BACKGROUND Both peripherally inserted central catheters (PICCs) and implanted port catheters (PORTs) are used for adjuvant chemotherapy (ACT) administration in patients with early breast cancer (EBC). We aimed to compare the safety between PICCs and PORTs in this setting. PATIENTS AND METHODS This monocentric phase II randomised trial (NCT02095743) included patients with EBC who were eligible for ACT. Patients with curative anticoagulation therapy were excluded. The primary objective was to identify which device has a lower probability of catheter-related significant adverse events (CR-SAEs) within the 35 weeks after device implantation. The secondary objective was to evaluate quality of life (QoL) and patient satisfaction. RESULTS From February 2014 to May 2018, 256 patients were included, and 253 (99%) were analysed. Overall, 31 patients (12.2%) experienced CR-SAEs, which mainly included thromboembolic events. In an intention-to-treat analysis, the probability that a CR-SAE would occur was 7.8% (10 events) with PORTs versus 16.6% (21 events) with PICCs (hazard ratio [HR] = 2.2 [1.03-4.62], P = 0.036). In a per-protocol analysis, PICCs were also associated with a higher risk of CR-SAEs than PORTs (HR = 2.82 [1.26-6.25], P = 0.007). Regarding the secondary objectives, if there was no difference in QoL between the arms, then significantly more discomfort was reported among patients with PICCs than among patients with PORTs (P = 0.002 after implantation and P < 0.001 at mid-treatment or at the end of treatment). CONCLUSIONS CR-SAEs in patients with EBC are frequent but rarely impact the ACT process. Compared with PORTs, PICCs are associated with a significantly higher risk of CR-SAEs and more discomfort. PORTs should be preferred for ACT administration in patients with EBC.

中文翻译：

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II期随机试验评估了早期乳腺癌患者辅助化疗期间外围插入导管与植入端口导管的安全性。

背景技术外周插入的中央导管（PICC）和植入的端口导管（PORT）都用于早期乳腺癌（EBC）患者的辅助化疗（ACT）给药。我们旨在比较这种情况下PICC和PORT之间的安全性。患者和方法该单中心II期随机试验（NCT02095743）包括符合ACT资格的EBC患者。排除抗凝治疗的患者。主要目的是确定在植入器械后35周内哪个器械发生导管相关重大不良事件（CR-SAE）的可能性较低。次要目标是评估生活质量（QoL）和患者满意度。结果2014年2月至2018年5月，共纳入256例患者，分析253例（99％）。总计31例（12。2％）经历过CR-SAE，主要包括血栓栓塞事件。在意向性分析中，使用PORT发生CR-SAE的概率为7.8％（10个事件），而使用PICC发生CR-SAE的概率为16.6％（21个事件）（危险比[HR] = 2.2 [1.03-4.62]， P = 0.036）。在按方案分析中，PICC与CR-SAE的风险也比PORT高（HR = 2.82 [1.26-6.25]，P = 0.007）。关于次要目标，如果两臂之间的QoL没有差异，则PICC患者的不适感要比PORT患者高得多（植入后P = 0.002，治疗中期或治疗结束时P <0.001）。治疗）。结论EBC患者中的CR-SAE很常见，但很少影响ACT过程。与PORT相比，PICC与CR-SAE的风险显着较高和不舒适感相关。对于EBC患者，应首选PORTs进行ACT治疗。