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

Autor: 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
Přispěvatelé: Hematology, Business Economics
Rok vydání: 2020
Předmět:
Adult
Male
Oncology
030213 general clinical medicine
medicine.medical_specialty
Risk Assessment
030226 pharmacology & pharmacy
Article
General Biochemistry
Genetics and Molecular Biology
03 medical and health sciences
0302 clinical medicine
Reference Values
Internal medicine
Biomarkers
Tumor
medicine
Humans
Multicenter Studies as Topic
Longitudinal Studies
Prospective Studies
Progression-free survival
General Pharmacology
Toxicology and Pharmaceutics
Survival analysis
Multiple myeloma
Randomized Controlled Trials as Topic
Lenalidomide
Receiver operating characteristic
Proportional hazards model
business.industry
Bortezomib
Research
General Neuroscience
Antibodies
Monoclonal
Daratumumab
Articles
General Medicine
Middle Aged
medicine.disease
Progression-Free Survival
Myeloma Proteins
Clinical Trials
Phase III as Topic
Drug Resistance
Neoplasm
Female
Neoplasm Recurrence
Local
Multiple Myeloma
business
medicine.drug
Zdroj: Clinical and Translational Science, 13(6), 1345-1354. Wiley-Blackwell Publishing Ltd
Clinical and Translational Science
ISSN: 1752-8062
1752-8054
Popis: 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.
Databáze: OpenAIRE
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