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INTRAPERITONEAL THERAPY FOR STAGE III, OPTIMALLY DEBULKED OVARIAN CANCER (OPTIMAL OV CA): ISN'T IT ABOUT TIME TO TAKE THE PHASE III TRIAL DATA SERIOUSLY?

The pharmacological basis for intraperitoneal therapy with cisplatin and paclitaxel is well established, with drug concentrations in the peritoneal cavity that are approximately 20-fold greater with cisplatin, and approximately 1000-fold greater with paclitaxel, than are achievable with intravenous administration. The Gynecologic Oncology Group (GOG) and Southwest Oncology Group (SWOG) have performed three large phase III trials of intraperitoneal cisplatin-based versus intravenous cisplatin-based chemotherapy in patients with optimal OV CA, shown in the table below. There continues concern about the neurotoxicity associated with the 100mg/m2 dose of cisplatin used in the intraperitoneal arms of these GOG/SWOG studies. In follow-up phase II pilot studies, the SWOG has documented the safety of intraperitoneal cisplatin administered in a dose of 75mg/m2 (in combination with IV paclitaxel at 135mg/m2 over 3 hours) (SWOG-9912) and intraperitoneal carboplatin (AUC1⁄4 5mg min/mL in combination with IV paclitaxel at 135mg/m2 over 3 hours) (SWOG-0009). Based on these results, it is imperative that we take the results of these large phase III trials seriously in the design of the next generation of studies for women with optimal OV CA.