Randomised phase II trial evaluating the safety of peripherally inserted catheters versus implanted port catheters during adjuvant chemotherapy in patients with early breast cancer

被引：30

作者：

Clatot, Florian ^{[1
]}

Fontanilles, Maxime ^{[1
]}

Lefebvre, Laureline ^{[2
]}

Lequesne, Justine ^{[3
]}

Veyret, Corinne ^{[1
]}

Alexandru, Cristina ^{[1
]}

Leheurteur, Marianne ^{[1
]}

Guillemet, Cecile ^{[1
]}

Gouerant, Sophie ^{[1
]}

Petrau, Camille ^{[1
]}

Thery, Jean-Christophe ^{[1
]}

Rigal, Olivier ^{[1
]}

Moldovan, Cristian ^{[1
]}

Tennevet, Isabelle ^{[1
]}

Rastelli, Olivier ^{[3
]}

Poullain, Amelie ^{[3
]}

Savary, Laetitia ^{[1
]}

Bubenheim, Michael ^{[4
]}

Georgescu, Dragos ^{[5
]}

Gouerant, Julien ^{[6
]}

Gilles-Baray, Marie ^{[6
]}

Di Fiore, Frederic ^{[1
,7
]}

机构：

[1] Ctr Henri Becquerel, Dept Med Oncol, Rouen, France

[2] Ctr Henri Becquerel, Dept Radiat Therapy, Rouen, France

[3] Ctr Henri Becquerel, Clin Res Unit, Rouen, France

[4] Rouen Univ Hosp, Dept Clin Res & Innovat, Rouen, France

[5] Ctr Henri Becquerel, Dept Surg, Rouen, France

[6] Ctr Henri Becquerel, Dept Anaesthesia, Rouen, France

[7] Rouen Univ Hosp, Dept Digest Oncol, Rouen, France

来源：

EUROPEAN JOURNAL OF CANCER | 2020年 / 126卷

关键词：

Peripherally inserted central catheters; Implanted port catheters; Breast cancer; Chemotherapy; Quality of life; Central venous device; CLINICAL-PRACTICE GUIDELINES; CENTRAL VENOUS CATHETERS; RETROSPECTIVE ANALYSIS; AMERICAN SOCIETY; ACCESS; THROMBOEMBOLISM; COMPLICATIONS; DIAGNOSIS; REGIMENS; WOMEN;

D O I：

10.1016/j.ejca.2019.11.022

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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. (C) 2019 Elsevier Ltd. All rights reserved.

引用

页码：116 / 124

页数：9

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