1.Potential utility of albumin-bilirubin and body mass index-based logistic model to predict survival outcome in non-small cell lung cancer with liver metastasis treated with immune checkpoint inhibitors.
Lianxi SONG ; Qinqin XU ; Ting ZHONG ; Wenhuan GUO ; Shaoding LIN ; Wenjuan JIANG ; Zhan WANG ; Li DENG ; Zhe HUANG ; Haoyue QIN ; Huan YAN ; Xing ZHANG ; Fan TONG ; Ruiguang ZHANG ; Zhaoyi LIU ; Lin ZHANG ; Xiaorong DONG ; Ting LI ; Chao FANG ; Xue CHEN ; Jun DENG ; Jing WANG ; Nong YANG ; Liang ZENG ; Yongchang ZHANG
Chinese Medical Journal 2025;138(4):478-480
2.Intracranial activity of first-line immune checkpoint inhibitors combined with chemotherapy in advanced non-small cell lung cancer.
Zhe HUANG ; Fang WU ; Qinqin XU ; Lianxi SONG ; Xiangyu ZHANG ; Zhan WANG ; Li DENG ; Yongchang ZHANG ; Liang ZENG ; Nong YANG
Chinese Medical Journal 2023;136(12):1422-1429
BACKGROUND:
Immune checkpoint inhibitors (ICIs) are increasingly used as first-line therapy for patients with advanced non-small cell lung cancer (NSCLC) harboring no actionable mutations; however, data on their efficacy among patients presenting with intracranial lesions are limited. This study aimed to explore the efficacy and safety of ICIs combined with chemotherapy in advanced NSCLC patients with measurable brain metastasis at initial diagnosis.
METHODS:
Our study retrospectively analyzed clinical data of a total of 211 patients diagnosed with driver gene mutation-negative advanced NSCLC with measurable, asymptomatic brain metastasis at baseline from Hunan Cancer Hospital between January 1, 2019 and September 30, 2021. The patients were stratified into two groups according to the first-line treatment regimen received: ICI combined with chemotherapy ( n = 102) or chemotherapy ( n = 109). Systemic and intracranial objective response rates (ORRs) and progression-free survival (PFS) were analyzed. Adverse events were also compared between the groups.
RESULTS:
Compared with the chemotherapy-based regimen, the ICI-containing regimen was associated with a significantly higher intracranial (44.1% [45/102] vs . 28.4% [31/109], χ2 = 5.620, P = 0.013) and systemic (49.0% [50/102] vs . 33.9% [37/109], χ2 = 4.942, P = 0.019) ORRs and longer intracranial (11.0 months vs . 7.0 months, P <0.001) and systemic (9.0 months vs . 5.0 months, P <0.001) PFS. Multivariable analysis consistently revealed an independent association between receiving ICI plus platinum-based chemotherapy as a first-line regimen and prolonged intracranial PFS (hazard ratio [HR] = 0.52, 95% confidence interval [CI]: 0.37-0.73, P <0.001) and systemic PFS (HR = 0.48, 95% CI: 0.35-0.66, P <0.001). No unexpected serious adverse effects were observed.
CONCLUSION:
Our study provides real-world clinical evidence that ICI combined with chemotherapy is a promising first-line treatment option for driver gene mutation-negative advanced NSCLC patients who present with brain metastasis at initial diagnosis.
CLINICAL TRIAL REGISTRATION
https://www.clinicaltrials.gov/ , OMESIA, NCT05129202.
Humans
;
Carcinoma, Non-Small-Cell Lung/genetics*
;
Lung Neoplasms/genetics*
;
Immune Checkpoint Inhibitors/therapeutic use*
;
Retrospective Studies
;
Brain Neoplasms/genetics*
3.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
;
East Asian People
;
Neoplasms/pathology*
;
Antibodies, Monoclonal, Humanized/therapeutic use*
4.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
;
East Asian People
;
Neoplasms/pathology*
;
Antibodies, Monoclonal, Humanized/therapeutic use*
5.Analysis of the new WHO guideline to accelerate the progress towards elimination of schistosomiasis in China.
Zhao Yu GUO ; Jia Xin FENG ; Li Juan ZHANG ; Yi Biao ZHOU ; Jie ZHOU ; Kun YANG ; Yang LIU ; Dan Dan LIN ; Jian Bing LIU ; Yi DONG ; Tian Ping WANG ; Li Yong WEN ; Min Jun JI ; Zhong Dao WU ; Qing Wu JIANG ; Song LIANG ; Jia Gang GUO ; Chun Li CAO ; Jing XU ; Shan LÜ ; Shi Zhu LI ; Xiao Nong ZHOU
Chinese Journal of Schistosomiasis Control 2022;34(3):217-222
On February 2022, WHO released the evidence-based guideline on control and elimination of human schistosomiasis, with aims to guide the elimination of schistosomiasis as a public health problem in disease-endemic countries by 2030 and promote the interruption of schistosomiasis transmission across the world. Based on the One Health concept, six evidence-based recommendations were proposed in this guideline. This article aims to analyze the feasibility of key aspects of this guideline in Chinese national schistosomiasis control program and illustrate the significance to guide the future actions for Chinese national schistosomiasis control program. Currently, the One Health concept has been embodied in the Chinese national schistosomiasis control program. Based on this new WHO guideline, the following recommendations are proposed for the national schistosomiasis control program of China: (1) improving the systematic framework building, facilitating the agreement of the cross-sectoral consensus, and building a high-level leadership group; (2) optimizing the current human and livestock treatments in the national schistosomiasis control program of China; (3) developing highly sensitive and specific diagnostics and the framework for verifying elimination of schistosomiasis; (4) accelerating the progress towards elimination of schistosomiasis and other parasitic diseases through integrating the national control programs for other parasitic diseases.
China/epidemiology*
;
Disease Eradication
;
Humans
;
Public Health
;
Schistosomiasis/prevention & control*
;
World Health Organization
6.Decoding the evolution of preventive chemotherapy schemes for schistosomiasis in China to improve the precise implementation of the WHO guideline on control and elimination of human schistosomiasis.
Jing XU ; Yi Feng LI ; Yi DONG ; Zheng Yuan ZHAO ; Li Yong WEN ; Shi Qing ZHANG ; Dan Dan LIN ; Jie ZHOU ; Song LIANG ; Jia Gang GUO ; Shi Zhu LI ; Xiao Nong ZHOU
Chinese Journal of Schistosomiasis Control 2022;34(3):223-229
Preventive chemotherapy is one of the pivotal interventions for the control and elimination of schistosomiasis, which is effective to reduce the morbidity and prevalence of schistosomiasis. In order to promote the United Nations' sustainable development goals and the targets set for schistosomiasis control in the Ending the neglect to attain the Sustainable Development Goals: a road map for neglected tropical diseases 2021-2030, WHO released the guideline on control and elimination of human schistosomiasis in 2022, with major evidence-based updates of the current preventive chemotherapy strategy for schistosomiasis. In China where great success has been achieved in schistosomiasis control, the preventive chemotherapy strategy for schistosomiasis has been updated several times during the past seven decades. This article reviews the evolution of the WHO guidelines on preventive chemotherapy and Chinese national preventive chemotherapy schemes, compares the current Chinese national preventive chemotherapy scheme and the recommendations for preventive chemotherapy proposed in the 2022 WHO guideline on control and elimination of human schistosomiasis, and proposes recommendations for preventive chemotherapy during the future implementation of the 2022 WHO guideline, so as to provide insights into schistosomiasis control among public health professionals engaging in healthcare foreign aid.
China/epidemiology*
;
Humans
;
Prevalence
;
Public Health
;
Schistosomiasis/prevention & control*
;
World Health Organization
7.Progress of schistosomiasis control in People’s Republic of China in 2021
Li-juan ZHANG ; Zhi-min XU ; Fan YANG ; Jun-yi HE ; Hui DANG ; Yin-long LI ; Chun-li CAO ; Jing XU ; Shi-zhu LI ; Xiao-nong ZHOU
Chinese Journal of Schistosomiasis Control 2022;34(4):329-336
This report presented the endemic status of schistosomiasis and analyzed the data collected from the national schistosomiasis prevention and control system and national schistosomiasis surveillance sites in the People’s Republic of China at a national level in 2021. Among the 12 provinces (municipality and autonomous region) endemic for schistosomiasis in China, Shanghai Municipality, Zhejiang Province, Fujian Province, Guangdong Province and Guangxi Zhuang Autonomous Region continued to consolidate the achievements of schistosomiasis elimination, and Sichuan and Jiangsu provinces maintained the criteria of transmission interruption, while Yunnan, Hubei, Anhui, Jiangxi and Hunan provinces maintained the criteria of transmission control by the end of 2021. A total of 451 counties (cites, districts) were found to be endemic for schistosomiasis in China in 2021, with 27 571 endemic villages covering 73 250 600 people at risk of infections. Among the 451 endemic counties (cities, districts), 75.17% (339/451), 22.17% (100/451) and 2.66% (12/451) achieved the criteria of elimination, transmission interruption and transmission control of schistosomiasis, respectively. By the end of 2021, 29 037 cases with advanced schistosomiasis were documented in China. In 2021, 4 405 056 individuals received serological tests and 72 937 were sero-positive. A total of 220 629 individuals received stool examinations and 3 were positive. In 2021, snail survey was performed in 19 291 endemic villages in China and Oncomelania snails were found in 7 026 villages, accounting for 36.42% of all surveyed villages, with 12 villages identified with emerging snail habitats. Snail survey was performed at an area of 686 574.46 hm2 and 191 159.91 hm2 snail habitats were found, including 1 063.08 hm2 emerging snail habitats and 5 113.87 hm2 reemerging snail habitats. In 2021, 525 878 bovines were raised in the schistosomiasis endemic areas of China, and 115 437 received serological examinations, with 231 positives detected. Among the 128 719 bovines received stool examinations, no positives were identified. In 2021, there were 19 927 schistosomiasis patients receiving praziquantel chemotherapy, and 729 113 person-time individuals and 256 913 herd-time bovines were given expanded chemotherapy. In 2021, snail control with chemicals was performed in 117 372.74 hm2 snail habitats, and the actual area of chemical treatment was 65 640.50 hm2, while environmental improvements were performed in snail habitats covering an area of 1 244.25 hm2. Data from the national schistosomiasis surveillance sites of China showed that the mean prevalence of Schistosoma japonicum infections were both zero in humans and bovines in 2021, and no S. japonicum infection was detected in snails. The results demonstrate that the overall endemic status of schistosomiasis remained at a low level in China in 2021; however, the progress towards schistosomiasis elimination was slowed and the areas of snail habitats rebounded mildly. Strengthening researches on snail diffusion and control, and improving schistosomiasis surveillance and forecast are recommended to prevent reemerging schistosomiasis.
8.Application of isotemporal substitution model in epidemiological research.
Yu Tong WANG ; Hui Meng LIU ; Sui Xia CAO ; Kun XU ; Bin Yan ZHANG ; Ya Ting HUO ; Jing Chun LIU ; Ling Xia ZENG ; Shao Nong DANG ; Hong YAN ; Bai Bing MI
Chinese Journal of Epidemiology 2022;43(11):1842-1847
Isotemporal substitution model is a powerful tool to explore the real association between physical behavior and health outcomes, which has the potential of the application in large-scale cohort study. This paper systematically introduces the principle of isotemporal substitution model and its implementation method in specific analysis to provide analytical ideas for the epidemiological research related to physical behavior in China. The baseline data of Regional Ethic Cohort Study in Northwest China conducted in Shaanxi province were used to analyze the relationship between physical behavior and cardiovascular disease with single-factor model, partition model and isotemporal substitution model. The advantages and disadvantages of different models were compared, and the advantages of isotemporal substitution model in quantifying physical activity health risk were introduced. Isotemporal substitution model could qualify physical behavior and health outcomes, which has wide application value in epidemiological research.
Humans
;
Cohort Studies
;
Epidemiologic Studies
;
Cardiovascular Diseases
;
China/epidemiology*
9.Study on knowledge, attitudes and practices of pulse oximetry among pediatric healthcare providers in China and their influencing factors
Fengxia XUE ; Yuejie ZHENG ; Adong SHEN ; Hanmin LIU ; Xing CHEN ; Lili ZHONG ; Guangmin NONG ; Xin SUN ; Gen LU ; Shenggang DING ; Yuanxun FANG ; Jiahua PAN ; Zhiying HAN ; Yun SUN ; Qiang CHEN ; Yi JIANG ; Xiaoping ZHU ; Suping TANG ; Xiufang WANG ; Changshan LIU ; Shaomin REN ; Zhimin CHEN ; Deyu ZHAO ; Yong YIN ; Rongfang ZHANG ; Ming LI ; Yunxiao SHANG ; Yaping MU ; Shuhua AN ; Yangzom YESHE ; Peiru XU ; Yan XING ; Baoping XU ; Jing ZHAO ; Shi CHEN ; Wei XIANG ; Lihong LI ; Enmei LIU ; Yuxin SONG ; Yonghong YANG ; Kunling SHEN
Chinese Journal of Applied Clinical Pediatrics 2022;37(23):1807-1812
Objective:To investigate the knowledge, attitudes, and practices (KAP) of pulse oximetry among pediatric healthcare providers in China and analyze the factor influencing the KAP.Methods:A self-developed questionnaire was used for an online research on the KAP of 11 849 pediatric healthcare providers from 31 provinces, autonomous regions, and municipalities of China from March 11 to 14, 2022.The factors influencing the KAP of pulse oximetry among pediatric healthcare providers were examined by Logistic regression. Results:The scores of KAP, of pulse oximetry were 5.57±0.96, 11.24±1.25 and 11.19±4.54, respectively.The corresponding scoring rates were 69.61%, 74.95%, and 55.99%, respectively. Logistic regression results showed that the gender and working years of pediatric healthcare providers, the region they were located, and whether their medical institution was equipped with pulse oximeters were the main factors affecting the knowledge score (all P<0.05). Main factors influencing the attitude score of pediatric healthcare providers included their knowledge score, gender, educational background, working years, region, medical institution level, and whether the medical institution was equipped with pulse oximeters (all P<0.05). For the practice score, the main influencing factors were the knowledge score, gender, age, and whether the medi-cal institution was equipped with pulse oximeters (all P<0.05). Conclusions:Chinese pediatric healthcare providers need to further improve their knowledge about and attitudes towards pulse oximetry.Pulse oximeters are evidently under-used.It is urgent to formulate policies or guidelines, strengthen education and training, improve knowledge and attitudes, equip more institutions with pulse oximeters, and popularize their application in medical institutions.
10.High frequency ultrasound combined with ultrasound-guided core needle biopsy for the diagnosis of primary thyroid lymphoma.
Li Long XU ; Shi Yan LI ; Jiang ZHU ; Jiang Hong LYU ; Ming Xuan ZHANG ; Li GAO ; Lei XIE ; Zhi Nong JIANG ; Guo Xiang FU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2021;56(8):858-862
Objective: To investigate the sonographic features of primary thyroid lymphoma (PTL) and to evaluate the clinical significance of ultrasound-guided core needle biopsy (US-CNB) in PTL. Methods: A total of 24 patients with suspected PTL in Sir Run Run Shaw Hospital from January 2013 to June 2018 were analyzed retrospectively. All cases were confirmed by pathology, of them 23 patients received US-CNB and 1 patient chose operation without US-CNB, including 5 males and 19 females, aged from 39 to 75 years old. The effectiveness and safety of 23 patients with US-CNB were evaluated, and the sonographic features of 20 patients with PTL diagnosed by pathology were analyzed. Descriptive statistical methods were used in the study. Results: In the 23 patients with suspected PTL underwent US-CNB, 18 patients were diagnosed as PTL, 4 patients were respectively diagnosed as subacute thyroiditis, anaplastic carcinoma, Hashimoto's thyroiditis, and fibro thyroiditis, and the another patient was hard to diagnose by US-CNB and then was diagnosed as PTL by surgical biopsy. The success rate of US-CNB for diagnosis of PTL was 18/19, and no severe complications occurred in the patients with US-CNB. The other case was diagnosed as PTL by surgical biopsy without US-CNB. Sonographic features of 20 cases with PTL (18 cases diagnosed by US-CNB and 2 cases by surgery or surgery biopsy) were as follows: (1) Most nodules had irregular shapes and unsmooth margins; (2) Hypoechoic or markedly hypoechoic nodules with honeycombed or cord structures were observed in most cases; (3) Calcification was rare; (4) Multiple lesions were common; (5) Abundant intralesional vascularization was commonly observed; (6) Most cases had intensification of posterior acoustic enhancement; (7) Thyroid gland enlargement or with irregular shape; and (8) PTL often accompanied with lymph nodes enlargement in lateral neck or central region. Conclusion: PTL has certain sonographic features, with assistance of US-CNB, more accurate diagnosis of PTL can be obtained.
Adult
;
Aged
;
Biopsy, Large-Core Needle
;
Female
;
Humans
;
Image-Guided Biopsy
;
Lymphoma/diagnostic imaging*
;
Male
;
Middle Aged
;
Retrospective Studies
;
Thyroid Gland
;
Thyroid Neoplasms/diagnostic imaging*
;
Thyroid Nodule
;
Ultrasonography, Interventional

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