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).

Objective:To explore the selection of surgical methods for different sites of symptomatic Rathke's cleft cyst (RCC) and the clinical efficacies of these patients.Methods:Forty-seven patients with symptomatic RCC, admitted to our hospital from January 2016 to December 2019, were chosen in our study; 21 patients with intrasellar symptomatic RCC accepted surgery via unilateral nasal approach at the right side, 19 patients with intra-suprasellar symptomatic RCC accepted surgery via bilateral nasal approach, 3 patients with suprasellar symptomatic RCC accepted endonasal transsphenoidal surgery under endoscope, and 4 patients with suprasellar symptomatic RCC accepted craniotomy via pterion approach. The clinical efficacies and complications of patients accepted different surgical methods were compared. All patients were followed up for 3-36 months to observe the recurrence.Results:The postoperative symptoms of the patients were effectively improved, including headache relief ratio of 27/31, vision loss improvement ratio of 5/5, high prolactin relief ratio of 11/13, pituitary function improvement ratio of 9/18. Complications occurred in 6 patients, presenting as diabetes insipidus. Four patients recurred during follow-up.Conclusion:Intrasellar and intra-suprasellar symptomatic RCC accepted surgery via endoscopic transnasal transsphenoidal approach are safe and effective; selection of surgical methods for suprasellar symptomatic RCC should be determined according to the sizes and growth directions of cysts.

Intestinal immunoregulatory cells are a variety of cells with immunosuppressive function, including regulatory T cells, regulatory B cells, regulatory dendritic cells, M2 macrophages, innate lymphoid cells, fibroblast reticular cells, etc., which are the keys for maintaining intestinal immune tolerance and mucosal homeostasis. Gut microbiota is closely related with immunoregulatory cells. It is shown that gut microbiota and their metabolites maintain the normal function of immunoregulatory cells through activating pattern recognition receptor signaling pathway. This article reviewed the roles of intestinal immunoregulatory cell in maintenance of intestinal mucosal homeostasis.

Objective To investigate the recurrence and risk factors of gastric high-grade intraepithelial neoplasia(HGIN)and early gastric cancer(EGC)after endoscopic submucosal dissection (ESD). Methods The clinical and follow-up data on 444 patients(451 lesion)with HGIN and EGC undergoing ESD in Digestive Endoscopy Center of Chinese PLA General Hospital from November 2006 to January 2016 were summarized, and the risk factors of recurrence were analyzed. Results A total of 410 patients were followed-up, and the recurrence rate was 3.2%(13 patients, 13 lesions), with mean recurrence time of 17.6±9.6 months(6-38 months). Univariate and multivariate analysis revealed that the size of the lesion>4.0 cm was the only risk factor of recurrence(P=0.012,OR=10.855,95%CI:1.673~70.442). Conclusion The rate of recurrence is increasing with the EGC extending, therefore, postoperative monitoring should be strengthened to patients with larger lesion.

Objective: To elucidate the correlation between the single nucleotide polymorphism of CKLF-like MARVEL transmembrane member 5 ( CMTM5 ) gene rs723840 and the occurrence of high on aspirin platelet reactivity ( HAPR) . Methods:The present study is a case-control study. A total of 210 hospitalized patients in Peking University First Hospital were enrolled. Aspirin response was assessed by 0. 5 g/L arachidonic acid (AA)-induced platelet aggregation ratio (PR), and ≥3/4 quartile of PR of the population was defined as HAPR. Accordingly all the enrolled 210 coronary artery diseases ( CAD) patients were divided into HAPR group and No-HAPR group. The genotypes were determined by poly-merase chain reaction ( PCR) and sequencing analysis for rs723840 of CMTM5 gene. Results:The geno-type frequencies in rs723840 C>T of CMTM5 gene conformed well to the Hardy-Weinberg equilibrium in both HAPR group and No-HAPR group. Between the two groups, the genotypes frequencies in HAPR and No-HAPR groups were 48 . 4%, 51 . 6%, 0 . 0% and 73 . 7%, 22 . 9%, 0 . 034%, respectively ( P=0. 004). The C, T allele frequencies were significantly different in the two groups (P =0. 031,OR =0 . 501 , 95%CI:0 . 264-0 . 947 ) . Conclusion:Our study finds a significant correlation between CMTM5 gene rs723840 polymorphism and high on aspirin platelet reactivity.

Objective:To elucidate the correlation between urinary 11-dehydro-thromboxane B2 ( 11 dhTxB2 ) and clinical efficacy of aspirin treatment in patients with type 2 diabete and coronary artery disease ( CAD) . Methods:In this prospective cohort study, 169 aged patients with type 2 diabete accom-panying CAD in Peking University First Hospital were enrolled. The level of urinary 11dhTxB2 was detec-ted using enzyme-linked immuno-sorbent assay. Low aspirin response or high on aspirin platelet reactivity (HAPR) was defined as urinary 11dhTxB2>1 500 ng/g. All the included patients were divided into two groups based on the results, HAPR group and No-HAPR group. Results:Baseline urinary 11dhTxB2 of the patients with type 2 diabete accompanying CAD was ( 3 687 ± 3 052 ) ng/g, while the urinary 11dhTxB2 was (1 954 ± 859) ng/g in patients after 100 mg/d aspirin treatment (P<0. 001). Preva-lence of HAPR in patients with type 2 diabete accompanying CAD were 32 . 5%. Within a mean follow-up time of 12 months, the outcomes occurred more frequently in HAPR group than in No-HAPR group ( P<0 . 05 ) . Conclusion:Urinary 11 dhTxB2 can be recognized as an effective indicator in evaluating aspirin clinical efficacy of patients with type 2 diabete accompanying CAD.

Objective:This study aimed to observe the synergistic effect of a new tumor vaccine combined with metronomic che-motherapy in vivo on breast cancer. This study was also conducted to investigate the mechanism of this combination. Methods:Balb/c mice inoculated with 4T1 mouse breast cancer cell were used as tumor models. High-mobility group nucleosome-binding protein 1 (HMGN1) gene was used to transfect 4T1 cell lines as cancer vaccines. After 4T1 cell was inoculated, the mice were randomized into four groups:normal saline (NS);metronomic gemcitabine (GEM) alone;cancer vaccine alone;and combination therapy group. Tumor growth and potential toxicities of these regimens were observed. The Foxp3 expression of regulatory T cells (Tregs) was detected by western blot and immunohistochemical staining. The microvessel density (MVD) of the tumor was also detected by immunohistochemi-cal staining. Results:The tumor volume of the mice was significantly lower in the combination group than in the MET group or cancer vaccine group (P<0.05). This result exhibited a higher significant difference than the tumor volume of the mice in the NS group (P<0.01). Foxp3 expression was significantly lower in the mice treated with GEM (combination or MET group). MVD was significantly lower in these two groups than in the cancer vaccine group or NS group (P<0.05). Furthermore, adverse reactions slightly occurred in each group. Conclusion: The combination of cancer vaccines and metronomic GEM is a very active and well-tolerated regimen for breast cancer in mice.

Objective To evaluate the correlation of the baseline clinical and laboratory test index with death,and to discuss the independent risk factors for long-term prognosis in elderly HIV/ AIDS patients who had accepted highly active antiretroviral therapy (HAART).Methods 1671 cases of HIV/AIDS patients were included in retrospective cohort study,divided into death group (183 cases) and non-death group (1488 cases) according to HIV/AIDS related death event,and followed up for 2 days to 120 months,an average of 427 days.Results During the period of followup,the proportion of male (12.45％) was higher than that of women (6.9％) in death group(x2 =10.42,P＜0.01).The mortality ratio of the WHO stage Ⅲ and Ⅳ was higher than that of the WHO stage Ⅰ and Ⅱ (x2 =18.67,P＜0.01).The mortality ratio was significantly higher in HIV/AIDS patients with baseline CD4+ T lymphocyte cell ＜100 cells/mm3 than ＞100 cells/mm3 (x2 =52.59,P＜0.01).The platelet (PLT),hemoglobin (HB),and blood glucose levels were lower in death group than in non-death group (P ＜ 0.05),but serum creatinine (SCR) and AST (aspartate aminotransferase) levels were higher than that in the non-death group (P＜0.05).There was no significantly differences between the death group and the non-death group in the index of white blood cell (WBC),blood urea nitrogen (BUN),total cholesterol (CH),triglyceride (TG),alanine aminotransferase (ALT) and total bilirubin (TB) levels (all P＞ 0.05).Multiple logistic regression analysis revealed that the WHO stage (OR=0.777,95％ CI:0.612～0.987,P＜0.05) and the baseline level of CD4+ T lymphocytes cell (OR=1.345,95％ CI:1.089～1.662,P＜0.01) were independent risk factors for long-term outcomes in elderly HIV/AIDS patients.Conclusions The WHO stage and baseline CD4+ T lymphocyte cell level are the independent risk factors for long-term prognosis in HIV/AIDS patients over 60 years of age.Early discovery and early beginning HAART can effectively improve the prognosis of elderly HIV/AIDS patients.

Objective To explore the reasons for lateral and basal incomplete resection of precancerous lesions or cancer from upper digestive tract by endoscopic submucosal dissection (ESD).Methods Data of 295 patients undergoing ESD for upper gastrointestinal precancerous lesions or cancer from November 2006 to October 2011 were collected,and reasons of basal or lateral incomplete resectin confirmed by postESD pathology were analyzed.Results The total incomplete resection rate after ESD was 3.05％ ( 9/295 ).Among 95 cases of esophageal ESD,there was 1 case of lateral margin incomplete resection because of the retraction of normal tissue after dissection.Among 200 cases of gastric ESD,there were 5 cases of lateral margin incomplete resection,in which 2 cases were signet ring carcinoma with submucosal infiltration and spreading,2 were due to retraction of normal tissue after dissection,and 1 was due to inaccurate judgment on cancer demarcation.There were 3 cases of basal incomplete resectin in gastric ESD,which was caused by incorrecte invasion depth estimation before ESD.Conclusion The rate of basal or lateral incomplete resection in upper gastrointestinal ESD was low,which is related to pathological type,ESD procedure and estimation of invasion depth before ESD.

Objective To investigate the expression and clinical significance of FoxA 2(hepatocyte nuclear factor 3β)in human non-small cell lung cancer(NSCLC)tissues and adjacent normal lung tissue.Methods The expressions of FoxA 2 protein in 80 cases with NSCLC tissues and adjacent normal lung tissue were tested by immunohistochemistry,the expressions of mRNA was detected by RT-PCR.Results The expressions of FoxA 2 both on protein and mRNA in NSCLC lung tissue were significantly less than those of adjacent normal lung tissue(protein expression comparison t value was 187.51,186.43,178.24 respectively;mRNA expression comparison t value was 236.70,260.13,126.27,respectively,P ＜ 0.05).However there was no difference on histopathological variability.F value equal to 1.86 and 1.69,P ＞ 0.05).In low differentiated group,the group of Ⅲ stage,with lymph node metastasis,the expression of FoxA 2 protein and mRNA was less than that in the group of high differentiated,the group of Ⅰ-Ⅱ stage,the group of non lymph node metastasis(pretein expression t values were 4.31,3.92,341,mRNA expression t values were 5.44,3.28,5.07,P＜0.05).Conclusion FoxA 2 might inhibit progression of human NSCLC.It may participate in the process of tumor tissue differentiation and lymph node metastasis in NSCLC.