Feasibility, Safety, and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastasis: A Registry Study

Abstract

Introduction Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel drug delivery system with superior pharmacological properties for treating peritoneal metastasis (PM). Safety and efficacy results of PIPAC with cisplatin/doxorubicin or oxaliplatin from a registry cohort are presented. Methods IRB-approved registry study. Retrospective analysis. No predefined inclusion criteria, individual therapeutic recommendation by the interdisciplinary tumor board. Safety assessment with CTCAE 4.0. Histological assessment of tumor response by an independent pathologist using the 4-tied peritoneal regression grading system (PRGS). Mean PRGS and ascites volume were assessed at each PIPAC. Results A total of 142 PIPAC procedures were scheduled in 71 consecutive patients with PM from gastric (n = 26), colorectal (n = 17), hepatobiliary/pancreatic (n = 9), ovarian (n = 6), appendiceal (n = 5) origin, pseudomyxoma peritonei (n = 4), and other tumors (n = 3). Mean age was 58 ± 13 years. Patients were heavily pretreated. Mean PCI was 19 ± 13. Laparoscopic nonaccess rate was 11/142 procedures (7.7%). Mean number of PIPAC/patient was 2. All patients were eligible for safety analysis. There was no procedure-related mortality. There were 2.8% intraoperative and 4.9% postoperative complications. 39 patients underwent more than one PIPAC and were eligible for efficacy analysis, and PRGS could be assessed in 36 of them. In 24 patients (67%), PRGS improved or remained unchanged at PIPAC#2, reflecting tumor regression or stable disease. Ascites was present in 24 patients and diminished significantly under therapy. Median survival was 11.8 months (95% CI: 7.45–16.2 months) from PIPAC#1. Conclusion PIPAC is feasible, safe, and well-tolerated and can induce histological regression in a significant proportion of pretreated PM patients. This trial is registered with NCT03210298.

Staging laparoscopy and Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) for peritoneal metastasis: safe access to the abdomen

“…In an US cohort, optical trocars have been used for abdominal access in 38 % patients with peritoneal metastasis [3]. However, in our bi-institutional series of 265 consecutive PIPAC between 6/2016 and 2/2019, we have three cases of bowel injury during access (1.1 %), one with optical trocar and two punctions during insufflation with Veress needle [5], but no one with the "finger access" technique. One lesion had to be sutured, chemotherapy was not delivered, there was no postoperative complication.…”

“…The nonaccess rate was higher after cytoreductive surgery and peritonectomy and HIPEC than after other surgeries. In most PIPAC series, bowel access lesions were rare (0-2 %) [5][6][7] . However, in a single cohort, incidence of bowel lesions during PIPAC was reported to be as high as 5.7 % [8].…”

Pressurized intraperitoneal aerosol chemotherapy: a review of the introduction of a new surgical technology using the IDEAL framework

“…Data on the occupational health and safety aspects of the technique were collected, with no evidence of platinum contamination in the operating theatres. As centres across Europe started performing the procedure, verification of its occupational health and safety was repeated.…”

Treatment of metastatic colorectal cancer: innovations in surgical techniques

“…35 Some centers, particularly in Europe, have introduced a novel technique to combat these limitations. 36,37 PIPAC has been shown in preclinical models to allow higher local penetration of chemotherapy with low systemic toxicity. 38,39 PIPAC administration is currently performed under experimental protocols and is conducted under general anesthesia via laparoscopy.…”