1.Efficacy and safety of subretinal fluid extraction combined with intravitreal injection of conbercept and gas in the treatment of polypoidal choroidal vas-culopathy complicated with serous retinal pigment epithelium detachment
Enpei XU ; Xianyong SUN ; Rongyu GAO ; Jiandong LIU ; Nan LI ; Juanjuan YANG
Recent Advances in Ophthalmology 2024;44(3):208-212
Objective To investigate the efficacy and safety of subretinal fluid extraction combined with intravitreal conbercept and gas injection in treating polypoidal choroidal vasculopathy(PCV)complicated with serous retinal pigment epithelium detachment(sPED).Methods From July 2019 to February 2021,13 patients(13 eyes)with PCV complicated with sPED who were treated with subretinal fluid extraction combined with intravitreal injection of conbercept and gas in the Weifang Eye Hospital were selected.All affected eyes received at least 3 times(once a month)of intravitreal anti-vas-cular endothelial growth factor(VEGF)(ranibizumab)injections before the surgery,and the treatment was ineffective.The changes in best corrected visual acuity(BCVA),central retinal thickness(CRT),macular foveal PED height and width before and 1 week,1 month,3 months and 6 months after the operation were observed,and the intraoperative and postop-erative complications were recorded.Results The BCVA of the affected eyes 1 week after operation was better than that before operation,and the difference was statistically significant(Z=-3.237,P=0.001).The CRT of the affected eyes at 1 week,1 month,3 months and 6 months after the operation were thinner than that before the operation,and the differ-ence was statistically significant(Z=-3.180,-3.180,-3.110 and-3.180,P=0.001,0.001,0.002 and 0.001).The height and width of PED at 1 week,1 month,3 months and 6 months after the operation were lower than those before the operation,and the differences were statistically significant(all P<0.05).Thirteen eyes received an average of(4.15±1.40)intravitreal injections(ranibizumab)before the surgery,and the treatment duration was(5.92±3.95)months(equivalent to one injection every 6 weeks).During the 6-month follow-up,13 eyes received an average of(2.31±1.97)intravitreal injections(conbercept)(equivalent to once every 10 weeks).Partial correlation analysis showed a weak positive correla-tion between the increase in BCVA and the decrease in CRT 6 months after operation(r=0.416,P=0.203).There was no significant correlation between the increase in BCVA and the changes in PED height and width 6 months after operation(r=0.218,0.209,P=0.520,0.538).At 1 month after the operation,9 eyes had PED recurrence or different degrees of retinal nerve subepithelial effusion,and PED improved after repeated intravitreal injection of conbercept.At 6 months after opera-tion,subfoveal PED completely disappeared in 3 eyes,and the retina was completely reattached.There was still active exu-dation in the retina of 1 eye.No systemic or severe ocular complications occurred in 13 eyes during the follow-up period.Conclusion Subretinal fluid extraction combined with intravitreal injection of conbercept and gas in the treatment of PCV complicated with sPED can safely and effectively reduce CRT,improve PED,and reduce the damage to the retina caused by long-term PED,but it has no significant effect on the improvement of BCVA at 6 months after the operation.
2.Diagnostic value of a combined serology-based model for minimal hepatic encephalopathy in patients with compensated cirrhosis
Shanghao LIU ; Hongmei ZU ; Yan HUANG ; Xiaoqing GUO ; Huiling XIANG ; Tong DANG ; Xiaoyan LI ; Zhaolan YAN ; Yajing LI ; Fei LIU ; Jia SUN ; Ruixin SONG ; Junqing YAN ; Qing YE ; Jing WANG ; Xianmei MENG ; Haiying WANG ; Zhenyu JIANG ; Lei HUANG ; Fanping MENG ; Guo ZHANG ; Wenjuan WANG ; Shaoqi YANG ; Shengjuan HU ; Jigang RUAN ; Chuang LEI ; Qinghai WANG ; Hongling TIAN ; Qi ZHENG ; Yiling LI ; Ningning WANG ; Huipeng CUI ; Yanmeng WANG ; Zhangshu QU ; Min YUAN ; Yijun LIU ; Ying CHEN ; Yuxiang XIA ; Yayuan LIU ; Ying LIU ; Suxuan QU ; Hong TAO ; Ruichun SHI ; Xiaoting YANG ; Dan JIN ; Dan SU ; Yongfeng YANG ; Wei YE ; Na LIU ; Rongyu TANG ; Quan ZHANG ; Qin LIU ; Gaoliang ZOU ; Ziyue LI ; Caiyan ZHAO ; Qian ZHAO ; Qingge ZHANG ; Huafang GAO ; Tao MENG ; Jie LI ; Weihua WU ; Jian WANG ; Chuanlong YANG ; Hui LYU ; Chuan LIU ; Fusheng WANG ; Junliang FU ; Xiaolong QI
Chinese Journal of Laboratory Medicine 2023;46(1):52-61
Objective:To investigate the diagnostic accuracy of serological indicators and evaluate the diagnostic value of a new established combined serological model on identifying the minimal hepatic encephalopathy (MHE) in patients with compensated cirrhosis.Methods:This prospective multicenter study enrolled 263 compensated cirrhotic patients from 23 hospitals in 15 provinces, autonomous regions and municipalities of China between October 2021 and August 2022. Clinical data and laboratory test results were collected, and the model for end-stage liver disease (MELD) score was calculated. Ammonia level was corrected to the upper limit of normal (AMM-ULN) by the baseline blood ammonia measurements/upper limit of the normal reference value. MHE was diagnosed by combined abnormal number connection test-A and abnormal digit symbol test as suggested by Guidelines on the management of hepatic encephalopathy in cirrhosis. The patients were randomly divided (7∶3) into training set ( n=185) and validation set ( n=78) based on caret package of R language. Logistic regression was used to establish a combined model of MHE diagnosis. The diagnostic performance was evaluated by the area under the curve (AUC) of receiver operating characteristic curve, Hosmer-Lemeshow test and calibration curve. The internal verification was carried out by the Bootstrap method ( n=200). AUC comparisons were achieved using the Delong test. Results:In the training set, prevalence of MHE was 37.8% (70/185). There were statistically significant differences in AMM-ULN, albumin, platelet, alkaline phosphatase, international normalized ratio, MELD score and education between non-MHE group and MHE group (all P<0.05). Multivariate Logistic regression analysis showed that AMM-ULN [odds ratio ( OR)=1.78, 95% confidence interval ( CI) 1.05-3.14, P=0.038] and MELD score ( OR=1.11, 95% CI 1.04-1.20, P=0.002) were independent risk factors for MHE, and the AUC for predicting MHE were 0.663, 0.625, respectively. Compared with the use of blood AMM-ULN and MELD score alone, the AUC of the combined model of AMM-ULN, MELD score and education exhibited better predictive performance in determining the presence of MHE was 0.755, the specificity and sensitivity was 85.2% and 55.7%, respectively. Hosmer-Lemeshow test and calibration curve showed that the model had good calibration ( P=0.733). The AUC for internal validation of the combined model for diagnosing MHE was 0.752. In the validation set, the AUC of the combined model for diagnosing MHE was 0.794, and Hosmer-Lemeshow test showed good calibration ( P=0.841). Conclusion:Use of the combined model including AMM-ULN, MELD score and education could improve the predictive efficiency of MHE among patients with compensated cirrhosis.
3.Spatial and temporal expression pattern of somatostatin receptor 2 in mouse.
Mingchuan TANG ; Chuan LIU ; Rongyu LI ; Huisang LIN ; Yanli PENG ; Yiming LANG ; Kecao SU ; Zhongliang XIE ; Mingyue LI ; Xiao YANG ; Guan YANG ; Xinjiong FAN ; Yan TENG
Chinese Journal of Biotechnology 2023;39(7):2656-2668
Somatostatin (SST) is an inhibitory polypeptide hormone that plays an important role in a variety of biological processes. Somatostatin receptor 2 (SSTR2) is the most widely expressed somatostatin receptor. However, the specific cell types expressing Sstr2 in the tissues have not been investigated. In this study, we detected the expression pattern of SSTR2 protein in mouse at different development stages, including the embryonic 15.5 days and the postnatal 1, 7, 15 days as well as 3 and 6 months, by multicolour immunofluorescence analyses. We found that Sstr2 was expressed in some specific cells types of several tissues, including the neuronal cells and astrocytes in the brain, the mesenchymal cells, the hematopoietic cells, the early hematopoietic stem cells, and the B cells in the bone marrow, the macrophages, the type Ⅱ alveolar epithelial cells, and the airway ciliated cells in the lung, the epithelial cells and the neuronal cells in the intestine, the hair follicle cells, the gastric epithelial cells, the hematopoietic stem cells and the nerve fibre in the spleen, and the tubular epithelial cells in the kidney. This study identified the specific cell types expressing Sstr2 in mouse at different developmental stages, providing new insights into the physiological function of SST and SSTR2 in several cell types.
Mice
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Animals
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Receptors, Somatostatin/metabolism*
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Hematopoietic Stem Cells/metabolism*
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Epithelial Cells
4.Addendum: A phase II trial of cytoreductive surgery combined with niraparib maintenance in platinum-sensitive, secondary recurrent ovarian cancer: SGOG SOC-3 study
Tingyan SHI ; Libing XIANG ; Jianqing ZHU ; Jihong LIU ; Ping ZHANG ; Huaying WANG ; Yanling FENG ; Tao ZHU ; Yingli ZHANG ; Aijun YU ; Wei JIANG ; Xipeng WANG ; Yaping ZHU ; Sufang WU ; Yincheng TENG ; Jiejie ZHANG ; Rong JIANG ; Wei ZHANG ; Huixun JIA ; Rongyu ZANG
Journal of Gynecologic Oncology 2022;33(4):e63-
5.Comparison of the efficacy of conbercept and intravitreal dexamethasone implant Ozurdex in the treatment of diabetic macular edema
Rongyu GAO ; Jiandong LIU ; Fangxing ZHU ; Juanjuan YANG ; Enpei XU ; Xinyan XU
Chinese Journal of Experimental Ophthalmology 2022;40(7):658-663
Objective:To compare the efficacy and safety of intravitreal injection of anti-vascular endothelial growth factor drug conbercept and intravitreal dexamethasone implant Ozurdex in the treatment of diabetic macular edema (DME).Methods:A randomized controlled clinical study was performed.Thirty-six DME patients (36 eyes) were enrolled in Weifang Eye Hospital from March 2018 to June 2019.The patients were randomized into Ozurdex group and conbercept group via a random number table, with 18 eyes in each group.Patients received Ozurdex injection once, which was maintained for 6 months, or conbercept injection once a month for 3 times according to grouping.Before and after treatment, the best corrected visual acuity (BCVA) was examined with the International Standard Visual acuity chart and converted to logarithm of minimal angle resolution unit.The intraocular pressure (IOP) was measured using a non-contact tonometer.The central retinal thickness (CRT) was detected by optical coherence tomography (OCT).This study followed the Declaration of Helsinki and was approved by the Ethics Committee of Weifang Eye Hospital.Results:All patients were followed up for 6 months.In Ozurdex group, the BCVA pre-injection and at 1 month, 3, 4, 6 months after the first injection was 0.59±0.22, 0.53±0.20, 0.41±0.16, 0.38±0.19 and 0.56±0.19, respectively.The BCVA at 1 month, 3 and 4 months after the first injection were better than that before injection, and the differences were statistically significant (all at P<0.05).In conbercept group, the BCVA pre-injection and at 1 month, 3, 4, 6 months after the first injection were 0.60±0.23, 0.51±0.17, 0.29±0.13, 0.56±0.18 and 0.60±0.18, respectively.The BCVA at 1 month and 3 months after the first injection were better than that before injection, showing statistically significant differences (all at P<0.05).The CRT at 1 month, 3 and 4 months after the first injection were significantly lower than that before treatment in both the two groups (all at P<0.05).The CRT pre-injection was (498.61±77.14)μm in Ozurdex group, which was significantly higher than (462.17±48.74)μm at 6 months after the first injection ( P<0.05).No significant difference in CRT was found between pre-injection and 6 months after the first injection in conbercept group ( P>0.05).The incidence of high IOP in Ozurdex group was 33.3%(6/18), which was higher than 5.56%(1/18) in conbercept group, with a significant difference ( χ2=4.433, P=0.035).No adverse effects such as aggravation of cataract, lens injury, endophthalmitis, vitreous hemorrhage and retinal detachment was found during the follow-up. Conclusions:For DME, both conbercept and Ozurdex can improve BCVA and reduce CRT.Ozurdex shows durable efficacy and needs fewer injections than conbercept, but conbercept has less effect on IOP and is safer than Ozurdex.
6.Clinical value of endoscopic stricturotomy under balloon-assisted enteroscopy in the treatment of benign jejuno-ileal stenosis
Rongyu LIU ; Bairong LI ; Manhua LI ; Tao SUN ; Xiao CHEN ; Jincheng WU ; Jing LI ; Chongxi FAN ; Shoubin NING
Chinese Journal of Digestion 2022;42(7):470-477
Objective:To evaluate the efficacy and safety of endoscopic stricturotomy (EST) under balloon-assisted enteroscopy (BAE) in treatment of benign jejuno-ileal stenosis.Methods:From December 2015 to August 2021, at the Air Force Medical Center, 41 patients who were diagnosed with benign jejuno-ileal stenosis underwent BAE deep small bowel EST and/or surgery due to ineffective or ineffective drug treatment were retrospectively analyzed. Twenty-one patients were treated with EST (EST group) and 20 patients were treated with surgery (surgery group). The etiology and follow-up time were analyzed, the general conditions (male proportion and age), the immediate technical success rate (the percentage of the stenosis that the enteroscope could pass through after EST in the total number of treated stenoses), the incidence of complications (including perforation, bleeding, etc.), the symptom remission rates at 3-month, 6-month, and 1-year after treatment (the percentage of patients with complete or partial remission in the total number of patients), cumulative symptom-free survival rate (no obstruction-related symptoms after EST or surgery till the last follow-up) and cumulative surgery-free survival rate of two groups were compared. Chi-square test, independent t-test, Fisher′s exact probability method and Kaplan-Meier analysis were used for statistical analysis. Results:The main etiology of stricture of EST group and surgery group was Crohn′s disease (71.4%, 15/21 and 60.0%, 12/20, respectively), and the median follow-up time was 12 months (6 to 46 months) and 45 months (14 to 73 months), respectively. There were no significant differences in male proportion, age, immediate technical success rate and incidence of complication between EST group and surgery group (57.1%, 12/21 vs. 65.0%, 13/20; (45.2±17.4) years old vs. (43.1±20.3) years old; 95.3%, 41/43 vs. 100.0%, 30/30; 26.9%, 7/26 vs. 10.0%, 2/20, all P>0.05). In the EST group, 9.5% (2/21) of the patients received surgery because of perforation during EST, 76.2% (16/21) of the patients did not need surgery after EST, and the median symptom-free survival time of patients without symptoms in EST group was 13.3 months. There was no significant difference in the symptom remission rate at 3-month after treatment between EST group and the surgery group (17/19 vs. 100.0%, 20/20, P>0.05). The symptom remission rate at 6-month and 1-year of EST group were lower than those of the surgery group (15/19 vs. 100.0%, 20/20; 8/11 vs. 100.0%, 20/20), and the differences were statistically significant (both were Fisher′s exact probability method, P=0.047 and 0.037). The cumulative symptom-free survival rates at 3-month, 6-month and 1-year of EST group and surgery group were 66.0% vs. 90.0%, 61.0% vs. 85.0% and 54.0% vs. 80.0%, respectively.The results of Kaplan-Meier analysis indicated that there was no significant difference in the symptom-free survival curve between two groups ( P>0.05). The 3-month, 6-month and 1-year cumulative surgery-free survival rates after treatment in EST group were 90.0%, 81.0% and 73.0%, respectively. The 3-month, 6-month and 1-year cumulative surgery-free survival rates after treatment in surgery group were all 100.0%. Conclusion:EST under BAE is technically feasible, and safe in the treatment of benign jejuno-ileal stenosis, and can effectively relieve clinical obstruction symptoms and avoid or delay surgery in the short term.
7.Hospitalization Due to Asthma Exacerbation: A China Asthma Research Network (CARN) Retrospective Study in 29 Provinces Across Mainland China
Jiangtao LIN ; Bin XING ; Huaping TANG ; Lan YANG ; Yadong YUAN ; Yuhai GU ; Ping CHEN ; Xiaoju LIU ; Jie ZHANG ; Huiguo LIU ; Changzheng WANG ; Wei ZHOU ; Dejun SUN ; Yiqiang CHEN ; Zhuochang CHEN ; Mao HUANG ; Qichang LIN ; Chengping HU ; Xiaohong YANG ; Jianmin HUO ; Xianwei YE ; Xin ZHOU ; Ping JIANG ; Wei ZHANG ; Yijiang HUANG ; Luming DAI ; Rongyu LIU ; Shaoxi CAI ; Jianying XU ; Jianying ZHOU ;
Allergy, Asthma & Immunology Research 2020;12(3):485-495
PURPOSE: Details of patients hospitalized for asthma exacerbation in mainland China are lacking. To improve disease control and reduce economic burden, a large sample survey among this patient population is indispensable. This study aimed to investigate the clinical characteristics and outcomes of such patients.METHODS: A retrospective study was conducted on patients hospitalized for asthma exacerbation in 29 hospitals of 29 regions in mainland China during the period 2013 to 2014. Demographic features, pre-admission conditions, exacerbation details, and outcomes were summarized. Risk factors for exacerbation severity were analyzed.RESULTS: There were 3,240 asthmatic patients included in this study (57.7% females, 42.3% males). Only 28.0% used daily controller medications; 1,287 (39.7%) patients were not currently on inhaled corticosteroids. Acute upper airway infection was the most common trigger of exacerbation (42.3%). Patients with severe to life-threatening exacerbation tended to have a longer disease course, a smoking history, and had comorbidities such as hypertension, chronic obstructive pulmonary disease (COPD), and food allergy. The multivariate analysis showed that smoking history, comorbidities of hypertension, COPD, and food allergy were independent risk factors for more severe exacerbation. The number of patients hospitalized for asthma exacerbation varied with seasons, peaking in March and September. Eight patients died during the study period (mortality 0.25%).CONCLUSIONS: Despite enhanced education on asthma self-management in China during recent years, few patients were using daily controller medications before the onset of their exacerbation, indicating that more educational efforts and considerations are needed. The findings of this study may improve our understanding of hospital admission for asthma exacerbation in mainland China and provide evidence for decision-making.
Adrenal Cortex Hormones
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Asthma
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China
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Comorbidity
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Disease Progression
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Education
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Female
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Food Hypersensitivity
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Hospitalization
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Humans
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Hypertension
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Inpatients
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Medication Adherence
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Mortality
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Multivariate Analysis
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Pulmonary Disease, Chronic Obstructive
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Retrospective Studies
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Risk Factors
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Seasons
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Self Care
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Smoke
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Smoking
8.Clinical effect of non-vitrectomy in the treatment of idiopathic macular epiretinal membranes
Jiandong LIU ; Rongyu GAO ; Xinyan XU ; Jie ZHANG ; Fangxing ZHU ; Xianyong SUN ; Juanjuan YANG
Chinese Journal of Ocular Fundus Diseases 2020;36(5):379-383
Objective:To observe the effect of non-vitrectomy in the treatment of idiopathic macular epiretinal membranes (IMEM).Methods:This study is a randomized controlled trial. From December 2017 to December 2018, 60 IMEM patients (60 eyes) diagnosed in Weifang Eye Hospital were included in the study. BCVA, intraocular pressure (IOP) and OCT were performed in all patients. The BCVA examination was performed using the international standard visual acuity chart, which was converted to logMAR. The CMT was measured by OCT. According to the surgical methods, the patients were divided into non-vitrectomy group and control group, 30 patients (30 eyes) in each group. The age ( t=1.723), logMAR BCVA ( t=1.703), CMT ( t=-0.956), IOP ( t=-1.434) were not significantly different between the two groups ( P=0.090, 0.094, 0.343, 0.157). 23G vitreous cutting system was used in all eyes. The macular epiretinal membranes was removed by non-vitrectomy in the non-vitrectomy group and by vitrectomy in the control group. The relevant examination with the same equipment and methods before the operation at 1 week and 1, 3, 6 months after operation. The time of surgery, the changes of BCVA, CMT and postoperative complications in the two groups were observed comparatively. Variance analysis of repeated measurements was performed for the comparison of BCVA, CMT and IOP after surgery in the two groups. Wilcoxon rank sum test of two independent samples was performed for the degree of vision improvement. The incidence of postoperative complications was compared by χ2 test. Results:At 6 months after operation, BCVA increased in 24 eyes (80%) and unchanged in 6 eyes (20%) in the non-vitrectomy group. Compared with preoperative BCVA, the difference was statistically significant ( P<0.05). BCVA increased in 25 eyes (83.4%), unchanged in 4 eyes (13.3%) and decreased in 1 eye (3.3%) in the control group. Compared with preoperative BCVA, the difference was statistically significant ( P<0.05). There was no significant difference between the two groups in BCVA improvement degree after operation ( Z=-0.26, P>0.05). At 6 months after operation, the average logMAR BCVA was statistically significant compared with the preoperative in the non-vitrectomy group ( P=0.002, 0.005) and control group ( P=0.004, <0.001). Visual stability occurred 1 month after operation in the non-vitrectomy group and 3 months after operation in the control group. The effective operative time of the non-vitrectomy group and control group was 4.50±1.41 and 15.50±2.33 min, respectively. The difference of effective operation time between the two groups was statistically significant ( t=-22.12, P <0.05). After surgery, no significant complications were found in the non-vitrectomy group. In the control group, there were 3 eyes with low IOP and 1 eye with macular hole during operation. Conclusions:Non-vitrectomy and vitrectomy have similar effects on IMEM. Non-vitrectomy has short effective operation time, faster recovery after surgery and no obvious complications.
9.A phase II trial of cytoreductive surgery combined with niraparib maintenance in platinum-sensitive, secondary recurrent ovarian cancer: SGOG SOC-3 study
Tingyan SHI ; Sheng YIN ; Jianqing ZHU ; Ping ZHANG ; Jihong LIU ; Libing XIANG ; Yaping ZHU ; Sufang WU ; Xiaojun CHEN ; Xipeng WANG ; Yincheng TENG ; Tao ZHU ; Aijun YU ; Yingli ZHANG ; Yanling FENG ; He HUANG ; Wei BAO ; Yanli LI ; Wei JIANG ; Ping ZHANG ; Jiarui LI ; Zhihong AI ; Wei ZHANG ; Huixun JIA ; Yuqin ZHANG ; Rong JIANG ; Jiejie ZHANG ; Wen GAO ; Yuting LUAN ; Rongyu ZANG
Journal of Gynecologic Oncology 2020;31(3):e61-
Background:
In China, secondary cytoreductive surgery (SCR) has been widely used in ovarian cancer (OC) over the past two decades. Although Gynecologic Oncology Group-0213 trial did not show its overall survival benefit in first relapsed patients, the questions on patient selection and effect of subsequent targeting therapy are still open. The preliminary data from our pre-SOC1 phase II study showed that selected patients with second relapse who never received SCR at recurrence may still benefit from surgery. Moreover, poly(ADP-ribose) polymerase inhibitors (PARPi) maintenance now has been a standard care for platinum sensitive relapsed OC. To our knowledge, no published or ongoing trial is trying to answer the question if patient can benefit from a potentially complete resection combined with PARPi maintenance in OC patients with secondary recurrence.
Methods
SOC-3 is a multi-center, open, randomized, controlled, phase II trial of SCR followed by chemotherapy and niraparib maintenance vs chemotherapy and niraparib maintenance in patients with platinum-sensitive second relapsed OC who never received SCR at recurrence. To guarantee surgical quality, if the sites had no experience of participating in any OC-related surgical trials, the number of recurrent lesions evaluated by central-reviewed positron emission tomography–computed tomography image shouldn't be more than 3. Eligible patients are randomly assigned in a 1:1 ratio to receive either SCR followed by 6 cyclesof platinum-based chemotherapy and niraparib maintenance or 6 cycles of platinum-based chemotherapy and niraparib maintenance alone. Patients who undergo at least 4 cycles of chemotherapy and must be, in the opinion of the investigator, without disease progression, will be assigned niraparib maintenance. Major inclusion criteria are secondary relapsed OC with a platinum-free interval of no less than 6 months and a possibly complete resection. Major exclusion criteria are borderline tumors and non-epithelial ovarian malignancies, received debulking surgery at recurrence and impossible to complete resection. The sample size is 96 patients. Primary endpoint is 12-month non-progression rate.
10.Study of upfront surgery versus neoadjuvant chemotherapy followed by interval debulking surgery for patients with stage IIIC and IV ovarian cancer, SGOG SUNNY (SOC-2) trial concept
Rong JIANG ; Jianqing ZHU ; Jae-Weon KIM ; Jihong LIU ; Kazuyoshi KATO ; Hee-Seung KIM ; Yuqin ZHANG ; Ping ZHANG ; Tao ZHU ; Daisuke AOKI ; Aijun YU ; Xiaojun CHEN ; Xipeng WANG ; Ding ZHU ; Wei ZHANG ; Huixun JIA ; Tingyan SHI ; Wen GAO ; Sheng YIN ; Yanling FENG ; Libing XIANG ; Aikou OKAMOTO ; Rongyu ZANG
Journal of Gynecologic Oncology 2020;31(5):e86-
Background:
Two randomized phase III trials (EORTC55971 and CHORUS) showed similar progression-free and overall survival in primary or interval debulking surgery in ovarian cancer, however both studies had limitations with lower rate of complete resection and lack of surgical qualifications for participating centers. There is no consensus on whether neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS) could be a preferred approach in the management of advanced epithelial ovarian cancer (EOC) in the clinical practice.
Methods
The Asian SUNNY study is an open-label, multicenter, randomized controlled, phase III trial to compare the effect of primary debulking surgery (PDS) to NACT-IDS in stages IIIC and IV EOC, fallopian tube cancer (FTC) or primary peritoneal carcinoma (PPC).The hypothesis is that PDS enhances the survivorship when compared with NACT-IDS in advanced ovarian cancer. The primary objective is to clarify the role of PDS and NACT-IDS in the treatment of advanced ovarian cancer. Surgical quality assures include at least 50% of no gross residual (NGR) in PDS group in all centers and participating centers should be national cancer centers or designed ovarian cancer section or those with the experience participating surgical trials of ovarian cancer. Any participating center should be monitored evaluating the proportions of NGR by a training set. The aim of the surgery in both arms is maximal cytoreduction. Tumor burden of the disease is evaluated by diagnostic laparoscopy or positron emission tomography/computed tomography scan. Patients assigned to PDS group will undergo upfront maximal cytoreductive surgery within 3 weeks after biopsy, followed by 6 cycles of standard adjuvant chemotherapy. Patients assigned to NACT group will undergo 3 cycles of NACT-IDS, and subsequently 3 cycles of adjuvant chemotherapy. The maximal time interval between IDS and the initiation of adjuvant chemotherapy is 8 weeks. Major inclusion criteria are pathologic confirmed stage IIIC and IV EOC, FTC or PPC; ECOG performance status of 0 to 2; ASA score of 1 to 2. Major exclusion criteria are non-epithelial tumors as well as borderline tumors; low-grade carcinoma; mucinous ovarian cancer. The sample size is 456 subjects. Primary endpoint is overall survival.

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