Magnitude of benefit of the addition of bevacizumab (BEVA) to first-line chemotherapy (CT) for advanced/metastatic colorectal cancer (MCRC): Meta-analysis of randomized clinical trials

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15021-e15021
Author(s):  
V. Vaccaro ◽  
F. Cuppone ◽  
F. Loupakis ◽  
M. Milella ◽  
P. Carlini ◽  
...  
Keyword(s):  
Sensitivity Analysis ◽  
Clinical Trials ◽  
Regression Analysis ◽  
Phase Ii ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Phase Iii ◽  
Phase Ii Trials ◽  
Meta Regression ◽  
Meta Regression Analysis

e15021 Background: The monoclonal antibody against vascular endothelial growth factor BEVA has recently demonstrated to improve survival for MRC patients (pts). Nevertheless, the magnitude of the provided benefit in the daily practice is still controversial. In order to quantify the benefit of adding BEVA to CT for MCRC, a literature-based meta-analysis was conducted. Methods: Survival Hazard Ratios (HR) were extracted from prospective, randomized clinical trials (RCTs, either phase II/III) reports. HR and event-based relative risks (RR) with 95% confidence intervals (CI) were derived through a random-effect model. Differences in primary (progression-free- and overall-survival, PFS/OS) and secondary outcomes (overall, partial and complete response rates, ORR/PR/CR) were explored. Absolute differences (AD) and the number of patients needed to treat (NNT) were calculated. Heterogeneity test and a meta-regression analysis with clinical predictors for outcomes were conducted as well. A sensitivity analysis according to the trial phase-design was accomplished. Results: Five trials (2,728 pts), 2 phase II (313 pts) and 3 phase III (2,415 pts), were gathered. No significant interaction was found in the sensitivity analysis between phase II and III, although a trend showed a better PFS results for BEVA in phase II trials (p=0.057). At the meta-regression analysis female gender and rectal primary site were significant predictors for PFS (p=0.003, p=0.005). Toxicity analysis is ongoing. Conclusions: Although concerns regarding costs and toxicities still exist, BEVA significantly improves the outcome of untreated MCRC pts. The absolute benefit provided into an unselected population for molecular features should be considered of paramount importance for advanced disease. [Table: see text] No significant financial relationships to disclose.

Is pancreaticogastrostomy safer than pancreaticojejunostomy after pancreaticoduodenectomy? A meta-regression analysis of randomized clinical trials

Pancreatology ◽  
2017 ◽  
Vol 17 (5) ◽  
pp. 805-813 ◽  
Author(s):  
Claudio Ricci ◽  
Riccardo Casadei ◽  
Giovanni Taffurelli ◽  
Carlo Alberto Pacilio ◽  
Denis Beltrami ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Regression Analysis ◽  
Randomized Clinical Trials ◽  
Meta Regression ◽  
Meta Regression Analysis

scholarly journals Value of Variation of End-Tidal Carbon Dioxide for Predicting Fluid Responsiveness During the Passive Leg Raising Test in Patients with Mechanical Ventilation: A Systematic Review and Meta-Analysis

2021 ◽  
Author(s):  
Haijun Huang ◽  
Chenxia Wu ◽  
Qinkang Shen ◽  
Yixin Fang ◽  
Hua Xu
Keyword(s):  
Carbon Dioxide ◽  
Mechanical Ventilation ◽  
Sensitivity Analysis ◽  
Regression Analysis ◽  
Fluid Responsiveness ◽  
Meta Analysis ◽  
End Tidal Carbon Dioxide ◽  
Meta Regression ◽  
Meta Regression Analysis ◽  
End Tidal

Abstract Background: The variation of end-tidal carbon dioxide(ΔEtCO2) has have been extensively studied with respect to its value in predicting fluid responsiveness, but the results are conflicting. This meta-analysis aimed to explore the value of ΔEtCO2 for predicting fluid responsiveness during the passive leg raising(PLR) test in patients with mechanical ventilation. Methods: PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched up to November 2021. The diagnostic odds ratio (DOR), sensitivity, and specificity were calculated. The summary receiver operating characteristic curve was estimated, and the area under the curve (AUROC) was calculated. We performed meta-regression analysis for heterogeneity exploration and sensitivity analysis for the publication bias.Results: Overall, 298 patients were included in this review, of whom 149 (50%) were fluid responsive. The cutoff values of ΔEtCO2 varied across studies, ranging from 5% to 5.8% or absolute increase 2mmHg. Heterogeneity between studies was assessed with an overall Q = 4.098, I2 = 51%, and P = 0.064. The pooled sensitivity and specificity for the overall population were 0.79 (95% CI: 0.72–0.85) and 0.90 (95% CI: 0.77–0.96), respectively. The DOR was 35 (95% CI: 12–107) (Fig. 4). The pooled AUROC was 0.81 (95% CI: 0.77–0.84). On meta-regression analysis, the number of patients was sources of heterogeneity. The sensitivity analysis showed that the pooled DOR ranged from 21 to 140 and the pooled AUC ranged from 0.92 to 0.96 when one study was omitted.Conclusions: This study was the first meta-analysis to evaluate the diagnostic accuracy of ΔEtCO2 in predicting fluid responsiveness during PLR test in patients with mechanical ventilation. This study confirmed that the ΔEtCO2 performed well in predicting fluid responsiveness in patients with mechanical ventilation.

Is pancreaticogastrostomy safer than pancreaticojejunostomy after pancreaticoduodenectomy? A meta-regression analysis of randomized clinical trials

Pancreatology ◽  
2017 ◽  
Vol 17 (3) ◽  
pp. S80
Author(s):  
Giovanni Taffurelli ◽  
Claudio Ricci ◽  
Carlo Alberto Pacilio ◽  
Denis Beltrami ◽  
Francesco Minni ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Regression Analysis ◽  
Randomized Clinical Trials ◽  
Meta Regression ◽  
Meta Regression Analysis

scholarly journals Factors Influencing the Efficacy of COVID-19 Vaccines: A Quantitative Synthesis of Phase III Trials

Vaccines ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 341
Author(s):  
Luigino Calzetta ◽  
Beatrice Ludovica Ritondo ◽  
Angelo Coppola ◽  
Maria Gabriella Matera ◽  
Nicola Di Daniele ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Meta Analysis ◽  
Analysis Data ◽  
Clinical Results ◽  
Phase Iii ◽  
Modifying Factors ◽  
Phase Iii Trials ◽  
Quantitative Synthesis ◽  
Meta Regression ◽  
Meta Regression Analysis

To date, there is still a paucity of data from Phase III trials concerning the efficacy of vaccines against COVID-19. Furthermore, no studies investigated the variables that may modulate the efficacy of vaccination. The aim of this analysis was to assess whether there are modifying factors that may potentially influence the clinical efficacy of COVID-19 vaccines. A quantitative synthesis of data from Phase III trials was performed via pairwise and network meta-analyses, along with meta-regression analysis. Data from Phase III trials are currently available only for AZD1222, BNT162b2, mRNA-1237, and Sputnik V. Vaccination resulted to be generally effective (90.0%, 95%CI 72.6–96.4; p < 0.001), although the efficacy of AZD1222 (62.1%) introduced a significant level of heterogeneity in the meta-analysis (I2 92.17%, p < 0.001). No significant modifying factors resulted from the meta-regression analysis. However, considering the mRNA-based vaccines, a trend toward significance (p = 0.081) resulted for age. The network meta-analysis provided the following rank of effectiveness: BNT162b2 ≃ mRNA-1273 > Sputnik V >> AZD1222. In conclusion, no modifying factors seem to modulate the efficacy of vaccines against COVID-19. This quantitative synthesis will need to be updated as soon as further clinical results on the efficacy profile are available from Phase III trials for further licensed COVID-19 vaccines.

Meta-analysis of hematologic toxicities in patients with solid tumors treated with everolimus.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15580-e15580
Author(s):  
Tomohiro Funakoshi ◽  
Asma Latif ◽  
Matt D. Galsky
Keyword(s):  
Clinical Trials ◽  
Solid Tumors ◽  
Phase Ii ◽  
Meta Analysis ◽  
Single Agent ◽  
Phase Iii ◽  
Systemic Review ◽  
High Grade ◽  
Phase Ii Trials ◽  
Increased Risk

e15580 Background: Everolimus is an orally administered targeted agent that inhibits mammalian target of rapamycin (mTOR) signaling involved in tumor growth and proliferation. Hematologic toxicities associated with everolimus have been reported with a substantial variation in the incidences among clinical studies without a systematic attempt to synthesize these data. We performed a systemic review and meta-analysis of published clinical trials to evaluate the overall risk of everolimus-related hematologic toxicities. Methods: We searched Medline and the American Society of Clinical Oncology online database of meeting abstracts up to December 2012 for relevant clinical trials. Eligible studies included phase II and III trials in patients with solid tumors treated with everolimus that reported adequate safety data profile reporting neutropenia, thrombocytopenia or anemia based on the CTCAE of the NCI. The relative risk (RR), summary incidence and 95% confidence intervals (CI) were calculated. Results: For the incidence analysis, we included a total of 1,090 patients from 14 studies (three phase III and 11phase II trials) considering only arms with everolimus as a single agent. The incidence of everolimus -associated all-grade and high-grade (Grade 3-4) hematologic toxicities were, respectively: neutropenia: 21.7% and 3.7%; thrombocytopenia: 36.0% and 4.7% and anemia: 61.2% and 4.4%. For the RR calculation, seven randomized trials with everolimus in only one of the arms in addition to similar therapy in both arms were available (five phase III and two phase II trials, representing 2,462 patients). Everolimus -treated patients had a significantly increased risk of all-grade neutropenia (RR = 2.24; 95% CI, 1.51–3.32), all-grade (RR = 9.19; 95% CI, 4.51–18.70) and high-grade (RR = 7.46; 95% CI, 2.58–21.61) thrombocytopenia and all-grade (RR = 1.58; 95% CI, 1.25–1.99) and high-grade (RR = 3.92; 95% CI, 1.46–10.52) anemia. RR of high-grade neutropenia was 1.40 (95% CI: 0.70-2.78; p=0.34). Conclusions: Everolimus is associated with a significant increase in the risk of developing all-grade and high-grade thrombocytopenia and anemia and all-grade neutropenia compared with control.

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