Bemiparin in Oncology

An association between cancer and thrombosis has been recognized since 1865. It is considered to be a two-way association; cancer is associated with an increased risk of venous thromboembolism (VTE), whereas activation of the coagulation cascade enhances the proliferation, angiogenesis potential and metastasis of tumour cells. A sizeable proportion of VTE events in cancer patients undergoing major surgery occur after discharge from hospital, suggesting that extended thromboprophylaxis beyond the normal 7-10 days is warranted in these patients. Studies have demonstrated reduced incidences of VTE with extended thromboprophylaxis using low molecular weight heparins (LMWH) and guidelines recommend continuing thromboprophylaxis after discharge in patients who have undergone major cancer surgery, but the evidence is still considered limited and of low quality, and the recommendations have not been widely implemented in clinical practice. Extended prophylaxis with bemiparin was shown to reduce significantly the incidence of major VTE in patients undergoing major cancer surgery in the Cancer, Bemiparin and Surgery Evaluation study, providing further support for the routine use of extended thromboprophylaxis with LMWH in cancer patients. Heparins, particularly LMWH, in addition to preventing VTE in cancer patients, can block tumour cell growth, invasion, metastasis and angiogenesis. As with other LMWH, bemiparin and its ultra-low molecular weight derivative, RO-14, appear to be effective in preventing angiogenesis in in-vitro models. Recent clinical studies have demonstrated significant survival advantages when LMWH have been added to chemotherapy in cancer patients. This could be partly due, not only to the prevention of thromboembolic diseases in these patients, but also to 'direct' antineoplastic properties of LMWH. The survival benefits appeared greater in patients with limited cancer, especially limited small cell lung cancer. The Adjuvant Bemiparin in Small Cell Lung Cancer study is assessing the effect of bemiparin on survival in patients with limited small cell lung cancer, and although results are not yet available, preliminary data appear very promising

The management of acute venous thromboembolism in clinical practice - study rationale and protocol of the European PREFER in VTE Registry

Background: Venous thromboembolism (VTE) is a major health problem, with over one million events every year in Europe. However, there is a paucity of data on the current management in real life, including factors influencing treatment pathways, patient satisfaction, quality of life (QoL), and utilization of health care resources and the corresponding costs. The PREFER in VTE registry has been designed to address this and to understand medical care and needs as well as potential gaps for improvement. Methods/design: The PREFER in VTE registry was a prospective, observational, multicenter study conducted in seven European countries including Austria, France Germany, Italy, Spain, Switzerland, and the UK to assess the characteristics and the management of patients with VTE, the use of health care resources, and to provide data to estimate the costs for 12 months treatment following a first-time and/or recurrent VTE diagnosed in hospitals or specialized or primary care centers. In addition, existing anticoagulant treatment patterns, patient pathways, clinical outcomes, treatment satisfaction, and health related QoL were documented. The centers were chosen to reflect the care environment in which patients with VTE are managed in each of the participating countries. Patients were eligible to be enrolled into the registry if they were at least 18 years old, had a symptomatic, objectively confirmed first time or recurrent acute VTE defined as either distal or proximal deep vein thrombosis, pulmonary embolism or both. After the baseline visit at the time of the acute VTE event, further follow-up documentations occurred at 1, 3, 6 and 12 months. Follow-up data was collected by either routinely scheduled visits or by telephone calls. Results: Overall, 381 centers participated, which enrolled 3,545 patients during an observational period of 1 year. Conclusion: The PREFER in VTE registry will provide valuable insights into the characteristics of patients with VTE and their acute and mid-term management, as well as into drug utilization and the use of health care resources in acute first-time and/or recurrent VTE across Europe in clinical practice. Trial registration: Registered in DRKS register, ID number: DRKS0000479