scholarly journals Analysis of response rate with ANTI PD1/PD-L1 monoclonal antibodies in advanced solid tumors: a meta-analysis of randomized clinical trials

Oncotarget ◽  
2018 ◽  
Vol 9 (9) ◽  
pp. 8706-8715 ◽  
Author(s):  
Alberto Carretero-González ◽  
David Lora ◽  
Ismael Ghanem ◽  
Jon Zugazagoitia ◽  
Daniel Castellano ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Monoclonal Antibodies ◽  
Solid Tumors ◽  
Randomized Clinical Trials ◽  
Response Rate ◽  
Meta Analysis ◽  
Advanced Solid Tumors

Toxicity profile of approved anti-PD1 monoclonal antibodies in solid tumors: A systematic review and meta-analysis of randomized clinical trials.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 3064-3064 ◽  
Author(s):  
Ricardo Lima Barros Costa ◽  
Benedito A. Carneiro ◽  
Alfred Rademaker ◽  
Mark Agulnik ◽  
Victoria Meucci Villaflor ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Monoclonal Antibodies ◽  
Solid Tumors ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Toxicity Profile

scholarly journals Toxicity profile of approved anti-PD-1 monoclonal antibodies in solid tumors: a systematic review and meta-analysis of randomized clinical trials

Oncotarget ◽  
2016 ◽  
Vol 8 (5) ◽  
pp. 8910-8920 ◽  
Author(s):  
Ricardo Costa ◽  
Benedito A. Carneiro ◽  
Mark Agulnik ◽  
Alfred W. Rademaker ◽  
Sachin G. Pai ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Monoclonal Antibodies ◽  
Solid Tumors ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Toxicity Profile

Meta-analysis of randomized trials testing the biochemical modulation of fluorouracil by methotrexate in metastatic colorectal cancer. Advanced Colorectal Cancer Meta-Analysis Project.

1994 ◽  
Vol 12 (5) ◽  
pp. 960-969 ◽  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Clinical Trials ◽  
Regression Model ◽  
Randomized Clinical Trials ◽  
Tumor Response ◽  
Advanced Colorectal Cancer ◽  
Response Rate ◽  
Meta Analysis ◽  
Biochemical Modulation

PURPOSE Even though fluorouracil (5FU) remains the standard treatment of advanced colorectal cancer, almost 90% of patients treated with 5FU alone do not achieve an objective response to chemotherapy. Biochemical modulation of 5FU by methotrexate (MTX) is an attempt to increase the sensitivity of tumor cells to 5FU. However, despite the inclusion of several hundreds of patients in randomized clinical trials, no definitive evidence is available on the clinical benefit of 5FU/MTX over 5FU alone. A meta-analysis was performed to assess this benefit objectively and quantitatively for tumor response rate and overall survival. DESIGN The meta-analysis was based on individual data of 1,178 patients included in eight randomized clinical trials comparing 5FU alone with 5FU/MTX. Patient data were provided by all principal investigators. The analyses were performed by an independent secretariat, and then discussed with all collaborators. RESULTS Tumor response rate was 10% for patients allocated to 5FU alone (complete response [CR] rate, 2%; partial response [PR] rate, 8%) compared with 19% for patients allocated to 5FU/MTX (CR rate, 3%; PR rate, 16%). This difference was highly significant, with an overall response odds ratio (OR) of 0.51 (95% confidence interval [CI], 0.37 to 0.70) (P < .0001). Median overall survival times were 9.1 months and 10.7 months in the 5FU-alone and 5FU/MTX groups, respectively. This difference was also statistically significant, with an overall survival OR of 0.87 (95% CI, 0.77 to 0.98) (P = .024). Logistic regression model and Cox regression model showed that performance status and randomized treatment were the only two significant predictors of tumor response and survival. CONCLUSION It is concluded that the modulation of 5FU by MTX doubles the response rate to 5FU, and yields a small improvement in survival.

scholarly journals Comparative safety analysis of immunotherapy combined with chemotherapy versus monotherapy in solid tumors: a meta-analysis of randomized clinical trials

Oncotarget ◽  
2019 ◽  
Vol 10 (35) ◽  
pp. 3294-3301 ◽  
Author(s):  
Alberto Carretero-González ◽  
David Lora ◽  
Ismael Ghanem ◽  
Irene Otero ◽  
Flora López ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Solid Tumors ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Safety Analysis ◽  
Comparative Safety

Analysis of response rate with anti-PD1/PDL1 antibodies in advanced solid tumors: A meta-analysis of randomized clinical trials (RCT).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14576-e14576 ◽  
Author(s):  
Alberto Carretero-González ◽  
David Lora ◽  
Ismael Ghanem ◽  
Jon Zugazagoitia ◽  
Daniel Castellano ◽  
...  
Keyword(s):  
Targeted Therapy ◽  
Solid Tumors ◽  
Randomized Clinical Trials ◽  
Response Rate ◽  
Meta Analysis ◽  
Significant Proportion ◽  
Response Rates ◽  
First Line ◽  
Subgroup Analyses ◽  
Line Setting

e14576 Background: Anti-PD1/PDL1 antibodies (mAbs) have been shown to increase overall survival (OS) compared to standard of care (SOC) in solid tumors (mainly melanoma and lung cancer). Despite the efficacy in OS, a significant proportion of patients (pts) will have progressive disease (PD) as best response. Therefore, we have conducted a meta-analysis to study the rates of response comparing these novel antibodies with SOC (chemotherapy or targeted therapy). Methods: We conducted a search of the published RCT in MEDLINE and EMBASE analyzing anti-PD1/PDL1mAbs monotherapy compared to SOC. All studies used RECIST v1.1. Relative risk (RR) with 95% confidence interval (CI) of response rates between groups was estimated. Clinical heterogeneity was explored via subgroup analyses for location of primary tumor, number of previous treatment lines and selected population by PDL1 expression. Results: Eleven studies accounting for 6,396 pts were included (anti-PD1/PDL1 mAbs: 3,333 pts; SOC: 3,063 pts[2,637 pts: chemotherapy, 426 pts: targeted therapy]). Adjusted response rates were (N ,%): Complete Response (CR)(50/3035, 1.65%), Partial Response (PR)(558/3035, 18.39%), Stable Disease (SD)(585/2345, 24.95%) and PD (896/2345, 38.21%); and CR (7/2769, 0.25%), PR (241/2769, 8.70%), SD (744/2083, 35.72%) and PD (744/2083, 35.72%) with anti-PD1/PDL1 mAbs and SOC, respectively. Anti-PD1/PDL1 mAbs improved CR rate (RR 4.70) and PR rate (RR 2.38). There were no differences in the PD rate between groups (RR 1.09; table 1). Subgroup analyses showed a significant improvement in clinical benefit with anti-PD1/PDL1 mAbs for melanoma (RR 1.5; 1.42-1.91 95% CI) and pts treated in the first line setting (RR 1.57; 1.27-1.95 95%CI). Conclusions: Anti-PD1/PDL1 mAbs increase overall response rate compared to SOC without an increase in PD rate. Melanoma and pts treated in first line setting seem to have greater benefit with anti-PD1/PDL1 mAbs. [Table: see text]

scholarly journals Effects of Anti-Calcitonin Gene-Related Peptide for Migraines: A Systematic Review with Meta-Analysis of Randomized Clinical Trials

2019 ◽  
Vol 20 (14) ◽  
pp. 3527 ◽  
Author(s):  
I-Hsin Huang ◽  
Po-Chien Wu ◽  
En-Yuan Lin ◽  
Chien-Yu Chen ◽  
Yi-No Kang
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Response Rate ◽  
Meta Analysis ◽  
Calcitonin Gene Related Peptide ◽  
Related Peptide ◽  
Long Term Effect ◽  
Calcitonin Gene ◽  
Quantitative Synthesis

We aimed to evaluate the response rate of migraines by using anti-calcitonin gene-related peptide (anti-CGRP) for patients with migraines. We searched three main medical databases up to 29 March 2019. No restriction on language and publication time were applied. Eligible trials included randomized clinical trials investigating a 50%, 75%, and 100% response rate of migraine patients after anti-CGRP intervention. The collected data were dichotomous, and risk ratios (RRs) with a 95% confidence interval (CI) were used to present the quantitative synthesis results. The systematic review identified 16 eligible randomized clinical trials (RCTs) with 9439 patients. Eight of the 16 trials with 2516 patients reported a 50% response rate, and the pooled results showed a significant benefit from anti-CGRP. However, the effects seem to gradually reduce from the first month (RR 1.99, 95% CI 1.59 to 2.49) to the third month (RR 1.48, 95% CI 1.26 to 1.75) of treatment. The magnitude of effect was influenced by the type of anti-CGRP, according to the test for differences between subgroups (I-square = 53%). The funnel plots and Egger’s tests did not show serious small study effects in the results. In conclusion, the current evidences confirmed that anti-CGRP treatment can reduce migraine pain in the short term (within three months), but the long-term effect should be investigated in the future. Moreover, its effects may be influenced by the type and dose of anti-CGRP. Therefore, future studies should make direct comparisons among anti-CGRP medications.

scholarly journals Risk of Serious Infections with Lenalidomide Based Regimens in Multiple Myeloma: A Network Meta-Analysis

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 12-12
Author(s):  
Nayab Mirza ◽  
Anum Javaid ◽  
Muhammad Ashar Ali ◽  
Wajeeha Aiman ◽  
Muhammad Yasir Anwar ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Clinical Trials ◽  
Monoclonal Antibodies ◽  
Maintenance Therapy ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Indirect Comparison ◽  
High Grade ◽  
Serious Infections ◽  
Grade 3

Background: Lenalidomide is an immune modulator, approved for use since 2005 for the treatment of multiple myeloma (MM) patients. Its use is associated with an increased risk of infections. Combination of lenalidomide with other drugs, monoclonal antibodies, proteasome inhibitors, dexamethasone, and alkylators, can enhance the risk of serious infections. We conducted a network meta-analysis to compare the incidence of ≥Grade 3 infections among lenalidomide based regimens used in MM that can help clinicians to monitor patients for the risk of infections. Methods: A search was performed on PubMed, Cochrane, Embase, and Web of Science. We used the following keywords, "lenalidomide" AND "multiple myeloma" from the inception of literature till 06/10/2020. We screened 14,684 articles and included 23 randomized clinical trials (RCT) (N=11,174) in network meta-analysis. We extracted the data for serious (≥Grade 3) infections in lenalidomide based regimens. We excluded case reports, case series, preclinical trials, non-randomized clinical trials, observational studies, review articles, meta-analysis, and RCTs not providing any information about ≥Grade 3 infections. We used the "netmeta" package by Rucker et al. in the R programming language (version 4.0.2) to conduct frequentist network meta-analysis. Results: In 23 RCTs, the median age was ≥65years in 11 RCTs (N=5585) and ≤65 in 12 RCTs (5589). 9 RCTs were performed on relapsed/refractory multiple myeloma (RRMM) patients (N=4254), while 13 RCTs were performed on newly diagnosed multiple myeloma (NDMM) patients (N=6920). Lenalidomide regimen was used as maintenance therapy in 8 RCT (N=4255). Table 1 reviews the baseline characteristics. The pooled incidence of high-grade infections in trials with a median age of ≥65 and ≤65 years is 1010/5585 and 634/5589, respectively. The incidence of high-grade infections is 693/4254 in RRMM patients, 951/6920 in NDMM patients, and 466/4255 in NDMM patients with maintenance therapy. P-score in table 2 represents the mean extent of certainty with which a regimen is better in terms of the incidence of high-grade infections, i.e., higher P-score means a lower risk of serious infections. According to P-score, lenalidomide with carfilzomib and dexamethasone is worst in terms of the incidence of infections. Indirect comparison of placebo with lenalidomide shows a risk ratio of high-grade infections of 2.87 (95% CI: 1.96; 4.23) in favor of placebo. Fig 1 outlines the indirect comparison of the incidence of high-grade infections with different lenalidomide based regimens vs. placebo. Table 3. shows the calculated indirect comparison of high-grade infections in each lenalidomide based regimen. Heterogeneity was not statistically significant. For serious infections, lenalidomide dexamethasone showed a risk ratio of 0.86, 0.70*, 0.76*, 0.78*, 0.77, and 0.77 in comparison with the combination of lenalidomide dexamethasone with bortezomib, carfilzomib, daratumumab, elotuzumab, ixazomib, and pembrolizumab respectively (*statistically significant). Conclusion: This network meta-analysis suggests an increase in the risk of high-grade infections with the addition of bortezomib, monoclonal antibodies, ixazomib, and carfilzomib to lenalidomide in multiple myeloma patients with the highest increase in risk with the addition of carfilzomib. Additional randomized clinical trials are needed on the toxicity of lenalidomide based regimens to confirm these results. Disclosures Anwer: Incyte, Seattle Genetics, Acetylon Pharmaceuticals, AbbVie Pharma, Astellas Pharma, Celegene, Millennium Pharmaceuticals.: Honoraria, Research Funding, Speakers Bureau.

Treatment-related fatigue with sorafenib, sunitinib and pazopanib in patients with advanced solid tumors: An up-to-date review and meta-analysis of clinical trials

2014 ◽  
Vol 136 (1) ◽  
pp. 1-10 ◽  
Author(s):  
Matteo Santoni ◽  
Alessandro Conti ◽  
Francesco Massari ◽  
Giorgio Arnaldi ◽  
Roberto Iacovelli ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Solid Tumors ◽  
Meta Analysis ◽  
Advanced Solid Tumors

scholarly journals Efficacy and Safety of Monoclonal Antibody Against Calcitonin Gene-Related Peptide or Its Receptor for Migraine: A Systematic Review and Network Meta-analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Xing Wang ◽  
Yuqi Chen ◽  
Jinlei Song ◽  
Chao You
Keyword(s):  
Monoclonal Antibody ◽  
Clinical Trials ◽  
Monoclonal Antibodies ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Calcitonin Gene Related Peptide ◽  
Adult Patients ◽  
Related Peptide ◽  
Calcitonin Gene

Background: The optimal monoclonal antibody against calcitonin gene-related peptide (CGRP) for adult patients with migraine has yet to be determined. Therefore, we aimed to compare the effectiveness of different monoclonal antibodies against CGRP or its receptor for adult patients with migraine through a network meta-analysis of randomized controlled trials.Methods: We systematically searched the MEDILNE, Embase, ClinicalTrials.gov, and Cochrane Library databases for relevant publications from inception until October 30, 2020. Only randomized clinical trials of adults with migraine that assessed any calcitonin gene-related peptide monoclonal antibody and reported clinical outcomes were included. The primary outcomes were changes in monthly migraine days and treatment-emergent adverse eventsResults: We initially retrieved 2,070 publications, and ultimately, 18 randomized clinical trials totaling 8,926 patients were included. In terms of efficacy, eptinezumab (MD −1.43, 95% CrI −2.59 to −0.36), erenumab (MD −1.61, 95% CrI −2.40 to −0.84), fremanezumab (MD −2.19, 95% CrI −3.15 to −1.25), and galcanezumab (MD −2.10, 95% CrI −2.76 to −1.45) significantly reduced MMDs compared with placebo. In terms of safety, only galcanezumab increased the incidences of TEAEs (RR 1.11, 95% CrI 1.01–1.22) and serious adverse events (RR 2.95, 95% CrI 1.41–6.87) compared with placebo.Conclusion: Most drugs performed similarly and were superior to placebo in most of our analyses. Further head-to-head research on different types of CGRP monoclonal antibodies is necessary to validate the present findings.

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