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Mini oral session - Supportive and palliative care

1670MO - Validation of a new risk-assessment model for prediction of venous thromboembolism in cancer outpatients: The ONKOTEV score


17 Sep 2021


Mini oral session - Supportive and palliative care


Supportive Care and Symptom Management

Tumour Site


Chiara Alessandra Cella


Annals of Oncology (2021) 32 (suppl_5): S1175-S1198. 10.1016/annonc/annonc714


C.A. Cella1, M. Knoedler2, M. Hall3, S. Pellicori1, L. Gervaso1, R. Schorling4, V. Bagnardi5, F. Lordick4, N. Fazio6

Author affiliations

  • 1 Divisione Di Oncologia Medica Gastrointestinale E Tumori Neuroendocrini, IEO - Istituto Europeo di Oncologia, 20141 - Milan/IT
  • 2 Krebszentrum, University of Leipzig, 04103 - Leipzig/DE
  • 3 Medical Oncology Dept., Mount Vernon Cancer Centre - East and North Herts NHS Trust, HA6 2RN - Northwood/GB
  • 4 Krebszentrum, Universitätsklinikum Leipzig, 04103 - Leipzig/DE
  • 5 4. department Of Statistics And Quantitative Methods, University of Milan-Bicocca, 20141 - Milan/IT
  • 6 Gastrointestinal Medical Oncology And Neuroendocrine Tumors, IEO - Istituto Europeo di Oncologia, 20141 - Milan/IT


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Abstract 1670MO


The assessment of Venous Thromboembolism (VTE) risk in cancer outpatients still represents an evolving topic. Current international guidelines recommend an intermediate to high-risk group as identified by a Khorana score (KS) ≥ 2 as the cut-off for considering primary prophylaxis. In the previously reported prospective ONKOTEV study, we developed a 4 variables risk-assessment-model (RAM): KS > 2, metastatic disease, vascular/lymphatic compression and previous VTE. The goal of the current study is to validate the ONKOTEV score as a novel RAM in an independent cohort.


ONKOTEV-2 is a prospective, observational study conducted in Italy, Germany, and United Kingdom from May 2015 to September 2019. Clinical, laboratory and imaging data were collected at baseline, to calculate the ONKOTEV score before any cancer treatment. Each patient was followed up for 8 months, to detect VTE, by clinical examination and/or imaging performed in the routine practice.


Overall, 473 patients were included in the study. The most common primary sites in all cohorts were breast, esophagus/stomach, colon, rectum, lung and pancreas. In accordance with the KS, the population study was stratified into the following risk categories: low (58%), high (18%) and very-high (24%). In accordance with the ONKOTEV score, 27 %, 55%, 15% and 2.4% of patients had 0, 1, 2 and 3 score, respectively. Overall, the cumulative incidence (CI) of VTE was 12.7%. The CI for the risk of developing VTE by KS and ONKOTEV score is shown in the table. Table: 1670MO

Cumulative incidence function (at 12 months) for the risk of VTE by Khorana and ONKOTEV score

Score 0 8.8% Score 0 3.7%
Score 1-2 9.2% Score 1 9.7%
Score 2 19.4%
Score > 2 21% Score > 2 33.9%


ONKOTEV score ≥ 2 identified a category of high-risk group of cancer outpatients and significantly improved the VTE predictability of pre-existing RAMs. Therefore, ONKOTEV score has been validated as a new easy-to-use RAM for risk stratification and decision making about primary prophylaxis in cancer outpatients, with promising implications in clinical practice. The study was awarded within the EORTC Young Investigator program (2015-2018).

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

C.A. Cella.




All authors have declared no conflicts of interest.

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