Supplementary Information
ascites, colorectal cancer, CRC, chemotherapy-refractory, Tumors, malignant bowel obstruction, gastrointestinal malignancies, appendiceal cancer
ASCITES, COLORECTAL CANCER, LIVER METASTASES, GASTRIC CANCER, TUMORS, OBSTRUCTIVE UROPATHY, CAVITY, METASTASES, APPENDICEAL CANCER
The online version contains supplementary material available at 10.1245/s10434-023-13941-2.Open access funding provided by SCELC, Statewide California Electronic Library ConsortiumPeritoneal metastases (PM) from colorectal cancer (CRC) and appendiceal cancer (AC) impact on morbidity with malignant bowel obstruction, ascites, or obstructive uropathy, and have a median overall survival (OS) of 14 months, worse than either isolated lung or liver metastases.Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is an intraperitoneal drug delivery modality administered via a minimally invasive laparoscopic approach that can be repeated. Pressurization and aerosolization were demonstrated in preclinical models to homogenously distribute chemotherapy throughout the abdominal cavity with good tissue penetration.Given these early clinical data from Europe and Asia indicating the overall safety of PIPAC with some efficacy in a challenging PM patient population who have progressed on previous lines of therapy and with limited alternative options, we sought to evaluate this novel therapy in the USA. While the prior studies in Europe and Asia include PM from gastrointestinal malignancies included gastric cancer, the focus of this trial was CRC and AC. Secondly, prior studies have included patients with heterogeneous exposure to prior systemic therapy. Here, we focused on a chemotherapy-refractory population. The primary aim of the study was to confirm the safety, feasibility, and pharmacokinetics of the previously studied dose and schedule of oxaliplatin PIPAC in combination with intravenous (IV) 5-FU and LV. Secondary aims included measures of clinical efficacy including OS, progression-free survival (PFS), response rate by laparoscopic PCI, radiographic response by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and histological response by PRGS. Lastly, to inform the design of future randomized phase II efficacy trial, we aimed to evaluate which surrogate markers of response correlate best with overall survival.