Delcath Systems announces results of single center study of PHP Therapy
Delcath Systems announced that results from a single-institution retrospective study conducted by University Hospital of Tubingen in ermany on the use of the Delcath Hepatic CHEMOSAT Delivery System to treat patients with metastatic ocular melanoma with liver metastases were published in the journal Cancer Imaging. The study, Chemosaturation with percutaneous hepatic perfusion of melphalan for liver dominant metastatic uveal melanoma: a single center experience, by Dr. Christoph Artzner, et al, evaluated the safety and efficacy of PHP Therapy in 16 patients with unresectable liver metastases from ocular melanoma treated with CHEMOSAT between June 2015 and December 2018. Tumor response was evaluated following each PHP treatment using Response Evaluation Criteria in Solid Tumors, and serious adverse events were evaluated using Common Criteria for Adverse Events. The 16 patients underwent a total of 28 PHP treatments. Results of the study in the 15 evaluable patients showed that after the first PHP treatment, nine patients had a partial response, five patients stable disease, and one patient had progressive disease for an initial disease control rate of 93%. Median progression free survival after the first treatment was 11.1 months. Six patients received a second PHP treatment, three patients received three treatments, and a single patient received six treatments. Median overall survival was 27.4 months. Safety analysis showed that grade three SAEs were observed in 14% of treatments, and these were anemia, leukopenia and thrombocytopenia. The sole grade four SAE observed was in one patient who suffered a cardiac arrest during the first PHP treatment and was removed from the study. Subsequent evaluation discovered this patient had coronary artery occlusion which was successfully treated. Retrospective evaluation of this patient's pre-procedure imaging reveal signs of coronary artery disease, and investigators subsequently modified their screening procedures for cardiovascular risk factors. Investigators stated that most SAEs were grade one or two and that 5% of the reported grade three and four SAEs required additional intervention.Investigators concluded that for patients with liver-dominant metastatic uveal melanoma, treatment with PHP Therapy had "observed rates for OS and PFS that exceeded the reported outcomes for traditional systemic treatment." Investigators stated that SAEs were frequent, but most did not require additional intervention, and that care should be taken in patients with suspected coronary heart disease.