Journal Article
. 2016 Mar; 32(7):1217-24.
doi: 10.1185/03007995.2016.1166102.

The West German Study Group Breast Cancer Intrinsic Subtype study: a prospective multicenter decision impact study utilizing the Prosigna assay for adjuvant treatment decision-making in estrogen-receptor-positive, HER2-negative early-stage breast cancer

R Wuerstlein 1 K Sotlar 2 O Gluz 1 B Otremba 3 R von Schumann 1 I Witzel 4 C Schindlbeck 5 W Janni 6 C Schem 7 I Bauerfeind 8 S Hasmueller 9 H Tesch 10 A Paulenz 11 N Ghali 12 E Orujov 12 R E Kates 1 W Cowens 12 J Hornberger 13 E Pelz 14 N Harbeck 1 
  • PMID: 26971372
  •     9 citations


Purpose: The West German Study Group (WSG) Breast Cancer Intrinsic Subtype (BCIST) study was designed to assess the influence of Prosigna gene signature assay results on physicians' adjuvant treatment recommendations by determining the extent of change in pre-test treatment recommendations following assay results. Secondary objectives were to assess the influence of Prosigna results on physicians' confidence in their therapeutic recommendations and on patients' decisional conflict status, anxiety levels, and functional status.

Methods: This prospective, observational, decision impact study enrolled consecutive postmenopausal patients with estrogen-receptor (ER)-positive, HER2-negative, lymph-node-negative early-stage breast cancer in 11 centers in Germany. Physicians based their pre-test adjuvant treatment recommendations on standard clinico-pathological parameters. Tumor specimens were assayed using the Prosigna test in a WSG central pathology laboratory following manufacturer's guidelines. An independent pathology laboratory performed subsequent Prosigna assays on tumor sections to assess assay result concordance with the central laboratory. Physicians completed treatment confidence questionnaires prior to and after receiving Prosigna test results. Patients completed standardized questionnaires on decisional conflict, anxiety, and health status both before and after Prosigna testing.

Results: The present study population consisted predominantly of low-to-intermediate risk patients (N = 198). Prosigna had 29.3% discordance in intrinsic subtyping with local immunohistochemistry test results. After Prosigna test results, a change in the adjuvant therapy recommendation occurred in 36 (18.2%) patients; 22 (11.1%) patients switched from no chemotherapy to chemotherapy. After Prosigna test results, physicians expressed increased confidence in their prognostic assessment in 87.9% of patients, and increased confidence in their treatment recommendation in 89.4%. Patients reported improved anxiety and emotional/functional well-being after receiving Prosigna test results.

Conclusions: Use of the Prosigna assay led to a change in 18.2% of adjuvant treatment decisions. Prosigna testing was associated with increased patient and physician confidence in treatment decisions, and with decreased patient anxiety and improved well-being. Any comparison of the therapeutic decision-making impacts of different genomic assays must account for potential confounding factors.

Keywords: Adjuvant therapy; Breast cancer; Genomic; Intrinsic subtypes; PAM50; Prosigna.

Subclonal analysis in a lobular breast cancer with classical and solid growth pattern mimicking a solid-papillary carcinoma.
Matthias Christgen, Stephan Bartels, +10 authors, Hans Kreipe.
J Pathol Clin Res, 2017 Aug 05; 3(3). PMID: 28770103    Free PMC article.
How Do Patients Experience Individualized Medicine? A Qualitative Interview-based Study of Gene Expression Analyses in the Treatment of Breast Cancer.
Sebastian Schleidgen, Sandra Thiersch, Rachel Wuerstlein, Georg Marckmann.
Geburtshilfe Frauenheilkd, 2017 Sep 30; 77(9). PMID: 28959062    Free PMC article.
Prospective, multicenter French study evaluating the clinical impact of the Breast Cancer Intrinsic Subtype-Prosigna® Test in the management of early-stage breast cancers.
Delphine Hequet, Céline Callens, +20 authors, Roman Rouzier.
PLoS One, 2017 Oct 19; 12(10). PMID: 29045452    Free PMC article.
Prognostic value of PAM50 and risk of recurrence score in patients with early-stage breast cancer with long-term follow-up.
Hege O Ohnstad, Elin Borgen, +11 authors, Bjørn Naume.
Breast Cancer Res, 2017 Nov 16; 19(1). PMID: 29137653    Free PMC article.
Gene Expression Profiling Tests for Early-Stage Invasive Breast Cancer: A Health Technology Assessment.
Ontario Health (Quality).
Ont Health Technol Assess Ser, 2020 Apr 15; 20(10). PMID: 32284770    Free PMC article.
Patients' perceptions of 70-gene signature testing: commonly changing the initial inclination to undergo or forego chemotherapy and reducing decisional conflict.
Julia E C van Steenhoven, Bianca M den Dekker, +6 authors, Thijs van Dalen.
Breast Cancer Res Treat, 2020 May 21; 182(1). PMID: 32430679    Free PMC article.
Personalised medicine and the decision to withhold chemotherapy in early breast cancer with intermediate risk of recurrence - a systematic review and meta-analysis.
Susanna M Wallerstedt, Astrid Nilsson Ek, +3 authors, Barbro Linderholm.
Eur J Clin Pharmacol, 2020 Jun 07; 76(9). PMID: 32504183    Free PMC article.
Systematic Review.
Reducing chemotherapy use in clinically high-risk, genomically low-risk pN0 and pN1 early breast cancer patients: five-year data from the prospective, randomised phase 3 West German Study Group (WSG) PlanB trial.
Ulrike Nitz, Oleg Gluz, +18 authors, Nadia Harbeck.
Breast Cancer Res Treat, 2017 Jul 01; 165(3). PMID: 28664507    Free PMC article.
PONDx: real-life utilization and decision impact of the 21-gene assay on clinical practice in Italy.
Francesco Cognetti, Riccardo Masetti, +28 authors, Sandro Barni.
NPJ Breast Cancer, 2021 May 07; 7(1). PMID: 33953182    Free PMC article.