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Safety and Efficacy of Oxaliplatin Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Colorectal and Appendiceal Cancer with Peritoneal Metastases: Results of a Multicenter Phase I Trial in the USA.

Authors :
Raoof M
Whelan RL
Sullivan KM
Ruel C
Frankel PH
Cole SE
Tinsley R
Eng M
Fakih M
Chao J
Lim D
Woo Y
Paz IB
Lew M
Cristea M
Rodriguez-Rodriguez L
Fong Y
Thomas RM
Chang S
Deperalta D
Merchea A
Dellinger TH
Source :
Annals of surgical oncology [Ann Surg Oncol] 2023 Nov; Vol. 30 (12), pp. 7814-7824. Date of Electronic Publication: 2023 Jul 27.
Publication Year :
2023

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.<br />Patients and Methods: We evaluated PIPAC with 90 mg/m <superscript>2</superscript> 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.<br />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).<br />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.<br /> (© 2023. The Author(s).)

Details

Language :
English
ISSN :
1534-4681
Volume :
30
Issue :
12
Database :
MEDLINE
Journal :
Annals of surgical oncology
Publication Type :
Academic Journal
Accession number :
37501051
Full Text :
https://doi.org/10.1245/s10434-023-13941-2