Comparison of different approaches for assessment of HER2 expression on protein and mRNA level: prediction of chemotherapy response in the neoadjuvant GeparTrio trial (NCT00544765)

Noske, Aurelia; Loibl, Sibylle; Darb‐Esfahani, Silvia; Roller, Marc; Kronenwett, Ralf; Müller, Berit; Steffen, Jan; Toerne, Christine von; Wirtz, Ralph M.; Baumann, Irith; Hoffmann, G. M.; Heinrich, Georg; Graßhoff, Sven-Thomas; Ulmer, Hans-Ullrich; Denkert, Carsten; Minckwitz, Gϋnter von

doi:10.1007/s10549-010-1316-y

Cited by 57 publications

(39 citation statements)

References 35 publications

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“…To the best of our knowledge with more than 1,000 ILCs, this is the largest cohort of neoadjuvant treated lobular carcinomas to date. The number of pCRs in the ILC group [31,32]. The rate of HER2-positive ILC is higher compared to data from the HERA trial [33].…”

Section: Discussionmentioning

confidence: 82%

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Response and prognosis after neoadjuvant chemotherapy in 1,051 patients with infiltrating lobular breast carcinoma

Loibl

Volz

Mau

et al. 2014

Breast Cancer Res Treat

101

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Response and prognosis after neoadjuvant chemotherapy in 1,051 patients with infiltrating lobular breast carcinoma 123Breast Cancer Res Treat (2014) 144:153-162 DOI 10.1007/s10549-014-2861 pCR and this is not well correlated with further outcome. The mastectomy rate was considerably high in ILC patients even after obtaining a pCR. We, therefore, suggest to offer NACT mainly to ILC patients with HR-negative tumours.

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Section: Discussionmentioning

confidence: 82%

“…In the older neoadjuvant trialsHER2-testing was not established as a routine method. This might explain the higher rate of HER2-positive cases compared to HERA [31]. In addition, we have performed central histology assessment in a subset of patients.…”

Section: Discussionmentioning

confidence: 99%

Response and prognosis after neoadjuvant chemotherapy in 1,051 patients with infiltrating lobular breast carcinoma

Loibl

Volz

Mau

et al. 2014

Breast Cancer Res Treat

101

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“…1,8,11,19,20 Despite 410 years of routine HER2 testing, studies have demonstrated variability in HER2 positivity assessments between local pathology laboratories and central testing centers, posing a challenge for clinicians. 15,[21][22][23][24][25] In some of these studies it was assumed that variations in HER2 positivity at individual centers equated to problems with testing quality. 15,22,26,27 To overcome this issue, monitoring of HER2 positivity rates has been suggested as a means for HER2 testing quality control in international guidelines.…”

mentioning

confidence: 99%

Assessing HER2 testing quality in breast cancer: variables that influence HER2 positivity rate from a large, multicenter, observational study in Germany

Rüschoff¹,

Lebeau

Kreipe

et al. 2017

Modern Pathology

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Despite 410 years of routine human epidermal growth factor receptor 2 (HER2) testing in breast cancer, testing quality is still an issue. Guidelines recommend assessing HER2 positivity rates as a quality indicator; however, the extent to which patient-or tumor-related factors influence HER2 positivity is still unknown. The present study analyzed these influences to identify pathology centers with HER2 positivity rates unexplained by patient-or tumor-related factors. This observational, prospective study monitored routine HER2 testing at 57 institutes of pathology in Germany (January 2013-August 2014). Data collected included HER2 test result, patient-and tumorrelated factors, sample source, and method of sample retrieval. Factors influencing HER2 positivity rates were identified by multiple logistic regression. Individual center effects were assessed in an extended multiple logistic regression model by their statistical significance after adjusting for the combined effect of patient-or tumorrelated covariates and multiple testing. Analyses included 15 332 invasive breast cancer samples. Histologic grade showed the strongest influence on HER2 positivity, followed by hormone receptor status, histologic subtype, age, and nodal status (all Po 0.0001). The overall HER2 positivity rate across centers was 14.4% (range 7.1-27.3%). A statistically significant center effect on the HER2 positivity rate was identified for three centers (Po 0.05), with a trend toward a center effect for a further three (P o0.2). This study, the first of its kind, highlights that assessing HER2 testing quality with HER2 positivity rates should include standardized assessment of patient-or tumor-related characteristics to identify centers with HER2 testing quality issues more effectively. As treatment options for HER2-positive breast cancer continue to evolve, identifying the right patients is key. Overexpression of the human epidermal growth factor receptor 2 (HER2) protein or amplification of the HER2 gene occurs in~15-20% of all breast cancers. 1 HER2-positive breast cancer has a worse prognosis than HER2-negative disease, having an increased risk of recurrence and a more aggressive disease course. 2-4 HER2 is a prognostic biomarker predictive for the response to HER2-targeted therapies including the recombinant monoclonal antibodies trastuzumab and pertuzumab, and the antibody-drug conjugate ado-trastuzumab emtansine, all of which specifically target HER2 and are effective treatments for HER2-positive breast Correspondence: Professor J

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“…Moreover, switching to four NX courses had a better toxicity profile than continuing TAC. The rates of pCR in both groups were low (5.3% in the TAC arm vs 6% in the NX arm) [28][29][30]. Other studies have tested the approach of response-adjusted sequential therapy, however, this remains to be investigated [31].…”

Section: Therapeutic Optionsmentioning

confidence: 99%

Primary Therapy in Breast Cancer: What Have We Learned from Landmark Trials?

Bozza

Osa

Puglisi

2013

Womens Health (Lond Engl)

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Primary anticancer therapy is currently accepted as a therapeutic option for patients with early-stage breast cancer. Its objectives are to increase the chance of achieving a conservative surgery and, similar to adjuvant chemotherapy, to reduce the risk of distant recurrence. The prognostic significance of obtaining a pathological complete response has been evaluated in several randomized clinical trials and meta-analyses. Growing evidence suggests that pathological complete response may act as a valid predictor of overall survival. Of note, a significant association between pathological complete response and outcome has especially been observed in patients with HER2-positive and triple-negative (hormonal receptors negative and HER2-negative) breast cancer. This review focuses on recent trials of neoadjuvant treatment with specific attention to HER2-negative disease. This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of Medscape, LLC and Future Medicine Ltd. Medscape, LLC is accredited by the ACCME to provide continuing medical education for physicians.Medscape, LLC designates this Journal-based CME activity for a maximum of 1 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.All other clinicians completing this activity will be issued a certificate of participation. To participate in this journal CME activity: (1) review the learning objectives and author disclosures; (2) study the education content; (3) take the post-test with a 70% minimum passing score and complete the evaluation at www.medscape.org/journal/wh; (4) view/print certificate. Release date: 28 October 2013; Expiration date: 28 October 2014 Learning objectivesUpon completion of this activity, participants should be able to:• Distinguish tumor characteristics that are favorable for neoadjuvant therapy• Compare outcomes among women with breast cancer treated with neoadjuvant therapy vs postoperative therapy• Assess the primary chemotherapy regimen recommended in neoadjuvant therapy• Evaluate the use and outcomes of endocrine treatment as neoadjuvant therapy CMe part of

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Comparison of different approaches for assessment of HER2 expression on protein and mRNA level: prediction of chemotherapy response in the neoadjuvant GeparTrio trial (NCT00544765)

Abstract: Introduction: Human epidermal growth factor receptor 2 (HER2) testing is an

Cited by 57 publications

References 35 publications

Response and prognosis after neoadjuvant chemotherapy in 1,051 patients with infiltrating lobular breast carcinoma

Response and prognosis after neoadjuvant chemotherapy in 1,051 patients with infiltrating lobular breast carcinoma

Assessing HER2 testing quality in breast cancer: variables that influence HER2 positivity rate from a large, multicenter, observational study in Germany

Primary Therapy in Breast Cancer: What Have We Learned from Landmark Trials?

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