Introduction: Cancer-associated venous thrombosis (CAT) is a common and serious complication of active malignancies, increasing in frequency during systemic treatment and radiotherapy. Due to a high risk of recurrence and bleeding, the administration of anticoagulants for initial treatment and secondary prevention of CAT is challenging. We conducted a prospective registry study of patients with acute CAT to evaluate the way treatment is given to these patients in routine practice. Methods: From May 2015 to May 2017, all consecutive patients with acute venous thromboembolism (VTE) admitted to specialty or emergency departments of the participating hospitals in Berlin, Germany, were entered in the registry. Patients with cancer underwent extensive baseline evaluation including the type and location of thrombosis and use of anticoagulant therapy. Follow-up assessments were made at discharge and by telephone interviews at 3 and 6 months. Results: A total of 382 patients with acute CAT were enrolled in the study, representing 24.5% of all patients with thrombosis. 70.4% of CAT patients had deep vein thromboses (DVT), 48.2% had pulmonary embolism (PE), and 18.6% had concurrent PE and DVT. A significant proportion of VTE (27%) were asymptomatic and were diagnosed only incidentally. At baseline, 97.9% of the patients received anticoagulant therapy, predominantly with low-molecular-weight heparin (LMWH) (n=334, 87.4%). Direct oral anticoagulants (DOACs) were given to 5.8% of patients, and vitamin K antagonists (VKAs) were rarely used (<2% of patients). Changes in the prescription of antithrombotic agents were seen at discharge from hospital and during follow-up. Overall, the use of LMWH declined during follow-up, while the proportion of patients treated with DOACs increased to 32.4% at 6 months. At baseline, the most frequently used LMWH were enoxaparin and nadroparin, but many patients were switched to once daily tinzaparin prior to discharge. Initially and after discharge the majority of patients were treated by oncologists. Overall, 263 (68.8%) and 222 (58,1%) patients were still alive and could be contacted at 3 and 6 months of follow-up, respectively. Of these, 84.0% and 71.6% were still on anticoagulant therapy (58.6% and 36.5% on LMWH). Conclusion: In accordance with the guidelines, the majority of CAT patients received anticoagulation therapy for the recommended minimum duration of 3-6 months. LMWH remained the preferred option throughout the study, demonstrating good patient adherence. In deviation from guideline recommendations and available study results during the study period, more than a quarter of CAT patients were treated with DOACs. Only recently, DOACs have been established as another option for anticoagulation in CAT patients.

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Background: National and international guidelines for the diagnosis and treatment of cancer associated venous thromboembolism (CAT) recommend anticoagulation treatment for 3 to 6 months and a re-evaluation for resumption depending on the individual risk of every patient. In CAT low molecular weight heparin (LMWH) was estimated to be the most effective and safest treatment option in 2015. However, it remains unclear how cancer patients with VTE were (treated in clinical daily care in Germany. In former register trials, the specific characteristics of individual cancer patients were insufficiently characterized and inadequately discussed. Special aspects of daily care are lacking in most publications. Methods: The GECAT register was set up for Berlin´s two main hospital companies Charité-Universitaetsmedizin Berlin and Vivantes, (both covering about 50 % of the hospital beds in Berlin) to document prospectively patients with a newly diagnosed VTE . Patients with the diagnosis of cancer within 2 years prior to the VTE got basis documentation by a physician after informed consent. A follow up of these patients was scheduled after 3 and 6 months per telephone interview. Points of interest were: kind and location of the VTE event, diagnostic procedures, drug and dosage of initial and follow-up anti-coagulation treatment, relapse of VTE or bleeding complications, serious adverse events, mortality, and date and reason for determination of anticoagulation. Primary objective was to evaluate the treatment reality of patients with cancer associated VTE in clinical daily practice. Results: Between May 2015 and May 2017, 382 patients (pts) with active cancer within the last 2 years and newly diagnosed VTE gave consent to this register trial. 193 (50.5%) were female, median age was 65 years (range 19-89). For 133 pts (34.8%), VTE was the primary reason for admission at hospital, 34.3% were referred by their oncologist, 13,6% by their general practitioner, 15,5% by other treating physicians and 36.6% directly via the emergency department. 182 pts (47.6%) had pulmonary embolism, 268 pts (70.2%) had venous thrombosis and 18,6%71 pts (18.6%) had both. The most common cancer sites were lung (n=57, 14,9%), gynecological (n=44, 11,5%), colorectal (n=40, 10,5%) and pancreatic cancer (n=33 8,6%); 204 pts (56%) with solid tumors presented with stage IV diseases; 60 pts (15.7%) had hematological malignancies. 279 pts (73%) received anticancer treatments at the time of diagnosis of VTE. 148 (38.7%) pts died in the 6 months study period (20 pts died in hospital after admission, 90 pts within the first 3 months and 38 pts within the 6 months follow up). Initially, the majority of pts (n=350; 91.6%) was treated with LMWH. After discharge from hospital 78.7% remained on LMWH and 12.7% were treated with direct oral anticoagulants (DOACs). After 3 months 64.9% of pts received LMWH and 26.1% DOACs; after 6 months 48.4% LMWH and 44% DOACs. Responsible for the anticoagulation treatment decisions was mostly the oncologist (58%), followed by the general practitioner (26.3%) and other physicians (15,7%) . During the initial hospital stay, 2.6% of pts had a bleeding complication and 0.8% were diagnosed with a progress of VTE. At 6 months follow up, 6.4% reported bleeding complications and 2.4% recurrent VTE. Conclusion: The GECAT register trial gives new and clinically relevant information about the clinical daily care practice of cancer patients with newly diagnosed VTE in Berlin, Germany. The treating oncologist is in most cases responsible for the treatment. Disclosures Sinn: LEO: Research Funding; Bayer Healthcare AG: Research Funding; Servier: Honoraria, Research Funding; Astra Zeneca: Honoraria, Research Funding; Amgen: Honoraria; Sanofi: Honoraria. Scholz:Celgene: Consultancy; GILEAD: Consultancy, Speakers Bureau; Roche: Consultancy; Janssen-Cilag: Consultancy; Hexal: Consultancy; Novartis: Consultancy; Pfizer: Speakers Bureau; Takeda: Consultancy; Daiichi Sankio: Consultancy. Klamroth:Bayer, Biomarin, CSL Behring, Novo Nordisk, Octapharma, Pfizer, Roche, SOBI, Takeda: Consultancy; Bayer, Novo Nordisk, SOBI: Research Funding.

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