Abstract
BackgroundPressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) is a novel laparoscopic intraperitoneal chemotherapy technique, with advantages such as homogeneous distribution of aerosol and deeper tissue penetration. Thus far, PIPAC oxaliplatin has been administered at an arbitrary dose of 92 mg/m2.AimWe aim to determine the dose-related safety profile and tolerability of PIPAC oxaliplatin using an evidence-based approach. The secondary aim is to evaluate clinic-pathologic response and the pharmacokinetic profile.MethodsThis is a phase I 3+3 dose escalation study for gastric and colorectal cancer with predominant peritoneal metastasis starting at a dose of 45 mg/m2. Safety is assessed according to Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (version 4.0). Clinico-pathologic response is assessed using the Peritoneal Regression Grading Score, Peritoneal Cancer Index, and Response Evaluation Criteria In Solid Tumour criteria (version 1.1). Pharmacokinetic analysis is performed using Inductively Coupled Plasma-Mass Spectrometry assay. This trial is registered on ClinicalTrials.gov (NCT03172416).ConclusionsThis phase I study can provide the scientific basis to identify the optimal dose for PIPAC with oxaliplatin such that the benefits of this novel and promising intraperitoneal chemotherapy delivery technique can be maximized.
Highlights
Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) is an innovative IP chemotherapy concept for treating peritoneal metastasis that enhances efficacy by taking advantage of the physical properties of gas and pressure [1]
The dose of oxaliplatin utilized for PIPAC in these studies was arbitrarily set at 92 mg/m2, which is approximately 20 % of the dose used in hyperthermic intraperitoneal chemotherapy (HIPEC)
Eligibility for recruitment would be based on the inclusion and exclusion criteria (Table 1). They should have undergone or have been offered at least first-line systemic chemotherapy, as PIPAC is still investigational with no phase III studies demonstrating superiority over first-line systemic chemotherapy
Summary
Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) is an innovative IP chemotherapy concept for treating peritoneal metastasis that enhances efficacy by taking advantage of the physical properties of gas and pressure [1]. This results in a superior distribution and depth of penetration of the drug [1, 2]. Oxaliplatin is an approved drug for systemic chemotherapy, with well documented use intraperitoneally via hyperthermic intraperitoneal chemotherapy (HIPEC) as well This makes it a favourable agent for PIPAC in early phase studies. The secondary aim is to evaluate clinicpathologic response and the pharmacokinetic profile
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