AIM To verify whether recurrence-free survival(RFS) surrogates overall survival(OS) in phase Ⅲ trials for resectable colorectal liver metastases(CRLM).METHODS MEDLINE,EMBASE,and Scopus databases were consulted.Eligib...AIM To verify whether recurrence-free survival(RFS) surrogates overall survival(OS) in phase Ⅲ trials for resectable colorectal liver metastases(CRLM).METHODS MEDLINE,EMBASE,and Scopus databases were consulted.Eligible studies were phase Ⅲ trials testing any type of systemic therapy(neoadjuvant,adjuvant or perioperative) added to surgery in patients with resectable CRLM.A linear regression model based on hazard ratios(HR) of OS and RFS was performed.RESULTS Of 3059 studies,5 phase Ⅲ trials(1162 patients) were included for analyses.A linear regression weighted by each trial was used to estimate the association between each HR and RFS.The originated formula was:OS HR =(0.93 × RFS HR) + 0.14;with RFS 95%CI(0.48-1.38),with P = 0.007.CONCLUSION This association suggests that RFS could work as a putative surrogate endpoint of OS in this population,avoiding bigger,longer and more resource-consuming trials.The OS could be assumed based on RFS and our model could be useful to better estimate sample size calculations of phase Ⅲ trials of CRLM aiming for OS.展开更多
AIM To evaluate the long-term effectiveness and late toxicities of paclitaxel(PTX) plus cisplatin(DDP) with concurrent radiotherapy for locally advanced esophageal squamous cancer.METHODS Between 2008 and 2011, 76 pat...AIM To evaluate the long-term effectiveness and late toxicities of paclitaxel(PTX) plus cisplatin(DDP) with concurrent radiotherapy for locally advanced esophageal squamous cancer.METHODS Between 2008 and 2011, 76 patients were enrolled in a phase Ⅱ study on the treatment of loco-regionally advanced esophageal cancer with radiotherapy(68.4 Gy/44 fractions or 61.2 Gy/34 fractions) combined with 4-cycle chemotherapy consisting of DDP(25 mg/m^2 per day for 3 d) and PTX(175 mg/m^2 for 3 h). The primary endpoints were overall survival and progression-free survival, and the secondary endpoints were toxicity and the treatment failure pattern.RESULTS A total of 76 patients were enrolled in this study, of whom 63.2% finished the whole regimen. The 5-year survival rates for the per-protocol population and intent-to-treat population were 25.4% and 26.4%, respectively, and the median survival rates were 23.7 mo and 28.5 mo, respectively. Grade 3 or 4 late toxicity was observed in only one patient(heart failure). In log-rank analysis, the pretreatment stage(stage Ⅱ + Ⅲ: 36.1 mo vs stage Ⅳ: 14.9 mo) and the completed cycle(1-3 cycles: 16.1 mo vs 4 cycles: 35.5 mo) were significant prognostic factors(P = 0.037 < 0.05 and P = 0.013 < 0.05).CONCLUSION Radiotherapy combined with chemotherapy consisting of PTX and DDP is a safe and effective definitive treatment for loco-regionally advanced esophageal squamous cancer.展开更多
OBJeCTIve：To systematically evaluate the long-term effect and safety ofXingnao Kaiqiao nee-dling method in ischemic stroke treatment. DATA ReTRIevAL： We retrieved relevant random and semi-random controlled trials th...OBJeCTIve：To systematically evaluate the long-term effect and safety ofXingnao Kaiqiao nee-dling method in ischemic stroke treatment. DATA ReTRIevAL： We retrieved relevant random and semi-random controlled trials that used theXingnao Kaiqiao needling method to treat ischemic stroke compared with various control treatments such as conventional drugs or other acupuncture therapies. Searched databases included China National Knowledge Infrastructure, Weipu Information Resources System, Wanfang Medical Data System, Chinese Biomedical Literature Database, Cochrane Library, and PubMed, from May 2006 to July 2014. SeLeCTION CRITeRIA： Two authors independently conducted literature screening, quality evaluation, and data extraction. The quality of articles was evaluated according to the Cochrane Reviewers’ Handbook 5.1, and the study was carried out using Cochrane system assessment methods. RevMan 5.2 was used for meta-analysis of the included studies. MAIN OUTCOMe MeASUReS： Mortality rate, recurrence rate, and disability rate were observed. ReSULTS：Nine randomized and semi-randomized controlled trials treating 931 cases of ischemic stroke were included in this review. Meta-analysis results showed that there were no sig-niifcant differences in mortality reduction （risk ratio （RR） = 0.58, 95% conifdence interval （CI）： 0.17–1.93,Z = 0.89,P = 0.37） or recurrence rate （RR = 0.55, 95%CI： 0.18–1.70,Z = 1.04,P = 0.30） of ischemic stroke patients between theXingnao Kaiqiao needling and control treatment groups. However, theXingnao Kaiqiao needling method had a tendency towards higher efifcacy in mor-tality reduction and recurrence rates. TheXingnao Kaiqiao needling method was signiifcantly better than that of the control treatment in reducing disability rate （RR = 0.51, 95%CI： 0.27–0.98, Z = 2.03,P 〈 0.05）. CONCLUSION：TheXingnao Kaiqiao needling method has a better effect than control treatment in reducing disability rate. The long-term effect ofXingnao Kaiqiao needling against ischemic stroke is better than that of control treatment. However, the limitations of this study limit the strength of the conclusions. Randomized controlled trials with a strict, reasonable design, and multi-center, large-scale samples and follow-up are necessary to draw conclusions aboutXingnao Kaiqiao needling.展开更多
文摘AIM To verify whether recurrence-free survival(RFS) surrogates overall survival(OS) in phase Ⅲ trials for resectable colorectal liver metastases(CRLM).METHODS MEDLINE,EMBASE,and Scopus databases were consulted.Eligible studies were phase Ⅲ trials testing any type of systemic therapy(neoadjuvant,adjuvant or perioperative) added to surgery in patients with resectable CRLM.A linear regression model based on hazard ratios(HR) of OS and RFS was performed.RESULTS Of 3059 studies,5 phase Ⅲ trials(1162 patients) were included for analyses.A linear regression weighted by each trial was used to estimate the association between each HR and RFS.The originated formula was:OS HR =(0.93 × RFS HR) + 0.14;with RFS 95%CI(0.48-1.38),with P = 0.007.CONCLUSION This association suggests that RFS could work as a putative surrogate endpoint of OS in this population,avoiding bigger,longer and more resource-consuming trials.The OS could be assumed based on RFS and our model could be useful to better estimate sample size calculations of phase Ⅲ trials of CRLM aiming for OS.
基金Supported by National Natural Science Foundation of China,No.21172043 and No.21441010
文摘AIM To evaluate the long-term effectiveness and late toxicities of paclitaxel(PTX) plus cisplatin(DDP) with concurrent radiotherapy for locally advanced esophageal squamous cancer.METHODS Between 2008 and 2011, 76 patients were enrolled in a phase Ⅱ study on the treatment of loco-regionally advanced esophageal cancer with radiotherapy(68.4 Gy/44 fractions or 61.2 Gy/34 fractions) combined with 4-cycle chemotherapy consisting of DDP(25 mg/m^2 per day for 3 d) and PTX(175 mg/m^2 for 3 h). The primary endpoints were overall survival and progression-free survival, and the secondary endpoints were toxicity and the treatment failure pattern.RESULTS A total of 76 patients were enrolled in this study, of whom 63.2% finished the whole regimen. The 5-year survival rates for the per-protocol population and intent-to-treat population were 25.4% and 26.4%, respectively, and the median survival rates were 23.7 mo and 28.5 mo, respectively. Grade 3 or 4 late toxicity was observed in only one patient(heart failure). In log-rank analysis, the pretreatment stage(stage Ⅱ + Ⅲ: 36.1 mo vs stage Ⅳ: 14.9 mo) and the completed cycle(1-3 cycles: 16.1 mo vs 4 cycles: 35.5 mo) were significant prognostic factors(P = 0.037 < 0.05 and P = 0.013 < 0.05).CONCLUSION Radiotherapy combined with chemotherapy consisting of PTX and DDP is a safe and effective definitive treatment for loco-regionally advanced esophageal squamous cancer.
基金financially supported by grants from Hebei Province Engineering Talent Cultivation Project and Hebei Province Science and Technology Research and Development Projects,No.11276103D-35
文摘OBJeCTIve：To systematically evaluate the long-term effect and safety ofXingnao Kaiqiao nee-dling method in ischemic stroke treatment. DATA ReTRIevAL： We retrieved relevant random and semi-random controlled trials that used theXingnao Kaiqiao needling method to treat ischemic stroke compared with various control treatments such as conventional drugs or other acupuncture therapies. Searched databases included China National Knowledge Infrastructure, Weipu Information Resources System, Wanfang Medical Data System, Chinese Biomedical Literature Database, Cochrane Library, and PubMed, from May 2006 to July 2014. SeLeCTION CRITeRIA： Two authors independently conducted literature screening, quality evaluation, and data extraction. The quality of articles was evaluated according to the Cochrane Reviewers’ Handbook 5.1, and the study was carried out using Cochrane system assessment methods. RevMan 5.2 was used for meta-analysis of the included studies. MAIN OUTCOMe MeASUReS： Mortality rate, recurrence rate, and disability rate were observed. ReSULTS：Nine randomized and semi-randomized controlled trials treating 931 cases of ischemic stroke were included in this review. Meta-analysis results showed that there were no sig-niifcant differences in mortality reduction （risk ratio （RR） = 0.58, 95% conifdence interval （CI）： 0.17–1.93,Z = 0.89,P = 0.37） or recurrence rate （RR = 0.55, 95%CI： 0.18–1.70,Z = 1.04,P = 0.30） of ischemic stroke patients between theXingnao Kaiqiao needling and control treatment groups. However, theXingnao Kaiqiao needling method had a tendency towards higher efifcacy in mor-tality reduction and recurrence rates. TheXingnao Kaiqiao needling method was signiifcantly better than that of the control treatment in reducing disability rate （RR = 0.51, 95%CI： 0.27–0.98, Z = 2.03,P 〈 0.05）. CONCLUSION：TheXingnao Kaiqiao needling method has a better effect than control treatment in reducing disability rate. The long-term effect ofXingnao Kaiqiao needling against ischemic stroke is better than that of control treatment. However, the limitations of this study limit the strength of the conclusions. Randomized controlled trials with a strict, reasonable design, and multi-center, large-scale samples and follow-up are necessary to draw conclusions aboutXingnao Kaiqiao needling.
