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A phase 1 open-label study of selinexor with paclitaxel and carboplatin in patients with advanced ovarian or endometrial cancers

Gynecologic Oncology Nov 05, 2020

Rubinstein MM, Grisham RN, Cadoo K, et al. - Researchers investigated the safety and tolerability of oral selinexor plus intravenous carboplatin and paclitaxel chemotherapy (selinexor + CP) in ovarian and endometrial cancers. In this phase I, 3 + 3 dose-escalation study of 4 selinexor + CP regimens, treatment was provided to 23 patients (5 serous ovarian cancer; 18 endometrial cancer, including 6 carcinosarcomas). They administered 1 of 4 alternating regimens (selinexor at 30 mg/m2 or 60 mg plus CP at AUC 5 and 175 mg/m2 or 80 mg/m2, respectively) to patients in cohorts of 3, regardless of disease type, for 6–10 cycles (1 cycle = 21 days), followed by selinexor maintenance. Outcomes support the safety and tolerability of the combination selinexor + CP in advanced ovarian and endometrial cancers. Thrombocytopenia (100%), leukopenia (91%), and hyperglycemia (87%) were the most common treatment-related adverse events (TRAEs). Leukopenia (70%), neutropenia (70%), lymphopenia (61%), anemia (57%), and alanine transaminase increase (43%) were the most common grade 3/4 TRAEs.

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