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.
Journal
Annals of surgical oncology
ISSN: 1534-4681
Titre abrégé: Ann Surg Oncol
Pays: United States
ID NLM: 9420840
Informations de publication
Date de publication:
25 Nov 2023
25 Nov 2023
Historique:
received:
11
09
2023
accepted:
13
10
2023
medline:
26
11
2023
pubmed:
26
11
2023
entrez:
25
11
2023
Statut:
aheadofprint
Résumé
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. 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. 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). 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.
Sections du résumé
BACKGROUND
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
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
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
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.
Identifiants
pubmed: 38006531
doi: 10.1245/s10434-023-14519-8
pii: 10.1245/s10434-023-14519-8
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : NIH HHS
ID : T32 CA160003
Pays : United States
Informations de copyright
© 2023. Society of Surgical Oncology.
Références
Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023;73(1):17–48.
doi: 10.3322/caac.21763
pubmed: 36633525
Engstrand J, Nilsson H, Strömberg C, Jonas E, Freedman J. Colorectal cancer liver metastases - a population-based study on incidence, management and survival. BMC Cancer. 2018;18(1):78.
doi: 10.1186/s12885-017-3925-x
pubmed: 29334918
pmcid: 5769309
Helling TS, Martin M. Cause of death from liver metastases in colorectal cancer. Ann Surg Oncol. 2014;21(2):501–6.
doi: 10.1245/s10434-013-3297-7
pubmed: 24081807
Groot Koerkamp B, Sadot E, Kemeny NE, et al. Perioperative hepatic arterial infusion pump chemotherapy is associated with longer survival after resection of colorectal liver metastases: A propensity score analysis. J Clin Oncol. 2017;35(17):1938–44.
doi: 10.1200/JCO.2016.71.8346
pubmed: 28426374
pmcid: 5466010
Sanoff HK, Sargent DJ, Campbell ME, et al. Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J Clin Oncol. 2008;26(35):5721–7.
doi: 10.1200/JCO.2008.17.7147
pubmed: 19001325
pmcid: 2645101
Cuschieri A, Swain C. Hepatic artery ligation and prolonged cytotoxic therapy in advanced primary and secondary liver tumours. Proc R Soc Med. 1975;68(11):678–80.
pubmed: 53844
pmcid: 1864195
Ensminger WD, Rosowsky A, Raso V, et al. A clinical-pharmacological evaluation of hepatic arterial infusions of 5-fluoro-2’-deoxyuridine and 5-fluorouracil. Cancer Res. 1978;38(11 Pt 1):3784–92.
pubmed: 151583
Anteby R, Kemeny NE, Kingham TP, et al. Getting chemotherapy directly to the liver: the historical evolution of hepatic artery chemotherapy. J Am Coll Surg. 2021;232(3):332–8.
doi: 10.1016/j.jamcollsurg.2020.11.013
pubmed: 33387624
Grady D, & Kaplan, S. A lifesaving pump for cancer patients is being phased out. The New York Times. 2018.
Cavnar M, Ghalambor T, Lidsky ME, et al. Considerations and barriers to starting a new HAI pump program: an international survey of the HAI Consortium Research Network. HPB (Oxford). 2022;24(12):2104–11.
doi: 10.1016/j.hpb.2022.08.008
pubmed: 36085262
Registry KC. Cancer rates info. https://www.cancer-rates.info/ . Published 2021. Accessed 2/17/2023, 2023.
Thiels CA, D’Angelica MI. Hepatic artery infusion pumps. J Surg Oncol. 2020;122(1):70–7.
doi: 10.1002/jso.25913
pubmed: 32215927
pmcid: 9014308
Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. NIH Division of Cancer Treatment and Diagnosis. https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_5x7.pdf . Published 2017. Accessed2023.
Clavien PA, Sanabria JR, Strasberg SM. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery. 1992;111(5):518–26.
pubmed: 1598671
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240(2):205–13.
doi: 10.1097/01.sla.0000133083.54934.ae
pubmed: 15273542
pmcid: 1360123
Rusz C-M, Ősz B-E, Jîtcă G, Miklos A, Bătrînu M-G, Imre S. Off-label medication: from a simple concept to complex practical aspects. Int J Environ Res Public Health. 2021;18(19):10447.
doi: 10.3390/ijerph181910447
pubmed: 34639747
pmcid: 8508135
Allen PJ, Nissan A, Picon AI, et al. Technical complications and durability of hepatic artery infusion pumps for unresectable colorectal liver metastases: an institutional experience of 544 consecutive cases. J Am Coll Surg. 2005;201(1):57–65.
doi: 10.1016/j.jamcollsurg.2005.03.019
pubmed: 15978444
Sharib JM, Creasy JM, Wildman-Tobriner B, et al. Hepatic artery infusion pumps: a surgical toolkit for intraoperative decision-making and management of hepatic artery infusion-specific complications. Ann Surg. 2022;276(6):943–56.
doi: 10.1097/SLA.0000000000005434
pubmed: 36346892
Goel V, Yang Y, Kanwar S, et al. Adverse events and complications associated with intrathecal drug delivery systems: Insights from the manufacturer and user facility device experience (MAUDE) database. Neuromodulation. 2021;24(7):1181–9.
doi: 10.1111/ner.13325
pubmed: 33306248
Rodriguez SD, Vanderford NL, Huang B, Vanderpool RC. A social-ecological review of cancer disparities in Kentucky. South Med J. 2018;111(4):213–9.
doi: 10.14423/SMJ.0000000000000794
pubmed: 29719033
pmcid: 5935122
Chow Z, Gan T, Chen Q, et al. Nonadherence to standard of care for locally advanced colon cancer as a contributory factor for high mortality rates in Kentucky. J Am Coll Surg. 2020;230(4):428–39.
doi: 10.1016/j.jamcollsurg.2019.12.041
pubmed: 32062006
pmcid: 9362651
McDonald HG, Patel RA, Ellis CS, et al. Starting a successful hepatic artery infusion pump program: a practical guide. Surgery. 2023;174(1):101–5.
doi: 10.1016/j.surg.2023.03.026
pubmed: 37137740
Cercek A, Boerner T, Tan BR, et al. Assessment of hepatic arterial infusion of floxuridine in combination with systemic gemcitabine and oxaliplatin in patients with unresectable intrahepatic cholangiocarcinoma. JAMA Oncol. 2020;6(1):60.
doi: 10.1001/jamaoncol.2019.3718
pubmed: 31670750
Buisman FE, Grünhagen DJ, Homs MYV, et al. Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases: results of a safety and feasibility study in the Netherlands. Ann Surg Oncol. 2019;26(13):4599–607.
doi: 10.1245/s10434-019-07973-w
pubmed: 31641947
pmcid: 6863781
Lorenz M, Müller HH. Randomized, multicenter trial of fluorouracil plus leucovorin administered either via hepatic arterial or intravenous infusion versus fluorodeoxyuridine administered via hepatic arterial infusion in patients with nonresectable liver metastases from colorectal carcinoma. J Clin Oncol. 2000;18(2):243–54.
doi: 10.1200/JCO.2000.18.2.243
pubmed: 10637236
Kemeny N, Huang Y, Cohen AM, et al. Hepatic arterial infusion of chemotherapy after resection of hepatic metastases from colorectal cancer. N Engl J Med. 1999;341(27):2039–48.
doi: 10.1056/NEJM199912303412702
pubmed: 10615075
Kemeny NE, Niedzwiecki D, Hollis DR, et al. Hepatic arterial infusion versus systemic therapy for hepatic metastases from colorectal cancer: A randomized trial of efficacy, quality of life, and molecular markers (CALGB 9481). J Clin Oncol. 2006;24(9):1395–403.
doi: 10.1200/JCO.2005.03.8166
pubmed: 16505413
Martin RCG II, Scoggins CR, Mc Masters KM. A phase II study of radiofrequency ablation of unresectable metastatic colorectal cancer with hepatic arterial infusion pump chemotherapy. J Surg Oncol. 2006;93(5):387–93.
doi: 10.1002/jso.20463
pubmed: 16550574
Muaddi H, D’Angelica M, Wiseman JT, et al. Safety and feasibility of initiating a hepatic artery infusion pump chemotherapy program for unresectable colorectal liver metastases: a multicenter, retrospective cohort study. J Surg Oncol. 2021;123(1):252–60.
doi: 10.1002/jso.26270
pubmed: 33095919
Creasy JM, Lidsky ME. ASO Author reflections: implementation of a new hepatic artery infusion program for colorectal liver metastases is safe, feasible, and effective. Ann Surg Oncol. 2020;27(13):5096–7.
doi: 10.1245/s10434-020-09040-1
pubmed: 32813201
Turley MC, Moore C, Creasy JM, et al. Combined primary resection with hepatic artery infusion pump implantation is safe for unresectable colorectal liver metastases. J Gastrointest Surg. 2022;26(4):764–71.
doi: 10.1007/s11605-021-05195-8
pubmed: 34820727