Methodological quality evaluation of systematic reviews or meta-analysis of trastuzumab-based therapy for breast cancer

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Abstract

Background:

To evaluate the methodological quality of systematic reviews (SRs) or meta-analysis of trastuzumab-based therapy for breast cancer.

Methods:

We searched the PubMed, EMBASE, Web of science, Cochrane library, international prospective register of systematic reviews, Chinese BioMedical Literature Database, Wan Fang, China National Knowledge Infrastructure and VIP database for SRs or meta-analysis. The methodological quality of included literatures was appraised by risk of bias in systematic review (ROBIS) tool.

Results:

Twenty three eligible systematic reviews or meta-analysis were included. Only 2 systematic reviews provided protocol. The most frequently searched databases were PubMed, MEDLINE, EMBASE, and the Cochrane. The two-reviewers model described in the screening for eligible original articles, data extraction, and methodological quality evaluation had 30%, 61%, and 26%, respectively. In methodological quality assessment, 52% SRs or meta-analysis used the Jadad scoring or Cochrane reviewer’ handbook. Research question were well matched to all SRs or meta-analysis in phase 1 and 35% of them evaluated “high” risk bias in study eligibility criteria. The “high” risk of bias in all non-Cochrane SRs or meta-analyses, which involve methods used to identify and/or select studies. And more than half SRs or meta-analysis had a high risk of bias in data collection and study appraisal. More than two-third of SRs or meta-analysis were accomplished with high risk of bias in the synthesis and findings.

Conclusions:

The study indicated poor methodological and reporting quality of SRs/meta-analysis assessing trastuzumab-based therapy for breast cancer. Registration or publishing the protocol and the reporting followed the PRISMA checklist are recommended in future research.

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Most cited references 40

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Cancer statistics, 2018

Kimberly D Miller, Rebecca Siegel, Ahmedin Jemal (2018)

Each year, the American Cancer Society estimates the numbers of new cancer cases and deaths that will occur in the United States and compiles the most recent data on cancer incidence, mortality, and survival. Incidence data, available through 2014, were collected by the Surveillance, Epidemiology, and End Results Program; the National Program of Cancer Registries; and the North American Association of Central Cancer Registries. Mortality data, available through 2015, were collected by the National Center for Health Statistics. In 2018, 1,735,350 new cancer cases and 609,640 cancer deaths are projected to occur in the United States. Over the past decade of data, the cancer incidence rate (2005-2014) was stable in women and declined by approximately 2% annually in men, while the cancer death rate (2006-2015) declined by about 1.5% annually in both men and women. The combined cancer death rate dropped continuously from 1991 to 2015 by a total of 26%, translating to approximately 2,378,600 fewer cancer deaths than would have been expected if death rates had remained at their peak. Of the 10 leading causes of death, only cancer declined from 2014 to 2015. In 2015, the cancer death rate was 14% higher in non-Hispanic blacks (NHBs) than non-Hispanic whites (NHWs) overall (death rate ratio [DRR], 1.14; 95% confidence interval [95% CI], 1.13-1.15), but the racial disparity was much larger for individuals aged <65 years (DRR, 1.31; 95% CI, 1.29-1.32) compared with those aged ≥65 years (DRR, 1.07; 95% CI, 1.06-1.09) and varied substantially by state. For example, the cancer death rate was lower in NHBs than NHWs in Massachusetts for all ages and in New York for individuals aged ≥65 years, whereas for those aged <65 years, it was 3 times higher in NHBs in the District of Columbia (DRR, 2.89; 95% CI, 2.16-3.91) and about 50% higher in Wisconsin (DRR, 1.78; 95% CI, 1.56-2.02), Kansas (DRR, 1.51; 95% CI, 1.25-1.81), Louisiana (DRR, 1.49; 95% CI, 1.38-1.60), Illinois (DRR, 1.48; 95% CI, 1.39-1.57), and California (DRR, 1.45; 95% CI, 1.38-1.54). Larger racial inequalities in young and middle-aged adults probably partly reflect less access to high-quality health care. CA Cancer J Clin 2018;68:7-30. © 2018 American Cancer Society.

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Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2.

Dennis J Slamon, Brian Leyland-Jones, Steven Shak … (2001)

The HER2 gene, which encodes the growth factor receptor HER2, is amplified and HER2 is overexpressed in 25 to 30 percent of breast cancers, increasing the aggressiveness of the tumor. We evaluated the efficacy and safety of trastuzumab, a recombinant monoclonal antibody against HER2, in women with metastatic breast cancer that overexpressed HER2. We randomly assigned 234 patients to receive standard chemotherapy alone and 235 patients to receive standard chemotherapy plus trastuzumab. Patients who had not previously received adjuvant (postoperative) therapy with an anthracycline were treated with doxorubicin (or epirubicin in the case of 36 women) and cyclophosphamide alone (138 women) or with trastuzumab (143 women). Patients who had previously received adjuvant anthracycline were treated with paclitaxel alone (96 women) or paclitaxel with trastuzumab (92 women). The addition of trastuzumab to chemotherapy was associated with a longer time to disease progression (median, 7.4 vs. 4.6 months; P<0.001), a higher rate of objective response (50 percent vs. 32 percent, P<0.001), a longer duration of response (median, 9.1 vs. 6.1 months; P<0.001), a lower rate of death at 1 year (22 percent vs. 33 percent, P=0.008), longer survival (median survival, 25.1 vs. 20.3 months; P=0.01), and a 20 percent reduction in the risk of death. The most important adverse event was cardiac dysfunction of New York Heart Association class III or IV, which occurred in 27 percent of the group given an anthracycline, cyclophosphamide, and trastuzumab; 8 percent of the group given an anthracycline and cyclophosphamide alone; 13 percent of the group given paclitaxel and trastuzumab; and 1 percent of the group given paclitaxel alone. Although the cardiotoxicity was potentially severe and, in some cases, life-threatening, the symptoms generally improved with standard medical management. Trastuzumab increases the clinical benefit of first-line chemotherapy in metastatic breast cancer that overexpresses HER2.

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ROBIS: A new tool to assess risk of bias in systematic reviews was developed

Penny Whiting, Jelena Savović, Julian P.T. Higgins … (2016)

Objective To develop ROBIS, a new tool for assessing the risk of bias in systematic reviews (rather than in primary studies). Study Design and Setting We used four-stage approach to develop ROBIS: define the scope, review the evidence base, hold a face-to-face meeting, and refine the tool through piloting. Results ROBIS is currently aimed at four broad categories of reviews mainly within health care settings: interventions, diagnosis, prognosis, and etiology. The target audience of ROBIS is primarily guideline developers, authors of overviews of systematic reviews (“reviews of reviews”), and review authors who might want to assess or avoid risk of bias in their reviews. The tool is completed in three phases: (1) assess relevance (optional), (2) identify concerns with the review process, and (3) judge risk of bias. Phase 2 covers four domains through which bias may be introduced into a systematic review: study eligibility criteria; identification and selection of studies; data collection and study appraisal; and synthesis and findings. Phase 3 assesses the overall risk of bias in the interpretation of review findings and whether this considered limitations identified in any of the phase 2 domains. Signaling questions are included to help judge concerns with the review process (phase 2) and the overall risk of bias in the review (phase 3); these questions flag aspects of review design related to the potential for bias and aim to help assessors judge risk of bias in the review process, results, and conclusions. Conclusions ROBIS is the first rigorously developed tool designed specifically to assess the risk of bias in systematic reviews.

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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: Lippincott Williams & Wilkins (Hagerstown, MD )

ISSN (Print): 0025-7974

ISSN (Electronic): 1536-5964

Publication date Collection: 29 January 2021

Publication date (Electronic): 29 January 2021

Volume: 100

Issue: 4

Electronic Location Identifier: e24389

Affiliations

[a ]School of Pharmacy, Chengdu Medical College, Chengdu

[b ]Department of Pharmacy

[c ]Department of Anesthesiology, Dujiangyan People's Hospital, Dujiangyan Medical Center, Dujiangyan

[d ]Department of Pharmacy, Sichuan Cancer Hospital & Institute, Sichuan Cancer Centre, School of Medicine, University of Electronic Science and Technology of China

[e ]Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.

Author notes

[∗ ]Correspondence: Qian Jiang, Department of Pharmacy, Sichuan Cancer Hospital & Institute, Sichuan Cancer Centre, School of Medicine, University of Electronic Science and Technology of China, Chengdu 610041, Sichuan, PR China (e-mail: jiangqian_3805.student@ 123456sina.com ).

Author information

Hua Wei http://orcid.org/0000-0003-3620-7620

Article

Publisher ID: MD-D-20-01854 Accession ID: 24389

DOI: 10.1097/MD.0000000000024389

PMC ID: 7850684

PubMed ID: 33530234

SO-VID: 081904ce-19ed-48bc-a233-4e0cad03a6a1

License:

This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc/4.0

History

Date received : 9 March 2020

Date revision received : 21 June 2020

Date accepted : 29 December 2020

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Keywords: breast cancer,methodological quality,robis,systematic review,trastuzumab

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Keywords: breast cancer, methodological quality, robis, systematic review, trastuzumab

Methodological quality evaluation of systematic reviews or meta-analysis of trastuzumab-based therapy for breast cancer : A systematic review

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Most cited references 40

Cancer statistics, 2018

Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2.

ROBIS: A new tool to assess risk of bias in systematic reviews was developed

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