A randomized trial comparing vascular access strategies for patients receiving chemotherapy with trastuzumab for early-s
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ORIGINAL ARTICLE
A randomized trial comparing vascular access strategies for patients receiving chemotherapy with trastuzumab for early-stage breast cancer Mark Clemons 1,2,3 & Carol Stober 2 & Anne Kehoe 1 & Debbie Bedard 4 & Fiona MacDonald 4 & Marie-Claude Brunet 4 & Deanna Saunders 2 & Lisa Vandermeer 2 & Sasha Mazzarello 2 & Arif Awan 1 & Bassam Basulaiman 1 & Andrew Robinson 5 & Ranjeeta Mallick 6 & Brian Hutton 3,6 & Dean Fergusson 3,6 Received: 15 October 2019 / Accepted: 23 January 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Purpose Trastuzumab-based chemotherapy is usually administered through either a peripherally inserted central catheter (PICC) or a totally implanted vascular access device (PORT). As the most effective type of access is unknown, a feasibility trial, prior to conducting a large pragmatic trial, was undertaken. Methods The trial methodology utilized the integrated consent model incorporating oral consent. Patients receiving trastuzumabbased neo/adjuvant chemotherapy for early-stage breast cancer were randomized to a PICC or PORT insertion. Feasibility was reflected through a combination of endpoints; however, the a priori definition of feasibility was > 25% of patients approached agreed to randomization and > 25% of physicians approached patients. Secondary outcomes included rates of line-associated complications such as thrombotic events requiring anticoagulation, line infections or phlebitis. Results During the study period, 4/15 (26.7%) medical oncologists approached patients about study participation. Of 59 patients approached, 56 (94.9%) agreed to randomization, 29 (51.8%) were randomized to PICC and 27 (48.2%) to PORT access. Overall, 17.2% (5/29) and 14.8% (4/27) of patients had at least one line-associated complication in the PICC and PORT arms respectively. The study was terminated early due to slow accrual. Conclusion The study met its feasibility endpoints with respect to patient and physician engagement. However, the slow rate of accrual (56 patients in 2 years) means that conducting a large pragmatic trial would require additional strategies to make such a study possible. Trial registration ClinicalTrials.gov Identifier: NCT02632435 Keywords Vascular access . Trastuzumab . Chemotherapy
Background * Mark Clemons [email protected] 1
Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada
2
Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada
3
Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada
4
Department of Nursing, Ottawa General Hospital, Ottawa, Canada
5
Division of Medical Oncology, Cancer Centre of Southeastern Ontario, Kingston, Canada
6
Department of Medicine, University of Ottawa, Ottawa, Canada
For patients receiving intravenous (IV) treatments for early-stage breast cancer (EBC), several vascular access strategies exist. These include peripheral access, peripherally inserted central catheters (i.e. PICC lin
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