Safety and feasibility of pressurized intraperitoneal aerosol chemotherapy (PIPAC) associated with systemic chemotherapy: an innovative approach to treat peritoneal carcinomatosis

Abstract

BackgroundPressurized intraperitoneal aerosol chemotherapy (PIPAC) is a new treatment that applies chemotherapeutic drugs into the peritoneal cavity as an aerosol under pressure. It improves local bioavailability of chemotherapeutic drugs as compared with conventional intraperitoneal chemotherapy. It has been proved to be safe and feasible if performed as an exclusive treatment in patients affected by peritoneal carcinomatosis. The first results in patients treated with PIPAC associated with systemic chemotherapy are presented.MethodsBetween June 2015 and February 2016, 57 PIPAC applications with oxaliplatin or cisplatin + doxorubicin every 6 weeks at 37 °C and 12 mmHg for 30 min were performed. Forty PIPAC procedures performed in 14 patients were included in this study; thirteen patients were undergoing systemic chemotherapy with a wash-out interval of at least 2 weeks before and 1 week after each PIPAC. Safety, tolerability, and postoperative complications were assessed by collection of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) 2.ResultsForty PIPAC administrations were performed in 14 patients with no major perioperative complications. CTCAE grades 1 and 2 were observed after six and eight procedures, respectively, for abdominal pain and nausea. Renal and hepatic functions were not impaired; no cumulative renal toxicity was observed after repeated PIPAC procedures in association with systemic chemotherapy.ConclusionsThese preliminary data show that the association of PIPAC and systemic chemotherapy does not induce significant hepatic and renal toxicity. It allows inclusion of patients with extraperitoneal disease or at a high risk of developing it. Further studies are needed to assess whether this combination therapy could become part of the standard treatment for peritoneal carcinomatosis.

Pressurized IntraPeritoneal Aerosol Chemotherapy – Practical aspects

“…Abdominal access rate and repeatability was high as it was reported from the German pioneer group and elsewhere. 12,13 Operation time showed little variation and was similar to previous reports. 4,12 Interestingly, no learning curve was observed as operation times did not decrease over time.…”

“…12,13 Operation time showed little variation and was similar to previous reports. 4,12 Interestingly, no learning curve was observed as operation times did not decrease over time. This could be attributed to the fact that PIPAC procedure was highly standardized as outlined in the accompanying material ( Figs.…”

“…1 Encouraging clinical results and lack of therapeutic alternatives in patients with advanced peritoneal cancer are stimuli for clinical implementation. 9,10,12,13 Therefore, PI-PAC is nowadays offered as treatment option in over 50 mostly European centers with about the same number of trained teams which are about to implement this novel approach in their respective institutions. This fast development entails also risks and calls for formal training, standardization and a safe implementation procedure.…”

Experimental pharmacokinetics evaluation of chemotherapy delivery by PIPAC for colon cancer: first evidence for efficacy

“…A first report described isolated PIPAC or PIPAC associated with systemic chemotherapy to control PM [14]. Different studies are under discussion in Europe and for different PM, such as ovarian, gastric or colon cancer.…”

Regimens of Intraperitoneal Chemotherapy for Peritoneal Carcinomatosis from Colorectal Cancer

“…Since only 10% of a typical systemic dose is enough to reach a high local concentration, side-effects may be reduced by maintaining a low serum concentration. Although major adverse effects were not reported according to several case series (73,74), the efficacy of this chemotherapeutic regimen has not been demonstrated.…”