1.Gemcitabine long-term maintenance chemotherapy benefits patients with survival: a multicenter, real-world study of advanced breast cancer treatment in China
Jian YUE ; Guohong SONG ; Huiping LI ; Tao SUN ; Lihua SONG ; Zhongsheng TONG ; Lili ZHANG ; Zhenchuan SONG ; Quchang OUYANG ; Jin YANG ; Yueyin PAN ; Peng YUAN
Chinese Journal of Oncology 2024;46(3):249-255
Objective:This study collected a real-world data on survival and efficacy of gemcitabine-containing therapy in advanced breast cancer. Aimed to find the main reasons of affecting the duration of gemcitabine-base therapy in advanced breast cancer patients.Methods:Advanced breast cancer patients who received gemcitabine-base therapy from January 2017 to January 2019 were enrolled(10 hospitals). The clinicopathological data, the number of chemotherapy cycles and the reasons for treatment termination were collected and analyzed. To identify the reasons related with continuous treatment for advanced breast cancer and the factors which affect the survival and efficacy.Results:A total of 224 patients with advanced breast cancer were enrolled in this study, with a median age of 52 years (26-77 years), 55.4%(124/224) was postmenopausal. Luminal type were 83 cases, TNBC were 97 cases, and human epidermal growth factor receptor 2 (HER's-2) overexpression were 44. At the analysis, 224 patients who received the gemcitabine-based regimens were evaluated, included 5 complete reponse (CR), 77 partial response (PR), 112 stable disease (SD) and 27 progressive disease (PD). The objective response rate (ORR) was 36.6%(82/224). Seventy patients had serious adverse diseases, including leukopenia (9), neutrophilia (49), thrombocytopenia (15), and elevated transaminase (2). The median follow-up time was 41 months (26~61 months), and the median PFS was 5.6 months. The reasons of termination treatment were listed: disease progression were 90 patients; personal reasons were 51 patients; adverse drug reactions were 18 patients; completed treatment were 65 patients. It was found that progression-free survival (PFS) was significantly longer in patients receiving >6 cycles than that in patients with ≤6 cycles (8.2 months vs 5.4 months, HR=2.474, 95% CI: 1.730-3.538, P<0.001). Conclusions:Gemcitabine-based regimen is generally well tolerated in the Chinese population and has relatively ideal clinical efficacy in the real world. The median PFS is significantly prolonged when the number of treatment cycles are appropriately increased.
2.Gemcitabine long-term maintenance chemotherapy benefits patients with survival: a multicenter, real-world study of advanced breast cancer treatment in China
Jian YUE ; Guohong SONG ; Huiping LI ; Tao SUN ; Lihua SONG ; Zhongsheng TONG ; Lili ZHANG ; Zhenchuan SONG ; Quchang OUYANG ; Jin YANG ; Yueyin PAN ; Peng YUAN
Chinese Journal of Oncology 2024;46(3):249-255
Objective:This study collected a real-world data on survival and efficacy of gemcitabine-containing therapy in advanced breast cancer. Aimed to find the main reasons of affecting the duration of gemcitabine-base therapy in advanced breast cancer patients.Methods:Advanced breast cancer patients who received gemcitabine-base therapy from January 2017 to January 2019 were enrolled(10 hospitals). The clinicopathological data, the number of chemotherapy cycles and the reasons for treatment termination were collected and analyzed. To identify the reasons related with continuous treatment for advanced breast cancer and the factors which affect the survival and efficacy.Results:A total of 224 patients with advanced breast cancer were enrolled in this study, with a median age of 52 years (26-77 years), 55.4%(124/224) was postmenopausal. Luminal type were 83 cases, TNBC were 97 cases, and human epidermal growth factor receptor 2 (HER's-2) overexpression were 44. At the analysis, 224 patients who received the gemcitabine-based regimens were evaluated, included 5 complete reponse (CR), 77 partial response (PR), 112 stable disease (SD) and 27 progressive disease (PD). The objective response rate (ORR) was 36.6%(82/224). Seventy patients had serious adverse diseases, including leukopenia (9), neutrophilia (49), thrombocytopenia (15), and elevated transaminase (2). The median follow-up time was 41 months (26~61 months), and the median PFS was 5.6 months. The reasons of termination treatment were listed: disease progression were 90 patients; personal reasons were 51 patients; adverse drug reactions were 18 patients; completed treatment were 65 patients. It was found that progression-free survival (PFS) was significantly longer in patients receiving >6 cycles than that in patients with ≤6 cycles (8.2 months vs 5.4 months, HR=2.474, 95% CI: 1.730-3.538, P<0.001). Conclusions:Gemcitabine-based regimen is generally well tolerated in the Chinese population and has relatively ideal clinical efficacy in the real world. The median PFS is significantly prolonged when the number of treatment cycles are appropriately increased.
3.Entinostat, a class I selective histone deacetylase inhibitor, plus exemestane for Chinese patients with hormone receptor-positive advanced breast cancer: A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial.
Binghe XU ; Qingyuan ZHANG ; Xichun HU ; Qing LI ; Tao SUN ; Wei LI ; Quchang OUYANG ; Jingfen WANG ; Zhongsheng TONG ; Min YAN ; Huiping LI ; Xiaohua ZENG ; Changping SHAN ; Xian WANG ; Xi YAN ; Jian ZHANG ; Yue ZHANG ; Jiani WANG ; Liang ZHANG ; Ying LIN ; Jifeng FENG ; Qianjun CHEN ; Jian HUANG ; Lu ZHANG ; Lisong YANG ; Ying TIAN ; Hongyan SHANG
Acta Pharmaceutica Sinica B 2023;13(5):2250-2258
Entinostat plus exemestane in hormone receptor-positive (HR+) advanced breast cancer (ABC) previously showed encouraging outcomes. This multicenter phase 3 trial evaluated the efficacy and safety of entinostat plus exemestane in Chinese patients with HR + ABC that relapsed/progressed after ≥1 endocrine therapy. Patients were randomized (2:1) to oral exemestane 25 mg/day plus entinostat (n = 235) or placebo (n = 119) 5 mg/week in 28-day cycles. The primary endpoint was the independent radiographic committee (IRC)-assessed progression-free survival (PFS). The median age was 52 (range, 28-75) years and 222 (62.7%) patients were postmenopausal. CDK4/6 inhibitors and fulvestrant were previously used in 23 (6.5%) and 92 (26.0%) patients, respectively. The baseline characteristics were comparable between the entinostat and placebo groups. The median PFS was 6.32 (95% CI, 5.30-9.11) and 3.72 (95% CI, 1.91-5.49) months in the entinostat and placebo groups (HR, 0.76; 95% CI, 0.58-0.98; P = 0.046), respectively. Grade ≥3 adverse events (AEs) occurred in 154 (65.5%) patients in the entinostat group versus 23 (19.3%) in the placebo group, and the most common grade ≥3 treatment-related AEs were neutropenia [103 (43.8%)], thrombocytopenia [20 (8.5%)], and leucopenia [15 (6.4%)]. Entinostat plus exemestane significantly improved PFS compared with exemestane, with generally manageable toxicities in HR + ABC (ClinicalTrials.gov #NCT03538171).
4.Machine learning modeling identifies hypertrophic cardiomyopathy subtypes with genetic signature.
Jiaqi DAI ; Tao WANG ; Ke XU ; Yang SUN ; Zongzhe LI ; Peng CHEN ; Hong WANG ; Dongyang WU ; Yanghui CHEN ; Lei XIAO ; Hao LIU ; Haoran WEI ; Rui LI ; Liyuan PENG ; Ting YU ; Yan WANG ; Zhongsheng SUN ; Dao Wen WANG
Frontiers of Medicine 2023;17(4):768-780
Previous studies have revealed that patients with hypertrophic cardiomyopathy (HCM) exhibit differences in symptom severity and prognosis, indicating potential HCM subtypes among these patients. Here, 793 patients with HCM were recruited at an average follow-up of 32.78 ± 27.58 months to identify potential HCM subtypes by performing consensus clustering on the basis of their echocardiography features. Furthermore, we proposed a systematic method for illustrating the relationship between the phenotype and genotype of each HCM subtype by using machine learning modeling and interactome network detection techniques based on whole-exome sequencing data. Another independent cohort that consisted of 414 patients with HCM was recruited to replicate the findings. Consequently, two subtypes characterized by different clinical outcomes were identified in HCM. Patients with subtype 2 presented asymmetric septal hypertrophy associated with a stable course, while those with subtype 1 displayed left ventricular systolic dysfunction and aggressive progression. Machine learning modeling based on personal whole-exome data identified 46 genes with mutation burden that could accurately predict subtype propensities. Furthermore, the patients in another cohort predicted as subtype 1 by the 46-gene model presented increased left ventricular end-diastolic diameter and reduced left ventricular ejection fraction. By employing echocardiography and genetic screening for the 46 genes, HCM can be classified into two subtypes with distinct clinical outcomes.
5.Therapeutic efficacy of the buccal masses after temporal autologous fat grafting
Fangwei LI ; Shengkang LUO ; Zhongsheng SUN
Chinese Journal of Medical Aesthetics and Cosmetology 2022;28(1):49-51
Objective:To investigate the causes of buccal masses after temporal autologous fat grafting, and to summarize the therapeutic methods to avoid medical disputes.Methods:Ten female patients (25-40 years; mean age, 33.1±7.5 years) with buccal mass complication after temporal autologous fat grafting were retrospectively analyzed, and statistics was done on their fat injection history, postoperative buccal mass symptom onset time, intraoperative mass conditions, postoperative pathological and fluid bacterial culture results, and postoperative recovery.Results:The unilateral temporal fat injection volume was 15-30 ml, and the buccal masses occurred 1-6 months after temporal autologous fat grafting. Lipoid masses were found in the buccal space during the operation, and some of them contained liquid. The postoperative pathological results indicated local necrosis in fibrotic adipose tissues. All the fluid bacteria cultures were negative, only one showed positive culture of acid-fast bacilli. 6-12 months postoperative follow-up visit was performed, and 9 patients recovered and 1 patient recovered after re-operation.Conclusions:The overfilled fat and liquefied necrotic fat after temporal fat grafting may move down to buccal space to form buccal masses, which should be treated by operation early to achieve a good prognosis.
6.Prevalence of Autism Spectrum Disorder in China: A Nationwide Multi-center Population-based Study Among Children Aged 6 to 12 Years.
Hao ZHOU ; Xiu XU ; Weili YAN ; Xiaobing ZOU ; Lijie WU ; Xuerong LUO ; Tingyu LI ; Yi HUANG ; Hongyan GUAN ; Xiang CHEN ; Meng MAO ; Kun XIA ; Lan ZHANG ; Erzhen LI ; Xiaoling GE ; Lili ZHANG ; Chunpei LI ; Xudong ZHANG ; Yuanfeng ZHOU ; Ding DING ; Andy SHIH ; Eric FOMBONNE ; Yi ZHENG ; Jisheng HAN ; Zhongsheng SUN ; Yong-Hui JIANG ; Yi WANG
Neuroscience Bulletin 2020;36(9):961-971
This study aimed to obtain the first national estimate of the prevalence of autism spectrum disorder (ASD) in Chinese children. We targeted the population of 6 to 12-year-old children for this prevalence study by multistage convenient cluster sampling. The Modified Chinese Autism Spectrum Rating Scale was used for the screening process. Of the target population of 142,086 children, 88.5% (n = 125,806) participated in the study. A total of 363 children were confirmed as having ASD. The observed ASD prevalence rate was 0.29% (95% CI: 0.26%-0.32%) for the overall population. After adjustment for response rates, the estimated number of ASD cases was 867 in the target population sample, thereby achieving an estimated prevalence of 0.70% (95% CI: 0.64%-0.74%). The prevalence was significantly higher in boys than in girls (0.95%; 95% CI: 0.87%-1.02% versus 0.30%; 95% CI: 0.26%-0.34%; P < 0.001). Of the 363 confirmed ASD cases, 43.3% were newly diagnosed, and most of those (90.4%) were attending regular schools, and 68.8% of the children with ASD had at least one neuropsychiatric comorbidity. Our findings provide reliable data on the estimated ASD prevalence and comorbidities in Chinese children.
7.Clinical effect of linear mastoplasty in treatment of mastoptosis
Li ZENG ; Shengkang LUO ; Haibin WANG ; Zhongsheng SUN ; Xiang XU
Chinese Journal of Medical Aesthetics and Cosmetology 2020;26(1):8-11
Objective To evaluate the effect of Lejours' procedure in the treatment of breast prolapse.Methods From July 2014 to July 2018,the Second People's Hospital of Guangdong Prov ince accepted 36 female patients with breast prolapse and correction failure,aged 25 42 years,with an average age of 32.1 years.According to the preoperative design,the pedicel epidermis,the redundant skin,the prosthesis and capsule were removed,and the mammary flap was fixed on the fascia of pectoralis major muscle,and the nipple and areola were fixed and sutured layer by layer.Results In 36 cases,the shape of breast was improved,the scar of incision was smaller,and the color of scar became lighter with time.There were no serious complications such as nipple and areola necrosis.The breast was straight and round after operation.After 6-24 months follow-up,one patient had delayed wound healing and received repeated dressing changes for 7 days.Conclusions The design of the op eration is simple,with little scar,few complications and good long term effect.The shape of the breast after repair is round and straight,which can be used as one of the feasible operation methods for the repair of breast ptosis.
8.The diagnostic value of chest CT imaging in differential diagnosis between common-type COVID-19 and mycoplasma pneumonia
Zhanguo SUN ; Zhengtong WANG ; Yueqin CHEN ; Wenheng QIN ; Wenwen ZHAO ; Wei LIU ; Zhongsheng ZHANG
Chinese Journal of Radiology 2020;54(7):683-687
Objective:To explore the diagnostic value of chest CT imaging in differential diagnosis between common-type COVID-19 and mycoplasma pneumonia (MP).Methods:From the January to February 2020, the clinical and imaging data of COVID-19 patients (diagnosed in the Affiliated Hospital of Jining Medical University, the Fourth People's Hospital of Jining and the Second People's Hospital of Jining) and MP patients (diagnosed in the Affiliated Hospital of Jining Medical University) were retrospectively collected and analyzed. Forty-three patients with common-type COVID-19 (28 males, 15 females, 43±14 years old) and 50 patients with MP (19 males, 31 females, 37±14 years old) were enrolled as COVID-19 group and MP group, respectively. The clinical manifestations, laboratory results and chest CT findings of these two groups were analyzed and compared.Results:(1) Clinical manifestations: there were more patients with muscle ache and asthenia in COVID-19 group than in MP group (χ 2=5.110, 4.834, P<0.05). No significant difference was found in fever and cough between two groups (χ 2=0.378, 0.097, P>0.05). (2) Laboratory examination: the procalcitonin level of cases in COVID-19 group was significantly lower than that in MP group (χ 2=12.263, P=0.001). No significant difference was found in leukocyte count, lymphocyte count, C-reactive protein level and erythrocyte sedimentation rate ( Z=-1.117, χ 2=2.410, 0.787, 0.800, all P>0.05) between two groups. (3) Chest CT findings bilateral lung involvement was found more in COVID-19 group than in MP group (χ 2=30.012, P<0.001); while the one lobe of ipilateral lung involvement was less in COVID-19 group than in MP group (χ 2=19.927, P<0.001); there was no significant difference in multiple lobes of ipilateral lung involvment between the two groups (χ 2=1.366, P>0.05). Ground glass, paving stone sign and air bronchus sign were found significantly more in COVID-19 group than in MP group (χ 2=30.171, 19.119, 9.790, all P<0.05); while the pulmonary consolidation, central lobular nodule and centripetal thickening of bronchus wall were found significantly less in COVID-19 group than in MP group (χ 2=25.450, 33.532, 48.553, all P<0.001). Conclusions:The clinical manifestations and laboratory examination have limited value in the differential diagnosis of common-type COVID-19 and MP, while chest CT imaging might be more valuable in the early differential diagnosis of these two diseases.
9.Plastic surgery for the serious breast asymmetry
Haibin WANG ; Zhongsheng SUN ; Xiang XU ; Shengkang LUO
Chinese Journal of Medical Aesthetics and Cosmetology 2016;22(1):17-20
Objective To evaluate mammaplasty for repairing the serious breast asymmetry.Methods Different mammaplasty was used to repair 38 cases of breast asymmetry,including 13 cases of unilateral breast augmentation,10 cases of breast reduction after different volume resection on each side,4 cases of unilateral partial breast resection,5 cases of breast reduction on one side and breast suspended on another side,4 cases of breast suspension on one side and augmentation on the other side,and 2 cases of only suspension on unilateral breast.The 38 cases were followed up for 3 to 12 months postoperatively to evaluate the results.Results One case had slight ptosis in half a year after breast suspension.Apart from mentioned above,the rest of 11 had favorable and satisfactory results.Conclusions The serious breast asymmetry deformities should be corrected with the method of the simple and minimum injuries to make the best result.
10.A multicenter, randomized, controlled, phase Ⅲ clinical study of PEG-rhG-CSF for preventing chemotherapy-induced neutropenia in patients with breast cancer and non-small cell lung cancer.
Binghe XU ; Fuguo TIAN ; Jingrui YU ; Yanqiu SONG ; Jianhua SHI ; Baihong ZHANG ; Yanjun ZHANG ; Zhiping YUAN ; Qiong WU ; Qingyuan ZHANG ; Kejun NAN ; Qiang SUN ; Weilian LI ; Jianbing HU ; Jingwang BI ; Chun MENG ; Hong DAI ; Hongchuan JIANG ; Shun YUE ; Bangwei CAO ; Yuping SUN ; Shu WANG ; Zhongsheng TONG ; Peng SHEN ; Gang WU ; Lili TANG ; Yongchuan DENG ; Liqun JIA ; Kunwei SHEN ; Wu ZHUANG ; Xiaodong XIE ; Youhua WU ; Lin CHEN
Chinese Journal of Oncology 2016;38(1):23-27
OBJECTIVETo explore the safety and efficacy of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in preventing chemotherapy-induced neutropenia in patients with breast cancer and non-small cell lung cancer (NSCLC), and to provide the basis for clinical application.
METHODSAccording to the principle of open-label, randomized, parallel-group controlled clinical trial, all patients were randomized by 1∶1∶1 into three groups to receive PEG-rhG-CSF 100 μg/kg, PEG-rhG-CSF 6 mg, or rhG-CSF 5 μg/kg, respectively. The patients with breast cancer received two chemotherapy cycles, and the NSCLC patients received 1-2 cycles of chemotherapy according to their condition. All patients were treated with the combination chemotherapy of TAC (docetaxel+ epirubicin+ cyclophosphamide) or TA (docetaxel+ epirubicin), or the chemotherapy of docetaxel combined with carboplatin, with a 21 day cycle.
RESULTSThe duration of grade 3-4 neutropenia in the PEG-rhG-CSF 100 μg/kg and PEG-rhG-CSF 6 mg groups were similar with that in the rhG-CSF 5 μg/kg group (P>0.05 for all). The incidence rate of grade 3-4 neutropenia in the PEG-rhG-CSF 100 μg/kg group, PEG-rhG-CSF 6 mg group, and G-CSF 5 μg/kg group were 69.7%, 68.4%, and 69.5%, respectively, with a non-significant difference among the three groups (P=0.963). The incidence rate of febrile neutropenia in the PEG-rhG-CSF 100 μg/kg group, PEG-rhG-CSF 6 mg group and G-CSF 5 μg/kg group were 6.1%, 6.4%, and 5.5%, respectively, showing no significant difference among them (P=0.935). The incidence rate of adverse events in the PEG-rhG-CSF 100 μg/kg group, PEG-rhG-CSF 6 mg group and G-CSF 5 μg / kg group were 6.7%, 4.1%, and 5.5%, respectively, showing a non-significant difference among them (P=0.581).
CONCLUSIONSIn patients with breast cancer and non-small cell lung cancer (NSCLC) undergoing TAC/TA chemotherapy, a single 100 μg/kg injection or a single fixed 6 mg dose of PEG-rhG-CSF at 48 hours after chemotherapy show definite therapeutic effect with a low incidence of adverse events and mild adverse reactions. Compared with the continuous daily injection of rhG-CSF 5 μg/kg/d, a single 100 μg/kg injection or a single fixed 6 mg dose of PEG-rhG-CSF has similar effect and is more advantageous in preventing chemotherapy-induced neutropenia.
Antineoplastic Agents ; adverse effects ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; Breast Neoplasms ; drug therapy ; Carboplatin ; administration & dosage ; adverse effects ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; Cyclophosphamide ; administration & dosage ; adverse effects ; Epirubicin ; administration & dosage ; adverse effects ; Female ; Granulocyte Colony-Stimulating Factor ; therapeutic use ; Humans ; Incidence ; Induction Chemotherapy ; Lung Neoplasms ; drug therapy ; Neutropenia ; chemically induced ; epidemiology ; prevention & control ; Polyethylene Glycols ; Recombinant Proteins ; administration & dosage ; Taxoids ; administration & dosage ; adverse effects

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