Safety and preliminary efficacy of electrostatic precipitation during pressurized intraperitoneal aerosol chemotherapy (PIPAC) for unresectable carcinomatosis |
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Affiliation: | 1. Department of Gastro-intestinal Surgery, Ghent University Hospital, Corneel Heymanslaan 10, B-9000, Ghent, Belgium;2. Laboratory of Experimental Surgery, Department of Human Structure and Repair, Ghent University, Corneel Heymanslaan 10, B-9000, Ghent, Belgium;3. Cancer Research Institute Ghent (CRIG), Ghent University, Belgium;1. Department of General Surgery and Surgical Oncology, Oncology Center, King Khalid Hospital, Najran, Saudi Arabia;2. Department of Surgical Oncology, Cancer Institute in Montpellier, France;3. Moscow Research Oncological Institute n.a. P.A. Herzen, Thoracoabdominal, Moscow, Russian Federation;4. University of Tuebingen, Germany;5. Fondazione Policlinico Universitario “A. Gemelli” IRCCS, Roma, Italy;6. National University Hospital, Singapore;7. QTI Comprehensive Cancer Center, Barcelona, Spain;8. CMC Volta, La Chaux-de-Fonds, Switzerland;9. Department of Visceral Surgery, Lausanne University Hospital CHUV, University of Lausanne (UNIL), Switzerland;10. Ghent University, Belgium;11. Université de Paris, UMR 1275 CAP Paris-Tech, F-75010, Paris, France;12. Service de Chirurgie Digestive et Cancérologie Hôpital Lariboisière, 2 rue Ambroise Paré, F-75010, Paris, France;1. Department of Surgical Oncology, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre-Bénite, France;2. EMR 3738, Lyon 1 University, Lyon, France;3. King Salman Scholarship Program, Saudi Arabian Cultural Bureau, Paris, France;4. Department of Digestive and Hepatobiliary Surgery, Centre Hospitalier Univeristaire de Clermont Ferrand, Clermont-Ferrand, France;5. Department of Surgery, Institut Du Cancer de Montpellier (ICM), 34298, Montpellier, France;6. Pharmacy Department, Lyon Sud Hospital, Pierre Benite, France;7. Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche, Unité de Recherche Clinique, Lyon, France;8. U1071 INSERM, Université Clermont Auvergne, Clermont-Ferrand, France;1. Department of Surgical Oncology, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre-Bénite, France;2. EMR 3738, Lyon 1 University, Lyon, France;3. Department of General Surgery and Surgical Oncology, King Khalid Hospital, Najran, Saudi Arabia;4. Department of Surgical Oncology, Centre Hospitalo-Universitaire de Montreal, Montreal, Canada;5. Department of Public Health, Clinical Research & Epidemiology, Lyon University Hospital, Lyon, France;1. Department of Obstetrics and Gynecology, Ruhr-Universität Bochum, Bochum, Germany;2. Labor MVZ Eberhard und Partner, Dortmund, Germany |
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Abstract: | IntroductionPressurized intraperitoneal aerosol chemotherapy (PIPAC) was recently introduced to treat unresectable peritoneal metastases. Adding an electrostatic field may enhance charged droplet precipitation and tissue penetration, resulting in improved anticancer efficacy. We report for the first time its safety and preliminary efficacy.Materials and methodsPatients underwent PIPAC combined with an electrostatic field, using the Ultravision™ apparatus. Adverse events were scored with the Common Terminology Criteria. Treatment response was assessed after more than one PIPAC, using clinical symptoms, tumor markers, CT imaging and histological regression.ResultsForty-eight patients (median age, 61 y) with diverse primary tumors underwent 135 procedures (median per patient, 3). Most (65.2%) were treated as outpatient. Twenty-eight (58.3%) patients received concomitant chemotherapy. The most frequent treatment-related toxicities were anemia (grade 1 to 3, 13 [9.6%]), ileus (grade 1 to 3, 5 [3.7%]), anorexia (grade 1 to 3, 6 [4.4%]), nausea (grade 1 to 3, 5 [3.7%]) and vomiting (grade 1 to 3, 7 [5.2%]). There was no grade 4 or 5 morbidity. Twenty (41.7%) patients did not complete three treatments, mainly because of disease progression (n = 13). After two procedures, there were one responder and 8 non-responders. After three treatments, we observed 11 responders, two patients with stable disease, and 15 non-responders. All but one patient with therapy response received simultaneous chemotherapy.ConclusionElectrostatic precipitation during PIPAC is well tolerated and safe. After three procedures and concomitant chemotherapy, response or stable disease is achieved in approximately half of cases. These findings warrant prospective trials in homogeneous patient cohorts. |
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Keywords: | Aerosol Intraperitoneal chemotherapy Peritoneal carcinomatosis PIPAC Pressure Toxicity |
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