Abstract
All vascular access strategies foradministering chemotherapy in early stage breast cancer (EBC) are associated with risks and benefits. As the most effective type of access is unknown a feasibility trial, prior to conducting a large pragmatic trial, was undertaken. The trial methodology utilized broad eligibility criteria and the integrated consent model incorporating oral consent. EBC patients receiving non-trastuzumab-containing chemotherapy were randomized to peripheral access or central line insertion. The a priori definition of feasibility was: > 25% of patients approached agreed to randomisation and > 25% of physicians approached patients. Secondary outcomes included rates of line-associated complications. Of 159 patients approached, 150 (94.3%) agreed to randomisation, 77 (51.3%) were randomized to peripheral and 73 (48.7%) to central access. 6/26 (23.1%) of medical oncologists approached patients. Rates of complications per chemotherapy cycles in the peripheral vs central access groups with risk difference (RD) (95% CI) were: thrombotic events requiring anticoagulation [1 (0.3%) vs. 3 (1.0%), RD - 0.7(- 1.9,0.5)], line infections [0 (0%) vs. 1 (0.3%), RD - 0.3(- 0.9,0.3)], phlebitis [2 (0.6%) vs. 0 (0%), RD 0.3(- 0.3,0....Continue Reading
References
Sep 28, 2001·Archives of Surgery·I Di CarloF Latteri
Oct 20, 2006·Advances in Therapy·Emine Ozyuvaci, Fikret Kutlu
Sep 12, 2007·Annals of Oncology : Official Journal of the European Society for Medical Oncology·S VesciaN Harbeck
Jul 17, 2009·Journal of Infusion Nursing : the Official Publication of the Infusion Nurses Society·Darcy DoellmanMarc Stranz
Mar 27, 2012·Thrombosis Research·Andrew AwJason Tay
Oct 12, 2012·Annals of Surgical Oncology·Shayna L ShowalterKathryn H Schmitz
May 24, 2013·Lancet·Vineet ChopraScott A Flanders
Nov 6, 2013·Thrombosis Research·Siavash PiranMarc Carrier
Dec 7, 2013·World Journal of Surgery·Kul Ranjan SinghPuneet Goyal
Feb 21, 2014·The New England Journal of Medicine·Scott Y H Kim, Franklin G Miller
May 9, 2014·JAMA : the Journal of the American Medical Association·Jeremy Sugarman, Robert M Califf
Aug 13, 2015·Journal of Oncology Practice·Allison Lipitz-SnydermanJennifer L Malin
Sep 22, 2016·Journal of Oncology Practice·John HiltonMark Clemons
Dec 6, 2017·The Breast Journal·Juan BayoFrancisco Jiménez
Jul 6, 2018·Breast Cancer Research and Treatment·Andrew RobinsonMark Clemons
Aug 17, 2018·Current Oncology·N LeVasseurM Clemons
Aug 17, 2018·Current Oncology·N LeVasseurM Clemons
Jan 27, 2019·BMJ Quality & Safety·Sarah L KreinVineet Chopra