Clemens B Tempfer1, Guido Winnekendonk2, Wiebke Solass3, Reinhard Horvat4, Urs Giger-Pabst3, Juergen Zieren3, Guenther A Rezniczek5, Marc-André Reymond3. 1. Department of Obstetrics and Gynecology, Ruhr University Bochum, Bochum, Germany. Electronic address: clemens.tempfer@marienhospital-herne.de. 2. Department of Radiology, Ruhr University Bochum, Bochum, Germany. 3. Department of Surgery, Ruhr University Bochum, Bochum, Germany. 4. Department of Pathology, Medical University of Vienna, Vienna, Austria. 5. Department of Obstetrics and Gynecology, Ruhr University Bochum, Bochum, Germany.
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. CONCLUSION: PIPAC is well tolerated and active in women with ROCPC and warrants further investigation in these patients.
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. CONCLUSION:PIPAC is well tolerated and active in women with ROCPC and warrants further investigation in these patients.
Authors: Philipp Horvath; Stefan Beckert; Florian Struller; Alfred Königsrainer; Marc André Reymond Journal: Clin Exp Metastasis Date: 2018-07-30 Impact factor: 5.150
Authors: Alexander Bellendorf; Veria Khosrawipour; Tanja Khosrawipour; Simon Siebigteroth; Joseph Cohnen; David Diaz-Carballo; Andreas Bockisch; Jürgen Zieren; Urs Giger-Pabst Journal: Surg Endosc Date: 2017-06-22 Impact factor: 4.584
Authors: Martin Graversen; Sönke Detlefsen; Jon Kroll Bjerregaard; Per Pfeiffer; Michael Bau Mortensen Journal: Clin Exp Metastasis Date: 2017-05-17 Impact factor: 5.150