Rationale and design of PROSPECT-CONKO 004: a prospective, randomized trial of simultaneous pancreatic cancer treatment with enoxaparin and chemotherapy

BACKGROUND: Advanced pancreatic cancer, in addition to its high mortality, is characterized by one of the highest rates of venous thromboembolic events (VTE) as compared to other types of cancer. Enoxaparin, a low molecular weight heparin (LMWH), has proven to be effective for the prevention and treatment of VTE in surgical and general medical patients. Results of some small studies suggest that this benefit might extend to patients with cancer, however, enoxaparin is not currently indicated for this use. This phase IIb study was designed to analyze the efficacy of enoxaparin in patients with locally advanced or metastatic pancreatic cancer undergoing systemic chemotherapy. METHODS: The aim of this prospective multicenter trial is to compare concomitant treatment with enoxaparin to no anticoagulation in 540 patients. Primary endpoint is the incidence of clinically relevant VTE (symptomatic deep venous thrombosis (DVT) of the leg and / or pelvic and / or pulmonary embolism (PE)) within the first 3 months. Secondary endpoints include the incidence of symptomatic and asymptomatic VTE after 6, 9 and 12 months as well as remission at 3, 6, 9 and 12 months, overall survival and bleeding. Trial registration: isrctn.org identifier CCT-NAPN-16752, controlled-trials.com identifier: ISRCTN02140505. RESULTS: An interim analysis for safety performed after inclusion of 152 patients revealed no increased risk of bleeding (5 pts vs. 6 pts, Chi2: 0.763). CONCLUSIONS: PROSPECT is a pivotal study in elucidating the role of low molecular weight heparins in advanced pancreatic cancer. Its results will lead to a new understanding of the role of heparins in the prevention of venous thromboembolism and of their effect on survival, remission rates and toxicity of chemotherapeutic regimens

[Thromboembolic risk and prophylaxis in hospitalized surgical and internal medicine patients. German results of the international ENDORSE study]

BACKGROUND AND OBJECTIVES: Venous thromboembolism (VTE) leads to an increased morbidity in hospitalized patients. This multinational cross-sectional survey was designed to assess the prevalence of VTE risk factors and to determine the proportion of at-risk patients who receive effective VTE-prophylaxis. The results of the 16 participating German hospitals of the study are presented and compared with the international results. PATIENTS AND METHODS: All hospital inpatients aged \u3eor= 40 years admitted to a medical ward and all surgical inpatients aged \u3eor= 18 years were enrolled. The American College of Chest Physicians (ACCP) guidelines (2004) were applied to assess VTE risk and to determine whether patients were receiving recommended VTE prophylaxis. RESULTS: Overall, 2,370 patients were enrolled: 1,210 (51 %) were categorised as surgical and 1,160 (49 %) as acute medically ill. 838 (69 %) of surgical and 479 (41 %) of medical patients were judged to be at risk for VTE. Of the surgical patients at risk, 772 (92 %) received ACCP-recommended VTE prophylaxis, compared with 337 (70 %) medical patients at risk of VTE. Low-molecular weight heparins were most frequently used. CONCLUSIONS: In total, in comparison to other countries, Germany has a leading position in the implementation of international guidelines with regard to VTE prophylaxis. Whereas in a surgical ward effective VTE prophylaxis is consistently standard care, in the medical indications there is still room for improvement in terms of stratification of VTE risk and corresponding VTE-prophylaxis