Date: 2015-09-30
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the Cardiovascular and Interventional Radiology Society (CIRSE) annual meeting being held in Lisbon, Portugal, September 26-30, 2015
Company: Delcath Systems (USA - NY)
Product: CHEMOSAT® Delivery System
Action mechanism:
Disease: liver metastases from ocular melanoma
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On September 30, 2015, Delcath Systems, a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announced that results of two European investigator-sponsored studies with the Delcath Hepatic CHEMOSAT® Delivery System (CHEMOSAT) for the treatment of liver metastases were presented as posters at the Cardiovascular and Interventional Radiology Society (CIRSE) annual meeting being held in Lisbon, Portugal, September 26-30, 2015. An investigator-sponsored study entitled \"Safety and Efficiency of The Delcath 2nd Generation Filter in Percutaneous Hepatic Perfusion (PHP) with Melphalan for Unresectable Hepatic Metastases of Colorectal Cancer and Uveal Melanoma\" conducted at the Leiden University Medical Center (LUMC) by M.C. Burgmans, N. de Leede, et al. analyzed safety and pharmacokinetics of CHEMOSAT. Investigators examined pharmacokinetic blood samples taken at baseline and set intervals during 15 PHP procedures performed with CHEMOSAT on 10 patients. The PHP procedures were performed with a melphalan dose of 3.0 mg/kg. Results showed grade 3 complications (mostly asymptomatic leukocytopenia and thrombocytopenia) in seven patients, and febrile neutropenia with bacterial pharyngitis in one patient. Febrile neutropenia was not seen again in the study after growth factors were instituted in a study protocol amendment. First blood sample showed filter efficiency of 93%. Investigators concluded that the efficiency of the Delcath 2nd Generation Filter was very high, and that PHP with the filter was associated with no mortality and acceptable morbidity consistent with commercial use in Europe. Another study, entitled \"Lessons and Early Results from the Largest Single Centre Experience in Europe of Treating Ocular Melanoma Liver Metastases with Chemosaturation via Percutaneous Hepatic Perfusion\" and conducted at Southampton University in the United Kingdom by G. Hickson, I. Wilson, B. Steadman, et al., reported results from a retrospective analysis of mortality, morbidity, intra-procedural imaging and complication data on 22 consecutive patients who were planned for PHP treatment over a 30-month period. Of the 20 patients who were able to receive treatment, 11 patients remained alive after a median of 280 days, with one complete response ongoing at more than one year post-treatment. Nine deaths from disease progression occurred after a median of 264 days from the first procedure. A complete imaging response in the liver was observed in two patients (10%), 13 patients (65%) had a partial liver response and two patients (10%) had stable disease for more than three months. Investigators concluded that \"PHP is an effective palliative treatment in a bleak disease with an acceptable side-effect profile. * On September 28, 2015, Delcath Systems announced that data from two EU treatment centers supporting treatment of patients with liver metastases from ocular melanoma with the Delcath Hepatic CHEMOSAT® Delivery System (CHEMOSAT) will be presented as a poster at the European Cancer Congress (ECCO) annual meeting, being held in Vienna, Austria from September 25-29, 2015. The study entitled, \"Treating Unresectable Liver Metastases of Uveal Melanoma with (Percutaneous) Isolated Hepatic Perfusion with Melphalan: Results from Two Experienced Centers,\" by E.M. De Leede, M.C. Burgmans, et al., was a retrospective study conducted by investigators at Leiden University Medical Center (LUMC) and Erasmus Medical Center (EMC) in the Netherlands. Investigators compared patients with uveal (ocular) melanoma liver metastases treated with isolated hepatic perfusion (IHP), an open surgical procedure that can be performed only once, with patients treated with repeatable percutaneous hepatic perfusion (PHP) using the CHEMOSAT system with an aim to treat patients twice with a six week interval. Treatment characteristics, complications, toxicity, progression free and overall survival of both therapeutic approaches were analyzed. Both IHP and PHP treatments were performed with melphalan. In the IHP cohort (30 patients treated between March 1999 and April 2009) progression free survival was 6 months and recurrence was mainly in the liver, and overall survival was 10 months. In the PHP cohort (9 patients who received 15 PHP treatments since February 2014), the maximum follow-up period was 14 months. Eight patients are still alive, seven without progression of disease. A decrease in red and white blood cell count and thrombocytes after the procedure was observed, and 3 patients needed blood transfusions or platelet infusion. Treatment was overall well tolerated. Investigators concluded that \"percutaneous hepatic perfusion appears to be an effective and safe procedure in selected patients with unresectable liver metastases of colorectal cancer or uveal melanoma and can be repeated.\" \"With eight out of nine patients still alive at 14 months in this retrospective analysis, this is an encouraging signal for PHP and we look forward to seeing the final data,\" said Jennifer Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath Systems. \"This study is the first of several scheduled posters on the clinical merits of CHEMOSAT to be presented at major medical meetings this fall. We expect this growing body of clinical data will advance the continued adoption of CHEMOSAT in Europe and will support our ongoing reimbursement efforts in those territories.\"
