Risk of Recurrent Venous Thromboembolism in Patients with Cancer: An Individual Patient Data Meta-analysis and Development of a Prediction Model.

Autor:	Lanting VR; Amsterdam UMC, University of Amsterdam, Department of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.; Department of Internal Medicine, Tergooi Hospital, Hilversum, The Netherlands., Takada T; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.; Department of General Medicine, Shirakawa Satellite for Teaching and Research (STAR), Fukushima Medical University, Fukushima, Japan., Bosch FTM; Amsterdam UMC, University of Amsterdam, Department of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.; Department of Internal Medicine, Tergooi Hospital, Hilversum, The Netherlands., Marshall A; Warwick Clinical Trials Unit, University of Warwick, Coventry, United Kingdom., Grosso MA; Clinical Development, Daiichi Sankyo, Basking Ridge, New Jersey, United States., Young AM; Warwick Clinical Trials Unit, University of Warwick, Coventry, United Kingdom.; Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, United Kingdom., Lee AYY; Division of Hematology, University of British Columbia, British Columbia Cancer Agency, Vancouver BC, Canada., Di Nisio M; Department of Medicine and Ageing Sciences, Gabriele D'Annunzio University, Chieti, Italy., Raskob GE; University of Oklahoma Health Sciences Center and OU Health, Oklahoma City, Oklahoma, United States., Kamphuisen PW; Amsterdam UMC, University of Amsterdam, Department of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.; Department of Internal Medicine, Tergooi Hospital, Hilversum, The Netherlands., Büller HR; Amsterdam UMC, University of Amsterdam, Department of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands., van Es N; Amsterdam UMC, University of Amsterdam, Department of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.
Jazyk:	angličtina
Zdroj:	Thrombosis and haemostasis [Thromb Haemost] 2024 Oct 16. Date of Electronic Publication: 2024 Oct 16.
DOI:	10.1055/a-2418-3960
Abstrakt:	Background:  About 7% of patients with cancer-associated venous thromboembolism (CAT) develop a recurrence during anticoagulant treatment. Identification of high-risk patients may help guide treatment decisions. Aim:  To identify clinical predictors and develop a prediction model for on-treatment recurrent CAT. Methods:  For this individual patient data meta-analysis, we used data from four randomized controlled trials evaluating low-molecular-weight heparin or direct oral anticoagulants (DOACs) for CAT (Hokusai VTE Cancer, SELECT-D, CLOT, and CATCH). The primary outcome was adjudicated on-treatment recurrent CAT during a 6-month follow-up. A clinical prediction model was developed using multivariable logistic regression analysis with backward selection. This model was validated using internal-external cross-validation. Performance was assessed by the c-statistic and a calibration plot. Results:  After excluding patients using vitamin K antagonists, the combined dataset comprised 2,245 patients with cancer and acute CAT who were treated with edoxaban (23%), rivaroxaban (9%), dalteparin (47%), or tinzaparin (20%). Recurrent on-treatment CAT during the 6-month follow-up occurred in 150 (6.7%) patients. Predictors included in the final model were age (restricted cubic spline), breast cancer (odds ratio [OR]: 0.42; 95% confidence interval [CI]: 0.20-0.87), metastatic disease (OR: 1.44; 95% CI: 1.01-2.05), treatment with DOAC (OR: 0.66; 95% CI: 0.44-0.98), and deep vein thrombosis only as an index event (OR: 1.72; 95% CI: 1.31-2.27). The c-statistic of the model was 0.63 (95% CI: 0.54-0.72) after internal-external cross-validation. Calibration varied across studies. Conclusion:  The prediction model for recurrent CAT included five clinical predictors and has only modest discrimination. Prediction of recurrent CAT at the initiation of anticoagulation remains challenging. Competing Interests: M.G. is an employee of Daiichi Sankyo. A.Y.Y.L. reports consulting fees and honoraria from Bayer AG, consulting fees and honoraria from LEO Pharma, consulting fees and honoraria from Pfizer, consulting fees from Servier, and honoraria from Bristol Myers Squibb. M.D.N. reports personal fees as an invited speaker from Bayer, Daiichi Sankyo, and Viatris, personal fees for advisory board membership from Leo Pharma, Janssen, and Pfizer, and institutional funding from Leo Pharma, all outside the submitted work. G.E.R. reports consultancy fees or honoraria from AMAG Pharma, Alnylam, Anthos Therapeutics, Bayer HealthCare Pharmaceuticals Inc., Bristol-Myers Squibb, Daiichi Sankyo Inc., Ionis, Janssen Global Services LLC, Pfizer, Regeneron, Sirius Pharmaceutical; honoraria from BMS, Pfizer, Daiichi Sankyo; DSMB or advisory board membership from Anthos Therapeutics, Janssen, Bristol-Myers Squibb, and Pfizer, leadership or fiduciary role in other board, society, committee or advocacy group of OU Health, and the National Blood Clot Alliance. P.W.K. reports research funding from Daiichi Sankyo and Roche diagnostics. H.R.B. reports research support from Sanofi-Aventis, Bayer HealthCare, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Pfizer, Roche, IONIS, Boehringer Ingelheim, Eli Lilly, and Novartis. Consultant from Sanofi-Aventis, Bayer HealthCare, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Pfizer, Roche, IONIS, Boehringer Ingelheim, Eli Lilly, and Novartis. Scientific advisory board from Sanofi-Aventis, Bayer HealthCare, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Pfizer, Roche, IONIS, Boehringer Ingelheim, Eli Lilly, and Novartis. N.v.E. reports advisory board honoraria from Daiichi Sankyo, LEO Pharma, and Bayer, which were transferred to his institute. The other authors have nothing to declare. (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).)
Databáze:	MEDLINE
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