Wiebke Solass, MD, Urs Pabst-Giger, MD, Thomas Murdter, PhD, Reinhold Kerb, MD, Matthias Schwab, MD, Jurgen Zieren, MD, Marc A Reymond, MD, MBA
Ruhr-University Bochum, Germany
With authorization of the IRB, we applied a pressurized aerosol of doxorubicin 1.5 mg/m2 and cisplatin 7.5 mg/m2 during 17 laparoscopies in 8 end-stage patients with therapy-resistant peritoneal carcinomatosis (PC), at a pressure of 12 mmHg for 30 minutes at 37 °C. PIPAC was well tolerated, operaring time was 82 min and patients discharged between POD 2 to 5.
Plasma concentration-time profile analysis after PIPAC indicated superior ratio between dose, systemic and local drug concentration: PIPAC required only 1/10th of the doxorubicin dose to achieve higher tumor concentrations (0.03-4.1 µmol/g) as reported for HIPEC (0.02 µmol/g). In contrast, systemic availability of PIPAC and HIPEC were equal as indicated by the approximately 10-times lower maximal plasma concentrations after PIPAC. Liver and renal tests showed neither acute nor cumulative toxicity.
PIPAC was applied 1-4 times/patient allowing direct response assessment. Six patients had a partial, two patients a complete response. Karnowsky-Index increased significantly. Mean postoperative survival was 154 days, with a single patient surviving after > 300 days.
To our knowledge, this is the first report of the successful application of chemotherapy as a pressurized aerosol within the abdomen of human patients. These early data show that PIPAC is a promising approach: it can induce regression of PC in end-stage, multiresistant tumors, and first safety data are encouraging. It is easy to use, and is well tolerated, a decisive feature in patients with limited life expectancy.
Session: Poster Presentation
Program Number: P569