Single-cell and bulk RNA sequencing analysis of B cell marker genes in TNBC TME landscape and immunotherapy.

Objective: This study amied to investigate the prognostic characteristics of triple negative breast cancer (TNBC) patients by analyzing B cell marker genes based on single-cell and bulk RNA sequencing. Methods: Utilizing single-cell sequencing data from TNBC patients, we examined tumor-associated B cell marker genes. Transcriptomic data from The Cancer Genome Atlas (TCGA) database were used as the foundation for predictive modeling. Independent validation set was conducted using the GSE58812 dataset. Immune cell infiltration into the tumor was assessed through various, including XCELL, TIMER, QUANTISEQ, CIBERSORT, CIBERSORT-ABS, and ssGSEA. The TIDE score was utilized to predict immunotherapy outcomes. Additional investigations were conducted on the immune checkpoint blockade gene, tumor mutational load, and the GSEA enrichment analysis. Results: Our analysis encompassed 22,106 cells and 20,556 genes in cancerous tissue samples from four TNBC patients, resulting in the identification of 116 B cell marker genes. A B cell marker gene score (BCMG score) involving nine B cell marker genes (ZBP1, SEL1L3, CCND2, TNFRSF13C, HSPA6, PLPP5, CXCR4, GZMB, and CCDC50) was developed using TCGA transcriptomic data, revealing statistically significant differences in survival analysis (P<0.05). Functional analysis demonstrated that marker genes were predominantly associated with immune-related pathways. Notably, substantial differences between the higher and lower- BCMG score groups were observed in terms of immune cell infiltration, immune cell activity, tumor mutational burden, TIDE score, and the expression of immune checkpoint blockade genes. Conclusion: This study has established a robust model based on B-cell marker genes in TNBC, which holds significant potential for predicting prognosis and response to immunotherapy in TNBC patients.

New treatment insights into pancreatic acinar cell carcinoma: case report and literature review.

Pancreatic acinar cell carcinoma (PACC) is a rare pancreatic malignancy with unique clinical, molecular, and morphologic features. The long-term survival of patients with PACC is substantially better than that of patients with ductal adenocarcinoma of the pancreas. Surgical resection is considered the first choice for treatment; however, there is no standard treatment option for patients with inoperable disease. The patient with metastatic PACC reported herein survived for more than 5 years with various treatments including chemotherapy, radiotherapy, antiangiogenic therapy and combined immunotherapy.

Comparison of case-based learning using Watson for oncology and traditional method in teaching undergraduate medical students.

BACKGROUND: Watson for Oncology (WFO) is a decision-making system generated by artificial intelligence (AI) and has been widely used in treatment recommendations of cancer patients. However, the application of WFO in clinical teaching among medical students has not been reported. OBJECTIVE: To establish a novel teaching and learning method with WFO in undergraduate medical students and evaluate its efficiency and students' satisfaction compared with traditional case-based learning model. METHODS: 72 undergraduates majoring in clinical medicine in Wuhan University were enrolled and were randomly divided into the WFO-based group and the control group. 36 students in the WFO-based group learned clinical oncology cases via WFO platform while 36 students in the control group using traditional teaching methods. After the course, final examination and questionnaire survey of teaching assessment were conducted on the two groups of students. RESULTS: According to the questionnaire survey of teaching assessment, WFO-based group showed significant higher score in the aspect of cultivating ability of independent learning (17.67 ± 1.39 vs. 15.17 ± 2.02, P = 0.018), increasing knowledge mastery (17.75 ± 1.10 vs. 16.25 ± 1.18, P = 0.001), enhancing learning interest (18.41 ± 1.42 vs. 17.00 ± 1.37, P = 0.002), increasing course participation (18.33 ± 1.67 vs. 15.75 ± 1.67, P = 0.001) and the overall course satisfaction (89.25 ± 5.92 vs. 80.75 ± 3.42, P = 0.001) than those of the control group students. CONCLUSION: Our practice has established a novel clinical case-based teaching pattern with WFO, providing undergraduate students with convenient and scientific training and guidance. It empowers students with improved learning experiences and equips them with essential tools for clinical practices.

SETD2-H3K36ME3: an important bridge between the environment and tumors.

Epigenetic regulation plays an important role in the occurrence, development and treatment of tumors. The histone methyltransferase SET-domain-containing 2 (SETD2) plays a key role in mammalian epigenetic regulation by catalyzing histone methylation and interacting with RNA polymerase II to mediate transcription elongation and mismatch repair. As an important bridge between the environment and tumors, SETD2-H3K36me3 plays an important role in the occurrence and development of tumors. Many tumors, including renal cancer, gastric cancer, lung cancer, are closely related to SETD2 gene mutations. As a key component of common tumor suppressor mechanisms, SETD2-H3K36me3is an important target for clinical disease diagnosis and treatment. Here, we reviewed the structure and function of the SETD2 and how SETD2-H3K36me3 functions as a bridge between the environment and tumors to provide an in-depth understanding of its role in the occurrence and development of various tumors, which is of great significance for future disease diagnosis and treatment.

Conversion therapy from unresectable stage IIIC non-small-cell lung cancer to radical surgery via anti-PD-1 immunotherapy combined with chemotherapy and anti-angiogenesis: A case report and literature review.

The prognosis of patients with stage IIIC non-small-cell lung cancer (NSCLC) is poor due to the loss of surgical treatment opportunities. Improving the prognosis of these patients with IIIC NSCLC urgently needs to be addressed. Here, we report a stage IIIC (T4N3M0 IIIC (AJCC 8th)) NSCLC patient treated with 2 cycles of anti-PD-1 immunotherapy combined with chemotherapy and anti-angiogenesis therapy; after two cycles of treatment, the patient achieved a partial response and obtained the opportunity for surgical treatment. After the operation, the patient achieved a pathological complete response and successfully transformed from unresectable stage IIIC lung cancer to radical surgery (ypT0N0M0). Our study is expected to provide new ideas for treating patients with unresectable stage IIIC NSCLC in the future.

Immunotherapy Combined With Chemotherapy for Postoperative Recurrent Penile Squamous Cell Carcinoma: A Case Report and Literature Review.

Penile squamous cell carcinoma (SCC) is a rare malignant tumor in males with a poor prognosis. Currently, the primary treatment is surgery. Recurrent cases have limited treatment options after failed radiotherapy and chemotherapy. The therapeutic effect of immunotherapy in penile SCCs has not been reported. Tislelizumab, a new PD1 inhibitor, has shown a satisfactory impact in treating head and neck SCC and lung SCC combined with chemotherapy. However, there is currently no report on its efficacy in penile SCC. Here, a 76-year-old man with multiple enlarged inguinal lymph nodes 11 months after radical surgery for penile SCC was administered immunotherapy (tislelizumab) combined with chemotherapy (albumin paclitaxel plus nedaplatin) for 2 cycles. Pelvic Magnetic resonance imaging (MRI) showed that the multiple lymph nodes in the groin area disappeared. To our knowledge, this is the first case report of immunotherapy combined with chemotherapy showing promising results in recurrent penile SCC. It provides a basis for developing a new treatment option combining immunotherapy and chemotherapy, whose efficacy needs to be further evaluated in penile SCC.

Anti-PD-1 Immunotherapy Combined With Stereotactic Body Radiation Therapy and GM-CSF as Salvage Therapy in a PD-L1-Positive Patient With Refractory Metastatic Thyroid Hürthle Cell Carcinoma: A Case Report and Literature Review.

Thyroid Hürthle cell carcinoma, known as thyroid eosinophilic carcinoma, is a rare pathological type of differentiated thyroid cancer (DTC), representing 3-4% of all thyroid cancers. However, given the high risk of invasion and metastasis, thyroid Hürthle cell carcinoma has a relatively poor prognosis. Traditional treatment methods have limited effects on patients with metastatic thyroid cancers. Developing a valuable therapy for advanced thyroid carcinomas is an unfilled need, and immunotherapy could represent another choice for these tumors. We herein reported the case of a patient with recurrent advanced thyroid Hürthle cell cancer and positive programmed death-ligand 1 (PD-L1) expression, who suffered tumor progression after re-surgery, radiotherapy, and targeted therapy. It is encouraging that PD-1 inhibitors in combination with GM-CSF and stereotactic body irradiation (SBRT) on metastatic disease have a significant anti-tumor effect.

Status of radiotherapy staff during the coronavirus disease 2019 (COVID-19) epidemic in China.

Objective: In December 2019, coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) broke out in Wuhan, China. The pandemic has posed a great challenge to radiation oncology departments, as interruptions in radiation therapy (RT) increase the risks of cancer recurrence or failure of the therapy as a whole. This study aimed to elucidate the impact of COVID-19 on radiation therapy staff in China. Methods: As many working staff at different radiation oncology departments in China as possible were retrospectively enrolled from 23 January to 9 March 2020. They were then invited to answer a questionnaire, for essential data collection, from which their basic information, anxiety level, and workload were analyzed. Results: Seven (0.39%) of the 1 755 radiation therapy staff who answered the questionnaire had contracted COVID-19, all of whom were from Wuhan. The factors influencing susceptibility were not sex (P  =  1.000), age (P  =  0.480), or comorbidities (P  =  0.600), but geographic location (P < 0.001) and whether the respondent worked in a designated COVID-19 hospital (P  =  0.003). In terms of protection procedures, four participants carried out basic, one second-level and two third-level protection procedures. The difference was not statistically significant (P  =  0.720). The infected respondents' anxiety level related to the outbreak (average score 6.57) was higher than that of their counterparts in Wuhan (5.18), as well as across the country (4.79), and 71.43% of those infected expressed the need for psychological interventions. During the epidemic, departments of 428 respondents (24.39%) shut down, while 76.71% of the respondents reported workload reduction. Conclusion: The factors related to COVID-19 infection were the geographic location and whether the respondent worked in a designated COVID-19 hospital. The infected respondents experienced greater psychological pressure than their uninfected counterparts and, therefore, required more psychological interventions.

Clinical features and short-term outcomes of elderly patients with COVID-19.

BACKGROUND: The outbreak of Coronavirus Disease 2019 (COVID-19) has become a global public health emergency. METHODS: 204 elderly patients (≥60 years old) diagnosed with COVID-19 in Renmin Hospital of Wuhan University from January 31st to February 20th, 2020 were included in this study. Clinical endpoint was in-hospital death. RESULTS: Of the 204 patients, hypertension, diabetes, cardiovascular disease, and chronic obstructive pulmonary disease (COPD) were the most common coexisting conditions. 76 patients died in the hospital. Multivariate analysis showed that dyspnea (hazards ratio (HR) 2.2, 95% confidence interval (CI) 1.414-3.517; p < 0.001), older age (HR 1.1, 95% CI 1.070-1.123; p < 0.001), neutrophilia (HR 4.4, 95% CI 1.310-15.061; p = 0.017) and elevated ultrasensitive cardiac troponin I (HR 3.9, 95% CI 1.471-10.433; p = 0.006) were independently associated with death. CONCLUSION: Although so far the overall mortality of COVID-19 is relatively low, the mortality of elderly patients is much higher. Early diagnosis and supportive care are of great importance for the elderly patients of COVID-19.

Palliative Gastrectomy and Survival in Patients With Metastatic Gastric Cancer: A Propensity Score-Matched Analysis of a Large Population-Based Study.

OBJECTIVES: The role of palliative gastrectomy in the management of metastatic gastric cancer remains inadequately clarified. METHODS: We analyzed patients with metastatic gastric cancer enrolled in the Surveillance, Epidemiology, and End Results registry from January 2004 to December 2012. Propensity score (PS) analysis with 1:1 matching and the nearest neighbor matching method was performed to ensure well-balanced characteristics of the groups of patients who undergone gastrectomy and those without gastrectomy. Data were analyzed by Kaplan-Meier and Cox proportional hazards regression models to evaluate the overall survival and cancer-specific survival rates with corresponding 95% confidence intervals (CIs). RESULTS: In general, receiving any kind of gastrectomy was associated with an improvement in survival in the multivariate analyses (hazard ratio [HR]os = 0.64, 95% CI = 0.59-0.70, HRcss = 0.63, 95% CI = 0.57-0.68) and PS matching (PSM) analyses (HRos = 0.63, 95% CI = 0.56-0.70, HRcss = 0.62, 95% CI = 0.55-0.70). After PSM, palliative gastrectomy was found to be associated with remarkably improved survival for patients with stage M1 with only 1 metastasis but not associated with survival of patients with stage M1 with extensive metastasis (≥2 metastatic sites). DISCUSSION: The results obtained from the Surveillance, Epidemiology, and End Results database suggest that patients with metastatic gastric cancer might benefit from palliative gastrectomy on the basis of chemotherapy. However, a PSM cohort study of this kind still has a strong selection bias and cannot replace a properly conducted randomized controlled trial.

Radiotherapy improves the survival of patients with extensive-disease small-cell lung cancer: a propensity score matched analysis of Surveillance, Epidemiology, and End Results database.

BACKGROUND: The survival advantage of radiotherapy for patients with extensive-disease small-cell lung cancer (ED-SCLC) has not been adequately evaluated. METHODS: We analyzed stage IV SCLC patients enrolled from the Surveillance, Epidemiology, and End Results (SEER) registry through January 2010 and December 2012. Propensity score analysis with 1:1 matching was performed to ensure well-balanced characteristics of all comparison groups. Kaplan-Meier and Cox proportional hazardous model were used to evaluate the overall survival (OS), cancer-specific survival (CSS), and corresponding 95% CI. RESULTS: Overall, for all metastatic ED-SCLC, receiving radiotherapy was associated with both improved OS and CSS. Radiotherapy for thoracic lesion and any metastatic sites could significantly improve the OS and CSS, except for brain metastasis. For M1a-SCLC patient, radiotherapy, most likely to the primary site, significantly improved the survival (P<0.001). Furthermore, for those ED-SCLC patients with ≥ 2 metastatic sites, that is, polymetastatic ED-SCLC patients, radiation also significantly improved the median OS from 6.0 to 8.0 months (P=0.015) and the median CSS from 7.0 to 8.0 months (P=0.020). CONCLUSION: The large SEER results support that radiotherapy in addition to chemotherapy might improve the survival of patients with metastatic ED-SCLC.

Radiotherapy improves the survival of patients with stage IV NSCLC: A propensity score matched analysis of the SEER database.

OBJECTIVES: The survival advantage of radiotherapy (RT) for patients with stage IV non-small cell lung cancer (NSCLC) has not been adequately evaluated. METHODS: We analyzed stage IV NSCLC patients enrolled from the Surveillance, Epidemiology, and End Results (SEER) registry through January 2010 to December 2012. Propensity score (PS) analysis with 1:1 nearest neighbor matching method was used to ensure well-balanced characteristics of all comparison groups by histological types and metastatic sites. Kaplan-Meier and Cox proportional hazardous model were used to evaluate the overall survival (OS), cancer-specific survival (CSS), and corresponding 95% confidence interval (95%CI). RESULTS: Generally speaking, there was a trend toward improved OS and CSS for using RT to stage IV NSCLC patients for any metastatic sites and for any histological types except adenocarcinoma (AD). Radiotherapy significantly improved the survival of NSCLC patients with metastasis to brain (P < 0.001), especially for AD (P < 0.001). For stage IV lung cancer patients with squamous cell carcinoma (SQC), RT for any metastatic sites could universally improve the OS (P < 0.001) and CSS (P < 0.001). In particular, RT was also associated with improving OS (P < 0.001) and CSS (P = 0.012) for stage IV patients with metastases of two or more sites, ie, polymetastatic disease. Furthermore, for those stage IV SQC patients without metastasis, RT, most likely to the primary site, also significantly improved the survival (P < 0.001). CONCLUSIONS: The results support that RT might improve the survival of patients with metastatic NSCLC in a PS-matched patient cohort from the large SEER database. It is prudent to carefully select patients for RT in metastatic NSCLC.

Radiotherapy Improves the Survival of Patients With Metastatic Cervical Cancer: A Propensity-Matched Analysis of SEER Database.

OBJECTIVE: To demonstrate whether radiotherapy has an effect on the survival of patients with stage IVb (M1) cervical cancer, as it has not been adequately clarified. METHODS: We analyzed International Federation of Gynecology and Obstetrics (FIGO) stage M1 cervical cancer diagnosed in patients between 1992 and 2013 using population-based data from the Surveillance, Epidemiology, and End Results registry. Propensity score (PS) analysis with 1:1 matching and the nearest neighbor matching method was performed to ensure well-balanced characteristics of comparison groups. Data were analyzed by Kaplan-Meier and Cox proportional hazards regression models to evaluate the overall survival (OS) and cancer-specific survival (CSS) months with corresponding 95% confidence intervals (95% CIs). RESULTS: In general, receiving radiotherapy significantly improved OS and CSS both before and after PS matching (PSM) (P < 0.001), with significantly improved OS (hazard ratio, 0.69; 95% CI, 0.62-0.76) and CSS (hazard ratio, 0.79; 95% CI, 0.70-0.89) after PSM in patients with stage M1 cervical cancer. Before PSM, radiotherapy was found to be associated with improved survival even for the patients with stage M1 cervical cancer with extensive metastasis (≥2 metastatic sites) (P < 0.001). Although P value was not significant for brain metastasis, the survival month was numerically improved before PSM (OS and CSS, 1 month vs 4 months). Overall, radiotherapy still significantly improved survival for patients with one metastatic site (ie, oligometastases) either before or after PSM (P < 0.05), with the survival month improved more than 6 months. CONCLUSIONS: The large Surveillance, Epidemiology, and End Results results support that radiotherapy might improve the survival of patients with metastatic cervical cancer. It might be prudent to carefully select suitable patients for radiation therapy for metastatic cervical cancer.

MiR-490-5p Suppresses Cell Proliferation and Invasion by Targeting BUB1 in Hepatocellular Carcinoma Cells.

OBJECTIVE: To verify that miR-490-5p could influence hepatocellular carcinoma (HCC) cells' proliferation, invasion, cycle, and apoptosis by targeting BUB1. METHODS: Quantitative real time-PCR (QRT-PCR) was used to determine the miR-490-5p expression. Immunohistochemistry, qRT-PCR, and Western blot were employed to detect BUB1 and transforming growth factor-beta (TGFß/Smad) signaling-related proteins expression in hepatic tissues and cells. The luciferase assay was used to confirm the targeting relationship between miR-490-5p and BUB1. The Cell Counting Kit-8, colony formation, Transwell invasion, scratch healing assays, and flow cytometry analysis were conducted to evaluate HCC cells proliferation, invasion, migration, and apoptosis alteration after transfection. RESULTS: In HCC tissues and cells, lower expression of miR-490-5p was detected, while BUB1 was overexpressed than controls. The upregulation of miR-490-5p inhibited BUB1 expression and the overexpression of miR-490-5p or the under-expression of BUB1 inhibited HCC cells proliferation, migration, invasion, and increased the apoptosis rate. CONCLUSION: MiR-490-5p could regulate TGFß/Smad signaling pathways by inhibiting BUB1, which could then inhibit HCC cells proliferation, invasion, and migration as well as decrease cell viability and increase apoptosis.

Tissue Metabonomic Phenotyping for Diagnosis and Prognosis of Human Colorectal Cancer.

Colorectal cancer (CRC) is one of the leading causes of cancer-related death worldwide and prognosis based on the conventional histological grading method for CRC remains poor. To better the situation, we analyzed the metabonomic signatures of 50 human CRC tissues and their adjacent non-involved tissues (ANIT) using high-resolution magic-angle spinning (HRMAS) (1)H NMR spectroscopy together with the fatty acid compositions of these tissues using GC-FID/MS. We showed that tissue metabolic phenotypes not only discriminated CRC tissues from ANIT, but also distinguished low-grade tumor tissues (stages I-II) from the high-grade ones (stages III-IV) with high sensitivity and specificity in both cases. Metabonomic phenotypes of CRC tissues differed significantly from that of ANIT in energy metabolism, membrane biosynthesis and degradations, osmotic regulations together with the metabolism of proteins and nucleotides. Amongst all CRC tissues, the stage I tumors exhibited largest differentiations from ANIT. The combination of the differentiating metabolites showed outstanding collective power for differentiating cancer from ANIT and for distinguishing CRC tissues at different stages. These findings revealed details in the typical metabonomic phenotypes associated with CRC tissues nondestructively and demonstrated tissue metabonomic phenotyping as an important molecular pathology tool for diagnosis and prognosis of cancerous solid tumors.

The SNP rs931794 in 15q25.1 Is Associated with Lung Cancer Risk: A Hospital-Based Case-Control Study and Meta-Analysis.

BACKGROUND: Lung cancer is one of the most common human malignant diseases and the leading cause of cancer death worldwide. The rs931794, a SNP located in 15q25.1, has been suggested to be associated with lung cancer risk. Nevertheless, several genetic association studies yielded controversial results. METHODS AND FINDINGS: A hospital-based case-control study involving 611 cases and 1062 controls revealed the variant of rs931794 was related to increased lung cancer risk. Stratified analyses revealed the G allele was significantly associated with lung cancer risk among smokers. Following meta-analysis including 6616 cases and 7697 controls confirmed the relevance of rs931794 variant with increased lung cancer risk once again. Heterogeneity should be taken into account when interpreting the consequences. Stratified analysis found ethnicity, histological type and genotyping method were not the sources of between-study heterogeneity. Further sensitivity analysis revealed that the study "Hsiung et al (2010)" might be the major contributor to heterogeneity. Cumulative meta-analysis showed the trend was increasingly obvious with adding studies, confirming the significant association. CONCLUSIONS: Results from our current case-control study and meta-analysis offered insight of association between rs931794 and lung cancer risk, suggesting the variant of rs931794 might be related with increased lung cancer risk.

Predictive value of serum CEA, CA19-9 and CA125 in diagnosis of colorectal liver metastasis in Chinese population.

BACKGROUND/AIMS: Liver metastases are associated with poor prognosis in patients with colorectal cancer (CRC). The objective of this study is to determine the possible indicators in identifying the predictive value of serum CEA, CA19-9 and CA-125 in diagnosis of liver metastases from CRC in the Chinese population. METHODOLOGY: We randomly selected 101 CRC patients with liver metastases and 81 patients without liver metastases. Several clinical pathological factors were analyzed for the correlation with liver metastases. The predictive value of CEA, CA19-9 and CA-125 for liver metastases from CRC was evaluated. RESULTS: There was no significant difference in gender, age, hepatitis B history, serum AFP level or lesion location. Patients with liver metastases had a tendency to have higher serum CEA, CA19-9 and CA-125 level. Multivariate analysis revealed that serum CEA level (p<0.001), CA19-9 level (p<0.001) and CA-125 level (p=0.001) were independent prognostic predictors for liver metastases. Combination of CEA, CA19-9 and CA-125 can enhance their sensitivity in diagnosis of synchronous and metachronous liver metastases. Serum CA19-9 level, combined test of CA19-9 and CA-125, combined test of triple markers have higher sensitivities in synchronous metastasis than those in metachronous metastasis. CONCLUSIONS: Combination test would enhance the sensitivities of serum CEA, CA19-9 and CA-125 levels, which are important in predicting liver metastases from CRC in the Chinese population, either synchronous or metachronous.

Treatment related severe and fatal adverse events with cetuximab in colorectal cancer patients: a meta-analysis.

PURPOSE: Cetuximab has been approved by FDA for the treatment of advanced/metastatic colorectal cancer. Whether cetuximab treatment is associated with an increase of severe adverse events in colorectal cancer (CRC) patients remains a question. The purpose is to assess the risk of severe adverse events of cetuximab treatment in advanced/metastatic CRC patients. PATIENTS AND METHODS: Search of EMBASE, PubMed, and ScienceDirect between 1 January, 2000 and 1 July 2012 for relevant randomized control trials (RCTs). Previous meta-analyses related with cetuximab treatment were also identified for eligible RCTs. Eligible studies were RCTs of advanced/metastatic CRC patients assigned to cetuximab or control group. Data were extracted by two authors for severe and fatal adverse events. RESULTS: Nine RCTs, involving 8520 patients with CRC were included. Using a fixed-effects model, the proportion of patients with severe adverse events was higher in the cetuximab group than in control group with Mantel-Haenszel methods (OR, 2·19; 95% CI, 1·99-2·41; incidence, 70·0% versus 51·2%; P<0·001). The most common severe adverse events were neutropenia, diarrhea, and rash. However, cetuximab was not associated with increased risk of fatal adverse events (OR, 1·41; 95% CI, 0·99-2·03; incidence, 1·8% versus. 1·3%). CONCLUSION: In this meta-analysis of RCTs, cetuximab was associated with an increased risk of severe adverse events. There is no evidence of an increased risk of fatal adverse events with cetuximab.

Meta-analysis: serious adverse events in Crohn's disease patients treated with TNF-alpha inhibitors.

BACKGROUND/AIMS: It remains a question whether anti-TNF-a treatment is associated with an increase of serious adverse events (SAE) in Crohn's Disease (CD) patients. This study aims to assess the risk of SAE of anti-TNF-a treatment in CD patients. METHODOLOGY: Literature search of EMBASE, PubMed, ScienceDirect, Cochrane Library and ClinicalTrials.gov until June 2012 was conducted. Eligible studies were randomized controlled trials (RCTs) ofTNF-a inhibitors treated for at least 24 weeks in CD patients. RESULTS: Thirteen RCTs, involving 4,257 patients with CD were included in analysis. SAE were reported in 364 patients (14.26%) in treatment groups and 263 patients (15.43%) in control groups. The proportion of patients with SAE was lower with TNF-a inhibitors than with placebo (OR, 0.80; 95% CI, 0.67-0.96; p=0.01). Compared with controls, the risks of malignancy and serious infection treated with TNF-a inhibitors showed no significant difference (p>0.05). CONCLUSIONS: In CD patients, anti-TNF-a treatment, especially for adalimumab, could decrease the incidence of SAE, without an increased risk of malignancy or serious infection. TNF-a inhibitors are safe in treatment of CD patients. To assess the risk of SAE, larger samples of randomized control trials with long term follow-up are needed.