Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) Applied to Platinum-Resistant Recurrence of Ovarian Tumor: A Single-Institution Experience (ID: PARROT Trial)

Abstract

Background We aimed to investigate the therapeutic efficacy and safety of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in platinum-resistant recurrence of ovarian cancer and peritoneal carcinomatosis, while our secondary endpoint was to establish any changes in quality of life estimated via the EORTC QLQ-30 and QLQ-OV28 questionnaires. Methods In this monocentric, single-arm, phase II trial, women were prospectively recruited and every 28–42 days underwent courses of PIPAC with doxorubicin 2.1 mg/m2 followed by cisplatin 10.5 mg/m2 via sequential laparoscopy. Results Overall, 98 PIPAC procedures were performed on 43 women from January 2016 to January 2020; three procedures were aborted due to extensive intra-abdominal adhesions. The clinical benefit rate (CBR) was reached in 82% of women. Three cycles of PIPAC were completed in 18 women (45%), and 13 (32.5%) and 9 (22.5%) patients were subjected to one and two cycles, respectively. During two PIPAC procedures, patients experienced an intraoperative intestinal perforation. There were no treatment-related deaths. Nineteen patients showed no response according to the Peritoneal Regression Grading Score (PRGS) and 8 patients showed minor response according to the PRGS. Median time from ovarian cancer relapse to disease progression was 12 months (95% confidence interval [CI] 6.483–17.517), while the median overall survival was 27 months (95% CI 20.337–33.663). The EORTC QLQ-28 and EORTC QLQ-30 scores did not worsen during therapy. Conclusions PIPAC seems a feasible approach for the treatment of this subset of patients, without any impact on their quality of life. Since this study had a small sample size and a single-center design, future research is mandatory, such as its application in addition to systemic chemotherapy.

Outcome of patients with peritoneal metastasis from ovarian cancer treated with Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)

“…Importantly, the AURELIA study used strict inclusion criteria and, therefore, excluded patients who had more than two previous anticancer regimens or who progressed during platinum-based treatment, which hinders comparison of survival rates. The recent PARROT trial investigated feasibility and radiological response to PIPAC C/D in 43 women with platinum-resistant recurrent ovarian cancer [ 20 ]. The authors reported a survival of 27 months, which is impressive.…”

“…In comparison, no patients in the aforementioned PARROT trial showed response according to PRGS. Of note, it is difficult to deduce the impact and clinical consequences of the biopsy strategy in the PARROT trial where biopsies were taken after administration of chemotherapy [ 20 ]. Most centres recommend biopsies before administration of chemotherapy [ 22 , 35 ].…”

“…is currently investigating efficacy in 100 women with recurrent platinum-resistant ovarian cancer randomly allocated to PIPAC C/D or systemic chemotherapy [ 19 ]. Further, the PARROT trial showed that PIPAC C/D was feasible and showed a clinical benefit rate in 33/40 (82 %) women with recurrent platinum-resistant ovarian cancer [ 20 ]. Still, more treatment specific data on PIPAC in women with primary unresectable or recurrent platinum resistant OC are needed before evaluating efficacy in large randomized clinical trials.…”