scholarly journals Clinical and Molecular Characteristics Associated with Survival in Advanced Melanoma Treated with Checkpoint Inhibitors

2018 ◽  
Vol 2018 ◽  
pp. 1-13 ◽  
Author(s):  
Sunil Badami ◽  
Sunil Upadhaya ◽  
Ravi Kanth Velagapudi ◽  
Pushyami Mikkilineni ◽  
Ranju Kunwor ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Checkpoint Inhibitors ◽  
Meta Analysis ◽  
Random Effect ◽  
Eastern Cooperative Oncology Group ◽  
Advanced Melanoma ◽  
Cochrane Library ◽  
Molecular Characteristics ◽  
Significant Heterogeneity

Background. We performed meta-analysis to gather more evidence regarding clinical-molecular subgroups associated with better overall survival (OS) in advanced melanoma treated with checkpoint inhibitors. Materials and Methods. We performed a systematic search of PubMed, Scopus, Cochrane Library, and clinical trial.gov. Randomized clinical trials that compared a checkpoint inhibitor (nivolumab or pembrolizumab) with investigator choice chemotherapy or ipilimumab were included in our study. Hazard ratios (HR) and confidence interval (CI) were calculated for progression-free survival (PFS) and OS for each subgroup using generic inverse model along with the random effect method. Results. A total of 6 clinical trials were eligible for the meta-analysis. OS was prolonged in wild BRAF subgroup (HR 0.65, 95% CI 0.49-0.85, p 0.002), Programmed cell death subgroup (PD-1+) (HR 0.57, 95% CI 0.41-0.80, p 0.001), and high lactate dehydrogenase (LDH) level subgroup (HR 0.60, 95% CI 0.38-0.95, p 0.03). Similarly, we found increased OS in eastern cooperative oncology group (ECOG) 1, males and age >65 years subgroups. Conclusions. Checkpoint inhibitors significantly increased OS in patients with wild BRAF, positive PD-1, and high LDH. However, results should be interpreted keeping in mind associated significant heterogeneity. The results of this study should help in designing future clinical trials.

Abiraterone acetate (AA) or docetaxel (D) in metastatic castration-sensitive prostate cancer (mCSPC): A systematic review and network meta-analysis of randomized clinical trials (RCTs).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 243-243
Author(s):  
Irbaz Bin Riaz ◽  
Abdulaali Almutairi ◽  
Zeeshan Ali ◽  
Abdullah Alhifany ◽  
Sandipan Bhattacharjee ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Trials ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Random Effect ◽  
Indirect Comparison ◽  
Cochrane Library ◽  
Cochrane Central Register

243 Background: AA and D have been shown in separate trials to increase overall survival in patients with mCSPC compared to Androgen Derivation Therapy (ADT). In the absence of head to head clinical trials and to provide clinical guidance, we performed an indirect comparison of AA and D using network meta-analysis. Methods: We performed a search of MEDLINE, EMBASE, Cochrane Library, and Cochrane Central Register of Controlled Trials to identify relevant clinical trials. Collected data included hazard ratio and confidence interval (CI) for Overall Survival (OS) and number of adverse events in each study arm. Risk for bias was assessed using the Cochrane Collaboration’s tool. Bayesian network meta-analysis was conducted using WinBUGS 1.4.3 software (MRC Biostatistics Unit, Cambridge, UK) to perform an indirect comparison of D and AA. Results: Five clinical trials were included in this analysis. Two trials (LATITUDE, STAMPEDE) compared AA to ADT and three trials (CHAARTED,STAMPEDE, GETUG-AFU 15 study) compared D to ADT. Results from both fixed effect and random effect network meta-analyses for the primary outcome (OS) revealed no statistical significance between AA and D (HR 0.81,95%CI 0.65-1.01; HR 0.81, 95%CI 0.40-1.82) respectively. Comparatively, abiraterone had statistically significant fewer events of anemia (OR 0.14,95%CI 0.08-0.23), neutropenia (OR 0.06,95%CI 0.03-0.12), peripheral edema (OR 0.21,95%CI 0.09-0.44), dyspnea (OR 0.22,95%CI 0.08-0.51), nausea (OR 0.09,95%CI 0.02-0.24), diarrhea (OR 0.06,95%CI 0.02-0.15), constipation (OR 0.25,95%CI 0.11-0.53), and fatigue (OR 0.12,95%CI 0.07-0.20). AA had statistically significant more events of hot flashes (OR 3.85, 95% CI2.33-6.25). For other adverse events, both drugs were statistically similar. Conclusions: There is no difference in OS using AA for longer periods in CSPC than a regimen of a limited number of cycles of D. There are significant differences in side effect profile of these drugs. Further analyses are needed to determine cost effectiveness of AA vs D under consideration of comparative efficacy and safety.

scholarly journals The Effects of Aromatherapy on Premenstrual Syndrome Symptoms: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-13
Author(s):  
Somayeh Es-haghee ◽  
Fatemeh Shabani ◽  
Jessie Hawkins ◽  
Mohammad Ali Zareian ◽  
Fatemeh Nejatbakhsh ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Premenstrual Syndrome ◽  
Randomized Clinical Trials ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Random Effect ◽  
Random Effect Model ◽  
Cochrane Library ◽  
Control Group ◽  
Childbearing Age

ObjectivesPremenstrual syndrome (PMS) is a common disturbance among women of childbearing age. Aromatherapy is a commonly used form of complementary and alternative medicine (CAM) to treat PMS. The purpose of this study is to quantify and summarize the effects of aromatherapy on premenstrual syndrome symptoms. Methods. PubMed, Scopus, and Cochrane Library databases were searched through relevant search terms until October 2020. The effect sizes were pooled as weighted mean difference (WMD) and 95% confidence interval (CI) using the random effect model. Egger tests and visual inspection of the funnel plot were performed to identify the existence of publication bias. The I-squared (I2) test was applied to measure heterogeneity. Results. Eight studies (n = 8) were included in this analysis. The quantitative synthesis of evidence found that aromatherapy decreases PMS scores (WMD –13.83; 95% CI (−22.04, −5.63), I2 = 94.5%), total psychological symptoms of PMS (WMD –3.51; 95% CI (−4.84, −2.18), I2 = 82.6%), anxiety of PMS (WMD–1.78; 95% CI (−3.17, −0.38), I2 = 94.2%), depression of PMS (WMD–2.0; 95% CI (−3.65, −0.34), I2 = 93.7%), and fatigue of PMS (WMD – 1.44; 95% CI (−2.44, −0.44), I2 = 89.7%) compared to the control group. Conclusion. Aromatherapy is an effective tool for the relief of PMS symptoms. Additional randomized controlled clinical trials with different durations and essential oils should be conducted to confirm our findings.

scholarly journals Effectiveness and Safety of Immune Checkpoint Inhibitors for Patients with Advanced Non Small-Cell Lung Cancer in Real-World: Review and Meta-Analysis

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1388
Author(s):  
Manlio Mencoboni ◽  
Marcello Ceppi ◽  
Marco Bruzzone ◽  
Paola Taveggia ◽  
Alessia Cavo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Real World ◽  
Group Performance ◽  
Checkpoint Inhibitors ◽  
Meta Analysis ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Small Cell ◽  
Small Cell Lung ◽  
Eligibility Criteria

Immunotherapy based on anti PD-1/PD-L1 inhibitors is the new standard of advanced non-small cell lung cancers. Pembrolizumab, nivolumab and atezolizumab are used in clinical practice. The strict eligibility criteria of clinical trials do not allow researchers to fully represent treatment effects in the patients that will ultimately use these drugs. We performed a systematic review and a meta-analysis to evaluate the effectiveness and safety of these drugs, and more generally of ICIs, as second-line therapy in NSCLC patients in real world practice. MEDLINE, PubMed, Scopus and Web of Science were searched to include original studies published between January 2015 and April 2020. A total of 32 studies was included in the meta-analysis. The overall radiological response rate (ORR), disease control rate (DCR), median progression-free survival (PFS) and overall survival (OS) were 21%, 52%, 3.35 months and 9.98 months, respectively. The results did not change when analysis was adjusted for Eastern Cooperative Oncology Group performance status (ECOG PS) and age. A unitary increase in the percent of patients with liver and CNS metastases reduced the occurrence of DCR by 7% (p < 0.001) and the median PFS by 2% (p = 0.010), respectively. The meta-analysis showed that the efficacy and safety of immunotherapy in everyday practice is comparable to that in clinical trials.

Novel oral anticoagulats for the treatment of left ventricle thrombosis: a systematic review and meta-analysis

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
M Serenelli ◽  
F Vitali ◽  
R Pavasini ◽  
E Tonet ◽  
G Pompei ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Random Effect ◽  
Random Effect Model ◽  
Left Ventricular ◽  
Left Ventricular Thrombus ◽  
Cochrane Library ◽  
Secondary Outcome ◽  
Ventricular Thrombus

Abstract Funding Acknowledgements Type of funding sources: None. Background novel oral anticoagulants (NOACs) are not guideline-recommanded treatment for left ventricular thrombus.  Purpose: the aim of this meta-analysis is to compare NOACs versus vitamin-K atagonsits (VKAs) efficacy in treating left ventricular thrombus (LVT). Methods: we systematically searched MEDLINE, Cochrane Library, Biomed Central, and Web of Science for trials comparing NOACs versus VKAs in the setting of LVT. Five studies, out of the 74 initially selected after first screening, were included in the meta-analysis. For the development of this meta-analysis, the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines were followed. The shortlisted studies were retrieved as full articles and appraised independently by two unblinded reviewers. The Mantel-Haensel method with a random effect model was used for the pooled analysis. The primary outcome was the occurrence of stroke and systemic embolism. Secondary outcome was occurrence of left ventricular thrombosis resolution during treatment.  Results: 707 patients were included in the analysis for the primary outcome. Of these, 230 were treated with NOACs and 477 with VKAs. The pooled OR for the primary outcome was 0.71 (95% CI 0.18-2.86, I2 67%), thus showing similar effect in term of ischaemic protection. A total of 698 patients, 228 on NOACs and 470 on VKAs were included in the analysis of the secondary outcome. The pooled OR for the secondary outcome pooled OR 0.97, 95% CI 0.56-1.68, I2 46%. Conclusions and Relevance: NOACs seem to have a similar efficacy profile compare to VKAs and so they should be considered as an alternative treatment for left ventricular thrombosis. Large prospective randomized clinical trials are needed to confirm this exploratory finding. Abstract Figure 1

Is first-line immune checkpoint inhibitors (ICI) beneficial to platinum-eligible patients (pts) with advanced urothelial carcinoma (aUC)? a meta-analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16506-e16506
Author(s):  
Ce Cheng ◽  
Iloabueke Gabriel Chineke ◽  
Ali McBride ◽  
Juan Chipollini ◽  
Edward Paul Gelmann ◽  
...  
Keyword(s):  
Publication Bias ◽  
Subgroup Analysis ◽  
Checkpoint Inhibitors ◽  
Meta Analysis ◽  
Random Effect ◽  
Fixed Effect Model ◽  
Cochrane Library ◽  
First Line ◽  
Significance Level ◽  
Line Setting

e16506 Background: ICI have proven to benefit patients diagnosed with aUC who are platinum-ineligible. The role of platinum-eligible patients, in the first-line setting is being further elucidated after single positive randomized clinical trial (RCT) with ICI. Hence, we performed a meta-analysis to interpret the association of Overall Survival (OS) and PD-1 or PD-L1 inhibitors as first-line therapies in platinum-eligible patients with aUC. Methods: Randomized controlled trials were retrieved from PubMed, Web of Science, and Cochrane Library according to established inclusion criteria. Each article was assessed by the Newcastle-Ottawa Scale. The Hazard Risk (HR) and 95% confidence intervals (CI) were calculated. Random effect or fixed-effect model was used to calculate the pooled HR, based on heterogeneity significance. Sensitivity analysis and publication bias detection were performed. All statistical analysis were performed using RevMan software (v5.4; Cochrane library) and R Core Team (2016, Vienna, Austria), and all p-values were two-tailed, and the significance level was 0.05. Results: Sixty-seven articles were obtained from the database search, and based on inclusion/exclusion criteria, five RCTs were selected involving 4063 patients. All studies were considered moderate to high quality. A statistically significant association was found between initiation of immunotherapy as first-line treatment to platinum-eligible patients and increased OS (HR 0.87; 95% CI: 0.81,0.94, p = 0.004, I2= 38%). The subgroup analysis included positive PD1 (HR 0.81; 95% CI: 0.70,0.94, p = 0.004, I2= 34%) vs. negative expression (HR 0.96; 95% CI: 0.83,1.11, p = 0.58, I2= 0%); cisplatin (HR 0.81; 95% CI: 0.69,0.96, p = 0.02, I2= 47%) vs. carboplatin administration (HR 0.87; 95% CI: 0.76,1.01, p = 0.06, I2= 21%); male (HR 0.87; 95% CI: 0.77,0.97, p = 0.01, I2= 44%) vs. female (HR 0.85; 95% CI: 0.70,1.04, p = 0.11, I2= 0%); ECOG score 0 (HR 0.77; 95% CI: 0.67,0.89, p = 0.0005, I2= 0%) vs. ≥ 1 (HR 0.90; 95% CI: 0.78,1.02, p = 0.11, I2= 6%); Caucasian (HR 0.81; 95% CI: 0.73, 0.91, p = 0.0003, I2= 39%) vs. other race (HR 0.92; 95% CI: 0.75, 1.13, p = 0.44, I2= 0%). Similar association regardless of visceral lesion or age. Funnel plot, Egger's test (p = 0.6944), and Begg's test (0.7726) found no publication bias of analysis. Conclusions: This meta-analysis showed improved OS in platinum-eligible patients receiving first-line ICI in aUC. Furthermore, a subgroup analysis yielded an increased OS and cisplatin, positive PD1 status, ECOG 0, male gender, and Caucasian race. In this rapidly evolving clinical practice changes, our meta-analysis provides support to currently recommended avelumab maintenance after platinum induction therapy in the first-line setting and further provide guidance on patient selection for aUC.

Abstract P391: Marine N-3 Fatty Acids Reduce Atherosclerosis Cardiovascular Disease: A Systemic Review and Meta-analysis of Clinical Trials

Circulation ◽  
2013 ◽  
Vol 127 (suppl_12) ◽  
Author(s):  
Akira Sekikawa ◽  
Nobutake Hirooka ◽  
Abhishek Vishnu ◽  
Vashudha Ahuja ◽  
Emmanuel Sampene ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Fatty Acids ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Imaging Techniques ◽  
Meta Analysis ◽  
Quantitative Information ◽  
Systemic Review ◽  
Cochrane Library ◽  
Cardiac Imaging Techniques

Introduction: Although marine n-3 fatty acids are believed to be cardioprotective through their anti-arrhythmic, anti-thrombotic, anti-atherogenic and other effects, results from recent meta-analyses of marine n-3 fatty acids on cardiovascular disease (CVD) are controversial. We performed a meta-analysis of marine n-3 fatty acids on CVD outcomes in randomized clinical trials (RCTs) to test the hypothesis that marine n-3 fatty acids are anti-atherogenic. We also tested the hypothesis that such benefit is dose-dependent. Methods: A systematic review of English language articles using PubMed, EMBASE and Cochrane Library through Aug 2012 was performed selecting RCTs evaluating the effect of marine n-3 fatty acids intake for 2 years or more on cardiovascular diseases, coronary disease, arteriosclerosis, cardiac imaging techniques, and carotid artery ultrasound. Descriptive and quantitative information was extracted. Odds ratios were calculated for cardiac event outcome. Correlation coefficients were obtained from studies of which outcome is intima-media thickness (IMT) and coronary lumen diameter (CD). We converted the estimates into a single effect size; the log odds ratio and its corresponding standard error. Results: Of 14,236 citations retrieved, 13 studies were selected, including studies reporting IMT (n=3) and CD (n=2) and major CVD events (n=8). Overall, marine n-3 fatty acids significantly reduced atherosclerotic CVD (RR 0.94: 95%CI 0.90 to 0.99, p<0.05). There was no evidence of heterogeneity (p=0.65) or publication bias (p=0.37, Begg’s test). A sub-analysis among 8 studies of major CVD events showed the similar results (RR 0.94: 95% CI 0.89 to 0.99, p<0.05). Another sub-analysis among 4 studies excluding sudden cardiac death as an outcome showed RR of 0.91 (95% CI 0.82 to 1.02, p=0.097). A meta-regression analysis shows that dose of marine n-3 fatty acids was inversely associated with CVD outcome, although the association was not statistically significant (p=0.06). Conclusions: The result of our meta-analysis supports a modest anti-atherogenic effect of marine n-3 fatty acids. This benefit may be proportional to the amount of marine n-3 fatty acids consumed.

scholarly journals Caries Removal by Chemomechanical (Carisolv™) vs. Rotary Drill: A Systematic Review

2015 ◽  
Vol 9 (1) ◽  
pp. 462-472 ◽  
Author(s):  
Viral P. Maru ◽  
B.S. Shakuntala ◽  
C. Nagarathna
Keyword(s):  
Clinical Trials ◽  
Patient Preference ◽  
Pain Perception ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Random Effect ◽  
Search Results ◽  
Randomized Controlled Studies ◽  
Caries Removal ◽  
Time Required

Background:Chemomechanical caries removal is an effective alternative to the traditional rotary drilling method. The advantages of chemomechanical techniques in terms of the need for anesthesia, pain perception and patient preference are systematically reviewed and a meta-analysis of the time required for caries removal is reported.Method: Randomized controlled studies of comparison of chemomechanical techniques with conventional rotary drill were selected from a systematic search of standard biomedical databases, including the PubMed and Cochrane clinical trials. Non-repeated search results were screened for relevance and risk of bias assessment, followed by methodology assessment. Statistical models were applied to the outcome parameters - time required, pain perception, need of anesthesia and patient preference - extracted from the studies.Results: Out of the 111 non-repeated search results, 26 studies receiving a low bias score were selected for the review, and 16 randomized clinical trials of rotary and Carisolv techniques were considered for meta-analysis. Meta-analysis by fixed effect as well as random effect models indicate that Carisolv takes more time (3.65 ± 0.05 and 4.09 ± 0.29 min) than rotary drill (8.65 ± 0.09 and 8.97 ± 0.66 min) method. Advantages of reduced pain (14.67 for Carisolvvs.6.76 for rotary drill), need for anesthesia (1.59%vs.10.52%) outweigh the longer time requirement and make it the preferred (18.68%vs.4.69%) method.Conclusion: Chemomechanical techniques stand out as a minimally invasive and preferred method based on the meta-analyses. Evaluation of pain experienced using robust methods is needed to strengthen the evidence for their use.

scholarly journals Efficacy of Low-Dose Paroxetine for the Treatment of Hot Flushes in Surgical and Physiological Postmenopausal Women: Systematic Review and Meta-Analysis of Randomized Trials

Medicina ◽  
2019 ◽  
Vol 55 (9) ◽  
pp. 554
Author(s):  
Gaetano Riemma ◽  
Antonio Schiattarella ◽  
Marco La Verde ◽  
Giuseppina Zarobbi ◽  
Simone Garzon ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Postmenopausal Women ◽  
Sleep Disturbances ◽  
Low Dose ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Hormonal Treatment ◽  
Significant Heterogeneity ◽  
Hot Flushes ◽  
Night Time

Background and Objectives: Hot flushes and sleep disturbances are the most common vasomotor symptoms (VMS) reported by postmenopausal women. Hormonal treatment is to date referred to as the gold standard approach but not suitable for all the patients. Alternative treatments are needed in case of a contraindication to menopausal hormone therapy (MHT), adverse side effects, and poor compliance. Paroxetine salt is the only nonhormonal medication approved by the US Food and Drug Administration for the management of VMS. Nonetheless, few trials with low consensus are available about this topic. In this review, we aimed to evaluate the efficacy of low-dose paroxetine therapy in the treatment of vasomotor hot flushes and night sleep disturbances in postmenopausal women. Materials and Methods: We performed an electronic search from the beginning of all databases to July 2019. All results were then limited to a randomized trial. Restrictions for language or geographic location were not utilized. Inclusion criteria were randomized clinical trials of physiological or surgical postmenopausal women experiencing hot flushes and sleep disturbances who were randomized to either low-dose paroxetine or placebo (i.e., formulations without active ingredients). The primary outcome evaluated was the mean weekly reduction of hot flushes. Results: Five randomized clinical trials, including 1482 postmenopausal women, were analyzed. Significant heterogeneity (I2 = 90%) between studies was noted. Hot flushes episodes were significantly reduced in the treatment arm compared to placebo (mean difference (MD) −7.97 [−10.51, −5.92] episodes/week). Results on the improvement on sleep were limited by being reported in only two studies; however, no significant reduction of night-time awakenings was observed (MD, −0.40 awakenings/night [−1.38, 0.58 CI]). Conclusions: Low-dose paroxetine is an effective treatment for vasomotor menopause symptoms, including hot flushes.

scholarly journals Serum Tumor Necrosis Factor-αand Interferon-γLevels in PediatricMycoplasma pneumoniaePneumonia: A Systematic Review and Meta-Analysis

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Ying Wang ◽  
Yongsheng Zhang ◽  
Wenting Lu ◽  
Liying Wang
Keyword(s):  
Tumor Necrosis Factor ◽  
Tumor Necrosis ◽  
Meta Analysis ◽  
Random Effect ◽  
Diagnostic Methods ◽  
Cochrane Library ◽  
Significant Heterogeneity ◽  
Healthy Children ◽  
Necrosis Factor ◽  
Serum Tumor Necrosis

Background.Mycoplasma pneumoniaepneumonia (MPP) is one of the most common forms of community-acquired pneumonia in children. The objective of this study was to explore potential changes in levels of serum tumor necrosis factor-α(TNF-α) and interferon-γ(IFN-γ) associated with pediatric MPP.Methods. This protocol has been registered (PROSPERO 2017: CRD42017077979). A literature search was performed in October 2017 using PubMed, Embase, the Cochrane Library, and other Chinese medical databases to identify studies. The meta-analysis was performed using Review Manager 5.3 software. Random-effect models were used to estimate mean differences (MDs) and 95% confidence intervals (CIs) of cytokine levels.Results. Twelve studies were included in the meta-analysis, encompassing 2,422 children with MPP and 454 healthy control children. Serum TNF-αlevels were significantly higher in children with MPP compared with healthy children (MD = 22.5, 95% CI = 13.78–31.22,P<0.00001), and there was significant heterogeneity across studies (I2 = 100%,P<0.00001). Subgroup analyses showed no evidence for a difference in serum TNF-αlevels between children with refractory and nonrefractory MPP. Serum IFN-γlevels did not significantly differ in children with MPP compared with healthy children (MD = 4.83, 95% CI = −3.27–12.93,P=0.24).Conclusions. Our meta-analysis showed that serum TNF-αand IFN-γlevels were significantly elevated and unchanged, respectively, in pediatric MPP. Because infection by different pathogens has variable effects on serum TNF-αand IFN-γlevels, the finding could be helpful in developing novel diagnostic methods.

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