Safety and clinical impact of totally implantable venous access ports during trabectedin therapy in advanced L-type sarcomas: A multicenter SEPSaC-01 analysis.

Abstract

e23564 Background: Totally implantable venous access ports (TIVAPs) are routinely used to secure long-term central venous access for repeated chemotherapy. Nevertheless, device use may be accompanied by mechanical problems as well as catheter-related thrombosis or infection, which can compromise treatment continuity. This issue is particularly relevant for trabectedin (T), delivered as a 24-hour continuous infusion via a central line because of its vesicant potential and the risk of delayed, severe tissue injury if extravasation occurs. We assessed how often port-related adverse events occurred during T therapy and evaluated their consequences for subsequent treatment administration in patients with L-type sarcomas. Methods: We conducted a retrospective analysis of the South-Eastern Poland Sarcoma Collaboration (SEPSaC)-01 database from five oncology centers. Patients with advanced L-type sarcomas who started T between August 2011 and September 2025 and had available information on TIVAP use were eligible. The data cut-off was October 2025. Collected variables included demographics, histopathology, date/indication for port implantation, treatment initiation delay > 2 weeks due to awaiting implantation, port-related complications, port removal, and reimplantation. Data were summarized descriptively as counts/percentages and median (range). Results: A total of 128 patients were included (66.4% women), median age at T start 59.6 years (range 24–78). Histopathology was available for 126 patients: leiomyosarcoma in 78 (60.9%) and liposarcoma in 48 (37.5%). TIVAP was implanted specifically for planned T therapy in 65 patients (50.8%). Waiting for implantation resulted in a > 2-week delay in treatment initiation in 6 patients (4.7%). Overall, 14 patients (10.9%) experienced TIVAP-related complications: infection in 7 (5.5%), occlusion in 2 (1.6%), thrombosis in 1 (0.8%), and other complications in 4 (3.1%). One patient discontinued T due to a port-related complication. Ports were removed because of complications in 10 patients (7.8%), and 3 (2.3%) required reimplantation. Conclusions: In patients with L-type sarcomas receiving T, TIVAPs were associated with a low frequency of clinically meaningful complications and supported safe drug administration. The observed complication (10.9%), removal (7.8%), and reimplantation (2.3%) rates were comparable to, or below, those reported in broader oncology populations using TIVAPs. No extravasation events occurred despite trabectedin’s vesicant properties, consistent with previous reports of rare extravasation when central venous access is used. Infection and thrombosis rates were within expected ranges. Implantation-related delays > 2 weeks were uncommon (4.7%), underscoring the importance of early planning of central venous access to prevent treatment postponements.