Continuous low-flow ascites drainage and sequential non-invasive tumor-cell sampling through the urinary bladder via the alfa-pump closed system in platinum-resistant ovarian cancer (PROC): First clinical experience in a cancer patient.

Abstract

5562 Background: Malignant ascites in PROC causes significant impairment in quality of life. The Sequana Medical alfapump System (AP), a remotely controlled device connecting the patients’ peritoneal cavity to their urinary bladder, has been evaluated for the continuous drainage of ascites in liver cirrhosis, but not as yet for malignant ascites. Methods: We implanted the AP in the peritoneal cavity of a 67y old heavily pretreated PROC patient with recurrent malignant ascites requiring 3-5 liters drained 3 times/month. The AP was evaluated for its ability to drain ascites into the urinary bladder using an electronic download of recorded volume pumped, cross correlated with weekly ultrasound, symptomatic scores and QoL evaluation. Early morning urine for evaluation of urinary cytology and tumor-cell molecular analysis was collected weekly. Results: The implantation was performed under general anaesthesia in a 60 minute procedure. Before insertion the patient had 3 liters of malignant ascites; 2 liters were drained during surgery. The pump, draining 350ml ascites per day successfully drained the ascites to dryness after 3 days. The patient underwent weekly sonography and monthly cystoscopies. She did not report pollaki- or dysuria, only an increased micturition volume. Histopathological analysis of the urine revealed rich malignant cell content, used to create FFPE cell blocks weekly for molecular- pathological profiling with sequential Caris Target Now analysis and full exome sequencing. Conclusions: On initial evaluation, the AP represents a tolerable and effective means of diverting peritoneal ascites into the urinary bladder and thus preventing its recumulation in PROC. This innovative approach not only addresses an area of unmet need for the control of malignant ascites but also provides a method of collecting tumor tissue and evaluating longitudinal change in molecular tumor characterization. A EUTROC multicenter European randomized trial (AMAZE) is planned for evaluation of clinical and translational implications of the AP in PROC.