Application of Arsenic Trioxide-Based Combined Sequential Chemotherapy in Recurrent Resistant and Refractory Ovarian Cancers: A Single-Center, Open Phase II Clinical Study

Abstract

Objective. Arsenic trioxide (ATO) has been effectively used for the treatment of hematological malignancies and some solid tumors, while ATO effects were not tested clinically in epithelial ovarian cancer (EOC). Methods. Patients with primary or secondary platinum-resistant EOC were enrolled from October 2015 to December 2019. Patients were mainly treated with ATO-based combined sequential chemotherapy as follows: Regimen 1 (ATO combined taxanes weekly therapy); Regimen 2 (ATO + taxanes + 5-fluorouracil + adriamycin ± bevacizumab sequential chemotherapy), for 5 patients platinum-free interval >12 months, added oxaliplatin). Prespecified end points in this cohort included confirmed best overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results. A total of 33 patients were enrolled in this study. After a median follow-up time of 22.1 months (range 5.5–42.9 months), ORR was 42% and DCR was 85%. The overall PFS was 9.5 months (range 1–38.4 months). The main side effect was myelosuppression. Conclusions. ATO-based sequential combined chemotherapy is effective for primary and recurrent drug-resistant EOC patients in clinical phase II trials. The associated side effects could be controlled, while further study is needed.