Prospective evaluation of percutaneous hepatic perfusion with melphalan as a treatment for unresectable liver metastases from colorectal cancer.

T Susanna Meijer,Rutger W Van Der Meer,Christian H Martini,Lioe-Fee De Geus-Oei,Jacob Lutjeboer,Alexander L Vahrmeijer,Arian R Van Erkel,Eleonora M De Leede,Mark C Burgmans,Ellen Kapiteijn,Jaap Vuijk,Fred G J Tijl,Jan H N Dieters,Stefano Guadagni

doi:10.1371/journal.pone.0261939

T Susanna Meijer, Rutger W Van Der Meer + Show 12 more

Open Access

https://doi.org/10.1371/journal.pone.0261939

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Journal: PloS one	Publication Date: Jan 13, 2022
Citations: 2	License type: CC BY 4.0

Affiliation: Leiden University Medical Center, University of Twente

Abstract

Percutaneous hepatic perfusion with melphalan (M-PHP) is increasingly used in patients with liver metastases from various primary tumors, yet data on colorectal liver metastases (CRLM) are limited. The aim of this study was to prospectively evaluate the efficacy and safety of M-PHP in patients with CRLM. Prospective, single-center, single-arm phase II study of M-PHP with hemofiltration in patients with unresectable CRLM. Proven, extrahepatic metastatic disease was one of the exclusion criteria. Primary outcomes were overall response rate (ORR) and best overall response (BOR). Secondary outcomes were overall survival (OS), progression-free survival (PFS), hepatic PFS (hPFS), and safety. A total of 14 M-PHP procedures were performed in eight patients between March 2014 and December 2015. All patients (median age 56 years, ranging from 46 to 68) had received (extensive) systemic chemotherapy before entering the study. The ORR was 25.0%, with two out of eight patients showing partial response as BOR. Median OS was 17.3 months (ranging from 2.6 to 30.9) with a one-year OS of 50.0%. Median PFS and hPFS were 4.4 and 4.5 months, respectively. No serious adverse events occurred. Grade 3/4 hematologic adverse events were observed in the majority of patients, though all were transient and well-manageable. M-PHP is a safe procedure with only limited efficacy in patients with unresectable CRLM who already showed progression of disease after receiving one or more systemic treatment regimens.

Highlights

Colorectal cancer (CRC) is the third most common cancer type worldwide
A total of 14 Percutaneous hepatic perfusion with melphalan (M-percutaneous hepatic perfusion (PHP)) procedures were performed in eight patients between March 2014 and December 2015
M-PHP is a safe procedure with only limited efficacy in patients with unresectable colorectal liver metastases (CRLM) who already showed progression of disease after receiving one or more systemic treatment regimens

Summary

Introduction

Colorectal cancer (CRC) is the third most common cancer type worldwide. Around 15–25% of patients will present with synchronous colorectal liver metastases (CRLM), and approximately 50% of patients with CRC will develop liver metastases at some point in the course of their disease [2,3]. Surgical resection is considered standard of care for patients with resectable CRLM with a median overall survival (OS) ranging from 36–56 months [4,5,6]. In patients with unresectable CRLM, systemic therapy is considered to be the first treatment modality with a reported median OS of approximately 2.5 years [8]. Liver-directed therapies such as radioembolization, chemoembolization, hepatic arterial infusion pump chemotherapy, or isolated hepatic perfusion (IHP) may offer an alternative treatment with limited systemic side-effects, but are generally not considered as first-line therapy in patients with CRLM

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