학술논문
Randomised phase II trial evaluating the safety of peripherally inserted catheters versus implanted port catheters during adjuvant chemotherapy in patients with early breast cancer.
Document Type
Article
Author
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
Source
Subject
*BREAST tumors
*CANCER patients
*COMBINED modality therapy
*PATIENT satisfaction
*QUALITY of life
*STATISTICAL sampling
*THROMBOEMBOLISM
*RANDOMIZED controlled trials
*TREATMENT effectiveness
*CENTRAL venous catheters
*PERIPHERALLY inserted central catheters
*DESCRIPTIVE statistics
*EARLY detection of cancer
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Language
ISSN
0959-8049
Abstract
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 < 0.001 at mid-treatment or at the end of treatment). 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. • Catheter-related severe adverse events (CR-SAE) are frequent. • The peripherally inserted central catheter (PICC) is associated with a significantly higher risk of CR-SAEs than the implanted port catheter (PORT). • Patients reported higher discomfort with PICCs than with PORTs. • These results support the preferential use of PORTs instead of PICCs in the case of early breast cancer adjuvant chemotherapy. [ABSTRACT FROM AUTHOR]