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Adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC) in suboptimally cytoreduced advanced ovarian
Alexey S Dzasokhov1, Vladimir M Khomyakov2, Artur V Turiev3
1Oncogynecology, Moscow Regional Oncological Dispensary, Balashikha, Russian Federation, Balashikha, Russian Federation. dzasokhov.pipac@gmail.com.
Purpose:
Patients with advanced epithelial ovarian cancer (EOC) who undergo suboptimal primary cytoreductive surgery (PCS) have poor outcomes with standard platinum-taxane chemotherapy. This randomized controlled trial evaluated whether adding adjuvant Pressurized Intraperitoneal Aerosol Chemotherapy with low-dose cisplatin and doxorubicin (PIPAC C/D) to first-line systemic therapy improves survival in this high-risk population.
Methods:
In this single-center, open-label trial, patients with advanced EOC and residual disease > 1 cm after PCS were randomly assigned (1:1) to receive six cycles of carboplatin/paclitaxel alone (control arm) or the same chemotherapy plus three adjuvant PIPAC C/D procedures (intervention arm). No patient received neoadjuvant chemotherapy. The primary endpoint was progression-free survival (PFS) from PCS. Secondary end points included overall survival (OS), CA-125 response, peritoneal disease control assessed macroscopically and histologically, and safety.
Trial Registration:
ISRCTN15843444.
Results:
A total of 186 patients were randomized. After excluding four after definitive histology, 182 comprised the mITT population (control, n = 91; PIPAC, n = 91). Median PFS was significantly longer with PIPAC (19.7 vs 12.5 months; HR, 0.31; 95% CI, 0.23-0.42; P < 0.001), as was OS (46.2 vs 38.1 months; HR, 0.48; 95% CI, 0.32-0.72; P < 0.001). In the PIPAC group, complete macroscopic regression occurred in 98.8% (83/84 treated patients), complete pathological regression in 85.7%, and ascites control in 98.8%. Treatment was well tolerated with no increase in grade 3-4 toxicity and minimal procedure-related morbidity.
Conclusion:
In patients with suboptimally debulked advanced EOC, the addition of adjuvant PIPAC C/D to first-line chemotherapy significantly improved PFS and OS while maintaining a favorable safety profile. These findings support further evaluation of PIPAC C/D as a component of primary treatment in this high-risk subgroup in confirmatory phase III trials.
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