Comparison of MammaPrint and TargetPrint results with clinical parameters in German patients with early stage breast cancer

Abstract

Abstract. The 70-gene expression profile MammaPrint is a powerful prognostic indicator for disease outcome in breast cancer patients with improved prediction of recurrence risk compared to currently used guidelines. The microarraybased test TargetPrint further provides reliable, quantitative assessment of mRNA expression levels of estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2). This study was performed as a validation of MammaPrint and TargetPrint in an unselected German breast cancer population and was designed to determine the degree of concordance with currently applied clinical parameters. One hundred and forty cases of breast cancer stage I and II were classified as being low or high risk for distant metastasis using MammaPrint. Results were compared to current clinical risk classifications and adjuvant treatment management. Immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH)/chromogenic in situ hybridization (CISH) assessments of ER, PR and HER2 were further compared with gene expression read-outs using TargetPrint. Thirty-two percent of patients (19/59) with a poor prognosis-signature identified via MammaPrint did not receive adjuvant systemic treatment apart from endocrine therapy and were potentially undertreated; whereas 42% (35/77) of patients with a good prognosis-signature received chemotherapy and were potentially overtreated. Comparison of microarray receptor results with IHC and FISH/CISH were concordant in 97% for ER; 86% for PR; and 94% for HER2. In this German study population, MammaPrint would have resulted in altered treatment advice for adjuvant systemic therapy in 40% of patients. Furthermore, TargetPrint presented high concordance for ER, PR and Her2 with IHC and FISH/CISH analysis.

Gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management: a systematic review and cost-effectiveness analysis

“…The methodological quality of the seven included studies 75,[92][93][94]96,99,100 is summarised in Figure 4 (further details are provided in Appendix 9). Generally, only two studies 75,93 performed well, receiving a positive assessment for at least 17 out of 21 methodological quality items.…”

“…A German-based study 95 investigating 140 majority LN-and ER+ patients was reported by Gevensleben et al 94 The authors made a comparison between risk prediction using the 70-gene prognostic signature and risk prediction using the St Gallen criteria 95 and Adjuvant! Online (Adjuvant!…”

“…Gevensleben et al 94 in their study investigating 140 LN-and ER+ German patients, also examined treatment advice. For 59 patients (out of 62) with poor prognosis identified by the 70-gene prognosis signature, the clinical treatment was recorded.…”

Clinical utility of gene-expression profiling in women with early breast cancer: an overview of systematic reviews

“…Among the participants who were recommended to receive adjuvant therapy after consideration of clinical guidelines, patient preference, and prognosis signature, 18, 29, and 13% of participants were recommended for chemotherapy alone, chemotherapy plus hormone therapy, and hormone therapy only, respectively. One additional study summarized by Ward et al 40 retrospectively compared actual treatment received with participants’ MammaPrint risk classifications. Among 59 participants classified as high risk, 19 (32%) did not receive chemotherapy, whereas 35 out of 77 participants classified as low risk did receive chemotherapy.…”

“…It was suggested that MammaPrint would affect the treatment 40% of the time based on the assumption that all high-risk participants would receive chemotherapy and all low-risk participants would not. 40 Heterogeneity in the study populations and in the initial criteria used to make treatment decisions limits the ability to generalize the impact of MammaPrint on clinical decision making. Indirectness in the interpretation of results, participant characteristics, and the lack of a reliable control groups led us to determine there is low-quality evidence for MammaPrint to lead to change in treatment decisions or recommendations ( Table 3 ).…”