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Development and validation of a new risk assessment model for immunomodulatory drug-associated venous thrombosis among Chinese patients with multiple myeloma
BACKGROUND: Individuals with multiple myeloma (MM) receiving immunomodulatory drugs (IMiDs) are at risk of developing venous thromboembolism (VTE), a serious complication. There is no established clinical model for predicting VTE in the Chinese population. We develop a new risk assessment model (RAM...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10552366/ https://www.ncbi.nlm.nih.gov/pubmed/37794471 http://dx.doi.org/10.1186/s12959-023-00534-y |
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author | Li, Xiaozhe Sun, Xiuli Fang, Baijun Leng, Yun Sun, Fangfang Wang, Yaomei Wang, Qing Jin, Jie Yang, Min Xu, Bing Fang, Zhihong Chen, Lijuan Chen, Zhi Yang, Qimei Zhang, Kejie Ye, Yinhai Geng, Hui Sun, Zhiqiang Hao, Dan Huang, Hongming Wang, Xiaotao Jing, Hongmei Ma, Lan Pan, Xueyi Chen, Wenming Li, Juan |
author_facet | Li, Xiaozhe Sun, Xiuli Fang, Baijun Leng, Yun Sun, Fangfang Wang, Yaomei Wang, Qing Jin, Jie Yang, Min Xu, Bing Fang, Zhihong Chen, Lijuan Chen, Zhi Yang, Qimei Zhang, Kejie Ye, Yinhai Geng, Hui Sun, Zhiqiang Hao, Dan Huang, Hongming Wang, Xiaotao Jing, Hongmei Ma, Lan Pan, Xueyi Chen, Wenming Li, Juan |
author_sort | Li, Xiaozhe |
collection | PubMed |
description | BACKGROUND: Individuals with multiple myeloma (MM) receiving immunomodulatory drugs (IMiDs) are at risk of developing venous thromboembolism (VTE), a serious complication. There is no established clinical model for predicting VTE in the Chinese population. We develop a new risk assessment model (RAM) for IMiD-associated VTE in Chinese MM patients. METHODS: We retrospectively selected 1334 consecutive MM patients receiving IMiDs from 16 medical centers in China and classified them randomly into the derivation and validation cohorts. A multivariate Cox regression model was used for analysis. RESULTS: The overall incidence of IMiD-related VTE in Chinese MM patients was 6.1%. Independent predictive factors of VTE (diabetes, ECOG performance status, erythropoietin-stimulating agent use, dexamethasone use, and VTE history or family history of thrombosis) were identified and merged to develop the RAM. The model identified approximately 30% of the patients in each cohort at high risk for VTE. The hazard ratios (HRs) were 6.08 (P < 0.001) and 6.23 (P < 0.001) for the high-risk subcohort and the low-risk subcohort, respectively, within both the derivation and validation cohorts. The RAM achieved satisfactory discrimination with a C statistic of 0.64. The stratification approach of the IMWG guidelines yielded respective HRs of 1.77 (P = 0.053) and 1.81 (P = 0.063). The stratification approach of the SAVED score resulted in HRs of 3.23 (P = 0.248) and 1.65 (P = 0.622), respectively. The IMWG guideline and the SAVED score-based method yielded C statistics of 0.58 and 0.51, respectively. CONCLUSIONS: The new RAM outperformed the IMWG guidelines and the SAVED score and could potentially guide the VTE prophylaxis strategy for Chinese MM patients. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12959-023-00534-y. |
format | Online Article Text |
id | pubmed-10552366 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-105523662023-10-06 Development and validation of a new risk assessment model for immunomodulatory drug-associated venous thrombosis among Chinese patients with multiple myeloma Li, Xiaozhe Sun, Xiuli Fang, Baijun Leng, Yun Sun, Fangfang Wang, Yaomei Wang, Qing Jin, Jie Yang, Min Xu, Bing Fang, Zhihong Chen, Lijuan Chen, Zhi Yang, Qimei Zhang, Kejie Ye, Yinhai Geng, Hui Sun, Zhiqiang Hao, Dan Huang, Hongming Wang, Xiaotao Jing, Hongmei Ma, Lan Pan, Xueyi Chen, Wenming Li, Juan Thromb J Research BACKGROUND: Individuals with multiple myeloma (MM) receiving immunomodulatory drugs (IMiDs) are at risk of developing venous thromboembolism (VTE), a serious complication. There is no established clinical model for predicting VTE in the Chinese population. We develop a new risk assessment model (RAM) for IMiD-associated VTE in Chinese MM patients. METHODS: We retrospectively selected 1334 consecutive MM patients receiving IMiDs from 16 medical centers in China and classified them randomly into the derivation and validation cohorts. A multivariate Cox regression model was used for analysis. RESULTS: The overall incidence of IMiD-related VTE in Chinese MM patients was 6.1%. Independent predictive factors of VTE (diabetes, ECOG performance status, erythropoietin-stimulating agent use, dexamethasone use, and VTE history or family history of thrombosis) were identified and merged to develop the RAM. The model identified approximately 30% of the patients in each cohort at high risk for VTE. The hazard ratios (HRs) were 6.08 (P < 0.001) and 6.23 (P < 0.001) for the high-risk subcohort and the low-risk subcohort, respectively, within both the derivation and validation cohorts. The RAM achieved satisfactory discrimination with a C statistic of 0.64. The stratification approach of the IMWG guidelines yielded respective HRs of 1.77 (P = 0.053) and 1.81 (P = 0.063). The stratification approach of the SAVED score resulted in HRs of 3.23 (P = 0.248) and 1.65 (P = 0.622), respectively. The IMWG guideline and the SAVED score-based method yielded C statistics of 0.58 and 0.51, respectively. CONCLUSIONS: The new RAM outperformed the IMWG guidelines and the SAVED score and could potentially guide the VTE prophylaxis strategy for Chinese MM patients. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12959-023-00534-y. BioMed Central 2023-10-04 /pmc/articles/PMC10552366/ /pubmed/37794471 http://dx.doi.org/10.1186/s12959-023-00534-y Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Li, Xiaozhe Sun, Xiuli Fang, Baijun Leng, Yun Sun, Fangfang Wang, Yaomei Wang, Qing Jin, Jie Yang, Min Xu, Bing Fang, Zhihong Chen, Lijuan Chen, Zhi Yang, Qimei Zhang, Kejie Ye, Yinhai Geng, Hui Sun, Zhiqiang Hao, Dan Huang, Hongming Wang, Xiaotao Jing, Hongmei Ma, Lan Pan, Xueyi Chen, Wenming Li, Juan Development and validation of a new risk assessment model for immunomodulatory drug-associated venous thrombosis among Chinese patients with multiple myeloma |
title | Development and validation of a new risk assessment model for immunomodulatory drug-associated venous thrombosis among Chinese patients with multiple myeloma |
title_full | Development and validation of a new risk assessment model for immunomodulatory drug-associated venous thrombosis among Chinese patients with multiple myeloma |
title_fullStr | Development and validation of a new risk assessment model for immunomodulatory drug-associated venous thrombosis among Chinese patients with multiple myeloma |
title_full_unstemmed | Development and validation of a new risk assessment model for immunomodulatory drug-associated venous thrombosis among Chinese patients with multiple myeloma |
title_short | Development and validation of a new risk assessment model for immunomodulatory drug-associated venous thrombosis among Chinese patients with multiple myeloma |
title_sort | development and validation of a new risk assessment model for immunomodulatory drug-associated venous thrombosis among chinese patients with multiple myeloma |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10552366/ https://www.ncbi.nlm.nih.gov/pubmed/37794471 http://dx.doi.org/10.1186/s12959-023-00534-y |
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