Abstract
6034 Background: Anlotinib is a novel multi-target tyrosine kinase inhibitor that has previously shown clinical antitumor activity in various cancers, including the phase I study on female genital tumors. This phase II study (ChiCTR1800020116) aims to further evaluate the safety and efficacy of anlotinib, in those patients with recurrent advanced cervical cancer. Methods: Eligible patients were advanced cervical cancer who had received at least two previous lines of chemotherapy. Patients were given anlotinib (12 mg/day) from day 1 to day 14 in a 21-day cycle until disease progression or had unacceptable toxic effects. The primary endpoint of this study was objective response rate (ORR) and the secondary endpoints were progression-free survival (PFS), overall survival (OS) and safety. Results: Between 2018 December and 2019 October, 41 patients (female) were enrolled. As of January 15, 2020, median follow-up duration, from randomization to data cutoff, was 2.6 months (range, 0.7-10.3). Therapeutic evaluation showed the ORR was 32.1% (95%CI, 13.7%-50.6%) and the median PFS was 3.9 months (95% CI, 1.3%-6.5%). The most frequently reported adverse events were lymphocyte count decreased, anemia, hand-foot syndrome, blood uric acid increased, blood creatinine increased, blood thyroid stimulating hormone increased. All frequently occurring AEs were grade 1 or 2. High grade AE was only observed in 1 patient with white blood cells urine positive of grade 3. Neither unexpected safety signals nor treatment related death occurred. Conclusions: Anlotinib showed a promising activity with an acceptable safety profile for patients with recurrent advanced cervical cancer. Clinical trial information: ChiCTR1800020116.
Published Version
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