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369 Phase II trial on the feasibility of single dose intraoperative normothermic intraperitoneal carboplatin (NIPEC) in advanced epithelial ovarian cancer following optimal cytoreductive surgery
  1. S Shivdas,
  2. P Rathod,
  3. P RM,
  4. N Jain and
  5. P VR
  1. Kidwai memorial Institute of Oncology, India


Introduction Intraperitoneal (IP) Chemotherapy and HIPEC have come to be accepted as standard options in advanced EOC, but are associated with morbidities and treatment delay. This study was done to evaluate the feasibility of administering single dose intraoperative normothermic IP carboplatin in advanced EOC after optimal primary or interval debulking surgery.

Methods In a Phase II non randomized prospective study from January 2015 to December 2019, patients of optimally cytoreduced advanced high grade serous ovarian cancer, were administered single dose intraoperative IP carboplatin at room temperature. The immediate (< 6 hours), early (6 – 48 hours) and late (48 hours – 21 days) perioperative complications were recorded, and analyzed.

Results Of 356 patients who underwent surgery for advanced EOC, 86 patients met the inclusion and exclusion criteria. 12 (14%) patients underwent PDS and 74 (86%) IDS. 13 (15.1%) patients underwent laparoscopic/robotic IDS. All patients tolerated IP carboplatin well with no or minimal adverse events. Three cases (3.5%) needed re-suturing for burst abdomen, three cases (3.5%) had paralytic ileus, one case underwent re-exploration for hemorrhage, and one patient died due to due late sepsis. 84 (97.7%) patients received adjuvant IV chemotherapy on time.

Conclusion Single dose normothermic intraoperative IP carboplatin is a feasible procedure with no or minimal manageable morbidity. The procedure is user friendly combining the prognostic benefits of IP chemotherapy with assurance of early timely administration of chemotherapy in advanced EOC. Our study is hypothesis generating for future clinical trials comparing single dose NIPEC versus HIPEC in advanced EOC.

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