Autor: |
Chiara A. Cella, Maren Knoedler, Marcia Hall, Michele Arcopinto, Vincenzo Bagnardi, Lorenzo Gervaso, Stefania Pellicori, Francesca Spada, Maria G. Zampino, Paola S. Ravenda, Samuele Frassoni, Antonio Passaro, Monica Milano, Alice Laffi, Nicola Fazio, Florian Lordick |
Přispěvatelé: |
Cella, C, Knoedler, M, Hall, M, Arcopinto, M, Bagnardi, V, Gervaso, L, Pellicori, S, Spada, F, Zampino, M, Ravenda, P, Frassoni, S, Passaro, A, Milano, M, Laffi, A, Fazio, N, Lordick, F |
Jazyk: |
angličtina |
Rok vydání: |
2023 |
Předmět: |
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Popis: |
ImportanceThe assessment of the risk of venous thromboembolism (VTE) among outpatients with cancer represents an unsolved topic. Current international guidelines recommend primary prophylaxis for patients at intermediate to high risk of VTE, indicated by a Khorana score of 2 or more. A previous prospective study developed the ONKOTEV score, a 4-variable risk assessment model (RAM) consisting of a Khorana score of more than 2, metastatic disease, vascular or lymphatic compression, and previous VTE event.ObjectiveTo validate the ONKOTEV score as a novel RAM to assess the risk of VTE among outpatients with cancer.Design, Setting, and ParticipantsONKOTEV-2 is a noninterventional prognostic study conducted in 3 European centers located in Italy, Germany, and the United Kingdom among a prospective cohort of 425 ambulatory patients with a histologically confirmed diagnosis of a solid tumor who were receiving active treatments. The total study duration was 52 months, with an accrual period of 28 months (from May 1, 2015, to September 30, 2017) and an overall follow up-period of 24 months (data were censored September 30, 2019). Statistical analysis was performed in October 2019.ExposuresThe ONKOTEV score was calculated for each patient at baseline by collecting clinical, laboratory, and imaging data from tests performed for routine practice. Each patient was then observed to detect any thromboembolic event throughout the study period.Main Outcomes and MeasuresThe primary outcome of the study was the incidence of VTE, including deep vein thrombosis and pulmonary embolism.ResultsA total of 425 patients (242 women [56.9%]; median age, 61 years [range, 20-92 years]) were included in the validation cohort of the study. The cumulative incidences for the risk of developing VTE at 6 months were 2.6% (95% CI, 0.7%-6.9%), 9.1% (95% CI, 5.8%-13.2%), 32.3% (95% CI, 21.0%-44.1%), and 19.3% (95% CI, 2.5%-48.0%), respectively, among 425 patients with an ONKOTEV score of 0, 1, 2, and greater than 2 (P Conclusions and RelevanceThis study suggests that, because the ONKOTEV score has been validated in this independent study population as a novel predictive RAM for cancer-associated thrombosis, it can be adopted into practice and into clinical interventional trials as a decision-making tool for primary prophylaxis. |
Databáze: |
OpenAIRE |
Externí odkaz: |
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