Hepatic arterial infusion pump chemotherapy combined with systemic chemotherapy for borderline resectable and unresectable colorectal liver metastases: Phase II feasibility study Journal Article

  

Authors:	Krul, M. F.; Kok, N. F. M.; Osmani, H.; Buisman, F. E.; Koerkamp, B. G.; Grunhagen, D. J.; Verhoef, C.; Mostert, B.; Snaebjornsson, P.; Westerink, B.; Klompenhouwer, E. G.; Donswijk, M. L.; Ruers, T. J. M.; Douma, J. A. J.; van Blijderveen, N.; Kingham, T. P.; D’Angelica, M. I.; Kemeny, N. E.; Bolhuis, K.; Buffart, T. E.; Kuhlmann, K. F. D.
Article Title:	Hepatic arterial infusion pump chemotherapy combined with systemic chemotherapy for borderline resectable and unresectable colorectal liver metastases: Phase II feasibility study
Abstract:	Background: Hepatic arterial infusion pump chemotherapy combined with systemic chemotherapy (HAIP-SYS) for liver-only colorectal liver metastases (CRLMs) has shown promising results but has not been adopted worldwide. This study evaluated the feasibility of HAIP-SYS in the Netherlands. Methods: This was a single-arm phase II study of patients with CRLMs who received HAIP-SYS consisting of floxuridine with concomitant systemic FOLFOX or FOLFIRI. Main inclusion and exclusion criteria were borderline resectable or unresectable liver-only metastases, suitable arterial anatomy and no previous local treatment. Patients underwent laparotomy for pump implantation and primary tumour resection if in situ. Primary end point was feasibility, defined as ≥70% of patients completing two cycles of HAIP-SYS. Sample size calculations led to 31 patients. Secondary outcomes included safety and tumour response. Results: Thirty-one patients with median 13 CRLMs (i.q.r. 6–23) were included. Twenty-eight patients (90%) received two HAIP-SYS cycles. Three patients did not get two cycles due to extrahepatic disease at pump placement, definitive pathology of a recto-sigmoidal squamous cell carcinoma, and progressive disease. Five patients experienced grade 3 surgical or pump device-related complications (16%) and 11 patients experienced grade ≥3 chemotherapy toxicity (38%). At first radiological evaluation, disease control rate was 83% (24/29 patients) and hepatic disease control rate 93% (27/29 patients). At 6 months, 19 patients (66%) had experienced grade ≥3 chemotherapy toxicity and the disease control rate was 79%. Conclusion: HAIP-SYS for borderline resectable and unresectable CRLMs was feasible and safe in the Netherlands. This has led to a successive multicentre phase III randomized trial investigating oncological benefit (EUDRA-CT 2023–506194-35-00). © The Author(s) 2024. Published by Oxford University Press on behalf of BJS Foundation Ltd. All rights reserved.
Keywords:	adult; cancer chemotherapy; clinical article; controlled study; cancer surgery; clinical trial; fatigue; squamous cell carcinoma; carcinoma, squamous cell; bevacizumab; fluorouracil; drug dose reduction; systemic therapy; liver neoplasms; outcome assessment; follow up; lymph node metastasis; laparotomy; metastasis; quality of life; computer assisted tomography; multiple cycle treatment; phase 2 clinical trial; anemia; tumor volume; randomized controlled trial; vomiting; abdominal abscess; local therapy; dexamethasone; irinotecan; panitumumab; lung embolism; colorectal neoplasms; questionnaire; alanine aminotransferase; alkaline phosphatase; aspartate aminotransferase; bilirubin; hospitalization; feasibility study; feasibility studies; multicenter study; colorectal tumor; folinic acid; liver tumor; nausea and vomiting; hepatectomy; liver enzyme; disease control; cholecystectomy; oxaliplatin; gamma glutamyltransferase; liver abscess; erythrocyte transfusion; anastomosis; hematoma; floxuridine; wound dehiscence; hepatic artery; anastomosis leakage; wedge resection; stomach pain; infusion pumps; gastroduodenal artery; colorectal liver metastasis; humans; human; male; female; article; european quality of life 5 dimensions 3 level questionnaire; european organization for research and treatment of cancer quality of life questionnaire core 30
Journal Title:	British Journal of Surgery
Volume:	111
Issue:	4
ISSN:	0007-1323
Publisher:	Oxford University Press
Date Published:	2024-04-01
Start Page:	znae089
Language:	English
DOI:	10.1093/bjs/znae089
PUBMED:	38608150
PROVIDER:	scopus
DOI/URL:	https://www.scopus.com/inward/record.uri?eid=2-s2.0-85190487138&doi=10.1093%2fbjs%2fznae089&partnerID=40&md5=1c69920fff7215bd098747e48fb3c9f9
Notes:	Article -- Source: Scopus

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