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

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. This monocentric phase II randomised t...

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Published in:European journal of cancer (1990) 2020-02, Vol.126, p.116-124
Main Authors: Clatot, Florian, Fontanilles, Maxime, Lefebvre, Laureline, Lequesne, Justine, Veyret, Corinne, Alexandru, Cristina, Leheurteur, Marianne, Guillemet, Cécile, Gouérant, Sophie, Petrau, Camille, Théry, Jean-Christophe, Rigal, Olivier, Moldovan, Cristian, Tennevet, Isabelle, Rastelli, Olivier, Poullain, Amélie, Savary, Laetitia, Bubenheim, Michael, Georgescu, Dragos, Gouérant, Julien, Gilles-Baray, Marie, Di Fiore, Frédéric
Format: Article
Language:English
Subjects:
Anticoagulants
Breast cancer
Catheters
Central venous device
Chemotherapy
Discomfort
Implantation
Implanted port catheters
Life Sciences
Medical instruments
Patient satisfaction
Peripherally inserted central catheters
Ports
Quality of life
Randomization
Safety
Thromboembolism
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Summary: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. 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. 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 
ISSN:0959-8049
1879-0852
DOI:10.1016/j.ejca.2019.11.022