Summary
Objective
The objective of this study was to provide an overview of published and ongoing trials of pressurized intraperitoneal chemotherapy (PIPAC) in ovarian cancer.
Design
The study comprised a systematic literature review.
Results
We identified 10 studies, including 2 ex vivo and in vitro studies, 6 clinical studies, and 2 ongoing clinical trials using PIPAC in women with recurrent ovarian cancer and pseudomyxoma peritonei. Experimental evidence and clinical study data demonstrate that PIPAC increases peritoneal cavity coverage and depth of peritoneal infiltration, and is technically feasible. Occupational safety has been established. PIPAC has demonstrated antitumor activity based on histological, radiological, and clinical evidence. The toxicity of PIPAC is manageable and restricted to Common Terminology Criteria for Adverse Events grade 2–3 events when used without concomitant cytoreductive surgery. Further clinical trials assessing efficacy and dose escalation are ongoing.
Conclusions
PIPAC is technically feasible, has a safe local and systemic safety profile, and has antitumor activity in women with peritoneal carcinomatosis from recurrent ovarian cancer.
Zusammenfassung
Zielsetzung
Ziel dieser systematischen Literaturübersicht war die Erfassung der publizierten experimentellen und klinischen Daten zur pressurized intraperitoneal chemotherapy (PIPAC) bei Frauen mit gynäkologischen Malignomen und Peritonealkarzinose (PC).
Methodik
Systematische Literaturübersicht über experimentelle und klinische Studien zum Thema PIPAC anhand der öffentlich zugänglichen Datenbanken PUBMED, EMBASE, Cochrane Controlled Trials Register, EudraCT und des US NIH ClinicalTrials.gov Registers.
Ergebnisse
Wir identifizierten 10 Studien, davon 2 ex-vivo und in-vitro Studien, 6 klinische Studien an Frauen mit rezidiviertem Ovarialkarzinom und Pseudomyxoma peritonei, sowie 2 laufende klinische Studien über PIPAC bei Frauen mit PC und Ovarialkarzinom-Rezidiv. Die experimentelle Evidenz und die Ergebnisse der klinischen Studien zeigen, dass mittels PIPAC die peritoneale Benetzungsfläche erhöht und die peritoneale Infiltrationstiefe erhöht werden kann und dass PIPAC technisch durchführbar ist. Die Arbeitssicherheit von PIPAC wurde unter kontrollierten Bedingungen bestätigt. Die verfügbaren klinischen Daten belegen eine Antitumoraktivität von PIPAC, basierend auf histologischen, radiologischen und klinischen Beobachtungsdaten. Die lokale und systemische Toxizität der Methode ist mit CTCAE Grad 2–3 Ereignissen gering, falls PIPAC ohne konkomitante zytoreduktive Chirurgie angewandt wird. Weitere klinische Studien zur Effektivität und Dosiseskalation werden derzeit durchgeführt.
Schlussfolgerungen
PIPAC ist technisch durchführbar, sicher in Anwendung und Patientinnentoxizität und hat nachweisliche Antitumoraktivität bei Frauen mit PC und Ovarialkarzinom oder PMP.
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Conflict of interest
Marc-André Reymond holds a patent related to the mechanical device used in PIPAC (patent number DE 2020 1110115U1).
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Tempfer, C., Solass, W. & Reymond, MA. Pressurized intraperitoneal chemotherapy (PIPAC) in women with gynecologic malignancies: a review. Wien Med Wochenschr 164, 519–528 (2014). https://doi.org/10.1007/s10354-014-0312-y
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DOI: https://doi.org/10.1007/s10354-014-0312-y