The Efficacy and Safety of Anlotinib in Neoadjuvant Treatment of Locally Advanced Thyroid Cancer: A Single-Arm Phase II Clinical Trial

Huang, Naisi; Wei, Wenjun; Xiang, Jun; Chen, Jiaying; Guan, Qing; Lu, Zhongxin; Ma, Ben; Sun, Guohua; Wang, Yulong; Ji, Qinghai; Wang, Yu

doi:10.1089/thy.2021.0307

Cited by 37 publications

(26 citation statements)

References 28 publications

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“…Previous phase II clinical studies have confirmed the efficacy and safety of apatinib monotherapy in patients with metastatic triple-negative breast cancer ( 17 ). As a novel oral TKI, which can effectively inhibit vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor (PDGFR), fibroblast growth factor receptor (FGFR) and c-Kit, anlotinib has proven efficacy in many solid tumors ( 18 – 20 ). The present study was conducted to evaluate the efficacy and safety of anlotinib as third-line or above therapy for patients with HER-2 negative metastatic breast cancer based on real-world clinical practice.…”

Section: Introductionmentioning

confidence: 99%

A real-world study of anlotinib as third-line or above therapy in patients with her-2 negative metastatic breast cancer

Shao

Luo²,

Yu³

et al. 2022

Front. Oncol.

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BackgroundAntiangiogenic agents provides an optional treatment strategy for patients with metastatic breast cancer. The present study was conducted to evaluate the efficacy and safety of anlotinib as third-line or above therapy for patients with HER-2 negative metastatic breast cancer.MethodsPatients with HER-2 negative metastatic breast cancer who have failed from prior therapy and treated with anlotinib monotherapy or combined with chemotherapy or immunotherapy from June 2018 to December 2020 were retrospectively analyzed based on real-world clinical practice. The primary end point was progression free survival (PFS). Secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety.Results47 patients with HER-2 negative metastatic breast cancer received anlotinib monotherapy or combination therapy as third-line or above therapy. In the general population, 10 patients achieved PR, 25 patients had SD and 12 patients had PD. The overall ORR and DCR were 21.3% and 74.5%, respectively. Subgroup analysis suggested that there were no statistically significant differences in ORR and DCR with respect to HR status (positive vs. negative), treatment programs (monotherapy vs. combination) and treatment type in combination group (chemotherapy vs. immunotherapy). The patients who did not received previously anti-angiogenesis therapy had superior DCR (84.8% vs. 50.0%, P=0.012). Median PFS and OS were 5.0 months (95% CI=4.3-5.7) and 21.0 (95% CI=14.9-27.1) months, respectively. The PFS (6.5m vs. 3.5m, P=0.042)and OS (28.2m vs. 12.6m, P=0.040) were better in HR positive patients than HR negative patients. And simultaneously, patients who received anlotinib combination therapy obtained better PFS (5.5m vs. 3.0m, P=0.045). The incidence of Grade 3-4 adverse events(AEs) was 31.9%.ConclusionsAnlotinib monotherapy or combination therapy provide a viable third-line or above therapeutic strategy in patients with HER-2 negative metastatic breast cancer, a median PFS of 5.0 months was obtained with well tolerated toxicity.

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Section: Introductionmentioning

confidence: 99%

A real-world study of anlotinib as third-line or above therapy in patients with her-2 negative metastatic breast cancer

Shao

Luo²,

Yu³

et al. 2022

Front. Oncol.

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“…All AEs were managed in an effective and timely manner by provision of supportive care. Further, AEs associated with anlotinib administration, especially of a haemorrhagic nature, had more favorable outcomes than expected [9][10][11], and most of these were evaluated to be of grade 1-2. These findings might be accounted for partially by the fact that patients with haemorrhagic symptoms, including haemoptysis and positivity of occult blood or those at the risk of haemorrha ge as seen by the invasion of great vessels and identification of cavity were excluded from the study.…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of anlotinib in combination with standard chemotherapy as first-line treatment for extensive-stage small cell lung cancer: A multi-center, prospective study (ACTION-2)

Zhang¹,

Deng²,

Kong³

et al. 2022

Lung Cancer

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“…Several reports have suggested that plasma concentrations are more predictive than the administered dose in predicting treatment response (Solassol et al, 2019;Yu et al, 2014). In addition, anlotinib has a high plasma protein binding rate, a long elimination half-life, and significant drug accumulation in the body after long-term continuous use, which may be one of the factors leading to adverse reactions (Han et al, 2018;Huang et al, 2021;Sun et al, 2016). Its instructions indicate that the main adverse effects in clinical experiments are hypertension (56.2%), handfoot syndrome (41.6%), gastrointestinal reaction (34.3%), proteinuria (34.9%), thyroid dysfunction (21.3%) and hyperlipemia (35.9%).…”

Section: Introductionmentioning

confidence: 99%

Establishment and validation of a LC–MS/MS method for the determination of anlotinib in human plasma: Application to therapeutic drug monitoring

Liang

Xiong

et al. 2022

Biomedical Chromatography

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Anlotinib is a novel small molecule multitarget tyrosine kinase inhibitor for the treatment of several cancers. We developed and validated a highly sensitive, rapid and stable high-performance liquid chromatography-mass spectrometrymethod for the determination of anlotinib in human plasma with anlotinib-d 5 as a stable isotopically labeled internal standard (SIL-IS). To explore the feasibility of therapeutic drug monitoring in the treatment of tumors with anlotinib, human plasma samples were prepared by protein precipitation. The mobile phases comprised of (A) 5.0 mM NH 4 AC aqueous solution containing 0.1% formic acid and (B) 100% methanol containing 0.1% formic acid. A gradient mobile phase system was adopted for chromatographic separation using a BEH C18 (2.1 Â 50 mm, 1.7 μm) column. A positive ion pattern was chosen for

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The Efficacy and Safety of Anlotinib in Neoadjuvant Treatment of Locally Advanced Thyroid Cancer: A Single-Arm Phase II Clinical Trial

Cited by 37 publications

References 28 publications

A real-world study of anlotinib as third-line or above therapy in patients with her-2 negative metastatic breast cancer

A real-world study of anlotinib as third-line or above therapy in patients with her-2 negative metastatic breast cancer

Safety and efficacy of anlotinib in combination with standard chemotherapy as first-line treatment for extensive-stage small cell lung cancer: A multi-center, prospective study (ACTION-2)

Establishment and validation of a LC–MS/MS method for the determination of anlotinib in human plasma: Application to therapeutic drug monitoring

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