Objective:The aim of this study was to evaluate the response rate,time to progression(TTP),overall survival,and safety of the combination of capecitabine plus oxaliplatin in treatment of advanced gastric cancer(AGC).M...Objective:The aim of this study was to evaluate the response rate,time to progression(TTP),overall survival,and safety of the combination of capecitabine plus oxaliplatin in treatment of advanced gastric cancer(AGC).Methods:All the patients with advanced gastric cancer who were not received any prior chemotherapy or radiotherapy were treated with combination of capecitabine(1250 mg/m2 twice daily,days 1-14) plus oxaliplatin(130 mg/m2 as a 2-h intravenous infusion on day 1) every 3 weeks.Results:Two cases of complete response(CR) and 34 cases of partial response(PR) were confirmed,giving an overall response rate of 52.9%,of the 68 patients with advanced gastric cancer.The median TTP and overall survival for all patients were 7.3 and 11.9 months,respectively.Grade 3 leukopenia,thrombocytopenia,nausea/vomiting,and diarrhea were observed in 3,5,1,and 4 patients,respectively.Yet,no grade 4 toxicity was observed.Conclusion:Capecitabine/ oxaliplatin combination chemotherapy is active in patients with advanced gastric cancer.展开更多
Aim of work: This study aimed to evaluate the resectability rate, rate of conservative surgery, toxicity, local control, and disease free survival for oxaliplatin and capecitabine based chemoradiation compared to stan...Aim of work: This study aimed to evaluate the resectability rate, rate of conservative surgery, toxicity, local control, and disease free survival for oxaliplatin and capecitabine based chemoradiation compared to standard 5-FU based chemoradiation in locally advanced cancer rectum. Patients and methods: 65 patients were eligible;33 patients received oxaliplatin and capecitabine based chemoradiation (arm I) and 32 patients received 5-FU based chemoradiation (arm II). Results: The overall response rate in arms I and II were 78.7% and 87.5% respectively. Conservative surgery was done in 81.81% and 53.13% of patients with arms I and II, pathologic complete response (pCR) rate was significantly better in arm I than arm II (30.3% vs. 21.9%, P < 0.01). 3-year recurrence rates were 54.5% and 56.2% in arms I, II respectively;the median disease free survival (DFS) were 30 months and 15 months in arms I and II respectively. Grade III anemia, grade IV diarrhea and severe proctitis were developed in a significantly large number of patients with arm I;in addition deep venous thrombosis (DVT) was developed in 15.15% of patients with arm I but none in arm II. Conclusion: The addition of oxaliplatin to the preoperative chemo radiation increased the response rate mainly pCR rate which was considered a target goal in the neoadjuvant treatment, but it was not recommended because of higher toxicity and no significant effect on DFS in different response groups of arm I when compared to arm II, but longer follow up may be needed to evaluate the overall survival.展开更多
BACKGROUND Many clinical studies for the long-term survival or efficacy of capecitabine plus oxaliplatin(XELOX)in colon cancer have already been studied,but its clinical benefit is controversial.AIM To evaluate the lo...BACKGROUND Many clinical studies for the long-term survival or efficacy of capecitabine plus oxaliplatin(XELOX)in colon cancer have already been studied,but its clinical benefit is controversial.AIM To evaluate the long-term efficacy of XELOX regimen in comparison with other adjuvant chemotherapy protocols in colon cancer.METHODS By searching the PubMed,EMBASE and Cochrane databases,a total of 12 randomized controlled trials involving 6698 stageⅢcolon cancer cases(XELOX protocol:n=3298 cases;other adjuvant chemotherapy protocol:n=3268 cases)were included.The parameter outcomes included the overall survival and the disease-free survival.The quality control of selected literature was based on the Jadad scale and the GRADE system.RESULTS In comparison to other adjuvant chemotherapy regimen,XELOX regimen showed a better overall survival(odds ratio=1.29,95% confidence interval:1.15-1.44,P<0.0001)and a better disease-free survival(odds ratio=1.32,95%confidence interval:1.18-1.46,P<0.0001)for colon cancer patients,suggesting the XELOX regimen can be a good option for postoperative treatment of stage III colon cancer.CONCLUSION The XELOX regimen can be a preferred option for adjuvant treatment of stageⅢcolon cancer after surgery.展开更多
Background:Patients with colon cancer who receive chemotherapy usually experience various gastrointestinal adverse reactions,including nausea,vomiting,and diarrhea,which make it challenging for them to adhere to treat...Background:Patients with colon cancer who receive chemotherapy usually experience various gastrointestinal adverse reactions,including nausea,vomiting,and diarrhea,which make it challenging for them to adhere to treatment.As an effective traditional Chinese medicine,the Jianpi Bushen formula has been widely used to alleviate the side effects of chemotherapy.Objective:To evaluate the efficacy and safety of Jianpi Bushen formulae for patients who undergo chemotherapy.This statistical analysis plan(SAP)is intended to enhance the transparency and research quality of our randomized controlled trial.Methods:Our study is a multicenter,double-blind,randomized controlled clinical trial.This trial aimed to compare the completion rate of chemotherapy in colon cancer patients who are using and not using Jianpi Bushen formula.To attenuate possible selection bias in the final report,we declared the overall trial design,outcome measures,subgroup analyses,and safety measures.Also,we described the data management and statistical analysis methods in detail.Conclusion:The SAP provides more detailed information than the trial protocol for data management and statistical analysis methods.Further post-hoc analyses can be performed by referring to the SAP,and possible selection bias can be attenuated.展开更多
目的研究探讨特瑞普利单抗联合卡培他滨化疗方案(XELOX)治疗晚期胃癌及对叉头框蛋白A2(recombinant forkhead box protein A2,FOXA2)及细胞周期素依赖的蛋白激酶抑制物(cyclin dependent protein kinase inhibitor,p27kip1)表达水平影...目的研究探讨特瑞普利单抗联合卡培他滨化疗方案(XELOX)治疗晚期胃癌及对叉头框蛋白A2(recombinant forkhead box protein A2,FOXA2)及细胞周期素依赖的蛋白激酶抑制物(cyclin dependent protein kinase inhibitor,p27kip1)表达水平影响。方法非随机选取2022年1月—2023年12月牡丹江医科大学附属红旗医院收治的96例晚期胃癌患者作为研究对象,按治疗方法不同分为观察组、对照组,各48例。对照组采用XELOX方案治疗,观察组在对照组基础上增加特瑞普利单抗治疗,对比两组患者的临床疗效、肿瘤标志物水平、FOXA2、p27kip1、生活质量评分、治疗安全性。结果观察组患者总有效率为77.08%(37/48),高于对照组的56.25%(27/48),差异有统计学意义(χ^(2)=4.688,P<0.05)。治疗后,观察组癌胚抗原、糖类抗原199、甲胎蛋白水平均低于对照组,差异有统计学意义(P均<0.05);治疗后,观察组FOXA2、p27kip1水平高于对照组,差异有统计学意义(P均<0.05);观察组癌症患者生命质量评分均高于对照组,差异有统计学意义(P均<0.05)。两组患者不良反应发生率对比,差异无统计学意义(P>0.05)。结论特瑞普利单抗联合XELOX方案治疗晚期胃癌效果良好,可降低肿瘤标志物水平,提高FOXA2、p27kip1表达水平,提高患者的生活质量水平,治疗安全性良好。展开更多
文摘Objective:The aim of this study was to evaluate the response rate,time to progression(TTP),overall survival,and safety of the combination of capecitabine plus oxaliplatin in treatment of advanced gastric cancer(AGC).Methods:All the patients with advanced gastric cancer who were not received any prior chemotherapy or radiotherapy were treated with combination of capecitabine(1250 mg/m2 twice daily,days 1-14) plus oxaliplatin(130 mg/m2 as a 2-h intravenous infusion on day 1) every 3 weeks.Results:Two cases of complete response(CR) and 34 cases of partial response(PR) were confirmed,giving an overall response rate of 52.9%,of the 68 patients with advanced gastric cancer.The median TTP and overall survival for all patients were 7.3 and 11.9 months,respectively.Grade 3 leukopenia,thrombocytopenia,nausea/vomiting,and diarrhea were observed in 3,5,1,and 4 patients,respectively.Yet,no grade 4 toxicity was observed.Conclusion:Capecitabine/ oxaliplatin combination chemotherapy is active in patients with advanced gastric cancer.
文摘Aim of work: This study aimed to evaluate the resectability rate, rate of conservative surgery, toxicity, local control, and disease free survival for oxaliplatin and capecitabine based chemoradiation compared to standard 5-FU based chemoradiation in locally advanced cancer rectum. Patients and methods: 65 patients were eligible;33 patients received oxaliplatin and capecitabine based chemoradiation (arm I) and 32 patients received 5-FU based chemoradiation (arm II). Results: The overall response rate in arms I and II were 78.7% and 87.5% respectively. Conservative surgery was done in 81.81% and 53.13% of patients with arms I and II, pathologic complete response (pCR) rate was significantly better in arm I than arm II (30.3% vs. 21.9%, P < 0.01). 3-year recurrence rates were 54.5% and 56.2% in arms I, II respectively;the median disease free survival (DFS) were 30 months and 15 months in arms I and II respectively. Grade III anemia, grade IV diarrhea and severe proctitis were developed in a significantly large number of patients with arm I;in addition deep venous thrombosis (DVT) was developed in 15.15% of patients with arm I but none in arm II. Conclusion: The addition of oxaliplatin to the preoperative chemo radiation increased the response rate mainly pCR rate which was considered a target goal in the neoadjuvant treatment, but it was not recommended because of higher toxicity and no significant effect on DFS in different response groups of arm I when compared to arm II, but longer follow up may be needed to evaluate the overall survival.
文摘BACKGROUND Many clinical studies for the long-term survival or efficacy of capecitabine plus oxaliplatin(XELOX)in colon cancer have already been studied,but its clinical benefit is controversial.AIM To evaluate the long-term efficacy of XELOX regimen in comparison with other adjuvant chemotherapy protocols in colon cancer.METHODS By searching the PubMed,EMBASE and Cochrane databases,a total of 12 randomized controlled trials involving 6698 stageⅢcolon cancer cases(XELOX protocol:n=3298 cases;other adjuvant chemotherapy protocol:n=3268 cases)were included.The parameter outcomes included the overall survival and the disease-free survival.The quality control of selected literature was based on the Jadad scale and the GRADE system.RESULTS In comparison to other adjuvant chemotherapy regimen,XELOX regimen showed a better overall survival(odds ratio=1.29,95% confidence interval:1.15-1.44,P<0.0001)and a better disease-free survival(odds ratio=1.32,95%confidence interval:1.18-1.46,P<0.0001)for colon cancer patients,suggesting the XELOX regimen can be a good option for postoperative treatment of stage III colon cancer.CONCLUSION The XELOX regimen can be a preferred option for adjuvant treatment of stageⅢcolon cancer after surgery.
基金funded by the Key R&D project of the Ministry of Science and Technology,China(2017YFC1700604).
文摘Background:Patients with colon cancer who receive chemotherapy usually experience various gastrointestinal adverse reactions,including nausea,vomiting,and diarrhea,which make it challenging for them to adhere to treatment.As an effective traditional Chinese medicine,the Jianpi Bushen formula has been widely used to alleviate the side effects of chemotherapy.Objective:To evaluate the efficacy and safety of Jianpi Bushen formulae for patients who undergo chemotherapy.This statistical analysis plan(SAP)is intended to enhance the transparency and research quality of our randomized controlled trial.Methods:Our study is a multicenter,double-blind,randomized controlled clinical trial.This trial aimed to compare the completion rate of chemotherapy in colon cancer patients who are using and not using Jianpi Bushen formula.To attenuate possible selection bias in the final report,we declared the overall trial design,outcome measures,subgroup analyses,and safety measures.Also,we described the data management and statistical analysis methods in detail.Conclusion:The SAP provides more detailed information than the trial protocol for data management and statistical analysis methods.Further post-hoc analyses can be performed by referring to the SAP,and possible selection bias can be attenuated.
文摘目的研究探讨特瑞普利单抗联合卡培他滨化疗方案(XELOX)治疗晚期胃癌及对叉头框蛋白A2(recombinant forkhead box protein A2,FOXA2)及细胞周期素依赖的蛋白激酶抑制物(cyclin dependent protein kinase inhibitor,p27kip1)表达水平影响。方法非随机选取2022年1月—2023年12月牡丹江医科大学附属红旗医院收治的96例晚期胃癌患者作为研究对象,按治疗方法不同分为观察组、对照组,各48例。对照组采用XELOX方案治疗,观察组在对照组基础上增加特瑞普利单抗治疗,对比两组患者的临床疗效、肿瘤标志物水平、FOXA2、p27kip1、生活质量评分、治疗安全性。结果观察组患者总有效率为77.08%(37/48),高于对照组的56.25%(27/48),差异有统计学意义(χ^(2)=4.688,P<0.05)。治疗后,观察组癌胚抗原、糖类抗原199、甲胎蛋白水平均低于对照组,差异有统计学意义(P均<0.05);治疗后,观察组FOXA2、p27kip1水平高于对照组,差异有统计学意义(P均<0.05);观察组癌症患者生命质量评分均高于对照组,差异有统计学意义(P均<0.05)。两组患者不良反应发生率对比,差异无统计学意义(P>0.05)。结论特瑞普利单抗联合XELOX方案治疗晚期胃癌效果良好,可降低肿瘤标志物水平,提高FOXA2、p27kip1表达水平,提高患者的生活质量水平,治疗安全性良好。
