Risk of venous thromboembolism (VTE)is elevated in cancer, but individual risk factors cannot identify a sufficiently highrisk group of outpatients for thromboprophylaxis. We developed a simple model for predicting chemotherapy-associated VTE using baseline clinical and laboratory variables. The association of VTE with multiple variables was characterized in a derivation cohort of 2701 cancer outpatients from a prospective observational study. A risk model was derived and validated in an independent cohort of 1365 patients from the same study. Five predictive variables were identified in a multivariate model: site of cancer (2 points for very high-risk site, 1 point for highrisk site), platelet count of 350 ؋ 10 9 /L or more, hemoglobin less than 100 g/L (10 g/dL) and/or use of erythropoiesisstimulating agents, leukocyte count more than 11 ؋ 10 9 /L, and body mass index of 35 kg/m 2 or more (1 point each). Rates of VTE in the derivation and validation cohorts, respectively, were 0.8% and 0.3% in low-risk (score ‫؍‬ 0), 1.8% and 2% in intermediate-risk (score ‫؍‬ 1-2), and 7.1% and 6.7% in high-risk (score > 3) category over a median of 2.5 months (Cstatistic ‫؍‬ 0.7 for both cohorts). This model can identify patients with a nearly 7% short-term risk of symptomatic VTE and may be used to select cancer outpatients for studies of thromboprophylaxis. IntroductionCancer and antineoplastic therapy are frequently complicated by the development of venous thromboembolism (VTE). Several risk factors for cancer-associated VTE have been described in recent studies and include primary site of cancer, presence of metastatic disease, and use of antineoplastic therapy including chemotherapy, hormonal therapy, surgery, and erythropoiesis-stimulating agents. [1][2][3][4] Cancer patients on active therapy are at greatest risk for development of VTE. In a population-based study, cancer was associated with a 4.1-fold greater risk of thrombosis, whereas the use of chemotherapy increased the risk 6.5-fold. 5,6 In women with stage II breast cancer, the risk of VTE decreases dramatically after chemotherapy is completed. 7,8 The occurrence of VTE has important implications for the cancer patient including requirement for chronic anticoagulation, possible delays in delivering chemotherapy, a high risk of recurrent VTE, risk of bleeding complications on anticoagulation, decreased quality of life, and consumption of health care resources. 9,10 Furthermore, cancer patients with VTE have a 2-fold or greater increase in mortality compared with cancer patients without VTE, even after adjusting for stage. 11,12 Indeed, thromboembolism is a leading cause of death in cancer patients. 13 Primary VTE prophylaxis can reduce deep vein thrombosis (DVT), pulmonary embolism (PE), and fatal PE in several highrisk populations such as hospitalized patients or in the postoperative setting. [14][15][16][17][18] In the cancer population, identification of patients most at risk for VTE followed by institution of effective prophylaxis could improve morbidity, m...

PURPOSE To provide updated recommendations about prophylaxis and treatment of venous thromboembolism (VTE) in patients with cancer. METHODS PubMed and the Cochrane Library were searched for randomized controlled trials (RCTs) and meta-analyses of RCTs published from August 1, 2014, through December 4, 2018. ASCO convened an Expert Panel to review the evidence and revise previous recommendations as needed. RESULTS The systematic review included 35 publications on VTE prophylaxis and treatment and 18 publications on VTE risk assessment. Two RCTs of direct oral anticoagulants (DOACs) for the treatment of VTE in patients with cancer reported that edoxaban and rivaroxaban are effective but are linked with a higher risk of bleeding compared with low-molecular-weight heparin (LMWH) in patients with GI and potentially genitourinary cancers. Two additional RCTs reported on DOACs for thromboprophylaxis in ambulatory patients with cancer at increased risk of VTE. RECOMMENDATIONS Changes to previous recommendations: Clinicians may offer thromboprophylaxis with apixaban, rivaroxaban, or LMWH to selected high-risk outpatients with cancer; rivaroxaban and edoxaban have been added as options for VTE treatment; patients with brain metastases are now addressed in the VTE treatment section; and the recommendation regarding long-term postoperative LMWH has been expanded. Re-affirmed recommendations: Most hospitalized patients with cancer and an acute medical condition require thromboprophylaxis throughout hospitalization. Thromboprophylaxis is not routinely recommended for all outpatients with cancer. Patients undergoing major cancer surgery should receive prophylaxis starting before surgery and continuing for at least 7 to 10 days. Patients with cancer should be periodically assessed for VTE risk, and oncology professionals should provide patient education about the signs and symptoms of VTE. Additional information is available at www.asco.org/supportive-care-guidelines .

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Purpose To provide guidance regarding the practical assessment and management of vulnerabilities in older patients undergoing chemotherapy. Methods An Expert Panel was convened to develop clinical practice guideline recommendations based on a systematic review of the medical literature. Results A total of 68 studies met eligibility criteria and form the evidentiary basis for the recommendations. Recommendations In patients ≥ 65 years receiving chemotherapy, geriatric assessment (GA) should be used to identify vulnerabilities that are not routinely captured in oncology assessments. Evidence supports, at a minimum, assessment of function, comorbidity, falls, depression, cognition, and nutrition. The Panel recommends instrumental activities of daily living to assess for function, a thorough history or validated tool to assess comorbidity, a single question for falls, the Geriatric Depression Scale to screen for depression, the Mini-Cog or the Blessed Orientation-Memory-Concentration test to screen for cognitive impairment, and an assessment of unintentional weight loss to evaluate nutrition. Either the CARG (Cancer and Aging Research Group) or CRASH (Chemotherapy Risk Assessment Scale for High-Age Patients) tools are recommended to obtain estimates of chemotherapy toxicity risk; the Geriatric-8 or Vulnerable Elders Survey-13 can help to predict mortality. Clinicians should use a validated tool listed at ePrognosis to estimate noncancer-based life expectancy ≥ 4 years. GA results should be applied to develop an integrated and individualized plan that informs cancer management and to identify nononcologic problems amenable to intervention. Collaborating with caregivers is essential to implementing GA-guided interventions. The Panel suggests that clinicians take into account GA results when recommending chemotherapy and that the information be provided to patients and caregivers to guide treatment decision making. Clinicians should implement targeted, GA-guided interventions to manage nononcologic problems. Additional information is available at www.asco.org/supportive-care-guidelines .

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.

BACKGROUND.Venous thromboembolism (VTE) contributes to morbidity and mortality in cancer patients and is a frequent complication of anticancer therapy. In the current study, the frequency, risk factors, and trends associated with VTE were examined among hospitalized cancer patients.METHODS.A retrospective cohort study was conducted using the discharge database of the University HealthSystem Consortium. This included 1,824,316 hospitalizations between 1995 and 2003 at 133 U.S. medical centers.RESULTS.Among 1,015,598 cancer patients, 34,357 (3.4%) were diagnosed with deep venous thrombosis and 11,515 with pulmonary embolism (PE) (1.1%) for an overall VTE rate of 4.1%. Subgroups of cancer patients with the highest rates included black ethnicity (5.1% per hospitalization) and those receiving chemotherapy (4.9%). Sites of cancer with the highest rates of VTE included pancreas (8.1%), kidney (5.6%), ovary (5.6%), lung (5.1%), and stomach (4.9%). Among hematologic malignancies, myeloma (5%), non‐Hodgkin lymphoma (4.8%), and Hodgkin disease (4.6%) had the highest rates of VTE. The rate of VTE increased by 28%, secondary to a near‐doubling of PE rates from 0.8% to 1.5% (P < .0001). Among patients receiving chemotherapy, the rates of VTE rose from 3.9% to 5.7%, an increase of 47% (P < .0001). In multivariate analysis, risk factors associated with VTE included age ≥65 years, female sex, black ethnicity, use of chemotherapy, primary site of cancer, presence of comorbidities, and year of admission.CONCLUSIONS.VTE, particularly PE, is an increasingly frequent complication of hospitalization in cancer patients. Patients with black ethnicity, specific sites of cancer, or those receiving chemotherapy are disproportionately at risk. Cancer 2007. © 2007 American Cancer Society.

BACKGROUNDAmbulatory patients receiving systemic cancer therapy are at varying risk for venous thromboembolism. However, the benefit of thromboprophylaxis in these patients is uncertain. METHODSIn this double-blind, randomized trial involving high-risk ambulatory patients with cancer (Khorana score of ≥2, on a scale from 0 to 6, with higher scores indicating a higher risk of venous thromboembolism), we randomly assigned patients without deep-vein thrombosis at screening to receive rivaroxaban (at a dose of 10 mg) or placebo daily for up to 180 days, with screening every 8 weeks. The primary efficacy end point was a composite of objectively confirmed proximal deep-vein thrombosis in a lower limb, pulmonary embolism, symptomatic deepvein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, and death from venous thromboembolism and was assessed up to day 180. In a prespecified supportive analysis involving the same population, the same end point was assessed during the intervention period (first receipt of trial agent to last dose plus 2 days). The primary safety end point was major bleeding. RESULTSOf 1080 enrolled patients, 49 (4.5%) had thrombosis at screening and did not undergo randomization. Of the 841 patients who underwent randomization, the primary end point occurred in 25 of 420 patients (6.0%) in the rivaroxaban group and in 37 of 421 (8.8%) in the placebo group (hazard ratio, 0.66; 95% confidence interval [CI], 0.40 to 1.09; P = 0.10) in the period up to day 180. In the prespecified intervention-period analysis, the primary end point occurred in 11 patients (2.6%) in the rivaroxaban group and in 27 (6.4%) in the placebo group (hazard ratio, 0.40; 95% CI, 0.20 to 0.80). Major bleeding occurred in 8 of 405 patients (2.0%) in the rivaroxaban group and in 4 of 404 (1.0%) in the placebo group (hazard ratio, 1.96; 95% CI, 0.59 to 6.49). CONCLUSIONSIn high-risk ambulatory patients with cancer, treatment with rivaroxaban did not result in a significantly lower incidence of venous thromboembolism or death due to venous thromboembolism in the 180-day trial period. During the intervention period, rivaroxaban led to a substantially lower incidence of such events, with a low incidence of major bleeding. (Funded by Janssen and others; CASSINI ClinicalTrials .gov number, NCT02555878.

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