1.Taiwanese Female Vegetarians Have Lower Lipoprotein-Associated Phospholipase A2 Compared with Omnivores.
Chih Wei CHEN ; Chih Ta LIN ; Ying Lung LIN ; Tin Kwang LIN ; Chin Lon LIN
Yonsei Medical Journal 2011;52(1):13-19
PURPOSE: Many studies supported that vegetarians have a lower risk of cardiac diseases and mortality, partly due to better blood pressure and serum cholesterol profiles. However, the inflammatory markers, especially lipoprotein-associated phospholipase A2 (Lp-PLA2), have not been well-studied. This study aimed to compare inflammatory markers and conventional risk factors between vegetarians and omnivores. MATERIALS AND METHODS: One hundred and seventy-three vegetarians and 190 omnivores were studied. Fasting blood samples were obtained to compare levels of glucose, total cholesterol, triacylglycerol, high density lipoprotein (HDL) and low density lipoprotein (LDL) cholesterol, homocysteine, Lp-PLA2 activity, and high-sensitivity C-reactive protein (hs-CRP). RESULTS: Vegetarians had higher serum levels of the following markers: hs-CRP (1.8 +/- 3.4 vs. 1.2 1.8 mg/L, respectively; p = 0.05), homocysteine (9.39 +/- 3.22 vs. 7.62 +/- 2.41 micromol/L, respectively; p < 0.01), and triacylglycerol (96.91 +/- 59.56 vs. 84.66 +/- 43.24 mg/dL, respectively; p < 0.05). Vegetarians also had lower levels of Lp-PLA2 (18.32 +/- 7.19 10-3 micromol/min/mL vs. 20.22 8.13 10-3 micromol/min/mL; p < 0.05), total cholesterol (180.62 +/- 36.55 mg/dL vs. 192.73 +/- 36.57 mg/dL; p < 0.01), LDL cholesterol (118.15 +/- 32.8 vs. 126.41 +/- 34.28 mg/dL; p < 0.05), and HDL cholesterol (55.59 +/- 13.30 vs. 62.09 +/- 14.52 mg/dL, p < 0.01). Multivariate analyses demonstrated that a vegetarian diet increases the chances for high serum hs-CRP and low Lp-PLA2 activity. CONCLUSION: In addition to lower total cholesterol, LDL-cholesterol, and HDL-cholesterol, Taiwanese female vegetarians have lower serum Lp-PLA2 activity but higher levels of hs-CRP, homocysteine, and triacylglyerol. It might be due to geographic differences of vegetarian diets, and further studies are needed.
1-Alkyl-2-acetylglycerophosphocholine Esterase/*blood
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Adult
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Asian Continental Ancestry Group
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C-Reactive Protein/metabolism
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Cholesterol/blood
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Cholesterol, HDL/blood
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Cholesterol, LDL/blood
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*Diet, Vegetarian
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Female
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Homocysteine/blood
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Humans
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Middle Aged
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Multivariate Analysis
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Risk Factors
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Taiwan
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Triglycerides/blood
2.Gemcitabine and cisplatin treatment over a 3-week versus a 4-week dosing schedule: a randomized trial conducted in Chinese patients with nonsmall cell lung cancer.
Mei-lin LIAO ; Yun-zhong ZHU ; Long-yun LI ; Huan-ying WAN ; Shi-ying YU ; Belinda HALL ; Teena WEST ; Li WANG
Chinese Medical Journal 2008;121(10):892-897
BACKGROUNDGemcitabine plus cisplatin is a standard treatment for stages IIIB and IV nonsmall cell lung cancer (NSCLC). This randomized phase II study evaluated a 3-week versus a 4-week schedule of gemcitabine-cisplatin as first line treatment for Chinese patients with advanced NSCLC.
METHODSPatients were randomized to receive cisplatin 75 mg/m(2) on day 1 plus either gemcitabine 1250 mg/m(2) on days 1 and 8 of a 21-day cycle (3-week group) or gemcitabine 1000 mg/m(2) on days 1, 8 and 15 of a 28-day cycle (4-week group).
RESULTSOne hundred patients were enrolled in this study. The response rate was 24% (12/51 patients) in the 3-week group and 27% (13/49 patients) in the 4-week group. There were no statistically significant differences between the two treatment groups in survival (hazard ratio: 1.19; 95% CI: 0.68 - 2.09) with a median survival of 12.1 months and 13.8 months in the 3-week group and the 4-week group respectively. The rate of grade 3/4 toxicity in the 3-week group was 55% compared with 86% in the 4-week group (P = 0.001). The difference in the incidence of grade 3/4 haematological toxicities did not reach statistical significance (3-week: 37%, 4-week: 57%), however grade 3/4 drug related neutropenia (3-week: 27%, 4-week: 51%) and thrombocytopenia (3-week: 8%, 4-week: 31%) were significantly lower in the 3-week group. Grade 3/4 nonhaematological toxicities were less in the 3-week group (33% cf 63%; P = 0.005).
CONCLUSIONSThe differences in the efficacy endpoints were all in favour of the 4-week schedule of gemcitabine plus cisplatin, however these differences did not reach statistical significance. Fewer grade 3/4 toxicities were observed in the 3-week group compared with the 4-week group.
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Asian Continental Ancestry Group ; statistics & numerical data ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; ethnology ; China ; Cisplatin ; administration & dosage ; Deoxycytidine ; administration & dosage ; analogs & derivatives ; Drug Administration Schedule ; Female ; Humans ; Lung Neoplasms ; drug therapy ; ethnology ; Male ; Middle Aged ; Treatment Outcome
3.Expressions of E-cadherin in non-small cell lung cancer and it correlation with prognosis.
Gui-bin QIAO ; Yi-long WU ; Wei OU ; Xue-ning YANG ; Wen-zhao ZHONG ; Jia-ying LIN ; Jian ZHAO ; Dan XIE ; Xin-yuan GUAN
Chinese Journal of Surgery 2005;43(14):913-917
OBJECTIVEThis study was to clarify E-cadherin expressions in non-small cell lung cancer (NSCLC) and its correlation with patients' prognosis.
METHODSTissue microarrays (TMAs) containing specimens from 365 different NSCLC were constructed, covering all stages and almost all histological types of this disease. Slides were immunohistochemically stained with antibodies against E-cadherin. Expression pattern of the protein was analyzed with relation to the clinicopathological. Correlations of the results with patients' overall survival were also examined.
RESULTSImmunohistochemical staining revealed that E-cadherin protein was localized mainly on membranes and the cytoplasm of NSCLC tumors cells. Reduced E-cadherin expression was evident in 32.1%. Reduced E-cadherin expression significantly correlated with lymph nodes metastasis (chi(2) = 16.430, P = 0.001), histological dedifferentiation (chi(2) = 9.243, P = 0.010) and advanced clinical stage (chi(2) = 9.421, P = 0.024). There was no significant difference in E-cadherin expression between squamous cell carcinoma and adenocarcinoma. E-cadherin reduced expression correlated with a poor prognosis (P < 0.0001) in univariate analysis. Multivariate analysis showed a significantly lower survival probability for patients with reduced E-cadherin (P < 0.001), and E-cadherin was an independent prognostic factor for survival of NSCLC patients.
CONCLUSIONSIt suggests that dysfunction of E-cadherin has an important impact in the progression of lung cancer. As an independent prognostic factor, expression of E-cadherin can predict outcome of different group, together with conventional prognostic factors, and subsequently make appropriate management.
Adult ; Aged ; Aged, 80 and over ; Cadherins ; biosynthesis ; Carcinoma, Non-Small-Cell Lung ; metabolism ; mortality ; secondary ; Female ; Follow-Up Studies ; Humans ; Immunohistochemistry ; Lung Neoplasms ; metabolism ; mortality ; pathology ; Lymphatic Metastasis ; Male ; Middle Aged ; Neoplasm Staging ; Prognosis ; Survival Rate
4.Human vascular smooth muscle cells and endothelial cells cocultured on polyglycolic acid (70/30) scaffold in tissue engineered vascular graft.
Shao-jun WEN ; Li-min ZHAO ; Shen-guo WANG ; Jing-xing LI ; Hua-ying CHEN ; Jie-lin LIU ; Ya LIU ; Yi LUO ; Roo CHANGIZI
Chinese Medical Journal 2007;120(15):1331-1335
BACKGROUNDCurrent prosthetic, small diameter vascular grafts showing poor long term patency rates have led to the pursuit of other biological materials. Biomaterials that successfully integrate into surrounding tissue should match not only the mechanical properties of tissues, but also topography. Polyglycolic acid (70/30) has been used as synthetic grafts to determine whether human vascular smooth muscle cells and endothelial cells attach, survive and secrete endothelin and 6-keto-prostaglandin F1alpha (6-keto-PGF1alpha).
METHODSEndothelial cells and smooth muscle cells were isolated from adult human great saphenous vein. They were seeded on polyglycolic acid scaffold in vitro separately to grow vascular patch (Groups A and B respectively) and cocultured in vitro to grow into vascular patch (Group C). Smooth muscle cells and endothelial cells were identified by immunohistochemical analysis and growth of cells on polyglycolic acid was investigated using scanning electron microscopy. The levels of endothelin and 6-keto-PGF1alpha in the culturing solutions were examined by radioimmunology to measure endothelial function.
RESULTSSeed smooth muscle cells adhered to polyglycolic acid scaffold and over 28 days grew in the interstices to form a uniform cell distribution throughout the scaffold. Then seed endothelial cells formed a complete endothelial layer on the smooth muscle cells. The levels of endothelin and 6-keto-prostaglandin F1 alpha in the culturing solution were (234 +/- 29) pg/ml and (428 +/- 98) pg/ml respectively in Group C and (196 +/- 30) pg/ml and (346 +/- 120) pg/ml in Group B; both significantly higher than in Groups A and D (blank control group, all P < 0.05).
CONCLUSIONSCells could be grown successfully on polyglycolic acid and retain functions of secretion. Our next step is to use human saphenous vein smooth muscle cells and endothelial cells to grow tubular vascular grafts in vitro.
6-Ketoprostaglandin F1 alpha ; analysis ; Adult ; Blood Vessel Prosthesis ; Coculture Techniques ; Endothelial Cells ; physiology ; Humans ; Muscle, Smooth, Vascular ; cytology ; Myocytes, Smooth Muscle ; physiology ; Polyglycolic Acid ; pharmacology ; Saphenous Vein ; cytology ; Tissue Engineering
5.Expression profile of miR-501-5p in lung adenocarcinoma patients from Xuanwei area.
Shuai CHEN ; Yong-Chun ZHOU ; Ying CHEN ; Xiao-Bo CHEN ; Guang-Jian LI ; Yu-Jie LEI ; Lin-Wei TIAN ; Guang-Qiang ZHAO ; Qiubo HUANG ; Yunc-Hao HUANG
Journal of Southern Medical University 2017;37(3):354-359
OBJECTIVETo investigate the relationship between miR-501-5p expression and the clinicopathological factors in patients with lung adenocarcinoma in Xuanwei area.
METHODSSurgical specimens of lung adenocarcinoma and paired adjacent tissues from 24 patients with lung adenocarcinoma from Xuanwei area were examined for miR-501-5p expression using microRNA microarray technique and qPCR. Chi-square test was used to analyze the association of miR-501-5P expression with the clinicopathological characteristics of the patients. Multiple regression analysis was performed to analyze the association of miR-501-5p expression with the patients' gender, age, tumor stage, and preoperative CEA level.
RESULTSMicroRNA microarray analysis and qPCR validation results revealed significantly upregulated expressions of miR-501-5p in patients with lung adenocarcinoma from Xuanwei area (Plt;0.01). The microarray data showed an up-regulation of miR-501-5p by 3.17 folds in lung adenocarcinoma tissue compared with the adjacent tissue (P=0.22376, FDR=0.071395). Chi-square test indicated that miR-501-5p expression level was associated with the patients' age (f=7.168, P=0.014), TNM stage (f=36.627, P<0.01), and preoperative serum CEA level (f=30.045, Plt;0.01), but not with the patients' gender (f=3.612, P=0.071). Multiple regression analysis revealed that miR-501-5p expression was positively correlated with the patients' age, TNM stage of the tumor, and serum CEA (Plt;0.05).
CONCLUSIONmiR-501-5p expression is up-regulated in lung adenocarcinoma with significant associations with the patients' age, TNM stages and serum CEA level in patients from Xuanwei area, suggesting its potential role in the tumorigenesis and progression of lung adenocarcinoma in Xuanwei area.
6.Outcome of endovascular stent graft placement in patients with acute thoracic aortic syndromes.
Zhi-zhong LI ; Shang-dong XU ; Tong LIU ; Ying TAO ; Su WANG ; Lin-an MA ; Fang-jiong HUANG ; Yan-qing SUN ; Zhao-guang ZHANG
Chinese Journal of Cardiology 2007;35(6):555-558
OBJECTIVETo evaluate the outcome of endovascular stent graft placement in patients with acute thoracic aortic syndromes.
METHODSEmergency stent-graft implantations were performed in 57 patients with acute thoracic aortic syndromes from May 2001 to December 2005 (45 Stanford B aortic dissections, 9 acute penetrating aortic ulcers or pseudoaneurysms. 3 traumatic thoracic aneurysms). The clinical data, efficacy and follow-up results were analyzed.
RESULTSProcedures were successful in all patients. Type I endoleaks were evidenced in 5 patients and ascending aortic dissection occurred in 1 patient during operation, 5 patients with acute penetrating aortic ulcer complicating with coronary artery disease received successful PCI immediately post endovascular stent graft placement. Adynamia in extremities occurred in 1 patient and recovered two days later post anisodamine and mcnicol treatments. Left vertebral artery ischemia was found in 1 patient due to coated subclavian artery by stent-graft and the patient recovered spontaneously after two days lethargy without special treatment. The mean ICU time after surgery was 3.5 days (1 - 8 days) and the mean hospitalization time was 10 days. The mean follow-up time was 25.30 +/- 13.1 months (1 - 47 months). Two patients died within 30 days after operation, 1 patient died of rupture of the ascending aortic dissection (7 days post operation), 1 patient died of acute renal failure at the 2nd day post operation. One patient died of empsyxis 3 months after procedure, 1 patient died at the 4th month post procedure for unknown reason, 1 patient received second stent-graft implantation because of a newly formed endoleak at the proximal end of the stent-graft, 5 patients received second stent-graft implantation because of newly formed leaks at the remote end of the stent-graft. No paraplegia or stent migration or stenosis was observed during the follow up period. Total mortality during hospitalization and follow-up was 7.0%.
CONCLUSIONPatients with acute thoracic aortic syndrome could be effectively and safely treated by coated stent-graft endovascular placement.
Acute Disease ; Adult ; Aged ; Aged, 80 and over ; Aneurysm, Dissecting ; surgery ; Aneurysm, False ; surgery ; Aorta, Thoracic ; Aortic Aneurysm, Thoracic ; surgery ; Blood Vessel Prosthesis Implantation ; methods ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Stents ; Syndrome
7.Scaling up the in-hospital hepatitis C virus care cascade in Taiwan
Chung-Feng HUANG ; Pey-Fang WU ; Ming-Lun YEH ; Ching-I HUANG ; Po-Cheng LIANG ; Cheng-Ting HSU ; Po-Yao HSU ; Hung-Yin LIU ; Ying-Chou HUANG ; Zu-Yau LIN ; Shinn-Cherng CHEN ; Jee-Fu HUANG ; Chia-Yen DAI ; Wan-Long CHUANG ; Ming-Lung YU
Clinical and Molecular Hepatology 2021;27(1):136-143
Background/Aims:
Obstacles exist in facilitating hepatitis C virus (HCV) care cascade. To increase timely and accurate diagnosis, disease awareness and accessibility, in-hospital HCV reflex testing followed by automatic appointments and a late call-back strategy (R.N.A. model) was applied. We aimed to compare the HCV treatment rate of patients treated with this strategy compared to those without.
Methods:
One hundred and twenty-five anti-HCV seropositive patients who adopted the R.N.A. model in 2020 and another 1,396 controls treated in 2019 were enrolled to compare the gaps in accurate HCV RNA diagnosis to final treatment allocation.
Results:
The HCV RNA testing rate was significantly higher in patients who received reflex testing than in those without reflex testing (100% vs. 84.8%, P<0.001). When patients were stratified according to the referring outpatient department, a significant improvement in the HCV RNA testing rate was particularly noted in patients from non-hepatology departments (100% vs. 23.3%, P<0.001). The treatment rate in HCV RNA seropositive patients was 83% (83/100) after the adoption of the R.N.A. model, among whom 96.1% and 73.9% of patients were from the hepatology and non-hepatology departments, respectively. Compared to subjects without R.N.A. model application, a significant improvement in the treatment rate was observed for patients from non-hepatology departments (73.9% vs. 27.8%, P=0.001). The application of the R.N.A. model significantly increased the in-hospital HCV treatment uptake from 6.4% to 73.9% for patients from non-hepatology departments (P<0.001).
Conclusions
The care cascade increased the treatment uptake and set up a model for enhancing in-hospital HCV elimination.
8.Artificial intelligence predicts direct-acting antivirals failure among hepatitis C virus patients: A nationwide hepatitis C virus registry program
Ming-Ying LU ; Chung-Feng HUANG ; Chao-Hung HUNG ; Chi‐Ming TAI ; Lein-Ray MO ; Hsing-Tao KUO ; Kuo-Chih TSENG ; Ching-Chu LO ; Ming-Jong BAIR ; Szu-Jen WANG ; Jee-Fu HUANG ; Ming-Lun YEH ; Chun-Ting CHEN ; Ming-Chang TSAI ; Chien-Wei HUANG ; Pei-Lun LEE ; Tzeng-Hue YANG ; Yi-Hsiang HUANG ; Lee-Won CHONG ; Chien-Lin CHEN ; Chi-Chieh YANG ; Sheng‐Shun YANG ; Pin-Nan CHENG ; Tsai-Yuan HSIEH ; Jui-Ting HU ; Wen-Chih WU ; Chien-Yu CHENG ; Guei-Ying CHEN ; Guo-Xiong ZHOU ; Wei-Lun TSAI ; Chien-Neng KAO ; Chih-Lang LIN ; Chia-Chi WANG ; Ta-Ya LIN ; Chih‐Lin LIN ; Wei-Wen SU ; Tzong-Hsi LEE ; Te-Sheng CHANG ; Chun-Jen LIU ; Chia-Yen DAI ; Jia-Horng KAO ; Han-Chieh LIN ; Wan-Long CHUANG ; Cheng-Yuan PENG ; Chun-Wei- TSAI ; Chi-Yi CHEN ; Ming-Lung YU ;
Clinical and Molecular Hepatology 2024;30(1):64-79
Background/Aims:
Despite the high efficacy of direct-acting antivirals (DAAs), approximately 1–3% of hepatitis C virus (HCV) patients fail to achieve a sustained virological response. We conducted a nationwide study to investigate risk factors associated with DAA treatment failure. Machine-learning algorithms have been applied to discriminate subjects who may fail to respond to DAA therapy.
Methods:
We analyzed the Taiwan HCV Registry Program database to explore predictors of DAA failure in HCV patients. Fifty-five host and virological features were assessed using multivariate logistic regression, decision tree, random forest, eXtreme Gradient Boosting (XGBoost), and artificial neural network. The primary outcome was undetectable HCV RNA at 12 weeks after the end of treatment.
Results:
The training (n=23,955) and validation (n=10,346) datasets had similar baseline demographics, with an overall DAA failure rate of 1.6% (n=538). Multivariate logistic regression analysis revealed that liver cirrhosis, hepatocellular carcinoma, poor DAA adherence, and higher hemoglobin A1c were significantly associated with virological failure. XGBoost outperformed the other algorithms and logistic regression models, with an area under the receiver operating characteristic curve of 1.000 in the training dataset and 0.803 in the validation dataset. The top five predictors of treatment failure were HCV RNA, body mass index, α-fetoprotein, platelets, and FIB-4 index. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the XGBoost model (cutoff value=0.5) were 99.5%, 69.7%, 99.9%, 97.4%, and 99.5%, respectively, for the entire dataset.
Conclusions
Machine learning algorithms effectively provide risk stratification for DAA failure and additional information on the factors associated with DAA failure.
9.Survival without common toxicity criteria grade 3/4 toxicity following second-line treatment with pemetrexed for nonsquamous non-small cell lung cancer in Chinese patients.
Yi-Long WU ; Yan SUN ; Cai-Cun ZHOU ; Li ZHANG ; Shi-Ying YU ; Sheng-Lin MA ; Ling Lucia HAN ; Xiao-Qing Rosetta ZHANG ; Mauro ORLANDO
Chinese Medical Journal 2013;126(24):4624-4628
BACKGROUNDThe efficacy of pemetrexed in the second-line treatment of Chinese patients with advanced non-small cell lung cancer (NSCLC) has been shown to be similar to that of docetaxel in a recent study; additionally, pemetrexed was associated with much better safety and toxicity profiles. Here, the survival without common toxicity criteria grade 3/4 toxicity (SWT) data from a post hoc analysis of this recent prospective NSCLC study in Chinese patients is reported. This post hoc analysis differs from the main study; it focuses on the nonsquamous population to align with the current approval for pemetrexed in China.
METHODSA total of 154 patients with nonsquamous NSCLC received either pemetrexed (500 mg/m(2) intravenously (IV)) or docetaxel (75 mg/m(2) IV) on day 1 of 21-day cycles. SWT was analyzed using Kaplan-Meier and univariate Cox methods.
RESULTSPatients treated with pemetrexed had a longer median SWT than patients treated with docetaxel (7.4 months versus 1.2 months; unadjusted hazard ratio = 0.59, 95% confidence interval (CI): 0.41-0.84; P = 0.003). At 12 and 18 months, the SWT event-free probability for pemetrexed patients (18 months: 24.5%, 95%CI 13.9%-36.6%, vs. 12.3%, 95% CI 4.8%-23.6%) was greater than that for docexatel patients (12 months: 37.3%, 95% CI 26.5%-48.0%, vs. 23.3%, 95% CI 14.4-33.4). The progression-free survival without common toxicity criteria grade 3/4 toxicity (PFS-WT) was also statistically significantly longer for patients treated with pemetrexed than patients treated with docetaxel (1.9 months vs. 1.1 months, P = 0.002).
CONCLUSIONSChinese patients with nonsquamous NSCLC disease treated with pemetrexed had improved SWT beyond 6 months than those receiving docetaxel. This analysis supports a benefit-to-risk profile that favors pemetrexed over docetaxel in the second-line treatment of Chinese nonsquamous NSCLC patients.
Adult ; Aged ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; mortality ; China ; Female ; Glutamates ; adverse effects ; therapeutic use ; Guanine ; adverse effects ; analogs & derivatives ; therapeutic use ; Humans ; Male ; Middle Aged ; Pemetrexed ; Treatment Outcome
10.A phase I study of subcutaneous envafolimab (KN035) monotherapy in Chinese patients with advanced solid tumors.
Rong Rui LIU ; Shan Zhi GU ; Tie ZHOU ; Li Zhu LIN ; Wei Chang CHEN ; Dian Sheng ZHONG ; Tian Shu LIU ; Nong YANG ; Lin SHEN ; Si Ying XU ; Ni LU ; Yun ZHANG ; Zhao Long GONG ; Jian Ming XU
Chinese Journal of Oncology 2023;45(10):898-903
Objective: To evaluate the safety and antitumor activity of envafolimab monotherapy in Chinese patients with advanced solid tumors. Methods: This open-label, multicenter phase I trial included dose escalation and dose expansion phases. In the dose escalation phase, patients received subcutaneous 0.1, 0.3, 1.0, 2.5, 5.0 or 10.0 mg/kg envafolimab once weekly (QW) following a modified "3+ 3" design. The dose expansion phase was performed in the 2.5 mg/kg and 5.0 mg/kg (QW) dose cohorts. Results: At November 25, 2019, a total of 287 patients received envafolimab treatment. During the dose escalation phase, no dose-limiting toxicities (DLT) was observed. In all dose cohorts, drug-related treatment-emergent adverse events (TEAEs) for all grades occurred in 75.3% of patients, and grade 3 or 4 occurred in 20.6% of patients. The incidence of immune-related adverse reactions (irAE) was 24.0% for all grades, the most common irAEs (≥2%) included hypothyroidism, hyperthyroidism, immune-associated hepatitis and rash. The incidence of injection site reactions was low (3.8%), all of which were grades 1-2. Among the 216 efficacy evaluable patients, the objective response rate (ORR) and disease control rate (DCR) were 11.6% and 43.1%, respectively. Median duration of response was 49.1 weeks (95% CI: 24.0, 49.3). Pharmacokinetic (PK) exposure to envafolimab is proportional to dose and median time to maximum plasma concentration is 72-120 hours based on the PK results from the dose escalation phase of the study. Conclusion: Subcutaneous envafolimab has a favorable safety and promising preliminary anti-tumor activity in Chinese patients with advanced solid tumors.
Humans
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East Asian People
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Neoplasms/pathology*
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Antibodies, Monoclonal, Humanized/therapeutic use*