Exploration and practice on risk management of scientific research project in hospital / 中华医学科研管理杂志

Objective:By sorting out the occurrence of the risk outcomes of scientific research project in the hospital, conducting root-cause analysis, the risk management theory, process and methodologies are introduced into the management system of hospital scientific research projects to reduce the occurrence of risk outcome of scientific research projects.Methods:Through literature review and the reflection of daily scientific research management practice, the risk characteristics of clinical scientific research projects were systematically summarized, comparative analysis were conducted to explore the effectiveness before and after the introduction of risk management, and the practical experiences of scientific research project risk management were summarized.Results:There are mainly six types of internal and external risks in hospital scientific research projects, which lead to project termination, project modifications, project delays, assessment index adjustments, budget adjustments and other risk issues. By establishing scientific research project risk management environment, standardizing risk management procedures, as well as establishing risk-monitoring and early warning information system, the introduction of risk management system enables more effective control of scientific research project risks in hospitals.Conclusions:The application of risk management in the management of scientific research projects in hospitals has showed positive impact. The risk management of scientific research projects in hospitals has certain practical value and feasibility. The exploration of risk management theories and methods should be continued to promote the high-quality development of hospital scientific research project management.

Randomized controlled trial of chemotherapy plus geiftinib as ifrst-line treatment for patients with advancedEGFR mutation-positive lung adenocarcinoma / 中国癌症杂志

Background and purpose:For patients with advanced lung adenocarcinoma harboring an activating EGFR gene mutation, the current standard of care is EGFR-TKI alone. This study aimed to compare efficacy and safety of gefitinib plus chemotherapy with gefitinib or chemotherapy alone for treating advanced lung adenocarcinoma with an activatingEGFR gene mutation.Methods:This study included 61 patients with lung adenocarcinoma harboring an acti-vatingEGFR gene mutation (19 exons deletion and exon 21 L858R mutations) whose ECOG performance status was 0 or 1. Patients were randomly divided into 3 groups. Group A (n=20) were given carboplatin/pemetrexed of a 4-week cycle, six cycles at most, plus gefitinib (pemetrexed 500 mg/m2, d1; carboplatin AUC 5, d1; gefitinib 250 mg/d, d 5-21), and then re-ceived pemetrexed of a 4-week cycle plus gefitinib as maintenance therapy; Group B (n=20) were given carboplatin/peme-trexed of a 4-week cycle, six cycles at most (pemetrexed 500 mg/m2, d1; carboplatin AUC 5, d1), then received pemetrexed as maintenance therapy; Group C (n=21) were given gefitinib (gefitinib 250 mg/d). Patients continued to receive therapy until disease progression or unacceptable toxicity or death. The primary end point was middle PFS and 12 months PFS rate. The secondary end points included objective response rate and adverse events.Results:Groups A and C both lost 1 case during follow-up. Median PFS for patients was 20.1 months (95%CI:18.0-22.2) in group A, 5.5 months (95%CI:3.9-7.2) in group B, and 9.8 months (95%CI:6.8-12.8) in group C. PFS rates of 12 months for groups A, B and C were 78.9%, 15.0% and 40.0%, respectively. The overall objective response rates for groups A, B and C were 84.2%, 35.0% and 65.0%, respectively. Serious adverse events were reported by 36.8% for group A, 30.0% for group B, and 5.0% for group C. The most common grade 3/4 adverse events were neutropenia (3 cases in group A, 4 cases in group B), fatigue (2 cases in group A, 2 cases in group B) and liver function impairment (2 cases in group A, 1 case in group C).Conclusion:Among patients withEGFR mutant lung adenocarcinoma, combination of chemotherapy with gefitinib as first-line treatment demonstrates an improvement in PFS. Long-term survival results will be further followed up.

Clinical observation of efficacy and safety of pemetrexed plus platinum as the first-line chemotherapy with advanced non-squamous non-small cell lung cancer / 中国癌症杂志

Background and purpose:The effective rate of ifrst-line chemotherapy for advanced lung cancer is 30%-40%. The purpose of this study was to evaluate the efifcacy and adverse effects of pemetrexed combined with carboplatin or cisplatin in the treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC). Methods:One hundrend and twenty-one patients with advanced non-squamous NSCLC were enrolled in this study and all of these patients had been conifrmed with pathology or cytology. Among the 121 cases, 60 cases were male and 61 were female, the median age was 59 years, adnenocarcinoma in 113 patients and large cell carcinoma in 8 patients. Combination regimen: patients received pemetrexed 500 mg/m2 on day 1 and carboplatin 300 mg/m2 or cisplatin 70 mg/m2 on day 1 by intravenous infusion, administrated every 3 weeks for 2 to 6 cycles. All patients who received 2 or more cycles could be evaluated. Disease control rate (DCR) was the primary end point; secondary end points included progression-free survival (PFS), 1-year survival rate and safety.Results:There was 1 case with complete response (CR), 44 cases achieved partial response (PR), 50 had stable disease (SD) and 26 cases had progressive disease (PD) in the overall cases. ORR and DCR were 37.2% (45/121) and 78.5% (95/121), respectively. The median PFS time was 5.2 months and 1-year survival rate was 59.0%. In pemetrexed combined with carboplatin group, the ORR and DCRwere 38.3% (23/60) and 78.3% (47/60), respectively; The median PFS was 5.1 months (95%CI: 3.8-6.4 month) and 1-year survival rate was 55.2%. The patients treated with pemetrexed plus cisplatin, the ORR and DCR were 36.1% (22/61) and 78.7% (48/61), respectively. Median PFS was 6.2 months (95%CI: 4.3-8.1 month) and 1-year survival rate was 62.5%. There were no statistical differences between carboplatin/pemetrexed and cisplatin/pemetrexed for both ORR, DCR, PFS and 1-year survival rate (P>0.05). The major adverse effects were leukopenia, neutropenia, fatigue and gastrointestinal reaction.Conclusion:Pemetrexed plus platinum chemotherapy could be considered as the ifrst-line treatment option for advanced non-squamous NSCLC patients. Pemetrexed combined with carboplatin/ cisplatin regimen has efifcacy with mild toxicity and better tolerability.

Clinical research of individualized therapy in advanced non-small cell lung cancer guiding by & nbsp;detection of ERCC1 protein / 中国癌症杂志

10.3969/j.issn.1007-3969.2013.05.002

Role of endobronchial ultrasound-guided transbronchial needle aspiration in the diagnosis of bronchogenic carcinoma / 中国肺癌杂志

<p><b>BACKGROUND AND OBJECTIVE</b>The aim of this study is to evaluate diagnostic yield and the safety of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in the diagnosis ofbronchogenic carcinoma.</p><p><b>METHODS</b>Between July, 2009 and February, 2010, 95 patients with mediastinal/hilar lymphadenopathy and/or intrathoracic peritracheal or peribronchial masses previously detected with CT scan underwent EBUS-TBNA. No rapid onsite cytology was performed.</p><p><b>RESULTS</b>In all 95 patients, 60 cases were newly diagnosed lung cancer through the pathological examination and clinical follow-up certification. In 60 lung cancer cases, 112 samples were obtained from lymph nodes (LNs) and 11 samples were obtained from intrapulmonary lesions. Fifty-eight cases of patients were diagnosed, false negative in 2 cases. Sensitivity and specificity of EBUS-guided TBNA method in distinguishing benign from malignant LNs or thoracic masses were 96.67% and 100%, respectively. There was any major complication in this series, the procedure was uneventful.</p><p><b>CONCLUSION</b>EBUSTBNA seemed a safe and effective technique in making bronchogenic carcinoma diagnosis for mediastinal/hilar LNs and intra-pulmonary masses.</p>

Expression and clinical significance of vascular endothelial growth factor and epidermal growth factor in non-small cell lung cancer / 中国癌症杂志

Background and purpose:Both very important therapeutic targets of NSCLC,vascular endothelial growth factor (VEGF) and epidermal growth factor receptors (EGFR),are over expressed in non-small cell lung cancer (NSCLC).The aim of this study was to discuss the expression of VEGF and EGFR in NSCLC as well as its clinical significance.Methods:The expression of VEGF and EGFR was detected in 186 NSCLC samples using the immunohistochemical method.The expression of VEGF and VEGR in NSCLC patients with various pathological characteristics was observed and the correlation between them was analyzed.Results:The expression of VEGF in NSCLC was correlated with lymph node metastasis (P

Analysis of prognostic factors in patients with non-small cell lung cancer treated by surgery and chemotherapy / 中国癌症杂志

Background and Purpose:Lung cancer is the most malignant tumour in the world.Its incidence is growing and NSCLC is predominent(80%) in lung cancer.Most patients with lung cancer were diagnosed in late stages.The tumour could be shrunk by neoadjuvant chemotherapy when the case with stage Ⅲ NSCLC was considered not possible for radical operated neoadjuvant chemotherapy may lead to the following,operation could be improved,micrometastasis could be annihilated and survival could be extended.Objective of this paper was to analyse the prognostic factors for survival in patients treated by surgery and chemotherapy for NSCLC.Methods:98 cases of neoadjuvant chemotherapy combined with surgery for NSCLC,stageⅠ~Ⅲ,were collected retrospectively in our hospital from 1995 to 1997.35 cases were stageⅠ.21 cases were stage Ⅱ.42 cases were stage Ⅲ.83 cases had 1 cycle of chemotherapy pre-operatively.15 cases had 2 cycles chemotherapy pre-operatively.Regimes of chemotherapy were MVP,MOP and MAP et al.Response rate(RR) of chemotherapy was:45 cases had partial response(PR) and 53 cases were stable disease(SD).Operative mode was lobectomy and pneumectomy with lymph nodes dissection.Pathologic type was squamous,adeno,adeno-squamous and others.All the patients were treated by chemotherapy for two or three cycles after surgery except for the patients in stageⅠin 1996~1997.After being followed-up for more than 5 years,data were examined using life table,KaplanMeier method,Log Rank statistic and Cox-mantel test.The possible factors affecting survival were tested with univariate and multivariate analysis.Results:The median followed-up time of 98 cases for NSCLC was 41.2 months.36 cases were alive.62 cases were dead.The 1-,3-,5-year survival rate of 98 cases for NSCLC was 88.78%、49.63% and 18.46%.The 5-year survival rates of stageⅠ、ⅡandⅢ were 33.23%、20.26% and 5.52% respectively(P=0.0002).The 5-year survival rates of N_(0)、N_(1)、N_(2) were 35.49%、19.08% and 4.90% respectively(P=0.0004).In the 98 cases of NSCLC,better prognosis was correlated with earlier stage.The prognosis was better if the period from last chemotherapy before operation to operation was no more than 1 month. The prognosis of lobectomy,lung hila activity,thorax lymph nodes negativity and squamous cancer was better.The prognosis was poorer if the tumor had invaded big vessels,viscera,chest wall,pericardium and quantity bleeding during≥400ml.The prognosis was better if the tumor was fibrotic.The prognosis of 2 cycles of chemotherapy pre-operatively might be better than 1 cycle.The prognosis of tumor necrosis was poorer and the prognosis of chemotherapy post-operatively was better.Conclusions:The main prognostic factors affecting survival in patients treated by surgery and chemotherapy for NSCLC was stage,the period from last chemotherapy before operation to operation,operation mode,lung hila activity,thorax lymph nodes,site of tumor invasion,bleeding quantity,pathologic type,tumor fibrosis and necrotis,cycles chemotherapy pro-operation and chemotherapy post-operation.

Randomized study of low molecular weight heparin (LMWH) plus chemtherapy in advanced non-small cell lung cancer / 中国癌症杂志

Purpose: To evaluate the efficacy, safety and survival of low molecular weight heparin ( LMWH) plus chemotherapy in patients with advanced non-small cell lung cancer. Methods: 46 patients with NSCLC were randomized into chemotherapy plus LMWH. (study group) and chemotherapy only( control group). Both groups received two cycles of MVP regimen (MMC 6 mg/m2, YDS 3 mg/m2 x 2, DDP 90 mg/m2). Patients in the study group were treated with LMWH 5000u twice daily from the third day before chemtherapy up to 7 days. Results: The response rate was 56. 5% (13/23) for the study group and 39. l%(9/23) for the control group. Median survival time( MST) and 1-year survival rate were 12, 1 months(95%CI:8.52~14.64) and 52.2% for the study group compare 8.4 months(95%CI:6.15 ~ 10. 85) and 34. 8% for the control group. There were significant differences for MST( 12. 1 vs 8. 4) and 1 year survival rate(52. 2% vs 34. 8%) in the study group as compared to the control group. No difference in response rate and toxicities were found between the two groups. Conclusions: Chemotherapy( MVP regimen) plus LMWH is effective and safe. Prolonged survival was observed in patients who received MVP regimen plus LMWH.