<abstract xmlns="http://www.w3.org/1999/xhtml">

<sec><h3>Background</h3>
<p>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).</p>
</sec>
<sec><h3>Patients and methods</h3>
<p>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.</p>
</sec>
<sec><h3>Results</h3>
<p>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 (<italic>p</italic> = 0.345) or DCR (<italic>p</italic> = 0.195) between the two groups. Adverse reactions were mainly hypertension, anorexia, fatigue, liver transaminase heightened and hand and foot skin reaction.</p>
</sec>
<sec><h3>Conclusions</h3>
<p>ANL monotherapy was effective in the treatment of advanced HCC, and adverse reactions have been able to tolerated.</p>
</sec>
</abstract>

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 (p = 0.345) or DCR (p = 0.195) between the two groups. Adverse reactions were mainly hypertension, anorexia, fatigue, liver transaminase heightened and hand and foot skin reaction.

Conclusions
ANL monotherapy was effective in the treatment of advanced HCC, and adverse reactions have been able to tolerated.

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

Affiliated Hospital of Guilin Medical University

Radiology and Oncology

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...

Adverse reactions	Group ANL (n=22)				Group ANL+S-1 (n=22)				x²	P

	Any level	1	2	3/4	Any level	1	2	3/4
Hypertension	11(50.0%)	7	2	2	12(54.5%)	6	3	3	0.910	0.763
Anorexia	5(22.7%)	4	1	0	8(36.4%)	5	3	0	0.983	0.322
Fatigue	16(72.7%)	14	2	0	18(81.8%)	16	2	0	0.518	0.472
Hand-foot-skin reaction	5(22.7%)	3	1	1	7(31.8%)	4	3	0	0.458	0.498
Leucopenia	3(13.6%)	2	1	0	4(18.2%)	3	1	0	0.170	0.680
Bleeding	1(4.5%)	0	1	0	0(0.0%)	0	0	0	0.410	0.235
ALT abnormal	6(27.3%)	6	0	0	8(36.4%)	7	1	0	0.419	0.517
Oral mucositis	3(13.6%)	1	2	0	5(22.7%)	3	2	0	0.617	0.432
Hypothyroidism	6(27.3%)	4	2	0	6(27.3%)	5	1	0	0.000	1.000
Diarrhea	1(4.5%)	0	0	1	2(9.1%)	1	1	0	0.364	0.546

	Group ANL n=27	Group ANL+S-1 n=27	x²	P
Gender n %
Male	23(85.2)	22(81.5)	0.133	0.715
Female	4(14.8)	5(18.5)
Age median	54	56
ECOG PS n %			0.912	0.340
1	8(29.6)	5(18.5)
2	19(70.4)	22(81.5)
Child-Pugh, n %			0.078	0.780
A grade	10(37.0)	11(40.7)
B grade ≤ 7	17(63.0)	16(59.3)
Stages (BCLC), n %
C	27(100.0)	27(100.0)
AFP n %			0.318	0.573
AFP ≥ 400 ng/mL	16(59.3)	18(66.7)
AFP < 400 ng/mL	11(40.7)	9(33.3)
HBV DNA n %			1.421	0.233
≥ 1.0 × 10³ IU/mL	6(22.2)	10(37.0)
< 1.0 × 10³ IU/mL	21(77.8)	17(63.0)
PVTT n %			0.092	0.761
PV1–3	18(66.7)	16(59.3)
PV4	2(7.4)	3(11.1)
EHS n %	9(33.3)	7(25.9)	0.355	0.551

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
hepatocellular carcinoma (HCC), anlotinib, S-1, molecule targeted therapy, chemotherapy

© 2023 Mafei Kang et al., published by Sciendo

This work is licensed under the Creative Commons Attribution 4.0 International License.

FIGURE 1.

FIGURE 2.

Incidence and grade of major adverse reactions in the ANL group and ANL+ S-1 group

Baseline characteristics of the ANL group and ANL+S-1 group were compared

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

Keywordshepatocellular carcinoma (HCC), anlotinib, S-1, molecule targeted therapy, chemotherapy

© 2023 Mafei Kang et al., published by Sciendo

This work is licensed under the Creative Commons Attribution 4.0 International License.

FIGURE 1.

FIGURE 2.

Incidence and grade of major adverse reactions in the ANL group and ANL+ S-1 group

Baseline characteristics of the ANL group and ANL+S-1 group were compared

Keywords
hepatocellular carcinoma (HCC), anlotinib, S-1, molecule targeted therapy, chemotherapy