scholarly journals The Relative Risk of Immune-Related Liver Dysfunction of PD-1/PD-L1 Inhibitors Versus Chemotherapy in Solid Tumors: A Meta-Analysis of Randomized Controlled Trials

2019 ◽  
Vol 10 ◽  
Author(s):  
Siyao Deng ◽  
Qinyan Yang ◽  
Xiaochen Shu ◽  
Jinyi Lang ◽  
Shun Lu
Keyword(s):  
Relative Risk ◽  
Randomized Controlled Trials ◽  
Solid Tumors ◽  
Liver Dysfunction ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled

scholarly journals Lower Risk of Recurrence After Mesh Repair Versus Non-Mesh Sutured Repair in Open Umbilical Hernia Repair: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2018 ◽  
Vol 108 (3) ◽  
pp. 187-193 ◽  
Author(s):  
T. Bisgaard ◽  
R. Kaufmann ◽  
M. W. Christoffersen ◽  
P. Strandfelt ◽  
L. L. Gluud
Keyword(s):  
Relative Risk ◽  
Confidence Interval ◽  
Randomized Controlled Trials ◽  
Mesh Repair ◽  
Umbilical Hernia ◽  
Meta Analysis ◽  
Seroma Formation ◽  
Controlled Trials ◽  
Randomized Controlled

Background and Aims: The use of mesh repair in a small- or middle-sized umbilical hernia remains controversial, and evidence is based on only few and small heterogeneous randomized trials. The primary aim was to assess differences, if any, in recurrence (clinical and reoperation), and secondary aim was to assess differences in infections, seroma formation, hematomas, chronic pain, cosmetic result, and quality of life. Method: A systematic review (predefined search strategy) and meta-analyses were conducted based on pre-study strict and well-defined methodology. The literature search was completed on 1 January 2018. The study protocol was registered in PROSPERO. Results: Five randomized controlled trials were identified (mesh repair, n = 326 versus non-mesh sutured repair, n = 330) and 602 records were excluded. Randomized controlled trials included patients with defect diameters of ⩾1 to 4 cm. Mesh repair reduced the risk of recurrence compared with sutured repair with a relative risk of 0.28 (95% confidence interval = 0.13–0.58, I2 = 0%, number needed to treat = 13 patients). Additional analyses found no differences between the two surgical techniques regarding infection (relative risk = 0.80, 95% confidence interval = 0.36–1.79), seroma formation (relative risk = 1.38, 95% confidence interval = 0.57–3.32), or hematomas (relative risk = 0.55, 95% confidence interval = 0.23–1.30). Lack of sufficient data precluded meta-analysis evaluating risk of seroma formation, hematomas, chronic pain, cosmetic result, and quality of life. Conclusion: Mesh repair is recommended for umbilical hernia of ⩾1 to 4 cm. More evidence is needed for the optimal placement of the mesh (sublay or onlay) and the role of mesh in patients with an umbilical hernia <1 cm.

Risk of gastrointestinal and hepatic toxicities in patients with metastatic solid tumors treated with cabozantinib: A systematic review and meta-analysis of randomized controlled trials.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 208-208
Author(s):  
Myo Zaw ◽  
Kyaw Zin Thein ◽  
Myat M. Han ◽  
Henry Palangdao Igid ◽  
Fred L. Hardwicke ◽  
...  
Keyword(s):  
Systematic Review ◽  
Side Effects ◽  
Randomized Controlled Trials ◽  
Solid Tumors ◽  
Tyrosine Kinases ◽  
Meta Analysis ◽  
Controlled Trials ◽  
High Grade ◽  
Randomized Controlled ◽  
Relative Risks

208 Background: The vascular endothelial growth factor (VEGF) signaling pathways and the proto-oncogenes MET, KIT and RET were implied in cancer development and progression. Cabozantinib is an oral inhibitor of multiple tyrosine kinases and hence employed in many solid tumors. We performed a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of gastrointestinal (GI) and hepatic toxicities among patients with metastatic solid tumors treated with cabozantinib. Methods: MEDLINE, EMBASE databases and meeting abstracts from inception to March 2017 were queried. Phase 3 RCTs that mention GI and elevation of liver enzymes as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio with 95% confidence interval (CI). Random effects model was applied. Results: We included 3 RCTs with a total of 1999 patients treated with cabozantinib for various solid tumors. The study arm used cabozantinib while the control arm utilized everolimus, placebo or prednisone. The relative risks (RR) of all-grade side effects were as follows: diarrhea, 2.39 (95% CI: 2.01 – 2.85, P < 0.0001); nausea, 1.86 (95% CI: 1.64 – 2.10, P < 0.0001); vomiting, 2.53 (95% CI: 1.60 – 3.99, P < 0.0001); stomatitis, 4.08 (95% CI: 0.55 – 30.01, P = 0.16); dysgeusia, 4.23 (95% CI: 2.30 – 7.76, P < 0.0001); elevated AST, 2.04 (95% CI: 1.12 – 3.73, P = 0.02); and elevated ALT, 1.61 (95% CI: 0.67 – 3.88, P = 0.28). The RR of high-grade side effects were as follows: diarrhea, 5.93 (95% CI: 3.43 – 10.25, P < 0.0001); nausea, 4.05 (95% CI: 1.99 – 8.23, P < 0.0001); vomiting, 2.37 (95% CI: 1.26 – 4.44, P = 0.007); stomatitis, 3.36 (95% CI: 0.45 – 24.98, P = 0.23); dysgeusia, 1.52 (95% CI: 0.15 – 14.57, P = 0.71); elevated AST, 1.70 (95% CI: 0.72 – 4.01, P = 0.22); and elevated ALT, 3.00 (95% CI: 0.60 – 14.93, P = 0.17). Conclusions: The risk of developing all-grade and high-grade diarrhea, nausea and vomiting with cabozantinib is high. Moreover, it is associated with all-grade elevated AST and dysgeusia. Timely recognition and providing good supportive care will enhance patients’ quality of life.

Mindfulness training for smoking cessation: A meta-analysis of randomized-controlled trials

2016 ◽  
Vol 22 (14) ◽  
pp. 1841-1850 ◽  
Author(s):  
Maria Theodora Oikonomou ◽  
Marios Arvanitis ◽  
Robert L Sokolove
Keyword(s):  
Systematic Review ◽  
Smoking Cessation ◽  
Relative Risk ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Mindfulness Training ◽  
Controlled Trials ◽  
Percent Confidence Interval ◽  
Review Of The Literature ◽  
Randomized Controlled

Recent studies have shown that mindfulness training has a promising potential for smoking treatment. In order to examine the efficacy of mindfulness training in smoking cessation, we performed a systematic review of the literature and meta-analysis of randomized controlled trials. Four randomized controlled trials with 474 patients were included in our analysis. The results showed that 25.2 percent of participants remained abstinent for more than 4 months in the mindfulness group compared to 13.6 percent of those who received usual care therapy (relative risk, 1.88; 95 percent confidence interval, 1.04–3.40). Our results suggest that mindfulness training may have an important role to play in efforts to lower cigarette smoking rates.

EPR19-74: Risk of Cabozantinib-Associated Gastrointestinal and Hepatic Toxicities in Patients With Metastatic Solid Tumors: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2019 ◽  
Vol 17 (3.5) ◽  
pp. EPR19-74
Author(s):  
Anita Sultan ◽  
Sriman Swarup ◽  
Francis Mogollon-Duffo ◽  
Ye Aung ◽  
Yin M. Myat ◽  
...  
Keyword(s):  
Systematic Review ◽  
Side Effects ◽  
Randomized Controlled Trials ◽  
Solid Tumors ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Growth Factor Signaling ◽  
High Grade ◽  
Phase 3 ◽  
Randomized Controlled

Background: Cabozantinib is an oral inhibitor of multiple tyrosine kinases and is used in treatment of multiple solid tumors, targeting several pathways such as vascular endothelial growth factor signaling pathway and proto-oncogenes MET, KIT, RET. These pathways are implicated in several tumor development and progression. We performed a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of gastrointestinal (GI) and hepatic toxicities among patients with metastatic solid tumors treated with cabozantinib. Methods: MEDLINE, EMBASE databases, and meeting abstracts from inception to September 2018 were queried. Phase 3 RCTs that mention GI and elevation of liver enzymes as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio (RR) with 95% CI. Random effects model was applied. Results: We included 4 phase 3 RCTs with a total of 2,703 patients with various solid tumors. The study arm used cabozantinib while the control arm utilized everolimus or placebo or prednisone. The relative risks of all-grade side effects were as follows: diarrhea, 2.495 (95% CI: 2.149–2.897, P<.0001); nausea, 1.849 (95% CI: 1.649–2.072; P<.0001); vomiting, 2.335 (95% CI: 1.724–3.163; P<.0001); stomatitis, 4.541 (95% CI: 0.908–22.696; P=.065); dysgeusia, 4.428 (95% CI: 2.67–7.343; P<.0001); elevated AST, 2.002 (95% CI: 1.331–3.011; P=.001); and elevated ALT, 1.988 (95% CI: 0.936–4.222; P=.074). The RR of high-grade side effects were as follows: diarrhea, 5.913 (95% CI: 3.655–9.566; P<.0001); nausea, 3.098 (95% CI: 1.266–7.581; P=.013); vomiting, 1.298 (95% CI: 0.395–4.265; P=.668); stomatitis, 3.837 (95% CI: 0.749–19.665; P=.107); dysgeusia, 1.522 (95% CI: 0.159–14.574; P=.716); elevated AST, 1.733 (95% CI: 1.101–2.728; P=.018); and elevated ALT, 2.489 (95% CI: 1.164–5.326; P=.019). Conclusion: The risk of developing all grades of diarrhea, nausea, elevated AST, and any-grade vomiting, dysgeusia as well as high-grade elevated ALT, was high in cabozantinib group. Timely recognition and providing good supportive care will enhance patients’ quality of life.

Relative risk of pneumonitis or interstitial lung disease (ILD) associated with the use of cyclin-dependent kinase inhibitors (CDK4/6i): A systematic review and meta-analysis of phase 3 randomized controlled trials.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1072-1072
Author(s):  
Nusrat Jahan ◽  
Sariya Wongsaengsak ◽  
Shabnam Rehman ◽  
Myrian Vinan-Vega ◽  
Lukman Aderoju Tijani ◽  
...  
Keyword(s):  
Systematic Review ◽  
Relative Risk ◽  
Interstitial Lung Disease ◽  
Lung Disease ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cyclin Dependent Kinase ◽  
Phase 3 ◽  
Randomized Controlled

1072 Background: All three currently approved cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) such as palbociclib, abemaciclib, and ribociclib are reported to cause significant pulmonary toxicities including fatal pneumonitis or interstitial lung disease (ILD). We conducted a systematic review and meta-analysis of phase 3 randomized controlled trials (RCTs) to determine the relative risk of pneumonitis or ILD associated with CDK4/6i. Methods: We conducted a systematic search using PRISMA guidelines in PubMed, EMBASE, American Society of Clinical Oncology and San Antonio Breast Cancer Symposium meeting abstracts from inception through Jan 30, 2021. Phase 3 RCTs using CDK4/6i in the intervention arm and reporting the number of events for pneumonitis or ILD were included in the analysis. The Cochran-Mantel-Haenszel method and random effects model were used to calculate the pooled risk ratio (RR) with 95% confidence interval (CI). Heterogeneity was tested by Cochran’s Q test and I2 value. Results: Five phase 3 RCTs — MONALEESA-3, MONALEESA-7, MONARCH plus, monarchE, and PALLAS — reported the number of events for any grade pneumonitis or ILD and were included in the final analysis. A total of 13,191 patients — 6,758 in the CDK4/6i arm and 6,433 in the control arm — were analyzed. Following regimens were used in CDK4/6i arms — MONALEESA-3: ribociclib + fulvestrant; MONALEESA-7: ribociclib + tamoxifen or a non-steroidal aromatase inhibitor + goserelin; MONARCH plus: in cohort A, abemaciclib + anastrozole or letrozole, and in cohort B, abemaciclib + fulvestrant; MonarchE: abemaciclib + standard-of-care adjuvant endocrine therapy (ET); PALLAS: Palbociclib + ET. In the control arms, all studies used placebo and respective endocrine therapies. Any grade pneumonitis or ILD was reported in 1.64% of patients in the CDK4/6i arm versus 0.68% of patients in the control arm. The pooled RR of any grade pneumonitis or ILD was 2.26, 95% CI: 1.60-3.19, P < 0.00001, I2 = 0%. Grade 3/4 pneumonitis or ILD was reported in 0.28% of patients in the CDK4/6i arm and 0.06% of patients in the control arm with pooled RR of 2.35, 95% CI: 0.37-15.08, P = 0.37, I2 = 34%. One grade 5 pneumonitis was reported in the monarchE. Conclusions: Cyclin-dependent kinase 4/6 inhibitors are associated with increased risk of any grade pneumonitis or ILD. Early detection and prompt initiation of appropriate interventions are vital to reduce the morbidity and mortality associated with CDK4/6i induced pneumonitis or ILD.

scholarly journals Intrawound Treatment for Prevention of Surgical Site Infections in Instrumented Spinal Surgery: A Systematic Comparative Effectiveness Review and Meta-Analysis

2018 ◽  
Vol 9 (2) ◽  
pp. 219-230 ◽  
Author(s):  
Justin V. C. Lemans ◽  
Sebastiaan P. J. Wijdicks ◽  
Willemijn Boot ◽  
Geertje A. M. Govaert ◽  
R. Marijn Houwert ◽  
...  
Keyword(s):  
Relative Risk ◽  
Randomized Controlled Trials ◽  
Spine Surgery ◽  
Spinal Surgery ◽  
Meta Analysis ◽  
Surgical Site Infections ◽  
Controlled Trials ◽  
Local Antibiotics ◽  
Randomized Controlled ◽  
Instrumented Spine Surgery

Study Design: Systematic review and meta-analysis. Objectives: To determine the efficacy of intrawound treatments in reducing deep surgical site infections (SSIs) in instrumented spinal surgery. Methods: The electronic databases MEDLINE, EMBASE, and Cochrane were systematically searched for intrawound treatments for the prevention of SSIs in clean instrumented spine surgery. Both randomized controlled trials and comparative cohort studies were included. The results of included studies were pooled for meta-analysis. Results: After full text- and reference screening, 20 articles were included. There were 2 randomized controlled trials and 18 observational studies. Sixteen studies investigated the use of intrawound antibiotics, and 4 studies investigated the use of intrawound antiseptics. The relative risk of deep SSI for any treatment was 0.26 (95% confidence interval [CI] 0.16-0.44, P < .0001), a significant reduction compared with controls receiving no treatment. For patients treated with local antibiotics the relative risk was 0.29 (95% CI 0.17-0.51, P < .0001), and patients treated with local antiseptics had a relative risk of 0.14 (95% CI 0.05-0.44, P = .0006). Conclusions: Both the use of antibiotic and antiseptic intrawound prophylactics was associated with a significant 3 to 7 times reduction of deep SSIs in instrumented spine surgery. No adverse events were reported in the included studies.

scholarly journals Comparative evaluation of cardiovascular risks among nine FDA-approved VEGFR-TKIs in patients with solid tumors: a Bayesian network analysis of randomized controlled trials

2021 ◽  
Author(s):  
Wanting Hou ◽  
Mingfu Ding ◽  
Xiaohua Li ◽  
Xiaohan Zhou ◽  
Qing Zhu ◽  
...  
Keyword(s):  
Bayesian Network ◽  
Randomized Controlled Trials ◽  
Solid Tumors ◽  
Meta Analysis ◽  
Splitting Method ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled ◽  
Increased Risk

Abstract Purpose The present meta-analysis study was performed to identify the potential cardiotoxicity risks when using Vascular Endothelial Growth Factor Receptor Tyrosine kinase inhibitors (VEGFR-TKIs) as anticancer drugs in patients with solid tumors. Methods Pubmed, Embase, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched for the randomized controlled trials. We have included 45 randomized controlled trials (RCTs) associated with nine VEGFR-TKIs Food and Drug Administration (FDA)-approved drugs used to treat patients with solid tumors. To evaluate the trials’ risk of bias, Cochrane Risk of Bias Tool was assessed. A direct comparison was assessed by RevMan5.3 software, calculating the odds ratio (OR) and 95% confidence interval (CI). Heterogeneity was tested by the I2 statistic and Chi-square test for P value. Bayesian network meta-analysis was performed using Stata 15.0 and GeMTC 0.14.3 software, calculated OR along with corresponding 95% credible interval (CrI). The model’s convergence was evaluated by the potential scale reduced factor (PSRF). Consistency between direct and indirect comparisons was assessed by the “node-splitting” method. Results In this network meta-analysis, a total of 20,027 patients from 45 randomized controlled trials and associated with nine FDA-approved VEGFR-TKIs (axitinib, cabozantinib, lenvatinib, nintedanib, pazopanib, regorafenib, sorafenib, sunitinib, vandetanib), were enrolled. Findings indicated that lenvatinib had the most significant probability of provoking all grades cardiovascular incident and hypertension, followed by vandetanib, cabozantinib, axitinib, pazopanib, sorafenib, sunitinib, regorafenib and nintedanib. The nine agent’s severe cardiovascular and severe hypertension risk was probably similar. The ranking probability of cardiac toxicity shows that vandetanib ranked most likely to have the highest risk for cardiotoxicity among all the VEGFR-TKIs reviewed, followed by pazopanib, axitinib, sorafenib, sunitinib. In contrast, regorafenib and nintedanib did not exhibit an increased risk of cardiac damage. Conclusions The association between the nine VEGFR-TKIs with potential cardiotoxicity occurrence was reviewed. Both the regorafenib and nintedanib did not display detectable signs of cardiotoxic damage. In contrast, lenvatinib and vandetanib are ranked to have the most severe cardiotoxicity side impacts. These results may provide information for clinical practice guidelines, implementing strategies in selecting the adequate VEGFR-TKIs, and understanding the cardiovascular toxicity inflicted by the VEGFR-TKIs. PROSPERO identifier CRD 42,020,167,307.

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