Anlotinib in patients with recurrent platinum-resistant or refractory ovarian carcinoma: A prospective, single-arm, single-center, phase II clinical study.

Abstract

e17524 Background: Anlotinib is a new multi-target tyrosine kinase inhibitor (TKI) and its anti-tumor targets include vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptor (PDGFR), and c-kit. This phase II study aims to evaluate the safety and efficacy of anlotinib monotherapy in patients with recurrent or refractory ovarian carcinoma. We have previously reported primary results (objective response rate (ORR) 35.7%, 95%CI: 12.8-64.9; and disease control rate (DCR) 85.7%, 95%CI: 57.2-98.2) in 14 patients), and we now present the updated ORR, DCR and safety data in more patients. Methods: Patients who have previously received second-line or more chemotherapy, with histopathologically confirmed ovarian high-grade serous gonadal ovarian carcer (including salpingocarcinoma and peritoneal carcinoma), ECOG 0-2 were considered eligible for enrollment. Anlotinib was administered orally (12 mg qd, d1-14; 21 days per cycle) till disease progression, death or intolerant toxicity. Therapeutic effects are evaluated every 6 weeks. The primary endpoint was ORR and the secondary endpoints included DCR, progression-free survival (PFS), overall survival (OS), safety and quality of life (QoL). Results: Between March 2019 and January 2021, 31 patients (female) with FIGO histopathological stage IC (1, 3.2%), IIC (1, 3.2%), IIIC (23, 74.2%) and IV (6, 19.4%) were enrolled and 24 patients were evaluable with a median age of 59 years (range: 37-73). The median treatment period was 4.96 months (95% CI: 4.50-7.56). Therapeutic evaluation showed the incidence of complete response, partial response, stable disease and progression disease was 4.2%, 25%, 45.8% and 25% respectively, yielding the ORR of 29.2% (7/24; 95% CI: 14.6-57.0) and the DCR of 75.0% (18/24; 95% CI: 53.3-90.2). The median PFS was 6.34 months (95% CI: 3.14-9.54). The median OS was not reached. Most of the occurring adverse events (AEs) were grade 1 and grade 2, and ≥10% grade 1 AEs included hypertention (45.83%), fatigue (29.17%), hand-foot syndrome (33.33%) and hoarseness (12.50%). Grade 2 AEs only included gingival bleeding (4.2%), hand-foot syndrome (4.2%), renal dysfunction (4.2%) and cancer pain (4.2%). No higher grade AEs were observed. Neither unexpected safety signals nor treatment related death occurred. Conclusions: Anlotinib showed a promising efficacy with an acceptable safety profile for patients with recurrent platinum-resistant or refractory ovarian carcinoma. Further evaluation of PFS and OS is ongoing. Clinical trial information: ChiCTR2000029654.