Early M-protein Dynamics Predicts Progression-Free Survival in Patients With Relapsed/Refractory Multiple Myeloma
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Early M-protein Dynamics Predicts Progression-Free Survival in Patients With Relapsed/Refractory Multiple Myeloma. / Yan, Xiaoyu; Xu, Xu Steven; Weisel, Katja C; Mateos, Maria-Victoria; Sonneveld, Pieter; Dimopoulos, Meletios A; Usmani, Saad Zafar; Bahlis, Nizar J; Puchalski, Thomas; Ukropec, Jon; Bellew, Kevin; Ming, Qi; Sun, Steven; Zhou, Honghui.
in: CTS-CLIN TRANSL SCI, Jahrgang 13, Nr. 6, 11.2020, S. 1345-1354.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Early M-protein Dynamics Predicts Progression-Free Survival in Patients With Relapsed/Refractory Multiple Myeloma
AU - Yan, Xiaoyu
AU - Xu, Xu Steven
AU - Weisel, Katja C
AU - Mateos, Maria-Victoria
AU - Sonneveld, Pieter
AU - Dimopoulos, Meletios A
AU - Usmani, Saad Zafar
AU - Bahlis, Nizar J
AU - Puchalski, Thomas
AU - Ukropec, Jon
AU - Bellew, Kevin
AU - Ming, Qi
AU - Sun, Steven
AU - Zhou, Honghui
N1 - © 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.
PY - 2020/11
Y1 - 2020/11
N2 - 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.
AB - 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.
U2 - 10.1111/cts.12836
DO - 10.1111/cts.12836
M3 - SCORING: Journal article
C2 - 32583948
VL - 13
SP - 1345
EP - 1354
JO - CTS-CLIN TRANSL SCI
JF - CTS-CLIN TRANSL SCI
SN - 1752-8054
IS - 6
ER -
