Abstract 841P
Background
Anlotinib is an oral multi-kinase inhibitor that widely inhibits VEGFR, PDGFR, FGFR and c-KIT. This investigator-initiated, single-arm, open-label, phase II trial (ChiCTR1800018192) assessed anlotinib combined with pemetrexed and continued as maintenance therapy for platinum-resistant epithelial ovarian cancer.
Methods
The eligible patients (pts) with platinum-refractory and platinum-resistant recurrent epithelial ovarian cancer, had received at least two different chemotherapy regimens, including one line platinum-based chemotherapy before enrolment. All pts were treated with intravenous pemetrexed (0.5 g/m2 on day 1) plus oral anlotinib (12 mg once daily on days 1-14), repeated every 21 days for six cycles, followed by daily maintenance anlotinib for up to 1 year in pts without progression. The primary endpoint of this study was objective response rate (ORR) and the secondary endpoints were disease control rate (DCR), median progression-free survival (mPFS) and safety.
Results
Between July 2018 and March 2020, 19 pts were enrolled. The median number of prior chemotherapy regimens was 6 (range, 2 to 11). 63.2% of pts had received antiangiogenic therapy previously. 3 pts were excluded from response assessments. During a median follow-up period of 3.8 months (range, 1.5 to 17.7), confirmed best overall response assessments showed partial response in 4 pts and stable disease in 12 pts, yielding the ORR of 25% (95% CI, 7.3 to 52.4) and the DCR of 100% (95% CI, 79.4 to 100). mPFS was not reached (NR). Besides, ORR of pts treated with prior additionally antiangiogenic therapy was 11.1% versus 42.9% (P=0.262) in pts treated with prior chemotherapy only. mPFS of pts with and without prior antiangiogenic therapy was 6.7 months and NR respectively (P=0.072). The grade 3-4 adverse events were observed in two pts, including one with grade 3 gum-pain and the other with grade 4 hemoglobin reduction. Neither unexpected safety signals nor treatment-related death occurred.
Conclusions
Anlotinib, when given orally in combination with pemetrexed and continued as maintenance therapy, showed an effective and well-tolerated anti-tumor activity in pts with platinum-resistant ovarian cancer regardless of whether antiangiogenic drugs were previously used.
Clinical trial identification
ChiCTR1800018192.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Beijing Medical and Health Found.
Disclosure
All authors have declared no conflicts of interest.