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Efficacy of Cancer Immunotherapy: An Umbrella Review of Meta-analyses of Randomized Controlled Trials.

ABSTRACT: We conducted a systematic review for evidence of the clinical efficacy of cancer immunotherapies. We searched PubMed from inception to 14 February 2018 for meta-analyses of randomized controlled trials (RCTs) of cancer immunotherapies. Re-analyses were performed to estimate the summary effect size under random-effects, the 95% confidence interval (CI), heterogeneity, and the 95% prediction interval, and we determined the strength of the evidence. We examined publication bias and excess significance bias. 63 articles corresponding to 247 meta-analyses were eligible. Nine meta-analyses were classified to have convincing evidence, and 75 were classified as suggestive evidence. The clinical benefit of immunotherapy was supported by convincing evidence in the following settings: anti-PD-1/PD-L1 monoclonal antibody (mAb) therapy for treating advanced melanoma and non-small cell lung cancer (NSCLC), the combination of rituximab and chemotherapy for treating chronic lymphocytic leukemia and B-cell non-Hodgkin's lymphoma, adoptive cell immunotherapy for NSCLC, and the combination of interferon ? and chemotherapy for metastatic melanoma. A further meta-analysis of 16 RCTs showed that anti-PD-1/PD-L1 mAb therapy had a benefit in patients with solid tumors (overall survival; hazard ratio = 0.73, 95% CI: 0.68-0.79; p < 0.001), supported by convincing evidence. In the future, rigorous approaches are needed when interpreting meta-analyses to gain better insight into the true efficacy of cancer immunotherapy.

SUBMITTER: Kim JY

PROVIDER: S-EPMC6895783 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Efficacy of Cancer Immunotherapy: An Umbrella Review of Meta-analyses of Randomized Controlled Trials.

Kim Jong Yeob JY Lee Keum Hwa KH Eisenhut Michael M van der Vliet Hans J HJ Kronbichler Andreas A Jeong Gwang Hun GH Shin Jae Il JI Gamerith Gabriele G

Cancers 20191115 11

We conducted a systematic review for evidence of the clinical efficacy of cancer immunotherapies. We searched PubMed from inception to 14 February 2018 for meta-analyses of randomized controlled trials (RCTs) of cancer immunotherapies. Re-analyses were performed to estimate the summary effect size under random-effects, the 95% confidence interval (CI), heterogeneity, and the 95% prediction interval, and we determined the strength of the evidence. We examined publication bias and excess significa ...[more]

PMID: 31731818

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Project description:IntroductionThe National Comprehensive Cancer Network guidelines for adult cancer pain indicate that acupuncture and related therapies may be valuable additions to pharmacological interventions for pain management. Of the systematic reviews related to this topic, some concluded that acupuncture was promising for alleviating cancer pain, while others argued that the evidence was insufficient to support its effectiveness.Methods and analysisThis review will consist of three components: (1) synthesis of findings from existing systematic reviews; (2) updated meta-analyses of randomised clinical trials and (3) analyses of results of other types of clinical studies. We will search six English and four Chinese biomedical databases, dissertations and grey literature to identify systematic reviews and primary clinical studies. Two reviewers will screen results of the literature searches independently to identify included reviews and studies. Data from included articles will be abstracted for assessment, analysis and summary. Two assessors will appraise the quality of systematic reviews using Assessment of Multiple Systematic Reviews; assess the randomised controlled trials using the Cochrane Collaboration's risk of bias tool and other types of studies according to the Newcastle-Ottawa Scale. We will use 'summary of evidence' tables to present evidence from existing systematic reviews and meta-analyses. Using the primary clinical studies, we will conduct meta-analysis for each outcome, by grouping studies based on the type of acupuncture, the comparator and the specific type of pain. Sensitivity analyses are planned according to clinical factors, acupuncture method, methodological characteristics and presence of statistical heterogeneity as applicable. For the non-randomised studies, we will tabulate the characteristics, outcome measures and the reported results of each study. Consistencies and inconsistencies in evidence will be investigated and discussed. Finally, we will use the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate the quality of the overall evidence.Ethics and disseminationThere are no ethical considerations associated with this review. The findings will be disseminated in peer-reviewed journals or conference presentations.Prospero registration numberCRD42017064113.

Project description:Background: The clinical selection of three CDK4/6 inhibitors presents a challenging issue, owing to the absence of distinct clinical case characteristics, biomarkers, and their comparable clinical benefits in progression-free survival and overall survival To inform clinical treatment decisions, we conducted a comprehensive evaluation of the adverse events associated with CDK4/6 inhibitors in combination with endocrine therapy for hazard ratio+/HER2-breast cancer. Methods: We searched Cochrane, PubMed, Embase, and Web of Science databases from their inception until 1 August 2022. The results were summarized narratively, and we assessed the methodological quality, reporting quality, and evidence quality of AEs by AMSTAR-2, PRISMA, and GRADE. Results: Our analysis included 24 meta-analyses systematic reviews that evaluated the quality of AEs in 13 cases of early breast cancer (EBC) and 158 cases of advanced breast cancer The addition of CDK4/6 inhibitors was found to significantly increase AEs of any grade and AEs of grade 3 or higher in early breast cancer, along with a significant increase in the risk of treatment discontinuation. In advanced breast cancer, high and moderate-quality evidence indicated that CDK4/6 inhibitors significantly increased AEs across all grades, including grade 3/4 AEs, leucopenia, grade 3/4 leucopenia, neutropenia, grade 3/4 neutropenia, anemia, grade 3/4 anemia, nausea, grade 3/4 constipation, fatigue, pyrexia, venous thromboembolism abdominal pain, and cough. However, they did not significantly elevate the incidence of grade 3/4 diarrhea. Subgroup analysis revealed that palbociclib primarily increased hematologic toxicity, particularly grade 3/4 neutropenia, anemia, and thrombocytopenia. Ribociclib was mainly associated with grade 3/4 neutropenia, prolonged QT interval, and alopecia. Abemaciclib was closely linked with diarrhea and elevated blood creatinine levels. Conclusion: The AEs associated with CDK4/6 inhibitors vary, necessitating individualized and precise clinical selection for optimal management. This approach should be based on the patient's medical history and the distinct characteristics of different CDK4/6 inhibitors to improve the patient's quality of life. Systematic Review Registration: [https://systematicreview.gov/], identifier [CRD42022350167].

Project description:The prevalence of overweight, obesity, and their related complications is increasing worldwide. The purpose of this umbrella review was to summarize and critically evaluate the effects of different diets on anthropometric parameters and cardiometabolic risk factors. Medline, Embase, Scopus, Cochrane Database of Systematic Reviews, and Web of Science, from inception to April 2019, were used as data sources to select meta-analyses of randomized controlled trials that examined the effects of different diets on anthropometric parameters and cardiometabolic risk factors. Strength and validity of the evidence were assessed through a set of predefined criteria. Eighty articles reporting 495 unique meta-analyses were examined, covering a wide range of popular diets: low-carbohydrate (n = 21 articles), high-protein (n = 8), low-fat (n = 9), paleolithic (n = 2), low-glycemic-index/load (n = 12), intermittent energy restriction (n = 6), Mediterranean (n = 11), Nordic (n = 2), vegetarian (n = 9), Dietary Approaches to Stop Hypertension (DASH) (n = 6), and portfolio dietary pattern (n = 1). Great variability in terms of definition of the intervention and control diets was observed. The methodological quality of most articles (n = 65; 81%), evaluated using the "A MeaSurement Tool to Assess systematic Reviews-2" questionnaire, was low or critically low. The strength of evidence was generally weak. The most consistent evidence was reported for the Mediterranean diet, with suggestive evidence of an improvement in weight, BMI, total cholesterol, glucose, and blood pressure. Suggestive evidence of an improvement in weight and blood pressure was also reported for the DASH diet. Low-carbohydrate, high-protein, low-fat, and low-glycemic-index/load diets showed suggestive and/or weak evidence of a reduction in weight and BMI, but contrasting evidence for lipid, glycemic, and blood pressure parameters, suggesting potential risks of unfavorable effects. Evidence for paleolithic, intermittent energy restriction, Nordic, vegetarian, and portfolio dietary patterns was graded as weak. Among all the diets evaluated, the Mediterranean diet had the strongest and most consistent evidence of a beneficial effect on both anthropometric parameters and cardiometabolic risk factors. This review protocol was registered at www.crd.york.ac.uk/PROSPERO/ as CRD42019126103.

Project description:Although several meta-analyses have revealed the beneficial effects of dietary fiber intake on human health, some have reported inconsistent findings. The purpose of this work was to perform an umbrella meta-analysis to evaluate the relevant evidence and elucidate the effect of dietary fiber intake on glycemic control, lipid profiles, systematic inflammation, and blood pressure. Eligible studies were searched in several electronic databases, including Web of Science, PubMed, Scopus, and the Cochrane Library, up to March 2022. A total of 52 meta-analyses involving 47,197 subjects were identified to assess the pooled effect size. Overall, higher dietary fiber intake was significantly associated with reductions in parameters involving glycemic control, including fasting plasma glucose (ES = -0.55, 95% CI: -0.73, -0.38, P < 0.001), fasting plasma insulin (ES = -1.22, 95% CI: -1.63, -0.82, P < 0.001), homeostasis model assessment of insulin resistance (HOMA-IR) (ES = -0.43, 95% CI: -0.60, -0.27, P < 0.001), and glycosylated hemoglobin (HbA1c) (ES = -0.38, 95% CI: -0.50, -0.26, P < 0.001). In terms of lipid profiles, higher dietary fiber intake was associated with significant reductions in the serum level of total cholesterol (ES = -0.28, 95% CI: -0.39, -0.16, P < 0.001) and low-density lipoprotein cholesterol (ES = -0.25, 95% CI: -0.34, -0.16, P < 0.001), but not triglycerides (ES = -0.001, 95% CI: -0.006, 0.004, P = 0.759) and high-density lipoprotein cholesterol (ES = -0.002, 95% CI: -0.004, 0.000, P = 0.087). Higher dietary fiber intake was also significantly associated with improved tumor necrosis factor-alpha serum levels (ES = -0.78, 95% CI: -1.39, -0.16, P = 0.013), while no significant effect was observed for C-reactive protein (ES = -0.14, 95% CI: -0.33, 0.05, P = 0.156). Finally, blood pressure was also significantly improved following higher dietary fiber intake (systolic blood pressure: ES = -1.72, 95% CI: -2.13, -1.30, P < 0.001; diastolic blood pressure: ES = -0.67, 95% CI: -0.96, -0.37, P < 0.001). Subgroup analysis revealed that the study population and type of dietary fiber could be partial sources of heterogeneity. In conclusion, the present umbrella meta-analysis provides evidence for the role of dietary fiber supplementation in the improvement of established cardiovascular risk factors.

Project description:ImportanceSeveral meta-analyses of randomized clinical trials (RCTs) have demonstrated the many health benefits of intermittent fasting (IF). However, there has been little synthesis of the strength and quality of this evidence in aggregate to date.ObjectiveTo grade the evidence from published meta-analyses of RCTs that assessed the associations of IF (zero-calorie alternate-day fasting, modified alternate-day fasting, the 5:2 diet, and time-restricted eating) with obesity-related health outcomes.Evidence reviewPubMed, Embase, and Cochrane database of systematic reviews were searched from database inception to January 12, 2021. Data analysis was conducted from April 2021 through July 2021. Meta-analyses of RCTs investigating effects of IF in adults were included. The effect sizes of IF were recalculated using a random-effects model. We assessed the quality of evidence per association by applying the GRADE criteria (Grading of Recommendations, Assessment, Development, and Evaluations) as high, moderate, low, and very low.FindingsA total of 11 meta-analyses comprising 130 RCTs (median [IQR] sample size, 38 [24-69] participants; median [IQR] follow-up period, 3 [2-5] months) were included describing 104 unique associations of different types of IF with obesity-related health outcomes (median [IQR] studies per association, 4 [3-5]). There were 28 statistically significant associations (27%) that demonstrated the beneficial outcomes for body mass index, body weight, fat mass, low-density lipoprotein cholesterol, total cholesterol, triglycerides, fasting plasma glucose, fasting insulin, homeostatic model assessment of insulin resistance, and blood pressure. IF was found to be associated with reduced fat-free mass. One significant association (1%) supported by high-quality evidence was modified alternate-day fasting for 1 to 2 months, which was associated with moderate reduction in body mass index in healthy adults and adults with overweight, obesity, or nonalcoholic fatty liver disease compared with regular diet. Six associations (6%) were supported by moderate quality evidence. The remaining associations found to be significant were supported by very low (75 associations [72%]) to low (22 associations [21%]) quality evidence.Conclusions and relevanceIn this umbrella review, we found beneficial associations of IF with anthropometric and cardiometabolic outcomes supported by moderate to high quality of evidence, which supports the role of IF, especially modified alternate-day fasting, as a weight loss approach for adults with overweight or obesity. More clinical trials with long-term follow-up are needed to investigate the effects of IF on clinical outcomes such as cardiovascular events and mortality.

Project description:IntroductionEpilepsy causes serious suffering in children and is associated with high morbidity and increased mortality. It impairs children's quality of life and places a heavy burden on healthcare resources. Levetiracetam has been used to prevent and treat paediatric epilepsy for years. To date, a number of systematic reviews have been performed to assess the efficacy and safety of levetiracetam in a variety of clinical settings. Conflicting outcomes have been reported for the same clinical issues. Our objective is to provide a comprehensive overview of the literature for clinicians and policymakers via an umbrella review that assesses the efficacy and safety of levetiracetam in children with epilepsy.Methods and analysisWe will follow the Joanna Briggs Institute's guidelines for umbrella reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The following seven databases will be searched from 1990 to February 2019: PubMed, Embase, Cochrane Database of Systematic Reviews, JBISRIR, EPPI, Epistemonikos and PROSPERO. We will provide evidence from existing systematic reviews and meta-analyses of randomised controlled trials regarding the use of levetiracetam in children with epilepsy. The intervention of interest is levetiracetam monotherapy and add-on therapies for prevention or treatment purposes. Studies will be individually selected and assessed by two reviewers. The primary outcomes of interest are epilepsy control, the efficacy of prophylaxis for provoked seizures and the mortality rate of children with epilepsy who received levetiracetam treatment. The secondary outcomes are adverse events and withdrawal rates due to adverse effects. The methodological quality of all reviews will be individually assessed by two reviewers using the 'A Measurement Tool to Assess Systematic Reviews' instrument. The Grading of Recommendations Assessment, Development and Evaluation assessment will be applied to evaluate the quality of evidence for each outcome of interest. A narrative description of an analysis of the systematic reviews will be tabulated to address objective and specific questions. Information from each review will be detailed in a table including the population, number of studies, total number of participants, year range of the trials, study designs of the primary trials, countries and settings of the trials, heterogeneity of results and assessment tools. Recommendations regarding each outcome of levetiracetam will be categorised based on a protocol.Ethics and disseminationThis umbrella review will inform clinical and policy decisions regarding the efficacy and safety of levetiracetam for preventing and treating paediatric epilepsy. The results will be disseminated through a peer-reviewed publication and conference presentations. Ethical approval is not required for this study.

Dataset Information

Efficacy of Cancer Immunotherapy: An Umbrella Review of Meta-analyses of Randomized Controlled Trials.

Publications

Efficacy of Cancer Immunotherapy: An Umbrella Review of Meta-analyses of Randomized Controlled Trials.

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