title: Pressurized Intraperitoneal Aerosol Chemotherapy with Cisplatin and Doxorubicin in Women with Peritoneal Carcinomatosis: A Cohort Study.
abstract: OBJECTIVE
  We aimed to assess the objective tumor response (OTR) to laparoscopic pressurized intraperitoneal aerosol chemotherapy (PIPAC) in women with peritoneal carcinomatosis (PC).
  
  
  METHODS
  We carried-out a retrospective cohort study of women with PC undergoing repeated courses of PIPAC with 7.5 mg/m(2) of cisplatin and 1.5 mg/m(2) of doxorubicin. OTR was defined as histological regression. Peritoneal carcinomatosis index (PCI) improvement on video-laparoscopy and ascites volume reduction were secondary outcomes. Quality of life was assessed by the European Organization for Research & Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-30+3.
  
  
  RESULTS
  A total of 252 PIPACs were performed in 99 women with PC and ovarian (n=84), primary peritoneal (n=6), cervical (n=3), endometrial (n=3), fallopian tube (n=1), and breast (n=1) cancer and pseudomyxoma peritonei (n=1). Laparoscopic non-access rate was 17% (17/99). Fifty women had more than one PIPAC procedures, with an OTR of 76% (38/50) and PCI improvement in 64% (32/50). Ascites volume significantly decreased from 762±1170 ml to 167±456 ml (p=0.02). A high initial Karnofsky Index was correlated with receiving more than one PIPAC (p<0.0001) and a high number of previous surgeries with laparoscopic non-access (p=0.01). Twenty adverse events of Common Terminology Criteria for Adverse Events grade 3 or more were noted. Absence of ascites (odds ratio=8.45, 95% confidence interval=1.9-3.6; p<0.0001), but not patient age, serum cancer antigen-125, and Karnofsky Index independently predicted OTR. EORTC QLQ-30+3 scores for global physical health, nausea/vomiting, appetite loss, and constipation improved during therapy.
  
  
  CONCLUSIONS
  PIPAC with cisplatin and doxorubicin is an active treatment in women with PC and preserves quality of life. Appropriate patient selection regarding performance status and the number of prior surgeries is important.
authors.affiliation: Department of Obstetrics and Gynecology, Ruhr University Bochum, Bochum, Germany clemens.tempfer@rub.de.
authors.forename: Clemens B
authors.initials: CB
authors.lastname: Tempfer
authors.affiliation: Department of Obstetrics and Gynecology, Ruhr University Bochum, Bochum, Germany.
authors.forename: Günther A
authors.initials: GA
authors.lastname: Rezniczek
authors.affiliation: Department of Obstetrics and Gynecology, Ruhr University Bochum, Bochum, Germany.
authors.forename: Paula
authors.initials: P
authors.lastname: Ende
authors.affiliation: Institute of Pathology, Medical School Hannover, Hannover, Germany.
authors.forename: Wiebke
authors.initials: W
authors.lastname: Solass
authors.affiliation: Department of Surgery, Ruhr University Bochum, Bochum, Germany.
authors.forename: Marc-André
authors.initials: MA
authors.lastname: Reymond
mesh_terms: D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000627:therapeutic use*; D015331:Cohort Studies; D004317:Doxorubicin / Q000008:administration & dosage / Q000627:therapeutic use*; D016503:Drug Delivery Systems / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D011788:Quality of Life; D012189:Retrospective Studies; D016019:Survival Analysis
chemical_list: D000903:Antibiotics, Antineoplastic; D004317:Doxorubicin; D002945:Cisplatin
keywords: Peritoneal metastasis; aerosol; cisplatin; doxorubicin; intraperitoneal chemotherapy; ovarian cancer; pressure; quality of life