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Anlotinib in the treatment of advanced hepatocellular carcinoma: an open-label phase II study (ALTER-0802 study)

PURPOSE: This study aimed to assess efficacy and safety of anlotinib as a first- or second-line treatment for advanced or metastatic hepatocellular carcinoma (aHCC) and to identify the predictive plasma cytokines on efficacy of anlotinib. METHODS: It was a phase II clinical study. Patients with aHCC...

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Autores principales: Sun, Yongkun, Zhou, Aiping, Zhang, Wen, Jiang, Zhichao, Chen, Bo, Zhao, Jianjun, Li, Zhiyu, Wang, Liming, Bi, Xinyu, Zhao, Hong, Liu, Kan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer India 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8286948/
https://www.ncbi.nlm.nih.gov/pubmed/33826043
http://dx.doi.org/10.1007/s12072-021-10171-0
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author Sun, Yongkun
Zhou, Aiping
Zhang, Wen
Jiang, Zhichao
Chen, Bo
Zhao, Jianjun
Li, Zhiyu
Wang, Liming
Bi, Xinyu
Zhao, Hong
Liu, Kan
author_facet Sun, Yongkun
Zhou, Aiping
Zhang, Wen
Jiang, Zhichao
Chen, Bo
Zhao, Jianjun
Li, Zhiyu
Wang, Liming
Bi, Xinyu
Zhao, Hong
Liu, Kan
author_sort Sun, Yongkun
collection PubMed
description PURPOSE: This study aimed to assess efficacy and safety of anlotinib as a first- or second-line treatment for advanced or metastatic hepatocellular carcinoma (aHCC) and to identify the predictive plasma cytokines on efficacy of anlotinib. METHODS: It was a phase II clinical study. Patients with aHCC were recruited from October 2016 to April 2019 and divided into two cohorts according to previous tyrosine kinase inhibitors (TKIs) therapy. Those without or with prior TKIs were in Cohort 1 or 2, respectively. All patients took anlotinib (12 mg/day, Day1–14, 3 weeks per cycle). The primary endpoint was 12-week progression-free survival (PFS) rate. Relationship between the series plasma cytokine level and the efficacy of anlotinib was analyzed. RESULTS: Enrolled 26 patients in Cohort 1 and 24 in Cohort 2. In Cohort 1, the 12-week PFS rate was 80.8% [95% confidence interval (CI); 59.8%–91.5%] and median time to progression (TTP) was 5.9 months (95% CI 4.8–6.9). In Cohort 2, the 12-week PFS rate and median TTP was 72.5% (95% CI 48.7%–86.6%) and 4.6 months (95% CI 2.7–10.0), respectively. The median TTP on patients with a baseline plasma level of CXCL1 (C-X-C motif chemokine ligand 1) less than 7.6 ng/μl was significantly longer in both cohorts. The most common grade 3–5 adverse events were hypertension (8%), diarrhea (8%) and hand-foot syndrome (6%). CONCLUSION: Anlotinib showed promising efficacy and safety as a first- or second-line treatment with a continuous TKIs treatment strategy in aHCC. The plasma CXCL1 might be a predictor for the efficacy of anlotinib. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12072-021-10171-0.
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spelling pubmed-82869482021-07-20 Anlotinib in the treatment of advanced hepatocellular carcinoma: an open-label phase II study (ALTER-0802 study) Sun, Yongkun Zhou, Aiping Zhang, Wen Jiang, Zhichao Chen, Bo Zhao, Jianjun Li, Zhiyu Wang, Liming Bi, Xinyu Zhao, Hong Liu, Kan Hepatol Int Original Article PURPOSE: This study aimed to assess efficacy and safety of anlotinib as a first- or second-line treatment for advanced or metastatic hepatocellular carcinoma (aHCC) and to identify the predictive plasma cytokines on efficacy of anlotinib. METHODS: It was a phase II clinical study. Patients with aHCC were recruited from October 2016 to April 2019 and divided into two cohorts according to previous tyrosine kinase inhibitors (TKIs) therapy. Those without or with prior TKIs were in Cohort 1 or 2, respectively. All patients took anlotinib (12 mg/day, Day1–14, 3 weeks per cycle). The primary endpoint was 12-week progression-free survival (PFS) rate. Relationship between the series plasma cytokine level and the efficacy of anlotinib was analyzed. RESULTS: Enrolled 26 patients in Cohort 1 and 24 in Cohort 2. In Cohort 1, the 12-week PFS rate was 80.8% [95% confidence interval (CI); 59.8%–91.5%] and median time to progression (TTP) was 5.9 months (95% CI 4.8–6.9). In Cohort 2, the 12-week PFS rate and median TTP was 72.5% (95% CI 48.7%–86.6%) and 4.6 months (95% CI 2.7–10.0), respectively. The median TTP on patients with a baseline plasma level of CXCL1 (C-X-C motif chemokine ligand 1) less than 7.6 ng/μl was significantly longer in both cohorts. The most common grade 3–5 adverse events were hypertension (8%), diarrhea (8%) and hand-foot syndrome (6%). CONCLUSION: Anlotinib showed promising efficacy and safety as a first- or second-line treatment with a continuous TKIs treatment strategy in aHCC. The plasma CXCL1 might be a predictor for the efficacy of anlotinib. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12072-021-10171-0. Springer India 2021-04-07 /pmc/articles/PMC8286948/ /pubmed/33826043 http://dx.doi.org/10.1007/s12072-021-10171-0 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Article
Sun, Yongkun
Zhou, Aiping
Zhang, Wen
Jiang, Zhichao
Chen, Bo
Zhao, Jianjun
Li, Zhiyu
Wang, Liming
Bi, Xinyu
Zhao, Hong
Liu, Kan
Anlotinib in the treatment of advanced hepatocellular carcinoma: an open-label phase II study (ALTER-0802 study)
title Anlotinib in the treatment of advanced hepatocellular carcinoma: an open-label phase II study (ALTER-0802 study)
title_full Anlotinib in the treatment of advanced hepatocellular carcinoma: an open-label phase II study (ALTER-0802 study)
title_fullStr Anlotinib in the treatment of advanced hepatocellular carcinoma: an open-label phase II study (ALTER-0802 study)
title_full_unstemmed Anlotinib in the treatment of advanced hepatocellular carcinoma: an open-label phase II study (ALTER-0802 study)
title_short Anlotinib in the treatment of advanced hepatocellular carcinoma: an open-label phase II study (ALTER-0802 study)
title_sort anlotinib in the treatment of advanced hepatocellular carcinoma: an open-label phase ii study (alter-0802 study)
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8286948/
https://www.ncbi.nlm.nih.gov/pubmed/33826043
http://dx.doi.org/10.1007/s12072-021-10171-0
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