Low-molecular-weight heparin beyond 12 months in patients with cancer-associated thrombosis

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ABSTRACT BACKGROUND Clinical guidelines indicate that in patients with cancer-associated thrombosis (CAT), anticoagulant treatment should be continued beyond 6 months as long as the cancer


is active. We aimed to analyse the safety of low-molecular-weight heparin (LMWH) beyond 12 months in patients with CAT. METHODS We performed a post hoc analysis of consecutive CAT patients


from October 2008 to December 2019. The primary outcome was the rate of clinically relevant bleeding (CRB), and we compared two periods (1–12 vs. 12–24 months). Hazard ratio (HR), competing


risk analysis and sensitivity analyses were performed. RESULTS Of the 588 patients included, 30.1% (_n_ = 177) received LMWH beyond 12 months. The rate of CRB in the first 12 months compared


to the 12–24 month period was 3.2 per 100 patients/month (95% CI 2.5–4.1) vs. 0.9 per 100 patients/month (95% CI 0.4–1.5), (_P_ < 0.0001). The competing risk analysis of CRB comparing


both periods showed a lower sub-distribution hazard ratio (SHR) during the period 12–24 months (SHR: 0.5, 95% CI: 0.3–0.8, _P_ < 0.001). CONCLUSION In patients with cancer-associated


thrombosis under anticoagulant treatment with LMWH, the rate of clinically relevant bleeding and major bleeding were lower beyond 12 months. Access through your institution Buy or subscribe


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an international prospective cohort study. J Clin Oncol. 2019;37:1713–20. Download references ACKNOWLEDGEMENTS We would like to thank Henry Antonio Andrade Ruiz, from the Methodological and


Statistical Support Unit, for his support and contribution to the statistical analysis. FUNDING This project was supported by LEO Pharma Research Foundation. AUTHOR INFORMATION AUTHORS AND


AFFILIATIONS * Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Hospital Virgen del Rocío, Sevilla, 41013, España Sergio Lopez-Ruz, Maria Barca-Hernando, Samira Marin-Romero, Teresa


Elias-Hernandez, Remedios Otero- Candelera & Luis Jara-Palomares * Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III,


Madrid, España Remedios Otero- Candelera & Luis Jara-Palomares Authors * Sergio Lopez-Ruz View author publications You can also search for this author inPubMed Google Scholar * Maria


Barca-Hernando View author publications You can also search for this author inPubMed Google Scholar * Samira Marin-Romero View author publications You can also search for this author


inPubMed Google Scholar * Teresa Elias-Hernandez View author publications You can also search for this author inPubMed Google Scholar * Remedios Otero- Candelera View author publications You


can also search for this author inPubMed Google Scholar * Luis Jara-Palomares View author publications You can also search for this author inPubMed Google Scholar CONTRIBUTIONS Conception


and design: MB-H, SL-R, SM-R and LJ-P. Data analysis and interpretation: MB-H, SL-R, SM-R and LJ-P. Synthesis of the results: all authors. Manuscript writing: SL-R and LJ-P. Manuscripts


review and edits. Final approval of manuscript: all authors. Accountable for all aspects of the work: all authors. CORRESPONDING AUTHOR Correspondence to Luis Jara-Palomares. ETHICS


DECLARATIONS COMPETING INTERESTS LJ-P reports personal fees from Bayer Hispania, Actelion, Rovi, Pfizer, Menarini, and Leo Pharma, outside the submitted work. ROC reports grant support from


Leo Pharma and Bayer Healthcare, and fees for serving on advisory boards and giving lectures from Leo Pharma, Rovi, Bayer Healthcare, MSD and Actelion. There are no other competing


interests. ETHICS APPROVAL AND CONSENT TO PARTICIPATE This post hoc analysis was evaluated and approved by the Ethical Committee of the centre according to Spanish Regulatory Authorities


(0511-N-22). This study was conducted in accordance with the principles of the Declaration of Helsinki and the International Council for Harmonisation (ICH) Guidelines for Good Clinical


Practice and in full conformity with relevant regulations. Documents constituting the master file of the study included all the documents established in good clinical practice


(CPMP/ICH/135/95). In this project, the collection, process and analysis of all data were anonymously carried out, and only for the purposes of the project. All data were protected in


accordance with the European Union directive 2016/679 of the European Parliament and the European Council, of April 27, 2016, regarding the protection of persons and their personal data.


CONSENT TO PUBLISH No publication consent is required for this specific study. This post hoc analysis was evaluated and approved by the Ethical Committee of the centre according to Spanish


Regulatory Authorities (0511-N-22). Original prospective studies required informed consent. ADDITIONAL INFORMATION PUBLISHER’S NOTE Springer Nature remains neutral with regard to


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Springer Nature or its licensor holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted


manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Reprints and permissions ABOUT THIS ARTICLE CITE THIS ARTICLE Lopez-Ruz,


S., Barca-Hernando, M., Marin-Romero, S. _et al._ Low-molecular-weight heparin beyond 12 months in patients with cancer-associated thrombosis. _Br J Cancer_ 127, 2234–2240 (2022).


https://doi.org/10.1038/s41416-022-02007-x Download citation * Received: 02 July 2022 * Revised: 28 September 2022 * Accepted: 29 September 2022 * Published: 14 October 2022 * Issue Date: 07


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