BACKGROUND: In the interim analysis of MONARCH plus, adding abemaciclib to endocrine therapy (ET) improved progression-free survival (PFS) and objective response rate (ORR) in predominantly Chinese postmenopausal women with HR+/HER2- advanced breast cancer (ABC). This study presents the final pre-planned PFS analysis. METHODS: In the phase III MONARCH plus study, postmenopausal women in China, India, Brazil, and South Africa with HR+/HER2- ABC without prior systemic therapy in an advanced setting (cohort A) or progression on prior ET (cohort B) were randomized (2:1) to abemaciclib (150 mg twice daily [BID]) or placebo plus: anastrozole (1.0 mg/day) or letrozole (2.5 mg/day) (cohort A) or fulvestrant (500 mg on days 1 and 15 of cycle 1 and then on day 1 of each subsequent cycle) (cohort B). The primary endpoint was PFS of cohort A. Secondary endpoints included cohort B PFS (key secondary endpoint), ORR, overall survival (OS), safety, and health-related quality of life (HRQoL). RESULTS: In cohort A (abemaciclib: n  = 207; placebo: n  = 99), abemaciclib plus a non-steroidal aromatase inhibitor improved median PFS vs . placebo (28.27 months vs . 14.73 months, hazard ratio [HR]: 0.476; 95% confidence interval [95% CI]: 0.348-0.649). In cohort B (abemaciclib: n  = 104; placebo: n  = 53), abemaciclib plus fulvestrant improved median PFS vs . placebo (11.41 months vs . 5.59 months, HR: 0.480; 95% CI: 0.322-0.715). Abemaciclib numerically improved ORR. Although immature, a trend toward OS benefit with abemaciclib was observed (cohort A: HR: 0.893, 95% CI: 0.553-1.443; cohort B: HR: 0.512, 95% CI: 0.281-0.931). The most frequent grade ≥3 adverse events in the abemaciclib arms were neutropenia, leukopenia, anemia (both cohorts), and lymphocytopenia (cohort B). Abemaciclib did not cause clinically meaningful changes in patient-reported global health, functioning, or most symptoms vs . placebo. CONCLUSIONS: Abemaciclib plus ET led to improvements in PFS and ORR, a manageable safety profile, and sustained HRQoL, providing clinical benefit without a high toxicity burden or reduced quality of life. TRIAL REGISTRATION ClinicalTrials.gov (NCT02763566).
Humans ; Female ; Fulvestrant/therapeutic use* ; Breast Neoplasms/metabolism* ; Aminopyridines/therapeutic use* ; Benzimidazoles/therapeutic use* ; Middle Aged ; Aromatase Inhibitors/therapeutic use* ; Aged ; Receptor, ErbB-2/metabolism* ; Adult ; Letrozole/therapeutic use* ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Anastrozole/therapeutic use*

This study aimed to provide scientific evidence for predicting quality markers(Q-markers) of Elephantopus scaber by establishing UPLC fingerprint of E. scaber from different geographical origins and determining the content of 13 major components, as well as conducting in vitro anti-cancer activity investigation of the main components. The chromatographic column used was Waters CORTECS UPLC C_(18)(2.1 mm×150 mm, 1.6 μm), and the mobile phase consisted of acetonitrile and 0.1% formic acid solution(gradient elution). The column temperature was set at 30 ℃, and the flow rate was 0.2 mL·min~(-1). The injection volume was 1 μL, and the detection wavelength was 240 nm. The UPLC fingerprint of E. scaber was fitted using the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(2012 edition) to determine common peaks, evaluate similarity, identify and determine the content of major components. The CCK-8 assay was used to explore the inhibitory effect of the main components on the proliferation of lung cancer cells. The results showed that in the established UPLC fingerprint of E. scaber, 35 common peaks were identified. Thirteen major components, including neochlorogenic acid(peak 1), chlorogenic acid(peak 2), cryptochlorogenic acid(peak 3), caffeic acid(peak 4), schaftoside(peak 6), galuteolin(peak 9), isochlorogenic acid B(peak 10), isochlorogenic acid A(peak 12), isochlorogenic acid C(peak 18), deoxyelephantopin(peak 28), isodeoxyelephantopin(peak 29), isoscabertopin(peak 31), and scabertopin(peak 32) were identified and quantified, and a quantitative analysis method was established. The results of the in vitro anti-cancer activity study showed that deoxyelephantopin, isodeoxyelephantopin, isoscabertopin, and scabertopin in E. scaber exhibited inhibition rates of lung cancer cell proliferation exceeding 80% at a concentration of 10 μmol·L~(-1), higher than the positive drug paclitaxel. These results indicate that the fingerprint of E. scaber is highly characteristic, and the quantitative analysis method is accurate and stable, providing references for the research on quality standards of E. scaber. Four sesquiterpene lactones in E. scaber show significant anti-cancer activity and can serve as Q-markers for E. scaber.
Humans ; Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal/chemistry* ; Asteraceae/chemistry* ; Lung Neoplasms/drug therapy*

Child ; Consensus ; Drugs, Chinese Herbal ; Humans ; Medicine, Chinese Traditional ; Respiratory System

OBJECTIVE: To establish a three-dimensional finite element model of osteoporosis and to study the stiffness recovery of injured vertebrae and stress analysis of adjacent vertebrae after percutaneous vertebroplasty under different perfusion and distribution conditions by simulating fluid flow into the vertebral body. METHODS: A male healthy volunteer was selected. CT scans were performed from T RESULTS: (1) The VonMises stress of T CONCLUSION Reliable biomechanical model of lumbar vertebral fracture can be established by using CT scanning data through software simulation. Vertebral fracture and vertebroplasty will cause biomechanical changes of adjacent vertebral bodies. With the increase of bone cement injection, the influence of biomechanical changes will increase significantly. Neighbouring vertebral fractures are more likely. For this experiment, percutaneous vertebroplasty has a suitable amount of cement injection of 4 ml.
Biomechanical Phenomena ; Bone Cements ; Finite Element Analysis ; Fractures, Compression/surgery* ; Humans ; Lumbar Vertebrae/surgery* ; Male ; Osteoporotic Fractures/surgery* ; Spinal Fractures/surgery* ; Vertebroplasty

China/epidemiology* ; Diabetes Mellitus, Type 2/etiology* ; Dyslipidemias/epidemiology* ; Humans ; Incidence ; Prospective Studies

Objective: Several COVID-19 patients have overlapping comorbidities. The independent role of each component contributing to the risk of COVID-19 is unknown, and how some non-cardiometabolic comorbidities affect the risk of COVID-19 remains unclear. Methods: A retrospective follow-up design was adopted. A total of 1,160 laboratory-confirmed patients were enrolled from nine provinces in China. Data on comorbidities were obtained from the patients' medical records. Multivariable logistic regression models were used to estimate the odds ratio ( Results: Overall, 158 (13.6%) patients were diagnosed with severe illness and 32 (2.7%) had unfavorable outcomes. Hypertension (2.87, 1.30-6.32), type 2 diabetes (T2DM) (3.57, 2.32-5.49), cardiovascular disease (CVD) (3.78, 1.81-7.89), fatty liver disease (7.53, 1.96-28.96), hyperlipidemia (2.15, 1.26-3.67), other lung diseases (6.00, 3.01-11.96), and electrolyte imbalance (10.40, 3.00-26.10) were independently linked to increased odds of being severely ill. T2DM (6.07, 2.89-12.75), CVD (8.47, 6.03-11.89), and electrolyte imbalance (19.44, 11.47-32.96) were also strong predictors of unfavorable outcomes. Women with comorbidities were more likely to have severe disease on admission (5.46, 3.25-9.19), while men with comorbidities were more likely to have unfavorable treatment outcomes (6.58, 1.46-29.64) within two weeks. Conclusion Besides hypertension, diabetes, and CVD, fatty liver disease, hyperlipidemia, other lung diseases, and electrolyte imbalance were independent risk factors for COVID-19 severity and poor treatment outcome. Women with comorbidities were more likely to have severe disease, while men with comorbidities were more likely to have unfavorable treatment outcomes.
Adult ; Aged ; COVID-19/virology* ; China/epidemiology* ; Comorbidity ; Female ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Severity of Illness Index ; Treatment Outcome

Objective To evaluate the actual effect of the schistosomiasis control program in Jiangsu Province from 2010 to 2015. Methods A total of 67 schistosomiasis-endemic counties in 10 cities were selected, and a combination of retrospective investigation and on-site investigation was adopted to collect and record the epidemic data of the counties from 2010 to 2015, and a retrospective survey database of epidemic situation was established. The effects of integrated control strategies with both Oncomelania hupensis snail control and infection source control were evaluated. Results From 2010 to 2015, 2 465 911 persons who lived in endemic areas were detected for schistosomiasis, with 16 974 positive cases of blood examinations, and 8 positive cases of fecal examinations. Totally 5 145 people with advanced schistosomiasis were treated and 40 460 people with the history of schistosome cercarial-infested water contact received the expanded chemotherapy. A total of 127 636 cattle raised in the endemic areas were detected, and 51 619 cattle (head-times) with the history of cercarial-infested water contact also received the expanded chemotherapy. The area with snails control by molluscicides was 18 604.84 hm². By the end of 2015, schistosomeinfected snails had not been found and there was no zoological schistosome infection for 5 consecutive years, and in addition, there had been no acute schistosome-infected persons for 6 consecutive years in the whole province. The area with snails dropped to 1 977.18 hm², with a decreasing rate of 55.24% compared with that in 2010. Conclusion After the implementation of the plan for the prevention and control of schistosomiasis in Jiangsu Province (2010–2015), the prevention and control of schistosomiasis has achieved remarkable effects and realized the goal of the plan.

Objective To investigate the curative effect of YU Yun pulse-feeling-based acupuncture therapy for the treatment of middle-late liver cancer. Methods A total of 60 middle-late liver cancer patients were divided into control group and treatment group by stratified randomization method,30 cases in each group. The control group was given integrated Chinese and western medicine therapy according to the clinical pathway, including anti-cancer treatment such as vascular interrention,molecular targeted therapy,chemotherapy,radio therapy, and focal ablation therapy,as well as chinese medicine treatment based on disease differentiation and syndrome differentiation. And the treatment group was given YU Yun pulse-feeling-based acupuncture therapy on the basis of treatment for the control group. The two groups received 12-week treatment, and then their curative effects were compared. Results The treatment group had better effect on increasing the survival rate, prolonging survival time, improving the scores of clinical symptoms, stabilizing tumor size, and increasing the scores of Karnofsky Performance Status (KPS)than the control group,the difference being significant (P < 0.05 or P <0.01). Conclusion YU Yun pulse-feeling-based acupuncture therapy exerts certain curative effect for the treatment of middle-late liver cancer.

Purpose To investigate the clinicopathological features and differential diagnosis of congenital nonprogressive hemangiomas in children.Methods The clinic pathologic data and follow-up results of 19 cases of congenital nonprogressive hemangiomas were collected.The histopathologic features of congenital nonprogressive hamangiomas were observed with HE staining and immunohistochemistry of EnVision two-step.Results Of the 19 patients,13 were males and 6 were females,with an average age of 52.4 months and medium age of 48 months.9 cases occurred in the limbs and trunk,10 lesions were located in head and face included 1 case with multifocal lesions.Grossly,the specimens were irregular solid mass with range from 0.4 cm to 7 cm in maximum diameter.Microscopically,the lesions were composed of capillary lobules that separated by abnormal dense fibrotic dermal stroma typically containing a prominent component of large vessels.Immunohistochemically,the tumor cells were positive for CD31,CD34,and WT1,but negative for D2-40 and GLUT1.All eases underwent surgical resection,and the follow-up period was 1-24 months.There was no recurrence or metastasis.Conclusion Congenital nonprogressive hemangioma is a rare benign vascular tumor in children,with characteristic clinical and pathologic features.So the exact diagnosis is very important for both pathologists and clinicians.

OBJECTIVE To establish an ovarian cancer xenograft model by fluorescence and study of the cancer staging. METHODS The human ovarian cancer HO-8910 cells were cultured for 10 generations in the cell culture dish,and the cells that could stably express fluorescence were selected and injected into nude mice.When the tumor grew to a mass volume of 1 mm3 ,it was implanted into the ovarian mucous membrane of nude mice through micro-surgery.The tumor growth and metas-tasis were observed by in vivo imaging technique,and the tumor tissue and surrounding tissues were observed through patholo-gy detection methods.RESULTS In vivo imaging technology successfully traced the development and metastasis of tumor. Pathological examination showed tumor cell metastasis trend.Both of them combining with TCM clinical ovarian cancer staging determined the ovarian cancer staging.CONCLUSION The experiment successfully establishes ovarian cancer orthotopic transplantation model and represents the evolution of clinical oncology.The stages will provide some experimental basis for the study of tumor and the evaluation criterion of antitumor drug effect.