Chemotherapy for patients with early stage breast cancer (EBC) can be administered through either a peripheral vein or a central line (i.e. PICC or PORT) associated with different risks, benefits and costs. As the optimal type of vascular access is unknown, the feasibility of using a novel pragmatic trial model with integrated oral consent model to compare peripheral with central access was performed.
Patients with EBC receiving non-trastuzumab containing chemotherapy were randomised to either peripheral or central line insertion. Our primary feasibility endpoint would be met if > 25% of appropriate patients approached agreed to randomisation and if > 25% of physicians who agreed to participate in the trial approached patients. Other outcomes included rates of line-associated complications.
Of 159 patients approached, 150/159 (94.3%) agreed to randomization and 7/31 (22.5%) of physicians approached patients. 77 (51.3%) patients were randomized to peripheral and 73 (48.7%) to central access. For patients in the central access arm, PICCs were used in 72/73 (99%). Rates of complications in the peripheral vs central access groups were; thrombotic events (1 [0.67%] vs 3 [2.0%], p = 0.35), line infections (0 [0%] vs 1 [0.67%], p = 0.1084), phlebitis (1 [0.67%] vs 0 [0%], p = 0.35), and extravasations/infiltrations (4 [2.67%] vs 0 [0%], p = 0.1245). Overall, 4.67% (7/150) and 4.67% (7/150) of patients had a complication in the peripheral and central access arms respectively (p = 1.00). Among patients randomized to peripheral access, 9/77 (11.7%) subsequently required a central line.
The study did not meet both its a priori criteria to demonstrate feasibility as physician engagement was <25%. However, this prospectively performed randomised trial demonstrated that while the frequency of access-associated complications was similar, the different nature of events (e.g. thrombosis versus extravasations/infiltrations/phlebitis) means that more studies are needed. Importantly, these future studies will need to overcome the barrier of physician participation.
NCT02688998.
Mark Clemons.
Rethinking Clinical Trials (REaCT Program).
All authors have declared no conflicts of interest.