One of the central problems in using chemotherapy to treat cancer is its harmful effect on organ health. Lower dosages of the drug are often used to limit side effects, which may diminish benefits of the therapy. Delcath has developed a drug delivery system that isolates the liver from the circulatory system. It allows chemotherapy agents to be administered to the liver and filters those agents from the blood before returning it to general circulation (in January, the company formed a collaboration with Aethlon Medical to advance this filtration technology). On Monday, the company announced results from a study of the chemotherapy agent melphalan, delivered via the company’s Percutaneous Hepatic Perfusion (PHP) system, in patients with inoperable liver metastases from primary neuroendocrine tumors. This process allows patients with large and diffuse liver tumors to receive a concentrated, site-specific treatment where resection, ablation, and embolization are not feasible or have failed to halt spread of the cancer. In 24 patients who presented with diffuse liver metastases of pancreatic neuroendocrine and carcinoid tumors, a total of 68 treatments were administered. Of 19 evaluable patients, complete radiographic tumor responses were observed in two patients and partial responses were observed in 13 patients resulting in an objective tumor response rate of 79%. Only one of the 19 evaluable patients showed disease progression on therapy. The study’s lead author, Dr. James Pingpank Jr., of the Surgery Branch of the National Institute of Health in Bethesda, MD, commented,
“Treatment options for patients with diffuse hepatic disease are very limited. The Delcath PHP System is unique in its ability to isolate then repeatedly treat unresectable liver tumors with high doses of anti-cancer agents such as Melphalan. This study shows that PHP with melphalan has efficacy in patients with diffuse metastatic neuroendocrine tumors of the liver that are too extensive for resection, ablation, or embolization. Responses to therapy tend to be durable, and repeat therapy is effective on progression or recurrence of disease. We look forward to further study of the PHP System and to understanding its full potential in treating patients with liver metastases.”Delcath plans to submit a new trial protocol to the FDA seeking to establish the use of PHP as a first line treatment of metastatic neuroendocrine tumors.