Randomized phase II trial evaluating the safety of peripherally inserted central catheters vs implanted port catheters during adjuvant chemotherapy in early breast cancer patients

Abstract

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. 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.