• Myrtle F Krul, KokNiels F MNFMDepartment of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Harun Osmani, Florian E Buisman, Bas Groot Koerkamp, Dirk J Grunhagen, Cornelis Verhoef, Bianca Mostert, Petur Snaebjornsson, Bram Westerink, Elisabeth G Klompenhouwer, Maarten L Donswijk, RuersTheo J MTJMDepartment of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Joeri A J Douma, Nico van Blijderveen, T Peter Kingham, Michael I D'Angelica, Nancy E Kemeny, Karen Bolhuis, Tineke E Buffart, and Koert F D Kuhlmann.
• Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
• Br J Surg. 2024 Apr 3; 111 (4).

BackgroundHepatic 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.MethodsThis 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.ResultsThirty-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%.ConclusionHAIP-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). Current trial registration number: clinicaltrials.gov (NCT04552093).© The Author(s) 2024. Published by Oxford University Press on behalf of BJS Foundation Ltd. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.

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