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Phase II trial of VEGFR2 inhibitor apatinib for metastatic sarcoma: focus on efficacy and safety
Zhichao Liao,Feng Li,Chao Zhang,Lei Zhu,Yehui Shi,Gang Zhao,Xu Bai,Shafat Hassan,Xinyue Liu,Ting Li,Peipei Xing,Jun Zhao,Jin Zhang,Ruwei Xing,Sheng Teng,Yun Yang,Kexin Chen,Jilong Yang 생화학분자생물학회 2019 Experimental and molecular medicine Vol.51 No.-
Apatinib (YN968D1) is a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2 (VEGFR- 2). We conducted a single-arm, nonrandomized phase II study (NCT03121846) to assess the efficacy and safety of apatinib in patients with stage IV sarcoma. We recruited 64 patients with stage IV sarcoma who had failed chemotherapy. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were progression-free survival rate (PFR), objective response rate (ORR), and disease control rate (DCR) at week 12. Treatment-related adverse effects (AEs) were evaluated. Fifty-nine patients were assessed for efficacy and 64 patients for AEs. The median PFS was 7.93 months. At 12 weeks, the PFR was 74%, the ORR was 16.95% (10/59), and the DCR was 86.44% (51/59). The final ORR was 15.25% (9/59) and the DCR was 57.63% (34/59). Notably, 22 patients (34.38%) who developed hypertension, hand-foot-skin reaction, or proteinuria had significantly longer OS than those without these AEs (18.20 vs. 10.73 months; P = 0.002). We conclude that apatinib is effective and well tolerated in patients with advanced sarcoma. The development of hypertension, hand-foot-skin reaction, or proteinuria may indicate a favorable prognosis, representing a novel finding in sarcoma patients.
Zhichao Xing,Yuxuan Qiu,Jingqiang Zhu,Anping Su,Wenshuang Wu 대한초음파의학회 2023 ULTRASONOGRAPHY Vol.42 No.4
Purpose: Ultrasound (US) risk stratification systems (RSSs) are increasingly being utilized for the optimal management of thyroid nodules, including those with indeterminate cytology. The goal of this study was to evaluate the category-based diagnostic performance of US RSSs in identifying malignancy in indeterminate nodules. Methods: This systematic review and meta-analysis was registered on PROSPERO (CRD42021266195). PubMed, EMBASE, and Web of Science were searched through December 1, 2022. Original articles reporting data on the performance of US RSSs for indeterminate nodules were included. The numbers of nodules classified as true negative, true positive, false negative, and false positive were extracted. Results: Thirty-three studies evaluating 7,225 indeterminate thyroid nodules were included. The diagnostic accuracy was quantitatively synthesized using a Bayesian bivariate model based on the integrated nested Laplace approximation in R. For the intermediate- to high-risk category, the sensitivity levels of the American College of Radiology, the American Thyroid Association, the European Thyroid Association, the Korean Thyroid Association/Korean Society of Thyroid Radiology, and Kwak et al. were found to be 0.80, 0.72, 0.76, 0.96, and 0.97, respectively. The corresponding specificity measurements were 0.36, 0.50, 0.49, 0.28, and 0.17. Furthermore, for the high-risk category, the sensitivity values were 0.40, 0.46, 0.55, 0.47, and 0.10, while the specificity levels were 0.91, 0.90, 0.71, 0.91, and 0.99, respectively. Conclusion: The overall diagnostic performance of the US RSSs was moderate in the differentiation of indeterminate nodules.
Yuxuan Qiu,Zhichao Xing,Qianru Yang,Yan Luo 대한초음파의학회 2022 ULTRASONOGRAPHY Vol.41 No.2
Purpose: This study aimed to assess the diagnostic performance of supersonic impulse (SSI) elastography in differentiating malignant and benign cervical lymph nodes.Methods: The Medline, Embase, and Cochrane Central databases were searched until December 1, 2020. Two different reviewers checked the studies and extracted the data. The diagnostic yields were quantitatively synthesized using a Bayesian bivariate model with an integrated nested Laplace approximation in R.Results: In total, 590 patients with 892 cervical lymph nodes who underwent SSI elastography were included. The total prevalence of malignancy was 33.7% (301/892), and the four elastic modulus values (mean, maximum, minimum, and standard deviation) were significantly different between malignant and benign lymph nodes. For the mean elastic modulus, the summary estimates for sensitivity and specificity were 0.720 (95% credible interval [CrI], 0.592 to 0.824) and 0.877 (95% CrI, 0.727 to 0.969), respectively. The estimated area under the curve (AUC) was 0.845 (95% CrI, 0.672 to 0.914). For the maximum elastic modulus, the sensitivity and specificity were estimated to be 0.809 (95% CrI, 0.698 to 0.899) and 0.816 (95% CrI, 0.643 to 0.924), respectively. The estimated AUC was 0.834 (95% CrI, 0.579 to 0.938). The minimum and standard deviation of the elastic modulus and the outcomes of the positive and negative likelihood ratio, diagnostic odds ratio, and risk difference were also calculated.Conclusion: SSI elastography is an acceptable imaging technique for diagnosing malignant cervical lymph nodes, and it can play a complementary role today. Both maximum and mean elastic modulus values should be taken into consideration to make a clinical judgment.