Abstract
BackgroundChemosaturation with percutaneous hepatic perfusion (CS-PHP; Hepatic CHEMOSAT® Delivery System; Delcath Systems Inc, USA) is a novel interventional procedure, which delivers high doses of melphalan directly to the liver in patients with liver tumors while limiting systemic toxicity through hemofiltration of the hepatic venous blood. We have previously shown promising efficacy for patients with ocular melanoma (OM) and cholangiocarcinoma (CCA) within our single-center and multi-center experiences. The aim of this study was to analyze the safety and efficacy of CS-PHP after 141 treatments at Hannover Medical School, Germany.MethodsOverall response rates (ORR) were assessed according to Response Evaluation Criteria In Solid Tumors (RECIST1.1). Median Overall survival (mOS), median progression-free survival (mPFS), and median hepatic PFS (mhPFS) were analyzed using the Kaplan–Meier estimation.ResultsOverall, 60 patients were treated with CS-PHP in the salvage setting from October 2014 until January 2019 at Hannover Medical School with a total of 141 procedures. Half of the patients were patients with hepatic metastases of ocular melanoma (OM) (n = 30), 14 patients had CCA (23.3%), 6 patients had hepatocellular carcinoma (10%), and 10 patients were treated for other secondary liver malignancies (16.7%). In total, ORR and disease stabilization rate were 33.3% and 70.3% (n = 25), respectively. ORR was highest for patients with OM (42.3%), followed by patients with CCA (30.8%). Independent response-associated factors were normal levels of lactate dehydrogenase (odds ratio (OR) 13.7; p = 0.015) and diagnosis with OM (OR 9.3; p = 0.028). Overall, mOS was 9 months, mPFS was 4 months, and mhPFS was 5 months. Patients with OM had the longest mOS, mPFS, and mhPFS with 12, 6, and 6 months, respectively. Adverse events included most frequently significant, but transient, hematologic toxicities (80% of grade 3/4 thrombopenia), less frequently hepatic injury up to liver failure (3.3%) and cardiovascular events including two cases of ischemic insults (5%).ConclusionSalvage treatment with CS-PHP is safe and effective particularly in patients OM and CCA. Careful attention should be paid to possible, serious hepatic, and cardiovascular complications.
Highlights
The Hepatic CHEMOSAT® Delivery System (Delcath Systems Inc., New York, NY, USA) is an innovative medical device for the treatment of patients with unresectable primary or secondary liver tumors
60 patients were treated with Chemosaturation with percutaneous hepatic perfusion (CS-PHP) from October 2014 to January 2019 at Hannover Medical School with a median follow-up of 27 months
Patients treated with CS-PHP for other secondary malignancies included colorectal cancer (n = 2; 3.3%), pancreatic cancer (n = 2; 3.3%), periampular carcinoma (n = 2; 3.3%), neuroendocrine tumors (n = 2; 3.3%), and breast and endometrial cancer
Summary
The Hepatic CHEMOSAT® Delivery System (Delcath Systems Inc., New York, NY, USA) is an innovative medical device for the treatment of patients with unresectable primary or secondary liver tumors. Within a phase I study including patients with solid tumors, amongst others hepatobiliary cancer, treatment with CS-PHP resulted in an overall response rate (ORR) of 30% including two complete responses (Pingpank et al 2005). First results from prospective, randomized-controlled trials including the second-generation filter showed an acceptable safety and toxicity profile in 35 patients treated for liver metastases from ocular melanoma (Meijer et al 2019). Chemosaturation with percutaneous hepatic perfusion (CS-PHP; Hepatic CHEMOSAT® Delivery System; Delcath Systems Inc, USA) is a novel interventional procedure, which delivers high doses of melphalan directly to the liver in patients with liver tumors while limiting systemic toxicity through hemofiltration of the hepatic venous blood. Results Overall, 60 patients were treated with CS-PHP in the salvage setting from October 2014 until January 2019 at Hannover Medical School with a total of 141 procedures. Careful attention should be paid to possible, serious hepatic, and cardiovascular complications
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