scholarly journals Prevention of venous thromboembolism in cancer patients: current approaches and opportunities for improvement

2011 ◽  
pp. 191-204
Author(s):  
Alpesh N. Amin ◽  
Steven B. Deitelzweig
Keyword(s):  
At Risk ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Assessment Model ◽  
Major Surgery ◽  
Medical Illness ◽  
Patients With Cancer ◽  
Increased Risk ◽  
National Quality ◽  
American Society

Venous thromboembolism (VTE), a common complication in patients with cancer, is associated with increased risk of morbidity, mortality, and recurrent VTE. Risk factors for VTE in cancer patients include the type and stage of cancer, comorbidities, age, major surgery, and active chemotherapy. Evidence-based guidelines for thromboprophylaxis in cancer patients have been published: the National Comprehensive Cancer Network and American Society for Clinical Oncology guidelines recommend thromboprophylaxis for hospitalized cancer patients, while the American College of Chest Physician guidelines recommend thromboprophylaxis for surgical patients with cancer and bedridden cancer patients with an acute medical illness. Guidelines do not generally recommend routine thromboprophylaxis in ambulatory patients during chemotherapy, but there is evidence that some of these patients are at risk of VTE; some may be at higher risk while on active chemotherapy. Approaches are needed to identify those patients most likely to benefit from thromboprophylaxis, and, to this end, a risk assessment model has been developed and validated. Despite the benefits, many at-risk patients do not receive any thromboprophylaxis, or receive prophylaxis that is not compliant with guideline recommendations. Quality improvement initiatives have been developed by the Centers for Medicare and Medicaid Services, National Quality Forum, and Joint Commission to encourage closure of the gap between guideline recommendations and clinical practice for prevention, diagnosis, and treatment of VTE in hospitalized patients. Health-care institutions and providers need to take seriously the burden of VTE, improve prophylaxis rates in patients with cancer, and address the need for prophylaxis across the patient continuum.

scholarly journals Prevention of venous thromboembolism in cancer patients: current approaches and opportunities for improvement

2011 ◽  
Vol 5 (3) ◽  
pp. 191
Author(s):  
Alpesh N. Amin ◽  
Steven B. Deitelzweig
Keyword(s):  
At Risk ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Assessment Model ◽  
Major Surgery ◽  
Medical Illness ◽  
Patients With Cancer ◽  
Increased Risk ◽  
National Quality ◽  
American Society

Venous thromboembolism (VTE), a common complication in patients with cancer, is associated with increased risk of morbidity, mortality, and recurrent VTE. Risk factors for VTE in cancer patients include the type and stage of cancer, comorbidities, age, major surgery, and active chemotherapy. Evidence-based guidelines for thromboprophylaxis in cancer patients have been published: the National Comprehensive Cancer Network and American Society for Clinical Oncology guidelines recommend thromboprophylaxis for hospitalized cancer patients, while the American College of Chest Physician guidelines recommend thromboprophylaxis for surgical patients with cancer and bedridden cancer patients with an acute medical illness. Guidelines do not generally recommend routine thromboprophylaxis in ambulatory patients during chemotherapy, but there is evidence that some of these patients are at risk of VTE; some may be at higher risk while on active chemotherapy. Approaches are needed to identify those patients most likely to benefit from thromboprophylaxis, and, to this end, a risk assessment model has been developed and validated. Despite the benefits, many at-risk patients do not receive any thromboprophylaxis, or receive prophylaxis that is not compliant with guideline recommendations. Quality improvement initiatives have been developed by the Centers for Medicare and Medicaid Services, National Quality Forum, and Joint Commission to encourage closure of the gap between guideline recommendations and clinical practice for prevention, diagnosis, and treatment of VTE in hospitalized patients. Health-care institutions and providers need to take seriously the burden of VTE, improve prophylaxis rates in patients with cancer, and address the need for prophylaxis across the patient continuum.

American Society of Clinical Oncology Guideline: Recommendations for Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer

2007 ◽  
Vol 25 (34) ◽  
pp. 5490-5505 ◽  
Author(s):  
Gary H. Lyman ◽  
Alok A. Khorana ◽  
Anna Falanga ◽  
Daniel Clarke-Pearson ◽  
Christopher Flowers ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Clinical Oncology ◽  
Malignant Disease ◽  
Major Surgery ◽  
Thromboembolism Prophylaxis ◽  
Patients With Cancer ◽  
Prevention And Treatment ◽  
American Society ◽  
The Impact

Purpose To develop guideline recommendations for the use of anticoagulation in the prevention and treatment of venous thromboembolism (VTE) in patients with cancer. Methods A comprehensive systematic review of the medical literature on the prevention and treatment of VTE in cancer patients was conducted and reviewed by a panel of content and methodology experts. Following discussion of the results, the panel drafted recommendations for the use of anticoagulation in patients with malignant disease. Results The results of randomized controlled trials of primary and secondary VTE medical prophylaxis, surgical prophylaxis, VTE treatment, and the impact of anticoagulation on survival of patients with cancer were reviewed. Recommendations were developed on the prevention of VTE in hospitalized, ambulatory, and surgical cancer patients as well as patients with established VTE, and for use of anticoagulants in cancer patients without VTE to improve survival. Conclusion Recommendations of the American Society of Clinical Oncology VTE Guideline Panel include (1) all hospitalized cancer patients should be considered for VTE prophylaxis with anticoagulants in the absence of bleeding or other contraindications; (2) routine prophylaxis of ambulatory cancer patients with anticoagulation is not recommended, with the exception of patients receiving thalidomide or lenalidomide; (3) patients undergoing major surgery for malignant disease should be considered for pharmacologic thromboprophylaxis; (4) low molecular weight heparin represents the preferred agent for both the initial and continuing treatment of cancer patients with established VTE; and (5) the impact of anticoagulants on cancer patient survival requires additional study and cannot be recommended at present.

Venous Thromboembolism Prophylaxis Practices in Acutely Ill Medical Patients with Either Previous Cancer or Currently Active Cancer: Findings from IMPROVE.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1767-1767
Author(s):  
Beng H. Chong ◽  
Ajay K. Kakkar ◽  
Victor F. Tapson ◽  
Gordon Fitzgerald ◽  
Frederick A. Anderson ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Major Surgery ◽  
Medical Illness ◽  
Medical Patients ◽  
Vte Prophylaxis ◽  
Increased Risk ◽  
Pharmacologic Prophylaxis ◽  
To Receive ◽  
Active Cancer

Abstract Background Patients with previous or current cancer have an increased risk for venous thromboembolism (VTE). However, little data is available on physician’s practices for providing VTE prophylaxis to these patients. The aim of this analysis of the International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) was to characterize VTE prophylaxis practices in acutely ill hospitalized medical patients who had previous cancer or currently active cancer. Methods Patient recruitment began in July 2002. Patients ≥18 years old and hospitalized for ≥3 days with an acute medical illness are enrolled consecutively. Exclusion criteria are: therapeutic antithrombotic agents or thrombolytics at admission, major surgery or trauma during 3 months prior to admission, and VTE treatment within 24 hours of admission. Results Data were from 4315 patients enrolled up to 30 June 2004 in 37 hospitals in 11 countries. 578 (13%) patients had currently active cancer (6% as the primary admission diagnosis). Patients with current cancer, previous cancer only, and no cancer were: 40%, 54% and 51% female, median (IQR) ages 72 (60–79), 77 (64–82) and 66 (47–80) years, median length of hospital stay 9 (5–18), 8 (5–12) and 8 (5–14) days, median duration of immobility 8 (5–19), 5 (4–11) and 6 (4–14) days (including immobility immediately prior to hospital admission). The percentages of patients with current or no cancer who received any pharmacologic prophylaxis were similar (see Table 1). However, aspirin was less likely to be prescribed, and intermittent pneumatic compression (IPC) more likely to be used in patients with current cancer than in those without cancer. Patients with previous cancer were more likely to receive pharmacologic prophylaxis, with increased use of unfractionated heparin (UFH) and aspirin, compared with patients without cancer. Conclusions Despite acutely ill medical patients with previous or current cancer having a higher risk for VTE, less than half received VTE prophylaxis, reflecting poor awareness of the benefits of prophylaxis. Physician’s perceptions of bleeding risks in cancer patients may influence prophylaxis practices; patients with current cancer were less likely to receive aspirin, but more likely to receive IPC, than patients without cancer. However, patients with previous cancer were more likely to receive pharmacologic prophylaxis than those without cancer, reflecting recognition by some physicians that these patients have an increased risk for VTE. Table 1. VTE prophylaxis in acutely ill medical patients with current, previous or no cancer VTE prophylaxis Current cancer (%) n=578 Previous cancer (%) n=266 No cancer (%) n=3471 *P<0.05, **P<0.01, ***P<0.001 (compared with patients with no cancer); †Some patients received >1 type of prophylaxis; ‡Without concomitant pharmacologic prophylaxis; ES, elastic stockings LMWH 24 24 23 UFH 10 21*** 13 Aspirin 1** 9** 4 Warfarin 0 1 1 Any pharmacologic prophylaxis† 34 46** 37 IPC‡ 7* 5 4 ES‡ 2 3 2

scholarly journals Preventing Venous Thromboembolism in Ambulatory Patients with Cancer: A Narrative Review

Cancers ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 612 ◽  
Author(s):  
Anne Rossel ◽  
Helia Robert-Ebadi ◽  
Christophe Marti
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Absolute Risk ◽  
Narrative Review ◽  
Relative Reduction ◽  
Number Needed To Treat ◽  
Chemotherapeutic Regimen ◽  
Patients With Cancer ◽  
Increased Risk ◽  
Risk Of Cancer

Venous thromboembolism (VTE) is frequent among patients with cancer. Ambulatory cancer patients starting chemotherapy have a 5% to 10% risk of cancer associated thrombosis (CAT) within the first year after cancer diagnosis. This risk may vary according to patient characteristics, cancer location, cancer stage, or the type of chemotherapeutic regimen. Landmark studies evaluating thrombophrophylaxis with low molecular weight heparin (LMWH) for ambulatory cancer patients have shown a relative reduction in the rate of symptomatic VTE of about one half. However, the absolute risk reduction is modest among unselected patients given a rather low risk of events resulting in a number needed to treat (NNT) of 40 to 50. Moreover, this modest benefit is mitigated by a trend towards an increased risk of bleeding, and the economic and patient burden due to daily injections of LMWH. For these reasons, routine thromboprophylaxis is not recommended by expert societies. Advances in VTE risk stratification among cancer patients, and growing evidence regarding efficacy and safety of direct oral anticoagulants (DOACs) for the treatment and prevention of CAT have led to reconsider the paradigms of this risk–benefit assessment. This narrative review aims to summarize the recent evidence provided by randomized trials comparing DOACs to placebo in ambulatory cancer patients and its impact on expert recommendations and clinical practice.

scholarly journals Canadian consensus recommendations on the management of venous thromboembolism in patients with cancer. Part 2: treatment

2015 ◽  
Vol 22 (2) ◽  
pp. 144 ◽  
Author(s):  
J.C. Easaw ◽  
M.A. Shea-Budgell ◽  
C.M.J. Wu ◽  
P.M. Czaykowski ◽  
J. Kassis ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Renal Insufficiency ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Factor Xa ◽  
Patients With Cancer ◽  
Clinical Scenarios ◽  
Increased Risk

Patients with cancer are at increased risk of venous thromboembolism (vte). Anticoagulation therapy is used to treat vte; however, patients with cancer have unique clinical circumstances that can often make decisions surrounding the administration of therapeutic anticoagulation complicated. No national Canadian guidelines on the management of established cancer-associated thrombosis have been published. We therefore aimed to develop a consensus-based, evidence-informed guideline on the topic.PubMed was searched for clinical trials and meta-analyses published between 2002 and 2013. Reference lists of key articles were hand-searched for additional publications. Content experts from across Canada were assembled to review the evidence and make recommendations.Low molecular weight heparin is the treatment of choice for cancer patients with established vte. Direct oral anticoagulants are not recommended for the treatment of vte at this time. Specific clinical scenarios, including the presence of an indwelling venous catheter, renal insufficiency, and thrombocytopenia, warrant modifications in the therapeutic administration of anticoagulation therapy. Patients with recurrent vte should receive extended (>3 months) anticoagulant therapy. Incidental vte should generally be treated in the same manner as symptomatic vte. There is no evidence to support the monitoring of anti–factor Xa levels in clinically stable cancer patients receiving prophylactic anticoagulation; however, levels of anti–factor Xa could be checked at baseline and periodically thereafter in patients with renal insufficiency. Follow-up and education about the signs and symptoms of vte are important components of ongoing patient care.

scholarly journals Cost-effectiveness analysis and budget impact of rivaroxaban compared with dalteparin in patients with cancer at risk of recurrent venous thromboembolism

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e039057
Author(s):  
Lisa A de Jong ◽  
Annette W G van der Velden ◽  
Marinus van Hulst ◽  
Maarten J Postma
Keyword(s):  
At Risk ◽  
Venous Thromboembolism ◽  
Cost Effectiveness ◽  
Cost Saving ◽  
Cancer Patients ◽  
Time Horizon ◽  
Budget Impact ◽  
Patients With Cancer ◽  
Effectiveness Analysis ◽  
The Cost

ObjectivesIn the ‘Comparison of an Oral Factor Xa Inhibitor With Low Molecular Weight Heparin in Patients With Cancer With Venous Thromboembolism’ (SELECT-D) trial, rivaroxaban showed relatively low venous thromboembolism (VTE) recurrence but higher bleeding compared with dalteparin in patients with cancer. We aim to calculate the cost-effectiveness and budget impact of rivaroxaban compared with dalteparin in patients with cancer at risk of recurrent VTE.SettingWe built a Markov model to calculate the cost-effectiveness from a societal perspective over a 5-year time horizon for the Dutch healthcare setting.ParticipantsA hypothetical cohort of 1000 cancer patients with VTE entered the model with baseline characteristics based on the SELECT-D trial.InterventionSix months of treatment with rivaroxaban (15 mg two times per day for first 3 weeks followed by 20 mg once daily) was compared with 6 months of treatment with dalteparin (200 IU/kg daily during month 1 followed by 150 IU/kg daily).Primary and secondary outcome measuresThe primary outcome of the cost-effectiveness analysis was the incremental cost-effectiveness ratio (ICER). The robustness of the model was evaluated in probabilistic and univariate sensitivity analyses. A budget impact analysis was performed to calculate the total annual financial consequences for a societal perspective in the Netherlands.ResultsIn the base case and all scenarios, rivaroxaban were cost-saving while also slightly improving the patient’s health, resulting in economically dominant ICERs. In the probabilistic sensitivity analysis, 77.8% and 98.7% of the simulations showed rivaroxaban to be cost-saving and more effective for a 5-year and 6-month time horizon, respectively. Rivaroxaban can save up to €11 326 763 (CI €5 164 254 to €17 363 231) in approximately 8000 cancer patients with VTE per year compared with dalteparin based on a 1-year time horizon.ConclusionsTreatment with rivaroxaban is economically dominant over dalteparin in patients with cancer at risk for recurrent VTE in the Netherlands. The use of rivaroxaban instead of dalteparin can save over €10 million per year, primarily driven by the difference in drug costs.

scholarly journals Recent advances in the treatment and prevention of venous thromboembolism in cancer patients: role of the direct oral anticoagulants and their unique challenges

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 974 ◽  
Author(s):  
Dominique Farge ◽  
Corinne Frere
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Patient Characteristics ◽  
Primary Prophylaxis ◽  
Disease Stage ◽  
Vte Prophylaxis ◽  
Patients With Cancer ◽  
Increased Risk

Venous thromboembolism (VTE) is a common complication in patients with cancer and is associated with poor prognosis. Low-molecular-weight heparins (LMWHs) are the standard of care for the treatment of cancer-associated thrombosis. Primary VTE prophylaxis with LMWH is recommended after cancer surgery and in hospitalized patients with reduced mobility. However, owing to wide variations in VTE and bleeding risk, based on disease stage, anti-cancer treatments, and individual patient characteristics, routine primary prophylaxis is not recommended in ambulatory cancer patients undergoing chemotherapy. Efforts are under way to validate risk assessment models that will help identify those patients in whom the benefits of primary prophylaxis will outweigh the risks. In recent months, long-awaited dedicated clinical trials assessing the direct oral anticoagulants (DOACs) in patients with cancer have reported promising results. In comparison with the LMWHs, the DOACs were reported to be non-inferior to prevent VTE recurrence. However, there was an increased risk of bleeding, particularly in gastrointestinal cancers. Safe and optimal treatment with the DOACs in the patient with cancer will require vigilant patient selection based on patient characteristics, co-morbidities, and the potential for drug–drug interactions.

scholarly journals The Current Status of Direct Oral Anticoagulants in Cancer-Related Venous Thromboembolism Treatment

2020 ◽  
Vol 16 (2) ◽  
pp. 286-295
Author(s):  
К. V. Lobastov ◽  
I. V. Schastlivtsev
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Similar Efficacy ◽  
Current Status ◽  
Patients With Cancer ◽  
Increased Risk ◽  
Discontinuation Of Treatment

This article is a review of epidemiology, pathogenesis and treatment of venous thromboembolism (VTE) in cancer patients. In accordance with actual guidelines, the duration of anticoagulant therapy of cancer-related venous thrombosis should be at least 6 months. The use of vitamin K antagonists (VKA) is associated with an increased risk of VTE recurrence and bleeding, so low molecular weight heparin (LMWH), in particular dalteparin, has been the "gold standard" until recently. Compared to VKA, prolonged use of LMWH can reduce the incidence of VTE recurrence without affecting the risk of bleeding or death. The main disadvantage of LMWH is low compliance, leading to premature discontinuation of treatment or switching to alternative anticoagulants. Direct oral anticoagulants (DOACs) have changed the situation. Compared to VKA, they demonstrated higher efficacy with a similar (or improved for individual DOACs) safety in patients with cancer-related VTE. Recently, the results of studies comparing the use of DOACs with dalteparin in cancer patients have been published: SELECT-D (rivaroxaban), HOKUSAI-VTE Cancer (edoxaban), ADAM VTE (apixaban), CARAVAGGIO (apixaban). Rivaroxaban showed higher efficacy than dalteparin with a similar risk of major bleeding, but an increased risk of clinically relevant non-major (CRNM) bleeding. Edoxaban had the same efficacy as dalteparin but increased risk of major but not CRNM bleeding. Apixaban showed similar efficacy and safety as dalteparin in the CARAVAGGIO study, but did not provide higher safety in the ADAM VTE study. It was noted that gastrointestinal and urogenital bleeding dominated in the structure of hemorrhagic complications of DOACs. The results of published trials are reflected in the current guidelines of the specialized societies. DOACs (particularly, rivaroxaban and edoxaban) are recommended for the VTE treatment in cancer patients.

Risk of Venous Thromboembolism with Thalidomide in Cancer Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3820-3820 ◽  
Author(s):  
Keriann N Gray ◽  
David Chu ◽  
Shenhong Wu ◽  
Richard Z. Lin
Keyword(s):  
Systematic Review ◽  
Multiple Myeloma ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Meta Analysis ◽  
Thrombosis Prophylaxis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Increased Risk ◽  
American Society

Abstract Background: Thalidomide, an oral angiogenesis inhibitor with immunomodulatory activity, is effective in the treatment of multiple myeloma, and also undergoing evaluation for other malignancies. The use of thalidomide is associated with significant side effects, including venous thromboembolism (VTE). Currently the overall risk of VTE with thalidomide is not well-defined. Objective: We conducted a systematic review and meta-analysis of published randomized controlled trials (RCT) to determine the risk of VTE with thalidomide in cancer patients, and assess whether it is affected by anti-thrombosis prophylaxis. Methods: We searched databases including PUBMED, the Web of Science (January, 1966–July, 2008), and abstracts presented at recent American Society of Clinical Oncology and American Society of Hematology conferences to identify relevant studies. Eligible studies included prospective RCT in which a standard anti-cancer therapy or placebo was employed with or without thalidomide with available data on VTE for analysis. The summary incidence, relative risk (RR), and 95% confidence interval (CI) were calculated using a random- or fixed-effects model based on the heterogeneity of the included studies. Results: From 17 RCTs, a total of 3977 patients with multiple myeloma and a variety of solid tumors (prostate, breast, renal cell, melanoma, ovarian) were included for analysis. The overall incidence of VTE was 11.7% (95% CI: 8.1–16.5%). Patients treated with thalidomide had a significantly increased risk of VTE with a RR of 2.4 (95% CI: 1.9–3.0, p<0.001) when compared to controls. The risk was significantly decreased with prophylaxis from a RR of 3.5 (95%CI: 2.5–4.9, p<0.001) in the absence of prophylaxis to 1.9 (95%CI: 1.4–2.5, p<0.001) in the presence of prophylaxis. The risk of VTE may vary with tumor types; in patients with multiple myeloma, the incidence and RR were 15.7% (95%CI: 10.9–22.1) and 3.1 (95%CI: 2.1–4.5, p<0.001) respectively; while for patients with solid tumors, the incidence and RR were 5.3% (95% CI 2.1–12.8) and 3.5 (95% CI: 1.1–10.6, p=0.028) respectively. Conclusion: Thalidomide therapy is associated with a significantly increased risk of VTE in cancer patients. The risk varies with anti-thrombosis prophylaxis and tumor type. It is strongly recommended to have surveillance for VTE in all patients receiving thalidomide, and prophylaxis to reduce the risk in patients with multiple myeloma.

Finding a risk assessment model for thromboembolic events in hospitalized cancer patients: The Indicate Study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24108-e24108
Author(s):  
Marco Platania ◽  
Federico Nichetti ◽  
Leonardo Provenzano ◽  
Giulia Montelatici ◽  
Andrea Franza ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Cancer Patients ◽  
Assessment Model ◽  
Study Endpoint ◽  
Primary Study ◽  
Medical Illness ◽  
Low Grade ◽  
Thromboembolic Events ◽  
Primary Analysis ◽  
Increased Risk

e24108 Background: Hospitalized cancer patients are at increased risk for Thromboembolic Events (TEs). Given the hemorrhagic risk associated with untailored thromboprophylaxis, the identification of patients at low TE risk who might not receive it during in-hospital stay would be clinically useful. Methods: The INDICATE study was a monocentric, observational study enrolling patients with active solid malignancy hospitalized for at least two nights for treatment administration, diagnostic procedures or acute medical illness (excluding TEs). The primary objective was to assess the Negative Predictive Value (NPV) of low-grade Khorana Score (e.g. KS = 0), evaluated at the time of patients’ in-hospital admission, for TEs prediction during and after (next 45 days) hospitalization. The primary analysis was conducted on patients with KS = 0. However, all-grade KS patients were enrolled for secondary outcomes analysis. Assuming a 7% of TEs as the unsatisfactory percentage and a 3% as the satisfactory percentage, expecting about 5% of collected data as incomplete, all consecutive patients who fulfil the inclusion criteria irrespective of the KS were enrolled, until a total of 149 patients with KS = 0 were included to detect the favorable NPV with one-sided alpha equal to 0.10 and power equal to 0.80. Results: Between November 2016 and May 2019, a total of 535 patients were enrolled. Among these, 153 (28.6%) had a KS = 0. The primary study endpoint was met: 29 (5.4%) patients received a diagnosis of TEs during or after hospitalization, with 7 (4.6%) cases in the KS = 0 group. However, patients with higher KS values did not show increasing TE incidence. Among the other evaluated risk assessment models, the ONKOTEV scoreshowed the best predictive potential, with significantly higher values in patients with TEs (p < 0.001).Of note, TEs were associated with poorer overall survival (median, 6.7 vs 24.8 months, log rank p < 0.001). Conclusions: The INDICATE study showed that hospitalized cancer patients with KS = 0 at admission have a low risk of TEs, and could thus be spared from routine thromboprophylaxis. Further studies are needed to better define a RAM in this population.

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