Venous thromboembolism in patients with cancer: design and rationale of a multicentre, prospective registry (Cancer-VTE Registry)

Yasuo Ohashi, Masataka Ikeda, Hideo Kunitoh, Mitsuru Sasako, Takuji Okusaka, Hirofumi Mukai, Keiichi Fujiwara, Mashio Nakamura, Tetsuya Kimura, Kei Ibusuki, Masato Sakon, Yasuo Ohashi, Masataka Ikeda, Hideo Kunitoh, Mitsuru Sasako, Takuji Okusaka, Hirofumi Mukai, Keiichi Fujiwara, Mashio Nakamura, Tetsuya Kimura, Kei Ibusuki, Masato Sakon

Abstract

Introduction: Patients with cancer are at higher risk of venous thromboembolism (VTE) than the general population as the malignancy itself and treatment modalities, including medication and surgery, contribute to the risk of developing VTE. Furthermore, patients with cancer developing VTE have a worse prognosis than those without cancer. There are no multicentre prospective data on the occurrence and treatment of VTE in patients with cancer in Japan, and data on the outcomes, complications and incidence of VTE in these patients have not been reported. In addition, Japanese patients with cancer are traditionally treated with unfractionated heparin or warfarin; however, the use of direct oral anticoagulants, which became available in 2014, has not been sufficiently examined in this patient group. Therefore, this multicentre, prospective registry has been designed to capture VTE data from Japanese patients presenting with six cancer types.

Methods and analysis: This registry will enrol 10 000 patients with colorectal, lung, stomach, breast, gynaecological (including endometrial, cervical, ovarian, fallopian tube and peritoneal) or pancreatic cancer between March 2017 and March 2019 and follow them for 1 year. We plan to collect data on the incidences of symptomatic VTE, bleeding events, stroke, systemic embolic events, incidental VTE requiring treatment in patients, overall survival and symptomatic VTE event-free survival.

Ethics and dissemination: All patients will provide written informed consent. Data will remain anonymous and will be collected using an online electronic data capture system. Study protocol, amendments and informed consent forms will be approved by the institutional review board/independent ethics committee at each site prior to study commencement. Results will be disseminated at national meetings and published in peer-reviewed journals.

Trial registration number: UMIN000024942.

Keywords: anticoagulant drugs; deep vein thrombosis; direct oral anticoagulants; pulmonary embolism; registries; venous thromboembolism.

Conflict of interest statement

Competing interests: All authors have received personal fees from Daiichi Sankyo during the conduct of study. KF has received research grants from Daiichi Sankyo. TK and KI are employees of Daiichi Sankyo.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Cancer-VTE Registry study design. VTE, venous thromboembolism.

References

    1. Japanese guidelines for the diagnosis, treatment and prevention of pulmonary thromboembolism and deep vein thrombosis. 2009.
    1. Blom JW, Doggen CJ, Osanto S, et al. . Malignancies, prothrombotic mutations, and the risk of venous thrombosis. JAMA 2005;293:715–22. 10.1001/jama.293.6.715
    1. Heit JA, Silverstein MD, Mohr DN, et al. . Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med 2000;160:809–15.
    1. Walker AJ, Card TR, West J, et al. . Incidence of venous thromboembolism in patients with cancer - a cohort study using linked United Kingdom databases. Eur J Cancer 2013;49:1404–13. 10.1016/j.ejca.2012.10.021
    1. Horsted F, West J, Grainge MJ. Risk of venous thromboembolism in patients with cancer: a systematic review and meta-analysis. PLoS Med 2012;9:e1001275 10.1371/journal.pmed.1001275
    1. Timp JF, Braekkan SK, Versteeg HH, et al. . Epidemiology of cancer-associated venous thrombosis. Blood 2013;122:1712–23. 10.1182/blood-2013-04-460121
    1. Sakuma M, Fukui S, Nakamura M, et al. . Cancer and pulmonary embolism: thrombotic embolism, tumor embolism, and tumor invasion into a large vein. Circ J 2006;70:744–9.
    1. Ro A, Kageyama N. Clinical significance of the soleal vein and related drainage veins, in calf vein thrombosis in autopsy cases with massive pulmonary thromboembolism. Ann Vasc Dis 2016;9:15–21. 10.3400/avd.oa.15-00088
    1. Ro A, Kageyama N, Tanifuji T, et al. . Pulmonary thromboembolism: overview and update from medicolegal aspects. Leg Med 2008;10:57–71. 10.1016/j.legalmed.2007.09.003
    1. Geerts WH, Heit JA, Clagett GP, et al. . Prevention of venous thromboembolism. Chest 2001;119:132S–75. 10.1378/chest.119.1_suppl.132S
    1. Khorana AA. Venous thromboembolism and prognosis in cancer. Thromb Res 2010;125:490–3. 10.1016/j.thromres.2009.12.023
    1. Sørensen HT, Mellemkjær L, Olsen JH, et al. . Prognosis of cancers associated with Venous thromboembolism. N Engl J Med Overseas Ed 2000;343:1846–50. 10.1056/NEJM200012213432504
    1. Ikushima S, Ono R, Fukuda K, et al. . Trousseau’s syndrome: cancer-associated thrombosis. Jpn J Clin Oncol 2016;46:204–8. 10.1093/jjco/hyv165
    1. National Comprehensive Cancer Network. NCCN Guidelines Version 2. 2014 Cancer-associated venous thromboembolic disease.
    1. Hutten BA, Prins MH, Gent M, et al. . Incidence of recurrent thromboembolic and bleeding complications among patients with venous thromboembolism in relation to both malignancy and achieved international normalized ratio: a retrospective analysis. J Clin Oncol 2000;18:3078–83. 10.1200/JCO.2000.18.17.3078
    1. Prandoni P, et al. . Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis. Blood 2002;100:3484–8. 10.1182/blood-2002-01-0108
    1. Krumholz HM. Registries and selection bias: the need for accountability. Circ Cardiovasc Qual Outcomes 2009;2:517–8. 10.1161/CIRCOUTCOMES.109.916601
    1. Nomura H, Wada H, Mizuno T, et al. . Negative predictive value of d-dimer for diagnosis of venous thromboembolism. Int J Hematol 2008;87:250–5. 10.1007/s12185-008-0047-x
    1. Tanaka S, Nishigami K, Taniguchi N, et al. . Criteria for ultrasound diagnosis of deep venous thrombosis of lower extremities. J Med Ultrason 2008;35:33–6. 10.1007/s10396-007-0160-0
    1. Matsuo H, Sato H. Vascular Ultrasound: Screening for venous diseases of lower extremity [DVD. Osaka: MEDICUS SHUPPAN, Publishers Co. Ltd, 2016.
    1. Japan cancer statistics 2015 Available from: (accessed 15 Mar 2017).
    1. The Hokusai-VTE Investigators. Edoxaban versus Warfarin for the Treatment of Symptomatic Venous Thromboembolism. N Engl J Med Overseas Ed 2013;369:1406–15.
    1. Raskob GE, van Es N, Segers A, et al. . Edoxaban for venous thromboembolism in patients with cancer: results from a non-inferiority subgroup analysis of the Hokusai-VTE randomised, double-blind, double-dummy trial. Lancet Haematol 2016;3:e379–e387. 10.1016/S2352-3026(16)30057-6
    1. Lee AYY, Levine MN, Baker RI, et al. . Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med Overseas Ed 2003;349:146–53. 10.1056/NEJMoa025313

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir