect of daratumumab. Specifically, the areas under the time-varying receiver operating characteristic curves for the model with the first 2 months of M-protein dynamic data were ~ 0.8 and 0.85 for POLLUX and CASTOR, respectively. Early M-protein data within the first 2 months can provide a prospective and reasonable prediction of future long-term clinical benefit for patients with MM.

Details

ISSN :
17528062 and 17528054
Volume :
13
Database :
OpenAIRE
Journal :
Clinical and Translational Science
Accession number :
edsair.doi.dedup.....1e3186d687846d3ca75a1f47577ccb43
Full Text :
https://doi.org/10.1111/cts.12836