Effectiveness and safety of anlotinib with or without S-1 in the treatment of patients with advanced hepatocellular carcinoma in a Chinese population: a prospective, phase 2 study
Article Category: Research Article
Published Online: Jul 26, 2023
Page range: 405 - 410
Received: Feb 16, 2023
Accepted: Jun 15, 2023
DOI: https://doi.org/10.2478/raon-2023-0036
Keywords
© 2023 Mafei Kang et al., published by Sciendo
This work is licensed under the Creative Commons Attribution 4.0 International License.
Background
The aim of the study was to observe the safety and efficacy of anlotinib (ANL) alone or combined with S-1 in the first-line treatment of advanced hepatocellular carcinoma (HCC).
Patients and methods
Fifty-four patients with untreated advanced HCC who could not be resected were randomly divided into the ANL group (n = 27) and ANL+S-1 group (n = 27). The ANL group was given 10 mg ANL orally once a day for 14 consecutive days, stopped for 1 week, and repeated every 21 days. The ANL+S-1 group was given 10 mg ANL once a day orally and 40 mg S-1 twice a day orally for 14 consecutive days, stopped for 1 week, repeated every 21 days. All patients were treated until the disease progressed or toxicity became unacceptable. For patients who could not tolerate adverse reactions, the ANL dose should be reduced to 8 mg per day. CT or MRI was reviewed every 6 weeks to evaluate the efficacy.
Results
A total of 44 patients were included in the results analysis, including 22 patients in the ANL group and 22 patients in the ANL+S-1 group. In the ANL group, the objective response rate (ORR) was 4.5% (1/22), the disease control rate (DCR) was 77.3% (17/22), the median progression-free survival (PFS) was 4.2 months (95% CI: 3.6–6.0) and the median overall survival (mOS) was 7.0 months (95% CI: 6.3–9.0). In the ANL+S-1 group, the ORR was 18.2% (4/22), the DCR was 59.1% (13/22), the median PFS was 4.0 months (95% CI: 3.6–5.4) and the mOS was 6.0 months (95% CI: 5.5–7.4). There was no significant difference in ORR (
Conclusions
ANL monotherapy was effective in the treatment of advanced HCC, and adverse reactions have been able to tolerated.