Abstract 3471
Background
Both peripherally inserted central catheters (PICC) and implanted port catheters (PORT) are used for adjuvant chemotherapy (ACT) administration in early breast cancer (EBC) patients. We evaluated the safety of the two devices in ACT setting.
Methods
This monocentric phase II randomized trial (NCT02095743) included patients with an EBC and eligible to an ACT. Patients with curative anticoagulation were excluded. The primary endpoint was to identify the device with the less probability of occurrence of a significant adverse event related to the central venous device (SAERCVD) during the 37 weeks following device implantation. A SAERCVD was defined as: CTCAE grade ≥3, inducing a delay in CT administration >7 days, or requiring a replacement of the implanted device. PICC were removed the day of last CT administration; PORT were removed within 4 weeks after the last CT administration. Based on our previous study (Support Care Cancer. 2016; 24(3):1397-403), 256 patients were needed to meet the primary endpoint.
Results
From February 2014 to April 2018, 256 patients were included; 248 (97%) were analyzed (PICC, n = 125; PORT, n = 123). Overall, 25 patients (10%) had a SAERCVD: thrombosis (n = 13), local infection (n = 6), systemic infection (n = 3) and mechanical complication (n = 3). Probability of occurrence of a SAERCVD within 37 weeks was 4.9% (6 SAERCVD) in PORT vs 15.2% (19 SAERCVD) in PICC (HR = 3.2 [1.3-8.1], p = 0.007). Regarding baseline characteristics, patients experiencing a SAERCVD had a trend toward a higher body mass index (p = 0.08) and a history of thrombo-embolic disease (p = 0.08) compared to patients without SAERCVD. Among the 223 patients without SAERCVD, probability of occurrence of a non-significant adverse event related to the device was 20.8% (22/106) in PICC vs 17.1% (20/117) in PORT (HR = 1.2 [0.7-2.2], p = 0.5), mainly grade 1 local pruritus. Grade≥3 adverse events not related to the implanted device were observed for 48 patients in each group (HR = 1 [0.7-1.5], p = 0.9), mainly CT induced neutropenia.
Conclusions
Although side effects related to central venous devices are rare during ACT in EBC patients, SAERCVD are more frequently observed with PICC rather than PORT.
Clinical trial identification
2012-A01440-43 NCT02095743.
Editorial acknowledgement
Legal entity responsible for the study
Florian Clatot.
Funding
La Ligue contre le cancer.
Disclosure
F. Clatot: Honoraria (self), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Lilly; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Research grant / Funding (institution): AstraZeneca; Travel / Accommodation / Expenses: Roche. All other authors have declared no conflicts of interest.
Resources from the same session
1757 - Development of chimeric antigenic receptor (CAR) against VEGFR2 for solid tumor treatment
Presenter: Li-Shuang Ai
Session: Poster Display session 1
Resources:
Abstract
4156 - Triple blockade of EGFR, MEK and PD-L1 as effective antitumor treatment in PD-L1 overexpressing, MEK inhibitor resistant colon cancer cells.
Presenter: Nunzia Matrone
Session: Poster Display session 1
Resources:
Abstract
2949 - EGFR-mediated PD-L1 upregulation in HER2+ breast cancer (BC) cell line models
Presenter: Nicola Gaynor
Session: Poster Display session 1
Resources:
Abstract
4270 - The impact of cortisol on immune cells and its effect on cancer-immune cells co-culture in a 3D spheroid of ovarian cancer
Presenter: Maysa Al-natsheh
Session: Poster Display session 1
Resources:
Abstract
1568 - Application of sonoporation to increase anticancer drug efficacy in 2D and 3D NSCLC cell cultures
Presenter: Vilma Petrikaite
Session: Poster Display session 1
Resources:
Abstract
5400 - Tr1-like cells in human peripheral blood are part of the T effector memory pool and are preferentially stimulated via CD55
Presenter: Iniobong Charles
Session: Poster Display session 1
Resources:
Abstract
5817 - Functional analysis of tumor infiltrating lymphocytes in triple negative breast cancer focusing on granzyme B
Presenter: Hitomi Kawaji
Session: Poster Display session 1
Resources:
Abstract
2287 - Aberrant glycolysis associates with inflammatory tumor microenvironment and promotes metastasis in triple-negative breast cancer
Presenter: Chengwei Lin
Session: Poster Display session 1
Resources:
Abstract
735 - Anti-cancer effects of differentiation-inducing factor-1 in triple negative breast cancer.
Presenter: Fumi Tetsuo
Session: Poster Display session 1
Resources:
Abstract
2105 - The Inhibitory Effect in Oral Squamous Cell Carcinoma Cells by Knocking down Matrix Metalloproteinase 9
Presenter: Xinyan Zhang
Session: Poster Display session 1
Resources:
Abstract