W Willaert1, L Van de Sande2, E Van Daele3, D Van De Putte3, Y Van Nieuwenhove3, P Pattyn3, W Ceelen4. 1. Department of Gastro-intestinal Surgery, Ghent University Hospital, Corneel Heymanslaan 10, B-9000, Ghent, Belgium; Laboratory of Experimental Surgery, Department of Human Structure and Repair, Ghent University, Corneel Heymanslaan 10, B-9000, Ghent, Belgium. Electronic address: wouter.willaert@ugent.be. 2. Laboratory of Experimental Surgery, Department of Human Structure and Repair, Ghent University, Corneel Heymanslaan 10, B-9000, Ghent, Belgium; Cancer Research Institute Ghent (CRIG), Ghent University, Belgium. 3. Department of Gastro-intestinal Surgery, Ghent University Hospital, Corneel Heymanslaan 10, B-9000, Ghent, Belgium. 4. Department of Gastro-intestinal Surgery, Ghent University Hospital, Corneel Heymanslaan 10, B-9000, Ghent, Belgium; Laboratory of Experimental Surgery, Department of Human Structure and Repair, Ghent University, Corneel Heymanslaan 10, B-9000, Ghent, Belgium; Cancer Research Institute Ghent (CRIG), Ghent University, Belgium.
Abstract
INTRODUCTION: Pressurized 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 METHODS: Patients 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. RESULTS: Forty-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. CONCLUSION: Electrostatic 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.
INTRODUCTION:Pressurized 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 METHODS:Patients 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. RESULTS: Forty-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. CONCLUSION: Electrostatic 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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