Abstract 732P
Background
Platinum-resistant ovarian cancer is characterized by its poor prognosis and limited treatment options. Anlotinib is a novel tyrosine kinase inhibitor targeting multiple receptors involved in tumor proliferation, vasculature, and tumor microenvironment.The current prospective clinical trial (ChiCTR1800018192) aimed to further assess the efficacy and safety of anlotinib combined with pemetrexed and continued as maintenance therapy for platinum-resistant ovarian cancer.
Methods
Patients who had received at least two different chemotherapy regimens (including the first-line platinum-based regimen), with histologically proven recurrent platinum-refractory or platinum-resistant epithelial ovarian cancer (including salpingocarcinoma and peritoneal carcinoma), ECOG 0-2, were considered eligible for enrollment to receive six 21-days cycles of anlotinib (12 mg QD from day 1 to 14) orally plus pemetrexed intravenously (0.5 g/m2 on day 1). Anlotinib monotherapy was subsequently performed up to 1 year in patients without disease progression or intolerable toxicity. The primary endpoint was objective response rate (ORR), and the secondary endpoints included disease control (DCR), progression-free survival (PFS) and safety.
Results
As of Jan 2021, 27 patients were enrolled. The median prior lines of chemotherapy was 4 (range, 2-10) and 51.9% of patients had ever received antiangiogenic therapy. 24 patients had the confirmed best overall response assessments which inferred the ORR of 33.3% (PR in 8 patients; 95% CI, 15.6%-55.3%) and the DCR of 100% (PR in 8 patients and SD in 16 patients; 95% CI, 85.8-100). The median PFS was 9.3 months (95% CI, 5.5-13.2). Frequently occurring adverse events were grade 1-2 containing allergic eruption (37.0%), hand-foot syndrome (37.0%), hypertension (29.6%), and fatigue (25.9%). The grade 3-4 adverse events were observed in 5 patients, including 1 with grade 3 proteinuria, 1 with grade 3 ascites, 1 with grade 3 platelet count decrease, 1 with grade 3 lymphedema and 1 with grade 4 anemia.
Conclusions
The treatment of anlotinib plus pemetrexed showed encouraging efficacy and satisfactory safety for platinum-resistant recurrent ovarian cancer patients who were previously treated with chemotherapy.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Z. Yanna.
Funding
Beijing Medical and Health Found.
Disclosure
All authors have declared no conflicts of interest.