Added value of HER-2 amplification testing by multiplex ligation-dependent probe amplification in invasive breast cancer.
<h4>Background</h4>HER-2 is a prognostic and predictive marker, but as yet no technique is perfectly able to identify patients likely to benefit from HER-2 targeted therapies. We aimed to prospectively assess the added value of first-line co-testing by IHC, and multiplex ligation-depende...
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2013
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oai:doaj.org-article:1f6119dbaea041c9aea6bb77eb8da9b52021-11-18T08:43:30ZAdded value of HER-2 amplification testing by multiplex ligation-dependent probe amplification in invasive breast cancer.1932-620310.1371/journal.pone.0082018https://doaj.org/article/1f6119dbaea041c9aea6bb77eb8da9b52013-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24324739/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>HER-2 is a prognostic and predictive marker, but as yet no technique is perfectly able to identify patients likely to benefit from HER-2 targeted therapies. We aimed to prospectively assess the added value of first-line co-testing by IHC, and multiplex ligation-dependent probe amplification (MLPA) and chromogenic in situ hybridization (CISH).<h4>Methods</h4>As local validation, HER-2 MLPA and CISH were compared in 99 breast cancers. Next, we reviewed 937 invasive breast cancers, from 4 Dutch pathology laboratories, that were prospectively assessed for HER-2 by IHC and MLPA (and CISH in selected cases).<h4>Results</h4>The validation study demonstrated 100% concordance between CISH and MLPA, if both methods were assessable and conclusive (81.8% of cases). Significant variation regarding percentages IHC 0/1+ and 2+ cases was observed between the laboratories (p<0.0001). Overall concordance between IHC and MLPA/CISH was 98.1% (575/586) (Kappa = 0.94). Of the IHC 3+ cases, 6.7% failed to reveal gene amplification, whereas 0.8% of the IHC 0/1+ cases demonstrated gene amplification. Results remained discordant after retrospective review in 3/11 discordant cases. In the remaining 8 cases the original IHC score was incorrect or adapted after repeated IHC staining.<h4>Conclusions</h4>MLPA is a low-cost and quantitative high-throughput technique with near perfect concordance with CISH. The use of MLPA in routinely co-testing all breast cancers may reduce HER-2 testing variation between laboratories, may serve as quality control for IHC, will reveal IHC 0/1+ patients with gene amplification, likely responsive to trastuzumab, and identify IHC 3+ cases without gene amplification that may respond less well.Chantal C H J KuijpersCathy B MoelansHenk-Jan van SlootenAnja HorstmanJohn W J HinrichsShaimaa Al-JanabiPaul J van DiestMehdi JiwaPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 8, Iss 12, p e82018 (2013) |
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Medicine R Science Q Chantal C H J Kuijpers Cathy B Moelans Henk-Jan van Slooten Anja Horstman John W J Hinrichs Shaimaa Al-Janabi Paul J van Diest Mehdi Jiwa Added value of HER-2 amplification testing by multiplex ligation-dependent probe amplification in invasive breast cancer. |
| description |
<h4>Background</h4>HER-2 is a prognostic and predictive marker, but as yet no technique is perfectly able to identify patients likely to benefit from HER-2 targeted therapies. We aimed to prospectively assess the added value of first-line co-testing by IHC, and multiplex ligation-dependent probe amplification (MLPA) and chromogenic in situ hybridization (CISH).<h4>Methods</h4>As local validation, HER-2 MLPA and CISH were compared in 99 breast cancers. Next, we reviewed 937 invasive breast cancers, from 4 Dutch pathology laboratories, that were prospectively assessed for HER-2 by IHC and MLPA (and CISH in selected cases).<h4>Results</h4>The validation study demonstrated 100% concordance between CISH and MLPA, if both methods were assessable and conclusive (81.8% of cases). Significant variation regarding percentages IHC 0/1+ and 2+ cases was observed between the laboratories (p<0.0001). Overall concordance between IHC and MLPA/CISH was 98.1% (575/586) (Kappa = 0.94). Of the IHC 3+ cases, 6.7% failed to reveal gene amplification, whereas 0.8% of the IHC 0/1+ cases demonstrated gene amplification. Results remained discordant after retrospective review in 3/11 discordant cases. In the remaining 8 cases the original IHC score was incorrect or adapted after repeated IHC staining.<h4>Conclusions</h4>MLPA is a low-cost and quantitative high-throughput technique with near perfect concordance with CISH. The use of MLPA in routinely co-testing all breast cancers may reduce HER-2 testing variation between laboratories, may serve as quality control for IHC, will reveal IHC 0/1+ patients with gene amplification, likely responsive to trastuzumab, and identify IHC 3+ cases without gene amplification that may respond less well. |
| format |
article |
| author |
Chantal C H J Kuijpers Cathy B Moelans Henk-Jan van Slooten Anja Horstman John W J Hinrichs Shaimaa Al-Janabi Paul J van Diest Mehdi Jiwa |
| author_facet |
Chantal C H J Kuijpers Cathy B Moelans Henk-Jan van Slooten Anja Horstman John W J Hinrichs Shaimaa Al-Janabi Paul J van Diest Mehdi Jiwa |
| author_sort |
Chantal C H J Kuijpers |
| title |
Added value of HER-2 amplification testing by multiplex ligation-dependent probe amplification in invasive breast cancer. |
| title_short |
Added value of HER-2 amplification testing by multiplex ligation-dependent probe amplification in invasive breast cancer. |
| title_full |
Added value of HER-2 amplification testing by multiplex ligation-dependent probe amplification in invasive breast cancer. |
| title_fullStr |
Added value of HER-2 amplification testing by multiplex ligation-dependent probe amplification in invasive breast cancer. |
| title_full_unstemmed |
Added value of HER-2 amplification testing by multiplex ligation-dependent probe amplification in invasive breast cancer. |
| title_sort |
added value of her-2 amplification testing by multiplex ligation-dependent probe amplification in invasive breast cancer. |
| publisher |
Public Library of Science (PLoS) |
| publishDate |
2013 |
| url |
https://doaj.org/article/1f6119dbaea041c9aea6bb77eb8da9b5 |
| work_keys_str_mv |
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| _version_ |
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