title: Safety and feasibility of pressurized intraperitoneal aerosol chemotherapy (PIPAC) associated with systemic chemotherapy: an innovative approach to treat peritoneal carcinomatosis.
abstract: BACKGROUND
  Pressurized 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.
  
  
  METHODS
  Between 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.
  
  
  RESULTS
  Forty 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.
  
  
  CONCLUSIONS
  These 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.
authors.affiliation: Unit of Surgical Oncology, Candiolo Cancer Institute-FPO, IRCCS, Strada Provinciale 142, km 3.95, 10060, Candiolo, TO, Italy. manuela.robella@hotmail.it.
authors.forename: Manuela
authors.initials: M
authors.lastname: Robella
authors.affiliation: Unit of Surgical Oncology, Candiolo Cancer Institute-FPO, IRCCS, Strada Provinciale 142, km 3.95, 10060, Candiolo, TO, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Vaira
authors.affiliation: Unit of Surgical Oncology, Candiolo Cancer Institute-FPO, IRCCS, Strada Provinciale 142, km 3.95, 10060, Candiolo, TO, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: De Simone
mesh_terms: D000328:Adult; D000336:Aerosols; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007274:Injections, Intraperitoneal; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000556:secondary; D011379:Prognosis; D012449:Safety; D015996:Survival Rate
chemical_list: D000336:Aerosols; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D004317:Doxorubicin; D002945:Cisplatin
keywords: Colorectal cancer; Gastric cancer; Metastasis; Peritoneum; Pneumoperitoneum; Surgery