Author:
Raoof Mustafa,Whelan Richard L.,Sullivan Kevin M.,Ruel Christopher,Frankel Paul H.,Cole Sarah E.,Tinsley Raechelle,Eng Melissa,Fakih Marwan,Chao Joseph,Lim Dean,Woo Yanghee,Paz Isaac Benjamin,Lew Michael,Cristea Michaela,Rodriguez-Rodriguez Lorna,Fong Yuman,Thomas Rebecca Meera,Chang Sue,Deperalta Danielle,Merchea Amit,Dellinger Thanh H.
Abstract
Abstract
Background
Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is a laparoscopic locoregional treatment for peritoneal metastases (PM) from colorectal cancer (CRC) or appendiceal cancer (AC) in patients who cannot undergo cytoreductive surgery (CRS). While PIPAC has been studied in Europe and Asia, it has not been investigated in the USA.
Patients and Methods
We evaluated PIPAC with 90 mg/m2 oxaliplatin alone (cycle 1) and preceded by systemic chemotherapy with fluorouracil (5-FU) and leucovorin (LV) (cycle 2–3) as a multicenter prospective phase I clinical trial (NCT04329494). The primary endpoint was treatment-related adverse events (AEs). Secondary endpoints included survival and laparoscopic, histologic, and radiographic response.
Results
12 patients were included: 8 with CRC and 4 with AC. Median prior chemotherapy cycles was 2 (interquartile range (IQR) 2–3). All patients were refractory to systemic oxaliplatin-based chemotherapy. Median peritoneal carcinomatosis index (PCI) was 28 (IQR 19–32). Six (50%) of twelve patients completed three PIPAC cycles. No surgical complications or dose-limiting toxicities were observed. Two patients developed grade 3 treatment-related toxicities (one abdominal pain and one anemia). Median overall survival (OS) was 12.0 months, and median progression-free survival (PFS) was 2.9 months. OS was correlated with stable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria but not with laparoscopic response by PCI or histologic response by peritoneal regression grading system (PRGS).
Conclusions
This phase I trial in the USA demonstrated safety, feasibility, and early efficacy signal of PIPAC with oxaliplatin and chemotherapy in patients with PM from AC or CRC who are refractory to standard lines of systemic chemotherapy.
Funder
Women’s Cancer’s Program
National Cancer Institute
City of Hope
Publisher
Springer Science and Business Media LLC
Cited by
6 articles.
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