On October 4, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that results of a multicenter analysis of outcomes in patients with intrahepatic cholangiocarcinoma (ICC) treated with CHEMOSAT has been published in the journal European Radiology (Press release, Delcath Systems, OCT 4, 2018, View Source;p=RssLanding&cat=news&id=2370255 [SID1234529788]). The study is the first analysis on the use of Delcath’s PHP Therapy for the treatment of ICC.

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The retrospective analysis—Percutaneous Hepatic Perfusion (Chemosaturation) with Melphalan in Patients with Intrahepatic Cholangiocarcinoma: European Multicentre Study on Safety, Short Term Effects and Survival—was conducted by investigators in Germany, Italy, Netherlands, Spain and France with Dr. Steffen Marquardt of Hannover Medical School serving as lead author. The study evaluated 15 patients with ICC who were selected for PHP treatment after failing prior therapies. The patients were treated at nine hospitals throughout Europe between 2012 and 2016. Treatment outcomes were assessed by imaging every three months following PHP treatment.

Results of the study showed that after the first PHP treatment, one patient (7%) has a complete response (CR), two patients (13%) had a partial response (PR), and stable disease (SD) was observed in eight patients (53%). This equates to a control rate (CR+PR+SD) of 73%. The complete response patient was not retreated and is still alive. Three patients (20%) progressed after the first treatment and one patient died prior to post-procedure imaging. Five of the patients with SD received a second PHP treatment, resulting in one PR (20%), three SD (60%), and one PD (20%). During the follow-up phase two of the SD patients received additional PHP treatments.

Median overall survival (OS) was 26.9 months from initial diagnosis and 7.6 months from first PHP treatment. One-year OS from first PHP was 40%. Median progression free survival (PFS) was 122 days, and median hepatic progression free survival (hPFS) was 131 days.

In this retrospective data collection, side-effects were potentially under-reported but were considered by the investigators to be tolerable and comparable to other systemic and local therapies. Nevertheless, in the context of the patient selection, baseline characteristics and number of PHP treatments provided in this retrospective study, practitioners observed no adverse events of grades 3 or 4 severity during the PHP procedure. Post-procedurally, significant hematological toxicity was observed in the form of anemia and thrombocytopenia 5-7 days after the PHP procedure. Management with Granulocyte Colony Stimulating Factor (GCSF) was employed in some patients. These toxicities were considered consistent with those toxicities reported in the ABC 02 trial of systemic chemotherapy in this patient population.

Investigators concluded that PHP Therapy provides "promising response rates in patients with ICC," and that side-effects were tolerable and comparable to other treatment strategies.

Commenting on the study, Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Delcath Systems, said, "Results of this study are very encouraging when you consider that PHP Therapy was used for these patients after failing prior therapy(ies) and that all patients had been heavily pre-treated. Additionally, many of the patients included in this retrospective analysis were treated before certain aspects of the PHP procedure had become standard, such as the prophylactic use of GCSF growth factors to mitigate certain side-effects. These data have been previously used to inform the trial design for our Phase 3 trial in ICC, and we look forward to further investigating the use of PHP Therapy in a disease that has particularly challenging patient outcomes."