1.Equivalence of SYN008 versus omalizumab in patients with refractory chronic spontaneous urticaria: A multicenter, randomized, double-blind, parallel-group, active-controlled phase III study.
Jingyi LI ; Yunsheng LIANG ; Wenli FENG ; Liehua DENG ; Hong FANG ; Chao JI ; Youkun LIN ; Furen ZHANG ; Rushan XIA ; Chunlei ZHANG ; Shuping GUO ; Mao LIN ; Yanling LI ; Shoumin ZHANG ; Xiaojing KANG ; Liuqing CHEN ; Zhiqiang SONG ; Xu YAO ; Chengxin LI ; Xiuping HAN ; Guoxiang GUO ; Qing GUO ; Xinsuo DUAN ; Jie LI ; Juan SU ; Shanshan LI ; Qing SUN ; Juan TAO ; Yangfeng DING ; Danqi DENG ; Fuqiu LI ; Haiyun SUO ; Shunquan WU ; Jingbo QIU ; Hongmei LUO ; Linfeng LI ; Ruoyu LI
Chinese Medical Journal 2025;138(16):2040-2042
2.Symptom burden among survivors with oropharyngeal cancer after radiotherapy
Ya LIU ; Dan ZUO ; Xinyi SONG ; Junlin YI ; Jingwei LUO ; Xiaodong HUANG ; Kai WANG ; Yuan QU ; Runye WU ; Jingbo WANG ; Xuesong CHEN ; Ye ZHANG
Chinese Journal of Radiation Oncology 2025;34(5):422-428
Objective:To investigate the prevalence and severity of symptom burden among long-term survivors of oropharyngeal cancer after radiotherapy, to identify core symptom clusters, and to explore their correlation with quality of life.Methods:A previous retrospective study was conducted by the Cancer Hospital, Chinese Academy of Medical Sciences on patients with oropharyngeal cancer who underwent radiotherapy between January 2010 and December 2020. Patients who were still alive as of December 2023 were further followed and analyzed. From December 2023 to August 2024, symptom burden and quality of life were assessed using the Chinese version of the MD Anderson Symptom Inventory–Head and Neck Module (MDASI-HN) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Exploratory factor analysis (principal component analysis with Promax rotation) were used to identify symptom clusters. Spearman correlation analysis was performed to explore the relationship between total symptom cluster scores and standardized domain scores of quality of life. Multivariate linear regression analysis was further employed to determine the relationship between identified symptom clusters and overall quality of life.Results:A total of 273 patients were included, with a median follow-up duration of 6.2 years (range: 3.5-14.5 years) and a median age of 61 years (range: 27-88 years) at follow-up. The top 5 incidence rates of symptom reported by patients were mucus problems in the mouth or throat (147 cases, 53.8%), dental or gum issues (143 cases, 52.4%), xerostomia (140 cases, 51.3%), difficulty swallowing or chewing (95 cases, 34.8%), and taste disturbance (79 cases, 28.9%). Among them, xerostomia was the most serious symptom. The most frequently reported interference was impact on work (including household chores) (55 cases, 20.1%). Exploratory factor analysis identified 3 symptom clusters: fatigue-nausea cluster, eating-voice cluster, and xerostomia-sleep cluster, all of which were significantly correlated with lower overall quality of life of patients (all P<0.001). Conclusion:Long-term survivors of oropharyngeal cancer after radiotherapy experience substantial symptom burden. The fatigue-nausea, eating-voice, and xerostomia-sleep clusters are the core symptom clusters impacting quality of life.
3.Symptom burden among survivors with oropharyngeal cancer after radiotherapy
Ya LIU ; Dan ZUO ; Xinyi SONG ; Junlin YI ; Jingwei LUO ; Xiaodong HUANG ; Kai WANG ; Yuan QU ; Runye WU ; Jingbo WANG ; Xuesong CHEN ; Ye ZHANG
Chinese Journal of Radiation Oncology 2025;34(5):422-428
Objective:To investigate the prevalence and severity of symptom burden among long-term survivors of oropharyngeal cancer after radiotherapy, to identify core symptom clusters, and to explore their correlation with quality of life.Methods:A previous retrospective study was conducted by the Cancer Hospital, Chinese Academy of Medical Sciences on patients with oropharyngeal cancer who underwent radiotherapy between January 2010 and December 2020. Patients who were still alive as of December 2023 were further followed and analyzed. From December 2023 to August 2024, symptom burden and quality of life were assessed using the Chinese version of the MD Anderson Symptom Inventory–Head and Neck Module (MDASI-HN) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Exploratory factor analysis (principal component analysis with Promax rotation) were used to identify symptom clusters. Spearman correlation analysis was performed to explore the relationship between total symptom cluster scores and standardized domain scores of quality of life. Multivariate linear regression analysis was further employed to determine the relationship between identified symptom clusters and overall quality of life.Results:A total of 273 patients were included, with a median follow-up duration of 6.2 years (range: 3.5-14.5 years) and a median age of 61 years (range: 27-88 years) at follow-up. The top 5 incidence rates of symptom reported by patients were mucus problems in the mouth or throat (147 cases, 53.8%), dental or gum issues (143 cases, 52.4%), xerostomia (140 cases, 51.3%), difficulty swallowing or chewing (95 cases, 34.8%), and taste disturbance (79 cases, 28.9%). Among them, xerostomia was the most serious symptom. The most frequently reported interference was impact on work (including household chores) (55 cases, 20.1%). Exploratory factor analysis identified 3 symptom clusters: fatigue-nausea cluster, eating-voice cluster, and xerostomia-sleep cluster, all of which were significantly correlated with lower overall quality of life of patients (all P<0.001). Conclusion:Long-term survivors of oropharyngeal cancer after radiotherapy experience substantial symptom burden. The fatigue-nausea, eating-voice, and xerostomia-sleep clusters are the core symptom clusters impacting quality of life.
4.An observational study of symptomatic changes in patients with nasopharyngeal carcinoma following nimotuzumab administration one week before radiotherapy
Zekun WANG ; Jianghu ZHANG ; Xuesong CHEN ; Jingbo WANG ; Runye WU ; Ye ZHANG ; Yuan QU ; Kai WANG ; Xiaodong HUANG ; Junlin YI ; Jingwei LUO
Chinese Journal of Radiation Oncology 2024;33(12):1125-1130
Objective:To prospectively observe the changes of tumor-related symptoms in patients with nasopharyngeal carcinoma following the administration of nimotuzumab one week before radiotherapy.Methods:Non-metastatic nasopharyngeal carcinoma patients with positive epidermal growth factor receptor (EGFR) expression and symptoms caused by the primary lesion or metastatic cervical lymph nodes admitted to Cancer Hospital of Chinese Academy of Medical Sciences were prospectively recruited. Investigators recorded tumor-related symptoms in recruited patients one day before the first administration of nimotuzumab (D0) and conducted follow-up visits from day 2 to day 7 after the first administration (D2-D7) to document symptom changes. All recruited patients were asked to assess tumor-related symptoms on D0 and D7 by visual analogue scale (VAS) scores. VAS scores were analyzed by paired t-test. Results:From June 2020 to April 2023, a total of 21 patients met the inclusion criteria. The median age was 49 years (range: 27-69 years), with a male-to-female ratio of 1.3:1. Among the patients, 17 patients (81%) received concurrent nimotuzumab for 8 cycles, 7 cycles for 3 cases (14%), and 6 cycles for 1 case (5%), respectively. All patients completed symptom assessments as required. The overall response rate of symptoms after the first administration of nimotuzumab was 62%, with response rates of 4/6、5/8、4/10、4/10、4/11、3/11 for tinnitus, headache, aural fullness, secondary pain caused by neck mass, nasal bleeding, and nasal obstruction, respectively. The VAS scores for overall symptoms were significantly decreased after the administration of nimotuzumab one week before radiotherapy ( P<0.001), with the most significant decrease in VAS scores for tinnitus, aural fullness, and headache. Conclusion:The administration of nimotuzumab one week before radiotherapy significantly alleviates tumor-related symptoms in patients with nasopharyngeal carcinoma, particularly in alleviating tinnitus, aural fullness, and headache.
5.Conventional and Contrast-enhanced Ultrasound Manifestations in Patient with Renal Epithelioid Angiomyolipoma
Ping ZHAO ; Shuyuan LIANG ; Jianing ZHU ; Jingbo LI ; Luda SONG ; Lianhua ZHU ; Xiang FEI ; Qiuyang LI ; Yukun LUO
Chinese Journal of Medical Imaging 2024;32(12):1277-1281
Purpose To investigate the features of conventional and contrast-enhanced ultrasound (CEUS) imaging in renal epithelioid angiomyolipoma (EAML). Materials and Methods We retrospectively analyzed the conventional ultrasound and CEUS images of the 30 patients with renal EAML who were confirmed by pathology in the General Hospital of the PLA from November 2010 to October 2022. The location,size,classfication,echo,boundary,shape,growth pattern and whether color Doppler ultrasound detects blood flow signals were observed by conventional ultrasound. CEUS was used to analyze the wash-in pattern,enhancement direction,peak enhancement intensity,the uniformity after enhancement,wash-out pattern and pseudocapsule sign,respectively. Results A total of 30 patients (n=30 lesions) were enrolled. The maximal diameter of the lesions varied from 1.4 to 12.6 cm. 17 cases occurred in the right kidney and 13 cases in the left kidney. On grayscale ultrasound,28 cases showed solid type,2 were cystic solid;18 cases demonstrated hypoechoic,10 were hyperechoic;the solid component in the cystic solid lesion was isoechoic in 1 case and hyperechoic in 1 case;24 cases displayed well-defined and 19 cases appeared regular shape;22 cases were presented exophytic growth. Color Doppler ultrasound detected blood flow in 24 cases. Of all 30 patients with EAML,CEUS was performed in 13 cases,6 lesions with simultaneous wash-in;10 cases with centripetal enhancement;9 cases with hyper-enhancement;10 cases with homogeneous enhancement;5 lesions with simultaneous wash-out;9 cases with pseudocapsule sign. Conclusion The ultrasonographic appearance of EAML has a tendency to be hypoechoic with exophytic growth and clear boundary on conventional ultrasound images,and centripetal enhancement,homogeneous hyperenhancement and presence of pseudocapsule on CEUS images. All these findings are contributed to the diagnosis of EAML.
6.Conventional and Contrast-enhanced Ultrasound Manifestations in Patient with Renal Epithelioid Angiomyolipoma
Ping ZHAO ; Shuyuan LIANG ; Jianing ZHU ; Jingbo LI ; Luda SONG ; Lianhua ZHU ; Xiang FEI ; Qiuyang LI ; Yukun LUO
Chinese Journal of Medical Imaging 2024;32(12):1277-1281
Purpose To investigate the features of conventional and contrast-enhanced ultrasound (CEUS) imaging in renal epithelioid angiomyolipoma (EAML). Materials and Methods We retrospectively analyzed the conventional ultrasound and CEUS images of the 30 patients with renal EAML who were confirmed by pathology in the General Hospital of the PLA from November 2010 to October 2022. The location,size,classfication,echo,boundary,shape,growth pattern and whether color Doppler ultrasound detects blood flow signals were observed by conventional ultrasound. CEUS was used to analyze the wash-in pattern,enhancement direction,peak enhancement intensity,the uniformity after enhancement,wash-out pattern and pseudocapsule sign,respectively. Results A total of 30 patients (n=30 lesions) were enrolled. The maximal diameter of the lesions varied from 1.4 to 12.6 cm. 17 cases occurred in the right kidney and 13 cases in the left kidney. On grayscale ultrasound,28 cases showed solid type,2 were cystic solid;18 cases demonstrated hypoechoic,10 were hyperechoic;the solid component in the cystic solid lesion was isoechoic in 1 case and hyperechoic in 1 case;24 cases displayed well-defined and 19 cases appeared regular shape;22 cases were presented exophytic growth. Color Doppler ultrasound detected blood flow in 24 cases. Of all 30 patients with EAML,CEUS was performed in 13 cases,6 lesions with simultaneous wash-in;10 cases with centripetal enhancement;9 cases with hyper-enhancement;10 cases with homogeneous enhancement;5 lesions with simultaneous wash-out;9 cases with pseudocapsule sign. Conclusion The ultrasonographic appearance of EAML has a tendency to be hypoechoic with exophytic growth and clear boundary on conventional ultrasound images,and centripetal enhancement,homogeneous hyperenhancement and presence of pseudocapsule on CEUS images. All these findings are contributed to the diagnosis of EAML.
7.Clinical characteristics and efficacy of second primary malignancies in hypopharyngeal carcinoma: an analysis of 216 real-world cases
Xi LUO ; Runye WU ; Shaoyan LIU ; Xiaolei WANG ; Xiaoguang NI ; Ye ZHANG ; Xiaodong HUANG ; Kai WANG ; Xuesong CHEN ; Jingbo WANG ; Jianghu ZHANG ; Yuan QU ; Jingwei LUO ; Junlin YI
Chinese Journal of Radiation Oncology 2023;32(3):194-200
Objective:To evaluate the incidence, clinical characteristics and prognosis of second primary malignancies (SPMs) among patients with hypopharyngeal carcinoma (HPC) in real-world analysis.Methods:A total of 594 HPC patients admitted to Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College from 2010 to 2018 were retrospectively analyzed.The incidence and clinical characteristics of HPC patients complicated with SPMs were analyzed. Clinical efficacy was compared among different groups.Results:With a median follow-up time of 66.9 months, SPMs were present in 36.4% (216/594) of HPC patients: 22.2% (132/594) were synchronous and 14.1% (84/594) were metachronous. The upper aerodigestive tract was the most common involved region. Compared with patients without SPMs, patients with synchronous and metachronous carcinoma in situ had similar 5-year overall survival (OS) of 42.2% vs. 44.5% ( P=0.958) and 62.2% vs. 44.5% ( P=0.240), respectively. Patients with synchronous invasive SPMs had a worse 5-year OS of 27.2% vs. 44.5% in their counterparts without SPMs ( P=0.001). Patients with metachronous invasive SPMs had similar 5-year OS of 50.2% vs. 44.5% in their counterparts without SPMs ( P=0.587). SPMs accounted for 42.5% of total death in metachronous invasive SPMs group. Conclusions:Patients with HPC have a high probability of developing SPMs. Moreover, the incidence of complicated with esophageal/gastric carcinoma in situ or metachronous SPMs exerts no effect on prognosis, while the occurrence of synchronous SPMs significantly affectes the prognosis of patients. However, the incidence of SPMs is still one of the main death causes in metachronous invasive SPMs group.
8.Comparison of different laryngeal preservation strategies based on chemoradiotherapy in locally advanced hypopharyngeal carcinoma.
Xi LUO ; Shiran SUN ; Yi XU ; Xiaodong HUANG ; Kai WANG ; Runye WU ; Jingbo WANG ; Ye ZHANG ; Jianghu ZHANG ; Xuesong CHEN ; Yuan QU ; Jingwei LUO ; Junlin YI
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2023;37(9):708-714
Objective:This study aimed to evaluate the clinical features and treatment outcomes of the value of response-adapted treatment following radiotherapy and induction chemotherapy follwing subsequent comprehensive therapy in patients with resectable locally advanced hypopharyngeal carcinoma. Methods:This cohort study was conducted from September 2010 to September 2020 in our hospital, 231 patients pathologically confirmed stage Ⅲ and ⅣB resectable locally advanced hypopharyngeal carcinoma included. For the IC-directed ART strategy, IC is used to select good candidates to receive radical RT or CCRT, and others undergo surgery. He response-adapted strategy was determined based on the primary tumor response, which was evaluated at a dose of 50 Gy. If the response reached complete response or partial response(more than 80% tumor regression), patients received radical RT or CCRT; otherwise, they received surgery, if possible, at 4 to 6 weeks after RT. The end points of the study were OS(overall survival), progression free survival(PFS), locoregional recurrence-free survival(LRRFS) and LDFS. Results:In IC-directed group, 75.0%(57/76) patients reached PR after 2 cycles of induction chemotherapy. While in RT-directed group, 70.3%(109/155) patients reached large PR at dose of 50 Gy. The median interquartile range follow-up period of the whole cohort was 63.8 months. The 5-year OS, PFS, LRRFS and SFL of the whole cohort were 47.9%、39.6%、44.3% and 36.2%, respectively. In evaluations based on the different treatment strategies, the 5-year OS and SFL were 51.3% versus 37.0%(HR 0.67; 95%CI 0.43-1.05; P=0.07) and 27.8% versus 39.8%(HR 0.68; 95%CI 0.46-0.99; P=0.04) between IC-directed and RT-directed groups. In additional, surgery complications did not significantly differ between these two groups. Conclusion:In this cohort study, the response-adapted strategy based on an early RT response facilitated better treatment tailoring, and higher laryngeal preservation compared with IC-directed strategies. This approach could provide a feasible laryngeal preservation strategy in patients with resectable locally advanced hypopharyngeal carcinoma.
Male
;
Humans
;
Cohort Studies
;
Chemoradiotherapy
;
Carcinoma
;
Hypopharyngeal Neoplasms/therapy*
;
Induction Chemotherapy
9.Clinical characteristics and efficacy of oropharyngeal carcinoma with secondary primary tumor.
Meilin HE ; Runye WU ; Ye ZHANG ; Xiaodong HUANG ; Kai WANG ; Xuesong CHEN ; Jingbo WANG ; Yuan QU ; Jingwei LUO ; Junlin YI
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2023;37(9):721-728
Objective:To analysis the clinical features and prognosis in oropharyngeal carcinoma with secondary primary tumor. Methods:A retrospective analysis was performed on 468 pathologically confirmed oropharyngeal cancer as the primary tumor patients with p16 status, excluded distant metastasis, and admitted to the Chinese Academy of Medical Sciences from January 2010 to December 2020. The clinical features and prognosis of the secondary primary tumor were analyzed. Results:Among 468 patients with oropharyngeal cancer treated at initial diagnosed, 222 cases were P16-negative. With a median follow-up time of 64.3 months, 66 cases developed second primary cancer, with an incidence of 29.3%, among which 63.6%(42/66) were synchronous and 36.4%(24/66) were heterochronous, esophagus was the most commonly involved site. The 5-year OS of p16-negative oropharyngeal carcinoma with synchronous second primary cancer, without second primary cancer and with heterogeneous second primary cancer were 26.3% and 57.3% and 73.2%(P=0.001); The second primary cancer accounted for 11.2%(12/107) of the deaths in the whole group, among them, the heterochronous second primary accounted for 75.0%(9/12). There were 246 patients with p16 positive, with a median follow-up time of 52.4 months, 20 patients developed second primary cancer(8.1%). Among them, 65.0%(13/20) were synchronous and 35.0%(7/20) were heterochronous. Esophagus was the most commonly involved site. The 4-year OS of p16-positive with synchronous, heterochronous and non-second primary cancer group were 51.9%, 80.7% and 83.3%. Secondary primary cancer accounted for 3.8%(2/52) of all deaths in p16 positvie group. Conclusion:The incidence of second primary cancer of p16 positive and negative oropharyngeal carcinoma were different. The esophagus was the most commonly involved site regardless of p16 status. Regardless of p16 status, the survival of patients with synchronous second primary cancer was worse than those without second primary cancer. For p16-negative oropharyngeal carcinoma, the prognosis was better in patients with heterogeneous second primary cancer, the second primary cancer is one of the main causes of death.
Humans
;
Carcinoma/diagnosis*
;
Oropharyngeal Neoplasms/diagnosis*
;
Retrospective Studies
;
Neoplasms, Second Primary/diagnosis*
10.A meta-analysis of efficacy and safety of nimotuzumab-containing regimens for locally advanced head and neck tumors
Meilin HE ; Ye ZHANG ; Runye WU ; Xiaodong HUANG ; Kai WANG ; Xuesong CHEN ; Jingbo WANG ; Yuan QU ; Jingwei LUO ; Junlin YI
Chinese Journal of Radiation Oncology 2023;32(11):963-969
Objective:To evaluate the efficacy and safety of nimotuzumab in the treatment of advanced head and neck tumors by using meta-analysis.Methods:Randomized controlled trials (RCT) of locally advanced head and neck squamous cell carcinoma (LA-HNSCC) treated with nimotuzumab were searched from databases (Cochrane Library, PubMed, Embase, Wanfang Data and CNKI) for meta-analysis. The efficacy evaluation indexes included overall survival, progression-free survival, disease-free survival, objective response rate, and complete response rate. Adverse reactions were analyzed for safety evaluation. The heterogeneity results were evaluated by Chi-square test, the degree of heterogeneity was evaluated by I2, and the literature was statistically analyzed by random effects model. Results:A total of 11 RCT were included, consisting of 1 202 patients (602 in the intervention group and 600 in the control group). Compared with the control group, the overall survival was significantly prolonged, death risk was decreased by 22% ( HR=0.78, 95% CI=0.63-0.95, P=0.014), the progression-free survival was prolonged and the risk of disease progression was declined by 35% ( HR=0.65, 95% CI=0.53-0.81, P<0.01), and the disease-free survival was prolonged and the risk of recurrence was decreased by 29% ( HR=0.71, 95% CI=0.55-0.91, P<0.01), the objective response rate ( RR=1.37, 95% CI=1.20-1.55, P<0.01) and complete response rate ( RR=1.30, 95% CI=1.15-1.46, P<0.01) were significantly improved in the intervention group. In addition, adding nimotuzumab did not increase the incidence of adverse reaction ( RR=0.98, 95% CI=0.93-1.03, P=0.41). Conclusion:Nimotuzumab can significantly prolong long-term survival and improve short-term efficacy with high safety in LA-HNSCC patients.

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