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CC BY-NC-ND 4.0 · Geburtshilfe Frauenheilkd 2020; 80(06): 619-627
DOI: 10.1055/a-1111-8734
GebFra Science
Original Article

Distribution of the 21-Gene Breast Recurrence Score in Patients with Primary Breast Cancer in Germany

Verteilung des 21-Gen-Rezidiv-Scores bei Patientinnen mit primärem Mammakarzinom in Deutschland
Vincent P. Walter
1   Department of Womenʼs Health, University of Tübingen, Tübingen, Germany
,
Florin-Andrei Taran
1   Department of Womenʼs Health, University of Tübingen, Tübingen, Germany
,
Markus Wallwiener
2   Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Germany
,
Armin Bauer
1   Department of Womenʼs Health, University of Tübingen, Tübingen, Germany
,
Eva-Maria Grischke
1   Department of Womenʼs Health, University of Tübingen, Tübingen, Germany
,
Christina Barbara Walter
1   Department of Womenʼs Health, University of Tübingen, Tübingen, Germany
,
Markus Hahn
1   Department of Womenʼs Health, University of Tübingen, Tübingen, Germany
,
Sara Y. Brucker
1   Department of Womenʼs Health, University of Tübingen, Tübingen, Germany
,
Andreas Daniel Hartkopf
1   Department of Womenʼs Health, University of Tübingen, Tübingen, Germany
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Abstract

Background Multigene assays are being used increasingly to aid in decision-making about chemotherapy in breast cancer. Here, we present the 21-gene recurrence score (RS) of patients tested in routine clinical practice in Germany.

Patients and Methods In a retrospective analysis, 4695 patients with hormone receptor-positive and HER2-negative early breast cancer (pT1 – 3, pN0 – 1, M0) were included in whom RS testing was conducted in Germany between November 2015 and July 2018. RS groups as defined in the TAILORx trial (RS result 0 – 10; 11 – 25; 26 – 100) were used.

Results Of these patients, 21% were assigned to the low RS group, 63% to the midrange RS group, and 15% to the high RS group. 1772 (81%) of 2175 node-negative patients over 50 years of age were grouped either into the low RS group or the midrange RS group. The portion of patients with a low or midrange RS was 90% among node-positive patients (1284 of 1432 patients), 79% among patients with Ki-67-high (≥ 20%) tumors (1829 of 2310 patients), 86% vs. 70% among patients with G2 and G3 tumors (3244 of 3762 patients and 368 of 522 patients), respectively, 88% among patients with a tumor size of > 5 cm (140 of 159 patients), and 82% among node-negative patients at high clinical risk (1110 of 1352).

Conclusions The distribution of the 21-gene RS in German patients that were tested in routine clinical practice indicates that, according to the results of the TAILORx trial, chemotherapy may not be beneficial in most of these.

Zusammenfassung

Einleitung Multigen-Assays werden zunehmend als Entscheidungshilfe für eine Chemotherapie beim Mammakarzinom verwendet. Wir stellen hier den 21-Gen-Recurrence-Score (RS) von Patientinnen mit Brustkrebs vor, die routinemäßig in Deutschland untersucht wurden.

Patientinnen und Methoden 4695 Patientinnen mit hormonrezeptorpositivem und HER2-negativem Brustkrebs im Frühstadium (pT1 – 3, pN0 – 1, M0) wurden einer retrospektiven Analyse unterzogen. Bei diesen Patientinnen wurde in Deutschland zwischen November 2015 und Juli 2018 der Genexpressionstest Oncotype DX zur Ermittlung des Recurrence-Scores durchgeführt. Die Klassifikation der RS-Gruppen erfolgte gemäß der TAILORx Studie (RS: 0 – 10; 11 – 25; 26 – 100).

Ergebnisse Von diesen Patientinnen wurden 21% in die niedrige RS-Gruppe, 63% in die mittlere RS-Gruppe, und 15% in die hohe RS-Gruppe eingeteilt. 1772 (81%) von 2175 Patientinnen im Alter von über 50 Jahren und ohne Lymphknotenbefall wurden entweder in die niedrige oder die mittlere RS-Gruppe eingeteilt. Der Prozentsatz an Patientinnen mit einem niedrigen oder mittleren RS betrug 90% bei Patientinnen ohne Lymphknotenbefall (1284 von 1432 Patientinnen), 79% bei Patientinnen mit einem hohen (≥ 20%) Ki-67-Wert (1829 von 2310 Patientinnen), 86% bzw. 70% bei Patientinnen mit G2- bzw. G3-Tumoren (3244 von 3762 Patientinnen bzw. 368 von 522 Patientinnen), 88% bei Patientinnen mit einem Tumordurchmesser von > 5 cm (140 von 159 Patientinnen), und 82% bei Patientinnen ohne Lymphknotenbefall, aber mit einem hohen klinischen Risiko (1110 von 1352).

Ergebnisse Die Verteilung des 21-Gens RS bei deutschen Patientinnen, die in der klinischen Routinepraxis getestet wurden, deutet darauf hin, dass gemäß den Ergebnissen der TAILORx-Studie die Chemotherapie bei den meisten dieser Patientinnen keinen Nutzen hat.

Key words

21-gene breast recurrence score - breast cancer - multigene assays - Oncotype DX

Schlüsselwörter

21-Gen-Rezidiv-Score - Mammakarzinom - Multigen-Assays - Oncotype DX


Publication History

Received: 04 June 2019
Received: 01 February 2020

Accepted: 02 February 2020

Article published online:
17 June 2020

© .

Georg Thieme Verlag KG
Stuttgart · New York

 

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