PMID- 38006531
OWN - NLM
STAT- MEDLINE
DCOM- 20240105
LR  - 20240105
IS  - 1534-4681 (Electronic)
IS  - 1068-9265 (Linking)
VI  - 31
IP  - 2
DP  - 2024 Feb
TI  - 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.
PG  - 1252-1263
LID - 10.1245/s10434-023-14519-8 [doi]
AB  - BACKGROUND: Discontinuation 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 METHODS: Under 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. RESULTS: A 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). CONCLUSIONS: The 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.
CI  - (c) 2023. Society of Surgical Oncology.
FAU - McDonald, Hannah G
AU  - McDonald HG
AD  - College of Medicine Department of Surgery, University of Kentucky, Lexington, KY, 
      USA.
FAU - Zaki, Omar A
AU  - Zaki OA
AD  - College of Medicine Department of Surgery, University of Kentucky, Lexington, KY, 
      USA.
FAU - Wright, Matt J
AU  - Wright MJ
AD  - College of Medicine Department of Surgery, University of Kentucky, Lexington, KY, 
      USA.
FAU - Jayswal, Rani
AU  - Jayswal R
AD  - Markey Cancer Center, University of Kentucky, Lexington, KY, USA.
FAU - Weiss, Heidi
AU  - Weiss H
AD  - Markey Cancer Center, University of Kentucky, Lexington, KY, USA.
FAU - Nair, Rashmi T
AU  - Nair RT
AD  - College of Medicine Department of Radiology, University of Kentucky, Lexington, 
      KY, USA.
FAU - Ganesh, Halemane
AU  - Ganesh H
AD  - College of Medicine Department of Radiology, University of Kentucky, Lexington, 
      KY, USA.
FAU - Ellis, Scott
AU  - Ellis S
AD  - College of Pharmacy, University of Kentucky, Lexington, KY, USA.
FAU - Kolesar, Jill M
AU  - Kolesar JM
AD  - College of Pharmacy, University of Kentucky, Lexington, KY, USA.
FAU - Moss, Jessica
AU  - Moss J
AD  - College of Medicine Department of Internal Medicine, University of Kentucky, 
      Lexington, KY, USA.
FAU - Barry-Hundeyin, Mautin
AU  - Barry-Hundeyin M
AD  - College of Medicine Department of Surgery, University of Kentucky, Lexington, KY, 
      USA.
FAU - Pandalai, Prakash K
AU  - Pandalai PK
AD  - College of Medicine Department of Surgery, University of Kentucky, Lexington, KY, 
      USA.
FAU - Kim, Joseph
AU  - Kim J
AD  - College of Medicine Department of Surgery, University of Kentucky, Lexington, KY, 
      USA.
FAU - Patel, Reema A
AU  - Patel RA
AD  - College of Medicine Department of Internal Medicine, University of Kentucky, 
      Lexington, KY, USA.
FAU - Cavnar, Michael J
AU  - Cavnar MJ
AD  - College of Medicine Department of Surgery, University of Kentucky, Lexington, KY, 
      USA. michael.cavnar@uky.edu.
LA  - eng
GR  - T32 CA160003/NH/NIH HHS/United States
GR  - T32 CA160003/NH/NIH HHS/United States
PT  - Journal Article
DEP - 20231125
PL  - United States
TA  - Ann Surg Oncol
JT  - Annals of surgical oncology
JID - 9420840
SB  - IM
MH  - Humans
MH  - *Colorectal Neoplasms/pathology
MH  - Hepatic Artery/pathology
MH  - Feasibility Studies
MH  - Antineoplastic Combined Chemotherapy Protocols
MH  - *Liver Neoplasms/secondary
MH  - Infusions, Intra-Arterial
MH  - *Vascular Access Devices
MH  - Bile Ducts, Intrahepatic/pathology
MH  - *Bile Duct Neoplasms/drug therapy/etiology
EDAT- 2023/11/26 07:43
MHDA- 2024/01/05 06:43
CRDT- 2023/11/25 11:07
PHST- 2023/09/11 00:00 [received]
PHST- 2023/10/13 00:00 [accepted]
PHST- 2024/01/05 06:43 [medline]
PHST- 2023/11/26 07:43 [pubmed]
PHST- 2023/11/25 11:07 [entrez]
AID - 10.1245/s10434-023-14519-8 [pii]
AID - 10.1245/s10434-023-14519-8 [doi]
PST - ppublish
SO  - Ann Surg Oncol. 2024 Feb;31(2):1252-1263. doi: 10.1245/s10434-023-14519-8. Epub 
      2023 Nov 25.