Clinical and health economic outcomes of alternative HER2 test strategies for guiding adjuvant trastuzumab therapy

Lee, James A.; Shaheen, Megan; Walke, Thomas; Daly, Matthew

doi:10.1586/erp.11.25

Cited by 16 publications

(29 citation statements)

References 75 publications

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“…Two studies for cetuximab and KRAS testing in colorectal cancer [26,27], three studies for crizotinib and ALK testing in lung cancer [28][29][30], one study for erlotinib and EGFR testing in lung cancer [31] and six studies for trastuzumab and HER2 testing in breast cancer [32][33][34][35][36][37].…”

Section: Primary Synthesismentioning

confidence: 99%

“…The two lower thresholds each had 17% of the studies in their respective ranges, while a quarter of the studies had ICERs greater than US$100,000/QALY. It is important to note that five studies [27,29,31,36,37] did not report an ICER for the comparison of interest of our study and therefore could not be included in this comparison. Mean overall study quality as assessed by the QHES scale was 73/100, ranging from 59 to 87.…”

Section: Primary Synthesismentioning

confidence: 99%

“…However, only half of the studies expressed decision uncertainty in the form of a costeffectiveness acceptability curve. Structural uncertainty was also poorly assessed with roughly one-third of the included studies CEA - [27] CUA - [26] MM -2 Crizotinib and ALK testing (n = 3) # CEA - [30] CUA - [28][29][30] AM -1 MM -1 NS -1 Trastuzumab and HER2 testing (BC) (n = 6) ‡ ‡ CEA - [33,34,37] CUA - [32][33][34][35][36][37] AM -1 DT -1 MM -4 Overall (n = 12)…”

Section: Secondary Synthesismentioning

confidence: 99%

“…† † Study did not report an ICER for a testing strategy and respective targeted therapy compared with BSC or no testing and no targeted therapy [31]. ‡ ‡ Two studies did not report an ICER for a testing strategy and respective targeted therapy compared with BSC or no testing and no targeted therapy [36,37]. Two studies reported ranges of ICERs that crossed over multiple thresholds [49,51]; three studies also only reported ICERs for the comparison of interest using LYs not QALYs using scenario analyses.…”

Section: Secondary Synthesismentioning

confidence: 99%

“…Only one study [35] compared the difference of using multiple tests either in parallel or in sequence, despite seven other studies using multiple tests either assumed to be done in parallel [26] or in sequence [30,[32][33][34]36,37]. Specific test thresholds for positivity were mentioned in only two studies [29,35] and limited to a discussion of the thresholds for the FISH tests.…”

Section: Comparison Of Study Characteristics From the Primary And Seconmentioning

confidence: 99%

See 4 more Smart Citations

Modeling companion diagnostics in economic evaluations of targeted oncology therapies: systematic review and methodological checklist

Doble

Tan

Harris

et al. 2014

Expert Review of Molecular Diagnostics

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The successful use of a targeted therapy is intrinsically linked to the ability of a companion diagnostic to correctly identify patients most likely to benefit from treatment. The aim of this study was to review the characteristics of companion diagnostics that are of importance for inclusion in an economic evaluation. Approaches for including these characteristics in model-based economic evaluations are compared with the intent to describe best practice methods. Five databases and government agency websites were searched to identify model-based economic evaluations comparing a companion diagnostic and subsequent treatment strategy to another alternative treatment strategy with model parameters for the sensitivity and specificity of the companion diagnostic (primary synthesis). Economic evaluations that limited model parameters for the companion diagnostic to only its cost were also identified (secondary synthesis). Quality was assessed using the Quality of Health Economic Studies instrument. 30 studies were included in the review (primary synthesis n = 12; secondary synthesis n = 18). Incremental cost-effectiveness ratios may be lower when the only parameter for the companion diagnostic included in a model is the cost of testing. Incorporating the test's accuracy in addition to its cost may be a more appropriate methodological approach. Altering the prevalence of the genetic biomarker, specific population tested, type of test, test accuracy and timing/sequence of multiple tests can all impact overall model results. The impact of altering a test's threshold for positivity is unknown as it was not addressed in any of the included studies. Additional quality criteria as outlined in our methodological checklist should be considered due to the shortcomings of standard quality assessment tools in differentiating studies that incorporate important test-related characteristics and those that do not. There is a need to refine methods for incorporating the characteristics of companion diagnostics into model-based economic evaluations to ensure consistent and transparent reimbursement decisions are made.

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Section: Primary Synthesismentioning

confidence: 99%

Section: Primary Synthesismentioning

confidence: 99%

Section: Secondary Synthesismentioning

confidence: 99%

Section: Secondary Synthesismentioning

confidence: 99%

Section: Comparison Of Study Characteristics From the Primary And Seconmentioning

confidence: 99%

See 3 more Smart Citations

Modeling companion diagnostics in economic evaluations of targeted oncology therapies: systematic review and methodological checklist

Doble

Tan

Harris

et al. 2014

Expert Review of Molecular Diagnostics

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Lnc RNA SNHG20 participated in proliferation, invasion, and migration of breast cancer cells via miR‐495

Guan

Zhang

Chen

et al. 2018

J of Cellular Biochemistry

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To explore the mechanism of lnc SNHG20 in the regulation of proliferation, invasion, and migration of breast cancer cells. mRNA levels of SNHG20, miR-495, and HER2 were detected by qRT-PCR. Protein level of HER2 was measured by Western blot. Cell proliferation, invasion, and migration were detected by CCK-8 assay, Boyden chamber assay, and Transwell assay. The combination between SNHG20 and miR-495 was confirmed by RNA pull down assay. The combination between miR-495 and HER2 was confirmed by luciferase report assays. We also established breast cancer-bearing mice model and analyzed tumor volumes. Our data showed SNHG20 expression was significantly upregulated, miR-495 expression was significantly downregulated, and HER2 expression was significantly upregulated in breast cancer tissues and cell lines. Besides, SNHG20 promoted the proliferation, invasion, and migration of breast cancer cells. We also found SNHG20 negatively regulated miR-495, and miR-495 could negatively regulate HER2. Moreover, we discovered that SNHG20 regulated HER2 via miR-495. SNHG20 regulated proliferation, invasion, and migration of breast cancer cells via miR-495/HER2. Finally, we confirmed the mechanism of SNHG20 in the regulation of proliferation, invasion, and migration in breast cancer-bearing mice model. SNHG20 regulates HER2 via miR-495 to promote proliferation, invasion, and migration of breast cancer cells.

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HER2 gene and protein expression status of breast carcinoma can be reliably tested on a single slide

et al. 2015

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Human epidermal growth factor receptor 2 (HER2) status in breast carcinomas serves as a predictor of benefit from anti-HER2 therapy. In providing clinicians with the information necessary to decide whether or not to treat with targeted therapy, it might be necessary to choose between methods assessing HER2 protein overexpression or gene amplification. A new diagnostic approach could be a combination of both tests on the same slide. If accurate and reproducible, this approach might optimize patient stratification for therapy. In this study, formalin-fixed paraffin-embedded tumor samples from 77 breast cancer patients were examined for HER2 by immunohistochemistry (IHC) and silver in situ hybridization (SISH) using HER2 IHC (clone 4B5), HER2/CEN17SISH, and combined IHC and SISH assay, called gene protein (GP). Cases were selected to ensure a sufficient number of borderline cases on the basis of IHC scores (0, 1+, 2+, 3+), obtained during diagnostic histopathological workup. The concordance between the HER2 IHC score obtained during diagnostic histopathological workup and GP was 93 %. Discordances had no influence on therapy decisions. The concordance between ISH results using dual ISH (DISH) and GP was 96 %. Of the 77 cases studied by GP, three cases with a ratio close to 2 would have been called amplified by DISH. The use of GP reduced the time for slide reading for a trained pathologist by up to 25 %, relative to sequential reading of IHC followed by SISH. For cases with an IHC score of 2+, the final result was obtained in 1 day, while the sequential technique would have required retesting by ISH on a second day. In conclusion, assessment of HER2 status by GP is an improvement for pathologists and facilitates clinical decision-making for breast cancer management.

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Clinical and health economic outcomes of alternative HER2 test strategies for guiding adjuvant trastuzumab therapy

Cited by 16 publications

References 75 publications

Modeling companion diagnostics in economic evaluations of targeted oncology therapies: systematic review and methodological checklist

Modeling companion diagnostics in economic evaluations of targeted oncology therapies: systematic review and methodological checklist

Lnc RNA SNHG20 participated in proliferation, invasion, and migration of breast cancer cells via miR‐495

HER2 gene and protein expression status of breast carcinoma can be reliably tested on a single slide

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