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Primary Prophylaxis for Venous Thromboembolism in Ambulatory Cancer Patients Receiving Chemotherapy (Review)

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Primary Prophylaxis for Venous Thromboembolism in Ambulatory Cancer Patients Receiving Chemotherapy (Review) View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Bern Open Repository and Information System (BORIS) Cochrane Database of Systematic Reviews Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy (Review) Di Nisio M, Porreca E, Candeloro M, De Tursi M, Russi I, Rutjes AWS Di Nisio M, Porreca E, Candeloro M, De Tursi M, Russi I, Rutjes AWS. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database of Systematic Reviews 2016, Issue 12. Art. No.: CD008500. DOI: 10.1002/14651858.CD008500.pub4. www.cochranelibrary.com Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy (Review) Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . ..... 4 BACKGROUND .................................... 7 OBJECTIVES ..................................... 7 METHODS ...................................... 8 RESULTS....................................... 10 Figure1. ..................................... 11 Figure2. ..................................... 15 Figure3. ..................................... 18 Figure4. ..................................... 19 Figure5. ..................................... 20 Figure6. ..................................... 21 ADDITIONALSUMMARYOFFINDINGS . 23 DISCUSSION ..................................... 48 AUTHORS’CONCLUSIONS . 50 ACKNOWLEDGEMENTS . 50 REFERENCES ..................................... 51 CHARACTERISTICSOFSTUDIES . 58 DATAANDANALYSES. 100 ADDITIONALTABLES. 106 WHAT’SNEW..................................... 110 HISTORY....................................... 110 CONTRIBUTIONSOFAUTHORS . 111 DECLARATIONSOFINTEREST . 111 SOURCESOFSUPPORT . 111 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . .... 112 INDEXTERMS .................................... 112 Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy (Review) i Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy Marcello Di Nisio1,2, Ettore Porreca1, Matteo Candeloro3, Michele De Tursi3, Ilaria Russi1, Anne WS Rutjes4,5 1Department of Medical, Oral and Biotechnological Sciences, University “G. D’Annunzio” of Chieti-Pescara, Chieti, Italy. 2 Department of Vascular Medicine, Academic Medical Center, Amsterdam, Netherlands. 3Internal Medicine Unit, “University G. D’Annunzio” Foundation, Chieti, Italy. 4Centre for Systematic Reviews, Fondazione “Università G. D’Annunzio”, Chieti, Italy. 5CTU Bern, Uni- versity of Bern, Bern, Switzerland Contact address: Marcello Di Nisio, Department of Medical, Oral and Biotechnological Sciences, University “G. D’Annunzio” of Chieti-Pescara, via dei Vestini 31, Chieti, 66013, Italy. [email protected]. Editorial group: Cochrane Vascular Group. Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 12, 2016. Review content assessed as up-to-date: 23 June 2016. Citation: Di Nisio M, Porreca E, Candeloro M, De Tursi M, Russi I, Rutjes AWS. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database of Systematic Reviews 2016, Issue 12. Art. No.: CD008500. DOI: 10.1002/14651858.CD008500.pub4. Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT Background Venous thromboembolism (VTE) often complicates the clinical course of cancer. The risk is further increased by chemotherapy, but the trade-off between safety and efficacy of primary thromboprophylaxis in cancer patients treated with chemotherapy is uncertain. This is the second update of a review first published in February 2012. Objectives To assess the efficacy and safety of primary thromboprophylaxis for VTE in ambulatory cancer patients receiving chemotherapy compared with placebo or no thromboprophylaxis. Search methods For this update the Cochrane Vascular Information Specialist searched the Cochrane Vascular Group Specialised Register (June 2016). In addition, the Information Specialist searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2016, Issue 5). Clinical trials registries were searched up to June 2016. Selection criteria Randomised controlled trials comparing any oral or parenteral anticoagulant or mechanical intervention to no thromboprophylaxis or placebo, or comparing two different anticoagulants. Data collection and analysis We extracted data on methodological quality, participant characteristics, interventions, and outcomes including symptomatic VTE and major bleeding as the primary effectiveness and safety outcomes, respectively. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy (Review) 1 Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Main results We identified five additional randomised controlled trials (2491 participants) in the updated search, considering in this update 26 trials with a total of 12,352 participants, all evaluating pharmacological interventions and performed mainly in people with locally advanced or metastatic cancer. The quality of the evidence ranged from high to very low across the different outcomes and comparisons. The main limiting factors were imprecision and risk of bias. One large trial of 3212 participants found a 64% (risk ratio (RR) 0.36, 95% confidence interval (CI) 0.22 to 0.60) reduction of symptomatic VTE with the ultra-low molecular weight heparin (uLMWH) semuloparin relative to placebo, with no apparent difference in major bleeding (RR 1.05, 95% CI 0.55 to 2.00). When compared with no thromboprophylaxis, LMWH significantly reduced the incidence of symptomatic VTE (RR 0.54, 95% CI 0.38 to 0.75; no heterogeneity, Tau2 = 0.00%) with a non-statistically significant 44% higher risk of major bleeding events (RR 1.44, 95% CI 0.98 to 2.11). In participants with multiple myeloma, LMWH was associated with a significant reduction in symptomatic VTE compared with the vitamin K antagonist warfarin (RR 0.33, 95% CI 0.14 to 0.83), while the difference between LMWH and aspirin was not statistically significant (RR 0.51, 95% CI 0.22 to 1.17). Major bleeding was observed in none of the participants treated with LMWH or warfarin and in less than 1% of those treated with aspirin. Only one study evaluated unfractionated heparin against no thromboprophylaxis but did not report on VTE or major bleeding. When compared with placebo, warfarin was associated with a non-statistically significant reduction of symptomatic VTE (RR 0.15, 95% CI 0.02 to 1.20). Antithrombin, evaluated in one study involving paediatric patients, had no significant effect on VTE or on major bleeding when compared with no antithrombin. The direct oral factor Xa inhibitor apixaban was evaluated in a phase II dose-finding study that suggested a low rate of major bleeding (2.1% versus 3.4%) and symptomatic VTE (1.1% versus 13.8%) in comparison with placebo. Authors’ conclusions In this second update, we confirmed that primary thromboprophylaxis with LMWH significantly reduced the incidence of symptomatic VTE in ambulatory cancer patients treated with chemotherapy. In addition, the uLMWH semuloparin, which is not commercially available, significantly reduced the incidence of symptomatic VTE. The risk of major bleeding associated with LMWH, while not reaching statistical significance, suggest caution and mandate additional studies to determine the risk-to-benefit ratio of LMWH in this setting. Despite the encouraging results of this review, routine prophylaxis in ambulatory cancer patients cannot be recommended before safety issues are adequately addressed. We need additional studies investigating targeted primary prophylaxis in people with specific types or stages of cancer associated with a higher risk of VTE. PLAIN LANGUAGE SUMMARY Prevention of blood clots in non-hospitalised cancer patients receiving chemotherapy Background Cancer patients are more likely than people without cancer to develop blood clots in their veins (known as venous thromboembolism). Chemotherapy further increases this risk. Yet a number of factors specific to the cancer, such as the bleeding tendency at the site of the cancer, or a relative decrease in the number of platelets in the blood (thrombocytopenia) caused by chemotherapy can increase the likelihood that cancer patients will have bleeding complications with medicines used to prevent and treat blood clots (anticoagulants). This systematic review looked at the effectiveness and safety of anticoagulants when used to prevent blood clots in cancer patients receiving chemotherapy. Key results We included 26 randomised controlled trials involving a total of 12,352 participants (current until June 2016). Low molecular weight heparin and the ultra-low molecular weight heparin semuloparin were associated with a significant reduction in symptomatic blood clots. We found no evidence that the risk of major bleeding is increased with semuloparin or low molecular weight heparin, but based on the uncertainty around the estimates, we cannot exclude that the risk is doubled. There was no clear survival benefit for semuloparin or low
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