英国格拉斯哥大学Jonathan G Moss团队比较了用于全身抗癌治疗的中心静脉通路装置的安全性和有效性。该项研究成果发表在2021年7月20日出版的《柳叶刀》杂志上。
希克曼型隧道导管（Hickman）、外周置入中心导管（PICCs）和完全植入式端口（PORTs）用于通过中心静脉进行全身抗癌治疗（SACT）。该研究旨在比较三种设备的并发症发生率和成本，以确定该设备对接受SACT的患者的可接受性、临床有效性和成本效益。
研究组针对三种中心静脉通路装置进行了一项开放标签、多中心、随机对照试验，其中PICCs与Hickman的非劣效性边缘为10%，PORTs与Hickman的非劣效性边缘为15%，PORTs与PICCs的非劣效性边缘为15%。
研究组招募接受SACT的超过18岁的成人患者，包括英国18个肿瘤科的实体恶性肿瘤或血液恶性肿瘤患者。有4种随机选项可供选择：Hickman vs PICCs vs PORTs（2:2:1） ，PICCs vs Hickman（1:1） ，PORTs vs Hickman（1:1），以及PORTs vs PICCs（1:1）。
采用最小算法按中心、体重指数、癌症类型、设备使用史和治疗模式分层进行随机分组。主要结局为并发症发生率（包括感染、静脉血栓形成、肺栓塞、无法吸出血液、机械故障和其他），直到器械取出、退出研究或1年随访。
2013年11月8日至2018年2月28日，在2714名筛选合格的参与者中纳入1061名并随机分配，参与相关的比较，其中PICC（212名） vs Hickman（212名），PORT（253名） vs Hickman（303名），PORT（147名） vs PICC（199名）。
第一组，PICCs组中有110名（52%）患者发生并发症，Hickman组有103名（49%），差异不显著。虽然观察到的差异小于10%，但由于效能不足，未证实PICCs的非劣效性。第二组，PORTs组有73名（29%）患者发生并发症，显著优于Hickman组（131名，43%）。第三组，PORTs组有47名（32%）患者发生并发症，显著优于PICCs组（93例，47%）。
研究结果表明，对于大多数接受SACT的患者，PORTs比Hickman和PICCs更有效、更安全。研究结果表明，大多数因实体肿瘤接受SACT治疗的患者应该使用PORTs。
附：英文原文
Title: Central venous access devices for the delivery of systemic anticancer therapy (CAVA): a randomised controlled trial
Author: Jonathan G Moss, Olivia Wu, Andrew R Bodenham, Roshan Agarwal, Tobias F Menne, Brian L Jones, Robert Heggie, Steve Hill, Judith Dixon-Hughes, Eileen Soulis, Evi Germeni, Susan Dillon, Elaine McCartney
Issue&Volume: 2021-07-20
Abstract:
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.
DOI: 10.1016/S0140-6736(21)00766-2
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00766-2/fulltext
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