Efficacy and safety of ramucirumab treatment in patients with advanced colorectal cancer

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Abstract

Background:

vascular endothelial growth factor receptor 2 (VEGFR-2) has an important role in colorectal cancer pathogenesis and progression. The aim of our study is to provide a protocol for assessing the efficacy and safety of ramucirumab (a monoclonal antibody VEGFR-2 antagonist) for the treatment of advanced colorectal cancer.

Methods:

The systematic review will be reported according to the preferred reporting items for systematic reviews and meta-analyses protocols. Relevant randomized controlled trials were searched from PubMed, Cochrane Library, Web of Science, Excerpt Medica Database, China National Knowledge Infrastructure, and Wanfang Database. Papers in English or Chinese published from their inception to February 2020 will be included without any restrictions.

Study selection and data extraction will be performed independently by 2 investigators. The clinical outcomes including overall response rate, complete response rate (disease control rate), overall survival, progression-free survival, quality of life, immune function, and adverse events, were systematically evaluated. Review Manager 5.3 and Stata 14.0 were used for data analysis, and a fixed or random-effect model of meta-analysis will be used depending upon the heterogeneity observed between studies. Subgroup analysis will be carried out depending on the availability of sufficient clinical data.

Results and Conclusion:

The findings of this systematic review and meta-analysis will be published in a peer-reviewed journal, and provide more evidence-based guidance in clinical practice.

PROSPERO registration number:

CRD42020165683.

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Most cited references 21

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Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial.

Andrew Zhu, Joon Park, Baek-Yeol Ryoo … (2015)

VEGF and VEGF receptor-2-mediated angiogenesis contribute to hepatocellular carcinoma pathogenesis. Ramucirumab is a recombinant IgG1 monoclonal antibody and VEGF receptor-2 antagonist. We aimed to assess the safety and efficacy of ramucirumab in advanced hepatocellular carcinoma following first-line therapy with sorafenib.

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Quantifying the impact of between-study heterogeneity in multivariate meta-analyses

Dan Jackson, Ian R White, Richard Riley (2012)

Measures that quantify the impact of heterogeneity in univariate meta-analysis, including the very popular I 2 statistic, are now well established. Multivariate meta-analysis, where studies provide multiple outcomes that are pooled in a single analysis, is also becoming more commonly used. The question of how to quantify heterogeneity in the multivariate setting is therefore raised. It is the univariate R 2 statistic, the ratio of the variance of the estimated treatment effect under the random and fixed effects models, that generalises most naturally, so this statistic provides our basis. This statistic is then used to derive a multivariate analogue of I 2, which we call . We also provide a multivariate H 2 statistic, the ratio of a generalisation of Cochran's heterogeneity statistic and its associated degrees of freedom, with an accompanying generalisation of the usual I 2 statistic, . Our proposed heterogeneity statistics can be used alongside all the usual estimates and inferential procedures used in multivariate meta-analysis. We apply our methods to some real datasets and show how our statistics are equally appropriate in the context of multivariate meta-regression, where study level covariate effects are included in the model. Our heterogeneity statistics may be used when applying any procedure for fitting the multivariate random effects model. Copyright © 2012 John Wiley & Sons, Ltd.

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The trim-and-fill method for publication bias: practical guidelines and recommendations based on a large database of meta-analyses

Linyu Shi, Lifeng Lin, Stefano Omboni (2019)

Abstract Publication bias is a type of systematic error when synthesizing evidence that cannot represent the underlying truth. Clinical studies with favorable results are more likely published and thus exaggerate the synthesized evidence in meta-analyses. The trim-and-fill method is a popular tool to detect and adjust for publication bias. Simulation studies have been performed to assess this method, but they may not fully represent realistic settings about publication bias. Based on real-world meta-analyses, this article provides practical guidelines and recommendations for using the trim-and-fill method. We used a worked illustrative example to demonstrate the idea of the trim-and-fill method, and we reviewed three estimators (R 0, L 0, and Q 0) for imputing missing studies. A resampling method was proposed to calculate P values for all 3 estimators. We also summarized available meta-analysis software programs for implementing the trim-and-fill method. Moreover, we applied the method to 29,932 meta-analyses from the Cochrane Database of Systematic Reviews, and empirically evaluated its overall performance. We carefully explored potential issues occurred in our analysis. The estimators L 0 and Q 0 detected at least one missing study in more meta-analyses than R 0, while Q 0 often imputed more missing studies than L 0. After adding imputed missing studies, the significance of heterogeneity and overall effect sizes changed in many meta-analyses. All estimators generally converged fast. However, L 0 and Q 0 failed to converge in a few meta-analyses that contained studies with identical effect sizes. Also, P values produced by different estimators could yield different conclusions of publication bias significance. Outliers and the pre-specified direction of missing studies could have influential impact on the trim-and-fill results. Meta-analysts are recommended to perform the trim-and-fill method with great caution when using meta-analysis software programs. Some default settings (e.g., the choice of estimators and the direction of missing studies) in the programs may not be optimal for a certain meta-analysis; they should be determined on a case-by-case basis. Sensitivity analyses are encouraged to examine effects of different estimators and outlying studies. Also, the trim-and-fill estimator should be routinely reported in meta-analyses, because the results depend highly on it.

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Author and article information

Journal

Journal ID (nlm-ta): Medicine (Baltimore)

Journal ID (iso-abbrev): Medicine (Baltimore)

Journal ID (publisher-id): MEDI

Title: Medicine

Publisher: Wolters Kluwer Health

ISSN (Print): 0025-7974

ISSN (Electronic): 1536-5964

Publication date Collection: 12 June 2020

Publication date (Electronic): 12 June 2020

Volume: 99

Issue: 24

Electronic Location Identifier: e20618

Affiliations

[a ]Department of Anus & Intestine Surgery

[b ]Department of Gastrointestinal Surgery, Liaocheng People's Hospital, Liaocheng, Shandong Province

[c ]Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shaanxi Province

[d ]Department of Radiotherapy, Liaocheng People's Hospital, Liaocheng, Shandong Province, China.

Author notes

[∗ ]Correspondence: Xiangqian Lu, Department of Radiotherapy, Liaocheng People's Hospital, Dongchang West Road, No.67, Liaocheng 252000, Shandong Province, China (e-mail: 419183372@ 123456qq.com ).

Article

Publisher ID: MD-D-20-03998 Accession ID: 20618

DOI: 10.1097/MD.0000000000020618

PMC ID: 7302601

PubMed ID: 32541497

SO-VID: f3ba0e2c-d8ac-4cc4-87c1-0dbb54c548f0

License:

This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0

History

Date received : 04 May 2020

Date accepted : 08 May 2020

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Keywords: colorectal cancer,efficacy,meta-analysis,ramucirumab,safety

Data availability:

Keywords: colorectal cancer, efficacy, meta-analysis, ramucirumab, safety

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Efficacy and safety of ramucirumab treatment in patients with advanced colorectal cancer : A protocol for systematic review and meta analysis

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Abstract

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Results and Conclusion:

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Most cited references 21

Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial.

Quantifying the impact of between-study heterogeneity in multivariate meta-analyses

The trim-and-fill method for publication bias: practical guidelines and recommendations based on a large database of meta-analyses

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Cited by 4

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