Article Text
Abstract
Introduction Most patients with ovarian cancer (OC) are diagnosed in advanced stages. A current therapy option for advanced OC patients is debulking surgery; followed by platinum-based chemotherapy ± bevacizumab; followed by maintenance therapy with bevacizumab or monotherapy with PARP inhibitors. The expense of OC maintenance therapy might be substantial. However, the potential benefits of alternating regimens of PARP inhibitors and chemotherapy have not yet been explored. In the alternating regimens of fluzoparib and oral etoposide, both drugs function by directly targeting the DNA of tumour cells. Additionally, the adverse effects of each treatment may be controlled separately without any additive effects. The FARE trial aims to evaluate the efficacy and safety of alternating regimens maintenance therapy in Chinese patients with newly diagnosed advanced OC who are not at high risk of recurrence.
Methods The FARE trial is a single-center, investigator-initiated, single-arm, phase II trial of patients with FIGO stage III-IV high-grade serous or high-grade endometrioid OC. This study includes patients with tumors sample had to be available for central testing to determine BRCA mutation status and homologous-recombination deficiency (HRD) status, no visible residual tumor after primary cytoreductive surgery, and responses to the postoperative platinum-based combination chemotherapy. All enrolled patients are treated with this alternating regimens maintenance therapy for 24 months, until disease progression or unacceptable toxicity, or withdrawal of patient consent. Primary endpoint is progression-free survival (PFS).
Current Trial Status Trial in progress: there are no available results at the time of submission, and there are no available conclusions at the time of submission.