Journal article
Phase I Safety and Feasibility Pilot of Hepatic Artery Infusion Chemotherapy in a Rural Catchment Area Using The Codman Vascular Catheter with The Medtronic SynchroMed II Pump for Intrahepatic Cancers
Annals of surgical oncology, Vol.31(2), pp.1402-1409
02/01/2024
DOI: 10.1245/s10434-023-14519-8
PMCID: PMC11466354
PMID: 38006531
Abstract
BackgroundDiscontinuation of the Codman 3000 pump in 2018 left no Food and Drug Administration (FDA)-approved hepatic artery infusion (HAI) device for unresectable colorectal liver metastases (uCLM) and intrahepatic cholangiocarcinoma (uIHC). Historically, HAI has been performed at academic medical centers in large metropolitan areas, which are often inaccessible to rural patients. Consequently, feasibility of dissemination of HAI to rural populations is unknown.Patients and MethodsUnder an FDA investigational device exemption, we opened the only HAI program in Kentucky and enrolled patients with uCLM and uIHC in a phase I clinical trial. The trial examined the safety of the hybrid Codman catheter/Medtronic SynchroMed II pump (hCMP) combination, defined as successful completion of one cycle of HAI chemotherapy. Rural feasibility was assessed by number of missed pump fills appointments.ResultsA total of 21 patients (n = 17 uCLM, n = 4 uIHC) underwent hCMP implantation before accrual was stopped early owing to FDA approval of the Intera 3000 pump. 20/21 (95%) patients met the primary safety endpoint. Serious adverse events (AEs) included a grade 5 coronavirus disease 2019 (COVID-19) infection (n = 1) and a grade 3 catheter erosion into the bowel (n = 1). Biliary sclerosis developed in two patients (9.5%). Median distance to infusion center was 47.6 miles (2-138 miles), and 62% were from Appalachia, yet there were no missed pump fill appointments. The 2-year overall survival was 82.4% (uCLM) and 50% (uIHC).ConclusionsThe hCMP device had an acceptable safety profile. Despite the complexity of starting a new HAI program, early results showed feasibility for HAI delivery in a rural catchment area and comparable outcomes to larger urban-based HAI centers.
Details
- Title: Subtitle
- Phase I Safety and Feasibility Pilot of Hepatic Artery Infusion Chemotherapy in a Rural Catchment Area Using The Codman Vascular Catheter with The Medtronic SynchroMed II Pump for Intrahepatic Cancers
- Creators
- Hannah G. McDonald - University of KentuckyOmar A. Zaki - University of KentuckyMatt J. Wright - University of KentuckyRani Jayswal - University of KentuckyHeidi Weiss - University of KentuckyRashmi T. Nair - University of KentuckyHalemane Ganesh - University of KentuckyScott Ellis - University of KentuckyJill M. Kolesar - University of KentuckyJessica Moss - University of KentuckyMautin Barry-Hundeyin - University of KentuckyPrakash K. Pandalai - University of KentuckyJoseph Kim - University of KentuckyReema A. Patel - University of KentuckyMichael J. Cavnar - University of Kentucky
- Resource Type
- Journal article
- Publication Details
- Annals of surgical oncology, Vol.31(2), pp.1402-1409
- DOI
- 10.1245/s10434-023-14519-8
- PMID
- 38006531
- PMCID
- PMC11466354
- NLM abbreviation
- Ann Surg Oncol
- ISSN
- 1068-9265
- eISSN
- 1534-4681
- Publisher
- Springer Nature
- Number of pages
- 8
- Grant note
- National Institutes of Health; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA
- Language
- English
- Date published
- 02/01/2024
- Academic Unit
- Pharmacy; Pharmaceutical Sciences and Experimental Therapeutics
- Record Identifier
- 9984695796702771
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