Apatinib, a novel VEGFR-2 tyrosine kinase inhibitor, for relapsed and refractory nasopharyngeal carcinoma: data from an open-label, single-arm, exploratory study

Li, Ling; Kong, Fei; Zhang, Lei; Li, Xin; Fu, Xiaorui; Wang, Xinhua; Wu, Jingjing; Zhang, Fangwen; Ren, Liangliang; Zhang, Mingzhi

doi:10.1007/s10637-020-00925-2

Cited by 30 publications

(24 citation statements)

References 31 publications

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“…As second-line and above treatment, the mOS of single-agent apatinib in nasopharyngeal carcinoma was 6.5 months, and no mPFS was obtained. The mOS of our study was much lower than the other study 19 . We compared patient baselines and treatment modalities with this study.…”

Section: Discussioncontrasting

confidence: 87%

“…Apatinib combined with carrelizumab in the treatment of advanced osteosarcoma, triple-negative breast cancer, advanced cervical cancer, advanced esophageal squamous cell carcinoma, and extensive-stage small cell lung cancer have obtained very good curative effects with acceptable safety 14 – 18 . In a previously published clinical study on the efficacy and safety of single-agent apatinib for relapsed/metastatic nasopharyngeal carcinoma that had failed previous chemotherapy, the median OS and PFS were 16 (95% confidence interval [CI], 9.3–22.7) and 9 months (95% CI 5.2–12.8), respectively 19 . This is the valuable clinical data regarding apatinib in the treatment of recurrent/metastatic head and neck malignancies so far, but comprehensive clinical data are still lacking.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of apatinib in patients with recurrent or metastatic head and neck squamous cell carcinoma: a retrospective multi-center study

Liu

Zheng

Dong

et al. 2022

Sci Rep

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Apatinib is a novel antiangiogenic agent that targets vascular endothelial growth factor 2. The aim of our study was to explore the efficacy and safety of apatinib in the treatment of patients with recurrence or metastasis (R/M) inoperable head and neck squamous cell carcinoma (HNSCC). This multi-center retrospective study analyzed 53 cases of recurrent or metastatic inoperable HNSCC who had progressed or recurred after undergoing standard radiotherapy, chemotherapy, and immunotherapy treated with apatinib from March 2017 to August 2021. Patients continued apatinib until the time of disease progression or onset of intolerable adverse events. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS), objective response rate (ORR), and disease control rate (DCR) and incidence of adverse events. Univariable and multivariable analyses were performed to determine prognostic factors. The main adverse events were counted, and the severity of the adverse reactions was evaluated. Fifty-three patients with recurrent or metastatic inoperable R/M HNSCC who had progressed or recurred after standard radiotherapy, chemotherapy, and immunotherapy were included. The ORR was 15.1%, and the DCR was 86.8%. The median PFS was 4.4 months (95% confidence interval [CI] 3.7–5.0 months) and the median OS was 6.6 months (95% CI 5.3–7.9 months). The number of apatinib lines was an influencing factor for both PFS and OS, and the Eastern Cooperative Oncology Group (ECOG) score, tumor differentiation, and apatinib duration were only the influencing factors for OS. Of these, only the ECOG score was an independent predictor of OS. The most common adverse reactions were hypertension (39.6%), hand-foot syndrome (32.1%), fatigue (32.1%), oral ulcers (28.3%), and nausea and vomiting (20.8%). Most adverse reactions were grade 1 or 2. Apatinib mesylate has good efficacy for recurrent/metastatic inoperable HNSCC as second-line and above-line treatment. ECOG score was an independent prognostic factors of OS in patients who were treated with apatinib. In addition, the adverse effects of apatinib mesylate were relatively mild.

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Section: Discussioncontrasting

confidence: 87%

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of apatinib in patients with recurrent or metastatic head and neck squamous cell carcinoma: a retrospective multi-center study

Liu

Zheng

Dong

et al. 2022

Sci Rep

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“…Previous studies have shown that the apatinib can inhibit the growth of nasopharyngeal carcinoma xenografts [ 22 ]. There is also a retrospective study, which shows that apatinib has good efficacy and safety in patients with recurrent and refractory nasopharyngeal carcinoma [ 23 ]. However, there is a lack of clinical control studies on the apatinib in the treatment of nasopharyngeal carcinoma.…”

Section: Discussionmentioning

confidence: 99%

Clinical Effect of Apatinib Mesylate Tablets Combined with Paclitaxel Concurrent Radiotherapy and Chemotherapy in the First-Line Treatment of Locally Advanced Nasopharyngeal Carcinoma

Zhan

Chen

Yang

et al. 2022

Emergency Medicine International

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Objective. To explore the clinical efficacy and safety of apatinib combined with paclitaxel in the first-line treatment of locally advanced nasopharyngeal carcinoma. Methods. From March 2016 to June 2018, 114 patients with locally advanced nasopharyngeal carcinoma who received first-line treatment in our hospital were selected as the patient group, and those who received apatinib combined with paclitaxel concurrent radiotherapy and chemotherapy were selected as the research group (n = 54), while those who received paclitaxel concurrent radiotherapy and chemotherapy were selected as the control group (n = 60). Sixty healthy individuals in our hospital were recruited in the same period as the healthy group. The clinical effective rate, adverse reactions, 2-year overall survival rate (OS), 2-year progression-free survival rate (PFS), and quality of life were compared between the two groups, and the expression of miR-655 in the serum of each group was tested by RT-qPCR. Results. The total clinical effective rate of the research group was higher than that of the control group, and the 2-year OS and PFS of the research group were also higher than those of the control group ( P < 0.05 ). Both groups of patients could tolerate the treatment, but the incidence of hypertension and proteinuria in the research group was higher than that in the control group ( P < 0.05 ). The expression of miR-655 in the serum of patients was lower than that of the healthy group ( P < 0.05 ). After treatment, miR-655 in serum increased in both the groups and miR-655 in the research group was higher than that in the control group ( P < 0.05 ). The 2-year survival rate of OS and PFS in patients with low expression of miR-655 was significantly lower than that in patients with high expression of miR-655 ( P < 0.05 ). Conclusion. Apatinib combined with paclitaxel concurrent radiotherapy and chemotherapy is effective and well-tolerated in the treatment of locally advanced nasopharyngeal carcinoma, which improves the quality of life of patients and can be popularized in clinical practice. In addition, the increase of miR-655 may be a target for treating nasopharyngeal carcinoma.

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“…The results demonstrated an ORR of 31.4% (16/51), with a median PFS of 9 months and OS of 16 months. 8 A phase II study also investigated the treatment efficacy of pazopanib in 33 patients with NPC. The ORR was 6.1% and the DCR was 54.5% at 3 months.…”

Section: Assessment Analysis and Discussionmentioning

confidence: 99%

A Phase Ib Study of Lucitanib (AL3810) in a Cohort of Patients with Recurrent and Metastatic Nasopharyngeal Carcinoma

Zhang

Luo

et al. 2022

The Oncologist

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Background Lucitanib is a novel multi-target inhibitor of FGFR1-3, VEGFR 1-3, and PDGFR α/β. Here, we evaluated the safety, tolerability, and preliminary efficacy of lucitanib in recurrent and metastatic nasopharyngeal carcinoma (RM-NPC). Methods Patients with pretreated RM-NPC were randomly divided into two treatment arms: continuous or intermittent treatment. The primary endpoint was safety and tolerability. Secondary endpoints were objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS). Results One hundred percent of patients in the continuous arm and 90% of patients in the intermittent arm had at least one treatment-related AE (TRAE). Grade ≥3 related TRAEs occurred in 5 patients in the continuous arm (5/10, 50%). No TRAEs grade >3 occurred in the intermittent arm. The ORR and DCR of the continuous arm was 20% and 90%, and the intermittent arm was 10% and 60%, respectively. All responses were observed by the first evaluation. The duration of response was more than 1 year, with two patients still on treatment with sustained response at more than 3 years. Conclusion Lucitanib has promising clinical activity and tolerable safety profile in heavily pretreated patients with NPC. Patients who responded to lucitanib treatment generally achieved a long DoR. Lucitanib is now being evaluated in phase II/III studies. ClinicalTrials.gov identifier NCT03260179

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Apatinib, a novel VEGFR-2 tyrosine kinase inhibitor, for relapsed and refractory nasopharyngeal carcinoma: data from an open-label, single-arm, exploratory study

Cited by 30 publications

References 31 publications

Efficacy and safety of apatinib in patients with recurrent or metastatic head and neck squamous cell carcinoma: a retrospective multi-center study

Efficacy and safety of apatinib in patients with recurrent or metastatic head and neck squamous cell carcinoma: a retrospective multi-center study

Clinical Effect of Apatinib Mesylate Tablets Combined with Paclitaxel Concurrent Radiotherapy and Chemotherapy in the First-Line Treatment of Locally Advanced Nasopharyngeal Carcinoma

A Phase Ib Study of Lucitanib (AL3810) in a Cohort of Patients with Recurrent and Metastatic Nasopharyngeal Carcinoma

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