Background:There is no consensus on whether triplet regimen is better than doublet regimen in the first-line treatment of advanced gastric cancer(AGC).We aimed to compare the efficacy and safety of oxaliplatin plus ca...Background:There is no consensus on whether triplet regimen is better than doublet regimen in the first-line treatment of advanced gastric cancer(AGC).We aimed to compare the efficacy and safety of oxaliplatin plus capecitabine(XELOX)and epirubicin,oxaliplatin,plus capecitabine(EOX)regimens in treating AGC.Methods:This phase III trial enrolled previously untreated patients with AGC whowere randomly assigned to receive the XELOXor EOXregimen.The primary endpoint was non-inferiority in progression-free survival(PFS)for XELOX as compared with EOX on an intention-to-treat basis.Results:Between April 10,2015 andAugust 20,2020,448AGCpatientswere randomized to receive XELOX(n=222)or EOX(n=226).The median PFS(mPFS)was 5.0 months(95%confidence interval[CI]=4.5-6.0 months)in the XELOX arm and 5.5 months(95%CI=5.0-6.0 months)in the EOX arm(hazard ratio[HR]=0.989,95%CI=0.812-1.203;P_(non-inferiority)=0.003).There was no significant difference inmedian overall survival(mOS)(12.0 vs.12.0months,P=0.384)or objective response rate(37.4%vs.45.1%,P=0.291)between the two groups.In patients with poorly differentiated adenocarcinoma and liver metastasis,the EOX arm had a significantly longer mOS(P=0.021)and a trend of longer mPFS(P=0.073)than the XELOX arm.The rate of grade 3/4 adverse events(AEs)was 42.2%(90/213)in the XELOX arm and 72.5%(156/215)in the EOX arm(P=0.001).The global health-related quality of life(QoL)score was significantly higher in the XELOX arm than in the EOX arm during chemotherapy.Conclusions:This non-inferiority trial demonstrated that the doublet regimen was as effective as the triplet regimen and had a better safety profile and QoL as a first-line treatment for AGC patients.However,the triplet regimen might have a survival advantage in patients with poorly differentiated adenocarcinoma and liver metastasis.展开更多
该研究建立了沙棘药材及食品制品中10种真菌毒素的分析方法,对其真菌毒素的污染情况进行分析。首先选取黄曲霉毒素、赭曲霉毒素、玉米赤霉烯酮和脱氧雪腐镰刀菌烯醇等10种真菌毒素的混合对照品溶液作为对照,并对沙棘药材及其食品制品进...该研究建立了沙棘药材及食品制品中10种真菌毒素的分析方法,对其真菌毒素的污染情况进行分析。首先选取黄曲霉毒素、赭曲霉毒素、玉米赤霉烯酮和脱氧雪腐镰刀菌烯醇等10种真菌毒素的混合对照品溶液作为对照,并对沙棘药材及其食品制品进行制备;其次基于超高效液相色谱-串联质谱法(ultra-performance liquid chromatography-tandem mass spectrometry,UPLC-MS/MS)对沙棘药材及食品制品中10种真菌毒素做定量方法学考察并对其含量进行测定;最后对真菌毒素的污染情况进行分析评价。分析结果确定了最佳分析条件,且方法学考察结果表明10种真菌毒素建立的线性关系良好(r>0.99),方法重复性,供试品专属性、稳定性,仪器精密度均良好;10种真菌毒素在沙棘药材、沙棘食品制品固体和沙棘食品制品液体3种基质中的平均加样回收率分别为90.31%~109.4%、87.86%~107.8%、85.61%~109.1%;RSD分别为0.22%~10%、0.75%~13%、0.84%~8.5%。说明该研究基于UPLC-MS/MS技术建立的10种真菌毒素限度的同时测定方法检测速度快、基质干扰较少、灵敏度高、结果准确,适用于沙棘药材及其食品制品中的10种真菌毒素的限度检查。展开更多
基金National Key Research and Development Program of China,Grant/Award Number:2017YFC1308900The clinical research and cultivation project of shanghai Shenkang hospital development center,Grant/Award Number:SHDC12017×01Sun Yat-sen University Xie Tong Chuang Xin Program,Grant/Award Number:ZLYXXTCX201504。
文摘Background:There is no consensus on whether triplet regimen is better than doublet regimen in the first-line treatment of advanced gastric cancer(AGC).We aimed to compare the efficacy and safety of oxaliplatin plus capecitabine(XELOX)and epirubicin,oxaliplatin,plus capecitabine(EOX)regimens in treating AGC.Methods:This phase III trial enrolled previously untreated patients with AGC whowere randomly assigned to receive the XELOXor EOXregimen.The primary endpoint was non-inferiority in progression-free survival(PFS)for XELOX as compared with EOX on an intention-to-treat basis.Results:Between April 10,2015 andAugust 20,2020,448AGCpatientswere randomized to receive XELOX(n=222)or EOX(n=226).The median PFS(mPFS)was 5.0 months(95%confidence interval[CI]=4.5-6.0 months)in the XELOX arm and 5.5 months(95%CI=5.0-6.0 months)in the EOX arm(hazard ratio[HR]=0.989,95%CI=0.812-1.203;P_(non-inferiority)=0.003).There was no significant difference inmedian overall survival(mOS)(12.0 vs.12.0months,P=0.384)or objective response rate(37.4%vs.45.1%,P=0.291)between the two groups.In patients with poorly differentiated adenocarcinoma and liver metastasis,the EOX arm had a significantly longer mOS(P=0.021)and a trend of longer mPFS(P=0.073)than the XELOX arm.The rate of grade 3/4 adverse events(AEs)was 42.2%(90/213)in the XELOX arm and 72.5%(156/215)in the EOX arm(P=0.001).The global health-related quality of life(QoL)score was significantly higher in the XELOX arm than in the EOX arm during chemotherapy.Conclusions:This non-inferiority trial demonstrated that the doublet regimen was as effective as the triplet regimen and had a better safety profile and QoL as a first-line treatment for AGC patients.However,the triplet regimen might have a survival advantage in patients with poorly differentiated adenocarcinoma and liver metastasis.
文摘该研究建立了沙棘药材及食品制品中10种真菌毒素的分析方法,对其真菌毒素的污染情况进行分析。首先选取黄曲霉毒素、赭曲霉毒素、玉米赤霉烯酮和脱氧雪腐镰刀菌烯醇等10种真菌毒素的混合对照品溶液作为对照,并对沙棘药材及其食品制品进行制备;其次基于超高效液相色谱-串联质谱法(ultra-performance liquid chromatography-tandem mass spectrometry,UPLC-MS/MS)对沙棘药材及食品制品中10种真菌毒素做定量方法学考察并对其含量进行测定;最后对真菌毒素的污染情况进行分析评价。分析结果确定了最佳分析条件,且方法学考察结果表明10种真菌毒素建立的线性关系良好(r>0.99),方法重复性,供试品专属性、稳定性,仪器精密度均良好;10种真菌毒素在沙棘药材、沙棘食品制品固体和沙棘食品制品液体3种基质中的平均加样回收率分别为90.31%~109.4%、87.86%~107.8%、85.61%~109.1%;RSD分别为0.22%~10%、0.75%~13%、0.84%~8.5%。说明该研究基于UPLC-MS/MS技术建立的10种真菌毒素限度的同时测定方法检测速度快、基质干扰较少、灵敏度高、结果准确,适用于沙棘药材及其食品制品中的10种真菌毒素的限度检查。
