Pressurized Intraperitoneal Aerosol Chemotherapy-Related Clinical Trials in the Treatment of Peritoneal Metastases

Abstract

<b><i>Introduction:</i></b> Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a treatment option for patients with peritoneal metastases. We evaluated the current status of ongoing prospective clinical trials investigating PIPAC to provide an overview and predict trends in this field. <b><i>Methods:</i></b> All 367,494 records of clinical trials registered at ClinicalTrials.gov were searched for trials dealing with PIPAC. Active or unpublished trials were further analyzed. <b><i>Results:</i></b> In total, 22 clinical trials were identified and selected for further analyses. Most trials had a single-arm design and were phase I or II. No phase III trials were registered. Academic centers were recorded as primary sponsors in the majority of trials (63.6%). Every year, between 2 and 5 new trials were initiated. In 17 trials (81.8%), PIPAC was used in a palliative setting only, 2 trials performed PIPAC in a neoadjuvant setting, and 2 trials performed PIPAC in an adjuvant setting. Six different drugs (doxorubicin, cisplatin, oxaliplatin, nab-paclitaxel, 5-fluorouracil, and docetaxel) were used in these clinical trials. Most trials investigated the efficacy (<i>n</i> = 15) or safety (<i>n</i> = 7) of PIPAC therapies. <b><i>Conclusions:</i></b> The results of ongoing clinical trials will bring specific information on indications for PIPAC as well as the impact of PIPAC on quality of life and overall survival.

Comprehensive Treatment Algorithms of the Swiss Peritoneal Cancer Group for Peritoneal Cancer of Gastrointestinal Origin

“…It is important to note that supplementing perioperative chemotherapy and surgery with CRS HIPEC allows for a 5-year overall survival of up to 27% in metastatic patients who would most likely have died earlier otherwise [ 5 , 26 , 27 , 75 , 81 , 82 , 83 , 84 ]. In addition, neoadjuvant PIPAC has been successfully assessed in many specialized centers [ 61 , 62 , 85 ] and it is currently investigated in a dedicated trial [ 86 ].…”