Abstract 730P
Background
Anlotinib is a new multi-target tyrosine kinase inhibitor (TKI), and this phase II study aims to evaluate the safety and efficacy of anlotinib monotherapy in patients with recurrent or refractory ovarian carcinoma. We now present the progression-free survival (PFS) for the first time and the updated objective response rate (ORR) 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 disease control rate (DCR), PFS, overall survival (OS), safety and quality of life (QoL).
Results
Between March 2019 and April 2021, 31 patients (female) with FIGO histopathological stage IC (1, 3.5%), IIC (2, 6.9%), IIIC (20, 69.0%) and IV (6, 20.7%) were enrolled and 27 patients were evaluable with a median age of 59 years (range: 39-73). Therapeutic evaluation showed the incidence of complete response, partial response, stable disease and progressive disease was 3.7%, 22.22%, 40.74% and 33.33%, respectively, yielding the ORR of 25.9% (7/27; 95% CI: 11.1-46.3) and the DCR of 66.7% (18/27; 95% CI: 46.0-83.5). The median PFS was 5.32 months (95% CI: 4.31-6.33). The median OS was not reached. Of all the 31 patients, most of the occurring adverse events (AEs) were grade 1 and grade 2, and ≥10% grade 1 AEs included hypertension (41.94%), fatigue (22.58%), and hand-foot syndrome (29.03%). Grade 2 AEs included gingival bleeding (4.76%), hand-foot syndrome (4.76%), renal dysfunction (4.76%) and cancer pain (4.76%). Grade 3 AEs only included myocardial infarction (4.76%) and urine occult blood (4.76%). 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.
Clinical trial identification
ChiCTR2000029654.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.