| Autor: |
Clemons, Mark, Stober, Carol, Kehoe, Anne, Bedard, Debbie, MacDonald, Fiona, Brunet, Marie-Claude, Saunders, Deanna, Vandermeer, Lisa, Mazzarello, Sasha, Awan, Arif, Basulaiman, Bassam, Robinson, Andrew, Mallick, Ranjeeta, Hutton, Brian, Fergusson, Dean |
| Předmět: |
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| Zdroj: |
Supportive Care in Cancer; Oct2020, Vol. 28 Issue 10, p4891-4899, 9p |
| Abstrakt: |
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 trastuzumab-based 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 [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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