title: Pressurized intraperitoneal aerosol chemotherapy in women with recurrent ovarian cancer: A phase 2 study.
abstract: OBJECTIVE
  Recurrent ovarian, fallopian or peritoneal cancer with peritoneal carcinomatosis (ROCPC) is resistant to systemic chemotherapy. We assessed the safety and activity of laparoscopic pressurized intraperitoneal aerosol chemotherapy (PIPAC) in women with this cancer.
  
  
  METHODS
  In this open-label, single-arm phase 2 study, patients underwent 3 courses q 28-42 days of PIPAC with doxorubicin 1·5 mg/m(2) followed by cisplatin 7·5 mg/m(2). A pressure of 12 mm Hg and a temperature of 37 °C were applied for 30 min/course. The primary endpoint was the proportion of patients who had an objective tumor response (OTR) according to RECIST version 1.1 criteria. Analysis was by intention to treat. Secondary endpoints were tumor regression on histology, PC Index improvement on repeated video-laparoscopy, and quality of life measured with the EORTC QLQ-30 questionnaire.
  
  
  RESULTS
  Sixty-four patients were enrolled. Laparoscopic non-access rate was 11/64 (17%). 53 patients were eligible for analyses. 33/53 (62%) patients had an OTR - three had a partial response and 30 patients had stable disease. Tumor regression on histology and PC Index improvement were observed in 26/34 (76%) and in 26/34 (76%) patients who underwent all 3 PIPACs. There were no treatment-related deaths. No grade 4 toxicity was observed. Grade 3 toxicities were trocar hernia (n=2), bowel obstruction (n=2), abdominal pain (n=2), hematoma (n=1), intraoperative bleeding (n=1), and cystitis with urosepsis (n=1). EORTC QLQ-30 global physical health scores, nausea/vomiting, appetite loss, diarrhea, and constipation improved during therapy.
  
  
  CONCLUSIONS
  PIPAC is well tolerated and active in women with ROCPC and warrants further investigation in these patients.
authors.affiliation: Department of Obstetrics and Gynecology, Ruhr University Bochum, Bochum, Germany. Electronic address: clemens.tempfer@marienhospital-herne.de.
authors.forename: Clemens B
authors.initials: CB
authors.lastname: Tempfer
authors.affiliation: Department of Radiology, Ruhr University Bochum, Bochum, Germany.
authors.forename: Guido
authors.initials: G
authors.lastname: Winnekendonk
authors.affiliation: Department of Surgery, Ruhr University Bochum, Bochum, Germany.
authors.forename: Wiebke
authors.initials: W
authors.lastname: Solass
authors.affiliation: Department of Pathology, Medical University of Vienna, Vienna, Austria.
authors.forename: Reinhard
authors.initials: R
authors.lastname: Horvat
authors.affiliation: Department of Surgery, Ruhr University Bochum, Bochum, Germany.
authors.forename: Urs
authors.initials: U
authors.lastname: Giger-Pabst
authors.affiliation: Department of Surgery, Ruhr University Bochum, Bochum, Germany.
authors.forename: Juergen
authors.initials: J
authors.lastname: Zieren
authors.affiliation: Department of Obstetrics and Gynecology, Ruhr University Bochum, Bochum, Germany.
authors.forename: Guenther A
authors.initials: GA
authors.lastname: Rezniczek
authors.affiliation: Department of Surgery, Ruhr University Bochum, Bochum, Germany.
authors.forename: Marc-André
authors.initials: MA
authors.lastname: Reymond
mesh_terms: D000336:Aerosols / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D000077216:Carcinoma, Ovarian Epithelial; D002945:Cisplatin / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007274:Injections, Intraperitoneal; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D011788:Quality of Life
chemical_list: D000336:Aerosols; D004317:Doxorubicin; D002945:Cisplatin
keywords: Chemotherapy; High pressure; Intraabdominal; Platinum-resistant; Recurrent ovarian cancer