{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T11:36:25Z","timestamp":1792582585170,"version":"4.5.0"},"reference-count":29,"publisher":"American Medical Association (AMA)","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Oncol"],"published-print":{"date-parts":[[2023,11,1]]},"abstract":"\n Importance<\/jats:title>\n Thromboprophylaxis for individuals receiving systemic anticancer therapies has proven to be effective. Potential to maximize benefits relies on improved risk-directed strategies, but existing risk models underperform in cohorts with lung and gastrointestinal cancers.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To assess clinical benefits and safety of biomarker-driven thromboprophylaxis and to externally validate a biomarker thrombosis risk assessment model for individuals with lung and gastrointestinal cancers.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n \n This open-label, phase 3 randomized clinical trial (Targeted Thromboprophylaxis in Ambulatory Patients Receiving Anticancer Therapies [TARGET-TP]) conducted from June 2018 to July 2021 (with 6-month primary follow-up) included adults aged 18 years or older commencing systemic anticancer therapies for lung or gastrointestinal cancers at 1 metropolitan and 4 regional hospitals in Australia. Thromboembolism risk assessment based on fibrinogen and\n d<\/jats:sc>\n -dimer levels stratified individuals into low-risk (observation) and high-risk (randomized) cohorts.\n <\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n High-risk patients were randomized 1:1 to receive enoxaparin, 40 mg, subcutaneously daily for 90 days (extending up to 180 days according to ongoing risk) or no thromboprophylaxis (control).<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary outcome was objectively confirmed thromboembolism at 180 days. Key secondary outcomes included bleeding, survival, and risk model validation.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of 782 eligible adults, 328 (42%) were enrolled in the trial (median age, 65 years [range, 30-88 years]; 176 male [54%]). Of these participants, 201 (61%) had gastrointestinal cancer, 127 (39%) had lung cancer, and 132 (40%) had metastatic disease; 200 (61%) were high risk (100 in each group), and 128 (39%) were low risk. In the high-risk cohort, thromboembolism occurred in 8 individuals randomized to enoxaparin (8%) and 23 control individuals (23%) (hazard ratio [HR], 0.31; 95% CI, 0.15-0.70;\n P<\/jats:italic>\n \u2009=\u2009.005; number needed to treat, 6.7). Thromboembolism occurred in 10 low-risk individuals (8%) (high-risk control vs low risk: HR, 3.33; 95% CI, 1.58-6.99;\n P<\/jats:italic>\n \u2009=\u2009.002). Risk model sensitivity was 70%, and specificity was 61%. The rate of major bleeding was low, occurring in 1 participant randomized to enoxaparin (1%), 2 in the high-risk control group (2%), and 3 in the low-risk group (2%) (\n P<\/jats:italic>\n \u2009=\u2009.88). Six-month mortality was 13% in the enoxaparin group vs 26% in the high-risk control group (HR, 0.48; 95% CI, 0.24-0.93;\n P<\/jats:italic>\n \u2009=\u2009.03) and 7% in the low-risk group (vs high-risk control: HR, 4.71; 95% CI, 2.13-10.42;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this randomized clinical trial of individuals with lung and gastrointestinal cancers who were stratified by risk score according to thrombosis risk, risk-directed thromboprophylaxis reduced thromboembolism with a desirable number needed to treat, without safety concerns, and with reduced mortality. Individuals at low risk avoided unnecessary intervention. The findings suggest that biomarker-driven, risk-directed primary thromboprophylaxis is an appropriate approach in this population.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ANZCTR Identifier:\n ACTRN12618000811202<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamaoncol.2023.3634","type":"journal-article","created":{"date-parts":[[2023,9,21]],"date-time":"2023-09-21T11:01:08Z","timestamp":1695294068000},"page":"1536","source":"Crossref","is-referenced-by-count":33,"title":["Risk-Directed Ambulatory Thromboprophylaxis in Lung and Gastrointestinal Cancers"],"prefix":"10.1001","volume":"9","author":[{"given":"Marliese","family":"Alexander","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia"},{"name":"Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Victoria, 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