Marc A Reymond. Ruhr-University Bochum
Objective of the technology or device: To develop a drug delivery system allowing effective therapy of peritoneal metastasis.
Description of the technology and method of its use or application: Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) is a drug delivery technique with superior pharmacological properties for treating peritoneal metastasis. Adding electrostatic loading (electrostatic precipitation PIPAC, ePIPAC) as an adjunct to aerosol form and artificial hydrostatic pressure improved tissue uptake in the preclinical model. Low-dose PIPAC with cisplatin 7.5 mg/m2 and doxorubicin 1.5 mg/m2 was applied intraperitoneally at a pressure of 12 mmHg and a temperature of 37°C for 30 minutes (off-label use of approved drugs). Additionally, a voltage 7500-9500 V and a current ≤ 10 µA were applied over a stainless steel brush electrode emitting a stream of electrons.
Preliminary results if available: We report about the first ePIPAC use in three human patients with histologically proved peritoneal metastasis of hepatobiliary-pancreatic (HBP) origin. ePIPAC was technically feasible and easy to perform. The therapeutic aerosol vanished within 30 seconds after electrostatic activation. No intraoperative or postoperative complication, in particular no bowel perforation, was noted. The procedures were well tolerated with no adverse event CTCAE > 2. No liver or renal toxicity was detected. The first patient with pancreatic cancer underwent secondary pancreas tail resection after ePIPAC and no peritoneal metastasis were documented; however, tumor recurred 5 months later and patient died 11 months after diagnosis. The second patient with peritoneal metastasis unknown origin (CUP with HBP phenotype) showed an objective histological and radiological tumor regression, improved quality of life and survived 11 months. The third patient with gallbladder cancer showed a radiological regression of liver infiltration and is alive with excellent quality of life after 16 months without histological evidence of intraperitoneal disease.
Conclusions / future directions: ePIPAC is technically feasible, can be well tolerated and can induce tumor regression of peritoneal metastasis in HBP tumors. These preliminary results justify prospective clinical studies with ePIPAC