Author:
Eylon Maya,Prabhu Snehit,John Samuel,King Maxwell J. M.,Bhatt Dhruv,Curran Kevin J.,Erickson Courtney,Karras Nicole A.,Phillips Christine L.,Satwani Prakash,Hermiston Michelle,Southworth Erica,Baumeister Susanne H. C.,Talano Julie-An,MacMillan Margaret L.,Rossoff Jenna,Bonifant Challice L.,Myers Gary Doug,Rouce Rayne H.,Toner Keri,Driscoll Timothy A.,Katsanis Emmanuel,Salzberg Dana B.,Schiff Deborah,De Oliveira Satiro N.,Capitini Christian M.,Pacenta Holly L.,Pfeiffer Thomas,Shah Niketa C.,Huynh Van,Skiles Jodi L.,Fraint Ellen,McNerney Kevin O.,Quigg Troy C.,Krueger Joerg,Ligon John A.,Fabrizio Vanessa A.,Baggott Christina,Laetsch Theodore W.,Schultz Liora M.
Abstract
IntroductionMediport use as a clinical option for the administration of chimeric antigen receptor T cell (CAR T cell) therapy in patients with B-cell malignancies has yet to be standardized. Concern for mediport dislodgement, cell infiltration, and ineffective therapy delivery to systemic circulation has resulted in variable practice with intravenous administration of CAR T cell therapy. With CAR T cell commercialization, it is important to establish practice standards for CAR T cell delivery. We conducted a study to establish usage patterns of mediports in the clinical setting and provide a standard of care recommendation for mediport use as an acceptable form of access for CAR T cell infusions. MethodsIn this retrospective cohort study, data on mediport use and infiltration rate was collected from a survey across 34 medical centers in the Pediatric Real-World CAR Consortium, capturing 504 CAR T cell infusion routes across 489 patients. Data represents the largest, and to our knowledge sole, report on clinical CAR T cell infusion practice patterns since FDA approval and CAR T cell commercialization in 2017. ResultsAcross 34 sites, all reported tunneled central venous catheters, including Broviac® and Hickman® catheters, as accepted standard venous options for CAR T cell infusion. Use of mediports as a standard clinical practice was reported in 29 of 34 sites (85%). Of 489 evaluable patients with reported route of CAR T cell infusion, 184 patients were infused using mediports, with no reported incidences of CAR T cell infiltration. Discussion/ConclusionBased on current clinical practice, mediports are a commonly utilized form of access for CAR T cell therapy administration. These findings support the safe practice of mediport usage as an accepted standard line option for CAR T cell infusion.
Subject
Immunology,Immunology and Allergy