학술논문
Hepatic arterial infusion pump chemotherapy combined with systemic chemotherapy for borderline resectable and unresectable colorectal liver metastases: phase II feasibility study.
Document Type
Article
Author
Krul, Myrtle F; Kok, Niels F M; Osmani, Harun; Buisman, Florian E; Groot Koerkamp, Bas; Grunhagen, Dirk J; Verhoef, Cornelis; Mostert, Bianca; Snaebjornsson, Petur; Westerink, Bram; Klompenhouwer, Elisabeth G; Donswijk, Maarten L; Ruers, Theo J M; Douma, Joeri A J; van Blijderveen, Nico; Kingham, T Peter; D'Angelica, Michael I; Kemeny, Nancy E; Bolhuis, Karen; Buffart, Tineke E
Source
Subject
*CANCER chemotherapy
*COLORECTAL liver metastasis
*CHEMOEMBOLIZATION
*CLINICAL trials
*FEASIBILITY studies
TUMOR surgery
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Language
ISSN
0007-1323
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). Current trial registration number: clinicaltrials.gov (NCT04552093). Treatment of unresectable or borderline-resectable CRLMs with hepatic arterial infusion pump chemotherapy (floxuridine) combined with systemic chemotherapy (FOLFOX or FOLFIRI) is feasible and safe in the Netherlands. These results have led to a subsequent multicentre phase III randomized trial investigating the oncological benefit of this combined therapy. [ABSTRACT FROM AUTHOR]