Background: To evaluate the safety and efficacy of weekly paclitaxel or cisplatin with electro-hyperthermia in patients with recurrent or persistent epithelial ovarian, fallopian tubal or primary peritoneal carcinoma.
Methods: This prospective trial employed ‘3+3 design’ with no dose escalation. Initially, patients were randomized to weekly paclitaxel (70mg/m2) or weekly cisplatin (40mg/m2) with electro-hyperthermia until three patients in each arm were evaluable for dose-limiting toxicities (DLTs). A cycle was 4 weeks long and paclitaxel or cisplatin was administered at day 1, 8, 15. Targeting tumor beds, electro-hyperthermia was administered semi-weekly (8 time/cycle) for 1 hour per session. DLT was defined as any adverse event possibly or probably related to therapy, that required intensive care or was not recovered to grade 2 or lower within 3 weeks. If ≤1 patient in an arm experienced DLT, additional 3 patients were enrolled to that arm. Unevaluable patients (n = 4) were replaced. Finally, 12 patients (6 in each arm) were evaluated for toxicities, response rate, progression-free survival (PFS) and overall survival (OS).
Results: Nine patients had high grade serous histology. Median number of previous regimen was 2 (range 1- 5) and median treatment-free interval from previous chemotherapy was 6 months (range 0 – 27). Nine patients were platinum resistant or refractory. No DLT was observed. Four grade 3 toxicities were observed (nausea 1, hematologic 3) in cisplatin arm. Overall response rate was 42% (5/12), median PFS was 4.3 months (range 1.7 – 11.8), and median OS was over 13.8 months (range 3.9 –> 38.5).
Conclusions: Both weekly paclitaxel and cisplatin with electro-hyperthermia are safe enough to be tested in further studies. Chemotherapy with electro-hyperthermia was seems to be an effective treatment strategy for recurrent or persistent epithelial ovarian, fallopian tubal or primary peritoneal carcinomas. No significant differences in oncologic outcomes and toxicities were observed between paclitaxel and cisplatin arms. Clinical trial information: NCT02344095