Objectives

Treatment options for patients with recurrent endometrial cancer remain limited with few targeted drugs available for selected patients. Previous studies have shown synergistic antitumor activity of anlotinib, a tyrosine kinase inhibitor with niraparib, a PARP inhibitor in solid tumors. This study aimed to evaluate the efficacy and safety of niraparib with anlotinib for recurrent or metastatic endometrial cancer.

Methods

Patients with histopathologically confirmed recurrent or metastatic endometrial cancer, receiving at least one systemic chemotherapy were enrolled between February 2021 and April 2022. Patients were orally administered with niraparib 200 mg QD; anlotinib 12 mg QD from days 1–14 for 21-days until disease progression, death or intolerant toxicity. Primary endpoint was objective response rate (ORR) and secondary endpoint included duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and safety.

Results

Out of 13 enrolled patients, 12 was evaluable for efficacy. The median age was 60 (range, 32–70 years) with a median follow-up time of 7.8 months. The complete response, partial response, stable disease and progression disease was achieved by 0%, 66.7%, 25.0%, 8.3% patients, respectively. The ORR and DCR was 66.7% and 91.7%, respectively. The median PFS was not reached. Most common any-grade treatment-related adverse events (TEAEs) were proteinuria (9[69.2%]), thrombocytopenia (4[30.8%]), leukopenia (4[30.8%]) and hypertension (4[30.8%]). Two patients had grade 3 TEAE of hypertension, one patient had grade 3 vomiting and anemia.

Conclusions

Niraparib combined with anlotinib showed promising efficacy and well tolerable safety in patients with recurrent, metastatic endometrial cancer.Clinical trial information: ChiCTR2000035853

EP148/#437 Combination of niraparib and anlotinib in patients with recurrent or metastatic endometrial cancer: an open-label, single-arm, two-stage, phase II study