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
5995 - Invasive fungal diseases caused by rare pathogens in patients after hematopoietic stem cell transplantation (HSCT) & chemotherapy
Presenter: Yuliya Rogacheva
Session: Poster Display session 1
Resources:
Abstract
2961 - Safety and pharmacokinetics of novel CXCR4 antagonist YF-H-2015005 in the mobilization of hematopoietic stem cells in patients with non-Hodgkin's lymphoma
Presenter: Weiping Liu
Session: Poster Display session 1
Resources:
Abstract
5771 - Chemotherapy associated Hyponatremia in Hematological Malignancies: A retrospective study of 189 patients treated in a single medical center
Presenter: Vadim Lesan
Session: Poster Display session 1
Resources:
Abstract
1165 - Risk factors for Bacteremia-Associated Mortality of Aeromona sobria in Hematologic Malignancies
Presenter: Gabriel De la Cruz-Kú
Session: Poster Display session 1
Resources:
Abstract
5287 - Use of droplet digital polymerase chain reaction for detecting minimal residual disease: a prospective, multi-institutional study
Presenter: Hyunkyung Park
Session: Poster Display session 1
Resources:
Abstract
1886 - RUBIH2 — Use of NGS in haematological malignancies: from real world data to national recommendations, an innovative program to evaluate the impact of healthcare technology on patient care
Presenter: Severine Coquerelle
Session: Poster Display session 1
Resources:
Abstract
1940 - Outcomes of chronic myeloid leukemia with T315I mutation in the absence of targeted therapy or hematopoietic stem cell transplantation
Presenter: Nageswara Palukuri
Session: Poster Display session 1
Resources:
Abstract
1946 - Is bone marrow examination indispensible in chronic myeloid Leukemia at diagnosis ?
Presenter: Nageswara Palukuri
Session: Poster Display session 1
Resources:
Abstract
1904 - Incidence of Imatinib Resistance in Chronic Myeloid Leukemia (CML) Patients: Experience from Resource Poor Centre of Eastern India
Presenter: Debmalya Bhattacharyya
Session: Poster Display session 1
Resources:
Abstract
3245 - BCR-ABL transcript variant’s significance in chronic myeloid leukemia in chronic phase: Institutional experience from a developing country
Presenter: Siva Prasad
Session: Poster Display session 1
Resources:
Abstract