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<p><b>BACKGROUND</b>Endostar™ (rh-endostatin, YH-16) is a new recombinant human endostatin developed by Medgenn Bioengineering Co. Ltd., Yantai, Shandong, P.R.China. Pre-clinical study indicated that YH-16 could inhibit tumor endothelial cell proliferation, angiogenesis and tumor growth. Phase I and phase II studies revealed that YH-16 was effective as single agent with good tolerance in clinical use.The current study was to compare the response rate , median ti me to progression (TTP) ,clinical benefit andsafety in patients with advanced non-small cell lung cancer ( NSCLC) , who were treated with YH-16 plus vi-norelbine and cisplatin (NP) or placebo plus NP.</p><p><b>METHODS</b>Four hundred and ninety-three histologically or cy-tologically confirmed stage IIIB and IV NSCLC patients , withlife expectancy > 3 months and ECOG perform-ance status 0-2 , were enrolledin a randomized ,double-blind ,placebo-controlled , multicenter trial ,either trialgroup : NP plus YH-16 (vinorelbine 25 mg/m² on day 1 and day 5 ,cisplatin 30mg/m² on days 2 to 4 , YH-167.5mg/m² on days 1 to 14) or control group : NP plus placebo (vinorelbine 25 mg/m² on day 1 and day 5 ,cis-platin 30 mg/m² on days 2 to 4 ,0.9% sodium-chloride 3 .75 ml on days 1 to 14) every 3 weeks for 2-6 cycles .The trial endpoints included response rate ,clinical benefit rate ,time to progression,quality of life and safety .</p><p><b>RESULTS</b>Of 486 assessable patients , overall response rate was 35.4% in trial group and 19.5% in controlgroup (P=0 .0003) . The median TTP was 6 .3 months and 3 .6 months for trial group and control group respectively (P < 0 .001) . The clinical benefit rate was 73 .3 %in trial group and 64.0% in control group (P=0 .035) .In untreated patients of trial group and control group ,the response rate was 40 .0% and 23.9%(P=0 .003) ,the clinical benefit rate was 76 .5 % and 65 .0 % (P=0 .023) ,the median TTP was 6 .6 and 3 .7months (P=0 .0000) ,respectively .In pretreated patients of trial group and control group ,the response ratewas 23.9% and 8.5%(P=0 .034) ,the clinical benefit rate was 65.2% and 61.7%(P=0 .68) ,the median TTP was 5 .7 and 3 .2 months (P=0 .0002) ,respectively . The relief rate of clinical symptoms in trial groupwas higher than that of those in control group ,but no significance existed (P > 0 .05) . The score of quality oflife in trial group was significantly higher than that in control group (P=0 .0155) after treatment . There were no significant differences in incidence of hematologic and non-hematologic toxicity , moderate and severe sideeffects betweentrial group and control group .</p><p><b>CONCLUSIONS</b>The addition of YH-16 to NP regimen results in significantly and clinically meaningful improvement in response rate , median time to tumor progression,and clinical benefit rate compared with NP alone in advanced NSCLC patients . YH-16 in combination with chemotherapy shows a synergic activity and a favorable toxic profile in advanced cancer patients .</p>
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Objective:The therapeutic efficacy and side effects of combined chemotherapy of HCPT,MTX,LV and 5-Fu for metastatic or recurrent breast cancer were evaluated in our study.Methods:A total of 43 cases of advanced metastatic or recurrent breast cancer were treated with chemotherapy regimen consisting of HCPT 10mg/m2 iv gtt for dl～5,MTX 100mg iv dl,Leucovorin 150mg/m2 iv gtt for d2～4,5-Fu 500mg/m2 iv gtt for dl～5.The cycle was repeated every 4 weeks,and 2 cycles were given as one course.Results:The overall CR+PR was 47%.One year survival rate was 54% and the median survival interval was 19 months.The main side effects were bone marrow suppression and gastrointestinal reaction.Conclusion:The combined chemotherapy regimen consisting of HCPT etc is beneficial for metastatic breast cancer.
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Objective To explore oligodendrocyte selective vulnerability in gray matter area and the effect of subhypothermia after transient forebrain ischemia in gerbils.Methods The gerbils model of forebrain ischemia was induced by 15 min bilateral carotid occlusion.All gerbils were divided randomly into sham operation group,ischemic reperfusion group and subhypothermia treatment group (32.5?0.5℃).Immunohistochemistry for cell specific antigens (transferrin,TF) was used to identify oligodendrocyte.Results The density of TF positive oligodendrocyte in the cortex at 1～2 days reperfusion following ischemia decreased remarkably (P
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Objective To explore the relationship between reactive astrogliosis and delayed neuronal ischemic tolerance by preconditioning ischemia in gerbil hippocampal CA 1 region.Methods All gerbils were divided randomly into sham operation group,cerebral ischemia group and preconditioning ischemia group and preconditioning ischemia plus subsequent ischemia group. Transient forebrain ischemia model was induced by bilateral carotid occlution in gerbils. Immunohistochemistry for cell specific markers (glial fibrillary acidic protein(GFAP)was used to identify astrocyte.Results The numbers of GFAP positive astrocyte in hippocampal CA 1 region increased slightly at 1~7days following preconditioning ischemia, but increased significantly at 28 days after preconditioning ischemia ( P