Secondary Cytoreductive Surgery Plus Niraparib for Recurrent Ovarian Cancer Under Study
Posted: Monday, August 17, 2020
Researchers in China led by Tingyan Shi, MD, PhD, of Fudan University in Shanghai, are investigating the utility of secondary cytoreductive surgery with niraparib maintenance in patients with platinum-sensitive secondary relapsed ovarian cancer. The protocol for this phase II study was published in the Journal of Gynecologic Oncology.
This study will be a multicenter, open, randomized, controlled trial recruiting 96 patients with platinum-sensitive secondary recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. Patients will be assigned 1:1 to receive either cytoreductive surgery followed by six cycles of chemotherapy with niraparib maintenance or chemotherapy and niraparib alone without surgery. Patients will be treated with a variety of third-line chemotherapeutic regimens, consisting of carboplatin/paclitaxel, carboplatin/docetaxel, carboplatin/gemcitabine, or carboplatin/doxorubicin. After chemotherapy, 200 or 300 mg of niraparib will be administered to patients depending on their baseline weight and platelet count. Only patients without disease progression on chemotherapy will receive niraparib.
Major exclusion criteria for this trial includes borderline tumors and nonepithelial ovarian malignancies, planned interval debulking, palliative surgery, and receipt of more than two chemotherapeutic regimens. Patients who have grade 3 or higher anemia, neutropenia, or thrombocytopenia lasting more than 4 weeks as a result of chemotherapy will be excluded from the trial as well.
The primary outcome of the trial is the 12-month nonprogression rate of cytoreductive surgery followed by chemotherapy and niraparib compared with no surgery. Progression of disease will be defined as general condition deterioration; an increased CA125 level; signs of new lesions clinically, on imaging, or histopathologically; new or re-emerging pleural effusion and ascites; or increased lesions. Other study objectives include progression-free survival, overall survival, safety, and quality of life.
Disclosure: The authors reported no conflict of interest.
