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Primary thromboprophylaxis in cancer outpatients – real-world evidence

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Abstract

Introduction

Cancer-associated thrombosis (CAT) is a significant concern among patients with malignant diseases, leading to increased mortality. While current guidelines recommend primary thromboprophylaxis for venous thromboembolism (VTE) in medium-to-high-risk outpatients, this practice remains controversial. A better understanding of primary thromboprophylaxis is crucial, yet there is a lack of Real-World Evidence (RWE) in Portugal.

Aims

This RWE study aimed to elucidate primary thromboprophylaxis practices among cancer outpatients in Portugal.

Methods

A five-year observational multicentric study in eight Portuguese health institutions enrolled 124 adult cancer outpatients under primary thromboprophylaxis for VTE. The endpoints were CAT, bleeding, cancer progression and death.

Results

High thrombotic risk tumours were prevalent, with 57% (71) of the patients presenting with pancreatic and gastric cancers. Regarding primary thromboprophylaxis, 55% (68) received Low-Molecular-Weight Heparin (LMWH). VTE was presented in 11% (14) of the patients and major bleeding in 2% (2). Vascular compression, elevated D-dimer and previous VTE were significantly associated with VTE occurrence under primary thromboprophylaxis. The Onkotev model was shown to be the best risk assessment model (RAM) in this population (p = 0.007). CAT patients exhibited a lower progression-free survival than non-CAT patients (p = 0.021), while thrombosis did not influence overall survival (p = 0.542).

Conclusion

Primary thromboprophylaxis in medium-to-high-risk cancer outpatients is a safe and effective practice in real-world settings. This study is the first Portuguese RWE on primary thromboprophylaxis, highlighting evidence for improving prophylactic strategies in this population.

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Data availability

The data presented in this study are available on request from the corresponding author.

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Acknowledgements

The authors would like to thank GESCAT, Hospital Center of Trás-os-Montes e Alto Douro, Health Local Unit of Nordeste, Hospital Center of Barreiro Montijo, Hospital Center of Lisboa Ocidental, Hospital of Luz Setúbal, Hospital of Espírito Santo de Évora, Hospital Center of Vila Nova de Gaia / Espinho, University Hospital Center of São João and Fundação para Ciência e Tecnologia (FCT).

Funding

Scholarship program “Trombose & Cancro 2018: Advancing the knowledge of Cancer Associated Thrombosis” supported by GESCAT – Study Group of Cancer Associated Thrombosis, the fund holder being J.-L.P. V.T. is a PhD scholarship holder (2020.08969.BD; https://doi.org/10.54499/2020.08969.BD) supported by Fundação para a Ciência e Tecnologia (FCT), co-financed by European Social Funds (FSE) and national funds of MCTES.

Author information

Authors and Affiliations

  1. Department of Medical Oncology, Hospital Center of Trás-Os-Montes E Alto Douro, 5000-508, Vila Real, Portugal

    Joana Liz-Pimenta, Rosa Gomes & Marta Sousa

  2. Faculty of Medicine of University of Porto (FMUP), 4200-072, Porto, Portugal

    Joana Liz-Pimenta, Valéria Tavares & Rui Medeiros

  3. Molecular Oncology and Viral Pathology Group, Research Center of IPO Porto (CI-IPOP) / Pathology and Laboratory Medicine Dep., Clinical Pathology SV / RISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPO Porto) / Porto Comprehensive Cancer Center (Porto. CCC), 4200-072, Porto, Portugal

    Valéria Tavares & Rui Medeiros

  4. ICBAS - Instituto de Ciências Biomédicas Abel Salazar, Universidade Do Porto, Porto, Portugal

    Valéria Tavares & Rui Medeiros

  5. Department of Medical Oncology, Hospital Center of Barreiro Montijo, 2830-003, Barreiro, Portugal

    João Gramaça

  6. Department of Medical Oncology, Hospital of Luz Setúbal, 2900-722, Setúbal, Portugal

    João Rato

  7. Department of Medical Oncology, Hospital of Espírito Santo de Évora, 7000-811, Évora, Portugal

    Maria Menezes

  8. Department of Medical Oncology, Hospital Center of Lisboa Ocidental, 1449-005, Lisbon, Portugal

    Mafalda Baleiras

  9. Department of Medical Oncology, Hospital Center of Vila Nova de Gaia / Espinho, 4434-502, Vila Nova de Gaia, Portugal

    Helena Guedes

  10. Department of Medical Oncology, University Hospital Center of São João, 4200-319, Porto, Portugal

    Joana Reis & Miguel Barbosa

  11. Department of Imunohemotherapy, Hospital of Senhora da Oliveira, 4835-044, Guimarães, Portugal

    Catarina Guedes

  12. Department of Hematology and Medical Oncology, Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, OH, 44106, USA

    Alok A. Khorana

  13. Research Department, Portuguese League Against Cancer - Regional Nucleus of the North, 4200-172, Porto, Portugal

    Rui Medeiros

  14. Biomedical Research Center, Faculty of Health Sciences of the Fernando Pessoa University, 4249-004, Porto, Portugal

    Rui Medeiros

Authors
  1. Joana Liz-Pimenta
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  2. Valéria Tavares
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  3. João Gramaça
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  4. João Rato
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  5. Maria Menezes
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  6. Mafalda Baleiras
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  7. Helena Guedes
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  8. Joana Reis
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  9. Catarina Guedes
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  10. Rosa Gomes
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  11. Miguel Barbosa
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  13. Alok A. Khorana
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  14. Rui Medeiros
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Contributions

Conceptualization, J.-L.P.; Methodology: J.L.P., J.G., M.B., J.R., M.M., H.G. and J.R. Writing—original draft preparation: J.-L.P. and V.T. Writing—review and editing: J.-L.P., V.T., C.G., R.G., M.S. and A.A.K; Funding acquisition: J.L.P. Supervision: M.B., A.A.K and R.M. All authors have read and agreed to the published version of the manuscript.

Corresponding author

Correspondence to Rui Medeiros.

Ethics declarations

Research involving human participants and/or animals

The study was approved by the ethics committee of Hospital Center of Trás-os-Montes and Alto Douro (CES. 489/2018, 20th December 2018).

Informed consent

Patients signed an informed written consent according to the principles of the Helsinki Declaration.

Conflicts of interest

J.-L.P. received funding from LEO Pharma to conduct this investigation. The funder had no role in the collection, analysis, and interpretation of data, writing of the manuscript, or in the decision to submit the paper for publication. The remaining authors declare no conflicts of interest.

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Bullet Points

1. Thrombosis contributes to elevated morbidity and mortality rates among cancer patients;.

2. Despite the importance of primary thromboprophylaxis, there is a lack of Real-World Evidence;.

3. This five-year observational multicentric study elucidated the practices of primary thromboprophylaxis in Portugal;.

4. Vascular compression, elevated D-dimer and a history of previous VTE were significantly associated with VTE occurrence under primary thromboprophylaxis;.

5. New insights could help refine the guidelines for primary thromboprophylaxis, improving the clinical outcomes of cancer patients.

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Liz-Pimenta, J., Tavares, V., Gramaça, J. et al. Primary thromboprophylaxis in cancer outpatients – real-world evidence. J Thromb Thrombolysis (2024). https://doi.org/10.1007/s11239-024-02984-1

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  • DOI: https://doi.org/10.1007/s11239-024-02984-1

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