دورية أكاديمية
Central venous access devices for the delivery of systemic anticancer therapy (CAVA): a randomised controlled trial.
| العنوان: | Central venous access devices for the delivery of systemic anticancer therapy (CAVA): a randomised controlled trial. |
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| المؤلفون: | Moss JG; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK. Electronic address: jonathan.moss@glasgow.ac.uk., Wu O; Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK., Bodenham AR; Intensive Care, Leeds General Infirmary, Leeds, UK., Agarwal R; Department of Oncology, Northampton General Hospital, Northampton, UK., Menne TF; Department of Haematology, The Freeman Hospital, Newcastle upon Tyne, UK., Jones BL; Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK., Heggie R; Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK., Hill S; Procedure Unit, The Christie NHS Foundation Trust, Withington, UK., Dixon-Hughes J; Cancer Research UK Glasgow Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK., Soulis E; Cancer Research UK Glasgow Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK., Germeni E; Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK., Dillon S; Cancer Research UK Glasgow Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK., McCartney E; Cancer Research UK Glasgow Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK. |
| مؤلفون مشاركون: | CAVA trial group |
| المصدر: | Lancet (London, England) [Lancet] 2021 Jul 31; Vol. 398 (10298), pp. 403-415. Date of Electronic Publication: 2021 Jul 21. |
| نوع المنشور: | Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: England NLM ID: 2985213R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1474-547X (Electronic) Linking ISSN: 01406736 NLM ISO Abbreviation: Lancet Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2004- : London : Elsevier Original Publication: London : J. Onwhyn |
| مواضيع طبية MeSH: | Catheterization, Peripheral*/adverse effects , Catheters, Indwelling*/adverse effects , Catheters, Indwelling*/economics , Central Venous Catheters*/adverse effects , Central Venous Catheters*/economics , Vascular Access Devices*/economics, Antineoplastic Agents/*administration & dosage , Neoplasms/*drug therapy, Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents/therapeutic use ; Catheter-Related Infections/etiology ; Cost-Benefit Analysis ; Female ; Humans ; Male ; Middle Aged ; Young Adult |
| مستخلص: | Background: Hickman-type tunnelled catheters (Hickman), peripherally inserted central catheters (PICCs), and totally implanted ports (PORTs) are used to deliver systemic anticancer treatment (SACT) via a central vein. We aimed to compare complication rates and costs of the three devices to establish acceptability, clinical effectiveness, and cost-effectiveness of the devices for patients receiving SACT. Methods: We did an open-label, multicentre, randomised controlled trial (Cancer and Venous Access [CAVA]) of three central venous access devices: PICCs versus Hickman (non-inferiority; 10% margin); PORTs versus Hickman (superiority; 15% margin); and PORTs versus PICCs (superiority; 15% margin). Adults (aged ≥18 years) receiving SACT (≥12 weeks) for solid or haematological malignancy from 18 oncology units in the UK were included. Four randomisation options were available: Hickman versus PICCs versus PORTs (2:2:1), PICCs versus Hickman (1:1), PORTs versus Hickman (1:1), and PORTs versus PICCs (1:1). Randomisation was done using a minimisation algorithm stratifying by centre, body-mass index, type of cancer, device history, and treatment mode. The primary outcome was complication rate (composite of infection, venous thrombosis, pulmonary embolus, inability to aspirate blood, mechanical failure, and other) assessed until device removal, withdrawal from study, or 1-year follow-up. This study is registered with ISRCTN, ISRCTN44504648. Findings: Between Nov 8, 2013, and Feb 28, 2018, of 2714 individuals screened for eligibility, 1061 were enrolled and randomly assigned, contributing to the relevant comparison or comparisons (PICC vs Hickman n=424, 212 [50%] on PICC and 212 [50%] on Hickman; PORT vs Hickman n=556, 253 [46%] on PORT and 303 [54%] on Hickman; and PORT vs PICC n=346, 147 [42%] on PORT and 199 [58%] on PICC). Similar complication rates were observed for PICCs (110 [52%] of 212) and Hickman (103 [49%] of 212). Although the observed difference was less than 10%, non-inferiority of PICCs was not confirmed (odds ratio [OR] 1·15 [95% CI 0·78-1·71]) potentially due to inadequate power. PORTs were superior to Hickman with a complication rate of 29% (73 of 253) versus 43% (131 of 303; OR 0·54 [95% CI 0·37-0·77]). PORTs were superior to PICCs with a complication rate of 32% (47 of 147) versus 47% (93 of 199; OR 0·52 [0·33-0·83]). Interpretation: For most patients receiving SACT, PORTs are more effective and safer than both Hickman and PICCs. Our findings suggest that most patients receiving SACT for solid tumours should receive a PORT within the UK National Health Service. Funding: UK National Institute for Health Research Health Technology Assessment Programme. Competing Interests: Declaration of interests JGM is paid a personal fee to run PORT training courses for Smith Medical and received PORTs free of charge from four manufacturers. OW is deputy chair of NIHR HTA general funding board (2020 onwards) and was a committee member of NIHR HTA general funding board 2016–19. BLJ receives payment for lectures from Merck Sharp and Dohme and Pfizer; attendance at advisory board for Menarini; owns shares in Novartis and Gilead Sciences; and is a member of the Scottish Medicines Consortium. All other authors declare no competing interests (Copyright © 2021 Elsevier Ltd. All rights reserved.) |
| التعليقات: | Comment in: Lancet. 2021 Jul 31;398(10298):367-368. (PMID: 34297999) |
| معلومات مُعتمدة: | 15960 United Kingdom CRUK_ Cancer Research UK |
| المشرفين على المادة: | 0 (Antineoplastic Agents) |
| تواريخ الأحداث: | Date Created: 20210723 Date Completed: 20210823 Latest Revision: 20240210 |
| رمز التحديث: | 20240210 |
| DOI: | 10.1016/S0140-6736(21)00766-2 |
| PMID: | 34297997 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1474-547X |
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| DOI: | 10.1016/S0140-6736(21)00766-2 |