Brustkrebs-Screening mit digitaler Brust-Tomosynthese: Ist weiterhin eine unabhängige Doppelbefundung erforderlich?

Zusammenfassung

Ziel

Die Europäischen Leitlinien empfehlen eine unabhängige Doppelbefundung in Mammografie-Screening-Programmen. Die prospektiv randomisiert-kontrollierte Studie TOSYMA prüfte die Überlegenheit der digitalen Brust-Tomosynthese und synthetischen Mammografie (DBT+SM) gegenüber der digitalen Mammografie (DM) für die Detektion invasiver Mammakarzinome. In dieser Subanalyse werden die richtig-positiven Karzinombefundungen verglichen, die bei unabhängigen Doppelbefundungen in den beiden Studienarmen auftraten.

Materialien und Methoden

Die 1:1 randomisierte TOSYMA-Studie wurde in 17 Screening-Einheiten von 7/2018 bis 12/2020 durchgeführt. In die Subanalyse wurden im DBT+SM-Arm 49.762 Frauen und im DM-Arm 49.796 Frauen eingeschlossen. Von 83 Befunderinnen und Befundern wurden die richtig-positiven Brustkrebsentdeckungsraten (invasive Mammakarzinome und duktales Carcinoma in situ) ermittelt und in einem Doppelbefundungsergebnis zusammengeführt.

Ergebnisse

Mit DBT+SM wurde bei 416 Frauen, mit DM bei 306 Frauen Brustkrebs entdeckt. Dabei trat im DBT+SM-Arm bei 112/416 (26,9 %) Frauen eine richtig-positive kombiniert mit einer falsch-negativen Befundung auf, im DM-Arm war dies bei 68/306 Frauen der Fall (22,2 %). Dies entsprach mit DBT+SM einer Detektionsrate von 2,3 pro 1.000 gescreenter Frauen mit diskordantem Ergebnis bzw. mit DM 1,4 pro 1.000. Unter diskordanten Diagnosen dominierten invasive Mammakarzinome [DBT+SM 75,9 % (85/112), DM 67,6 % (46/68)], die Kategorie T1 [DBT+SM 67,9 % (76/112), DM 55,9 % (38/68)] und die Befundstufe 4a [DBT+SM: 73/112 (67,6 %); DM: 55/68 (84,6 %)].

Schlussfolgerung

Die insgesamt höhere Detektionsrate für Mammakarzinome im DBT-Screening umfasst bei einer unabhängigen Doppelbefundung einen relevanten Anteil von Karzinomen, der nur durch einen Befunder entdeckt wird. Wie im digitalen Mammografie-Screening behält die unabhängige Doppelbefundung ihre Rationale auch beim Screening mit digitaler Brust-Tomosynthese.

Kernaussagen

• Diskordante Karzinom-Befundungen lagen mit DBT+SM bzw. DM zu 26,9 % bzw. 22,2 % vor.

• Die einfach-positive Detektionsrate betrug mit DBT+SM 2,3 ‰ und mit DM 1,4 ‰.

• Ein relevanter Anteil Screening-detektierter Mammakarzinome wurde durch eine einfach richtig-positive Befundung diagnostiziert.

Zitierweise

• Weigel S, Hense HW, Weyer-Elberich V et al. Breast cancer screening with digital breast tomosynthesis: Is independent double reading still required?. Fortschr Röntgenstr 2025; 22: 59–67

Abstract

Purpose

The European guidelines recommend independent double reading in mammography screening programs. The prospective randomized controlled trial TOSYMA tested the superiority of digital breast tomosynthesis and synthetic mammography (DBT+SM) over digital mammography (DM) for invasive breast cancer detection. This sub-analysis compares the true-positive readings of screening-detected breast cancers resulting from independent double readings in the two trial arms.

Materials and Methods

The 1:1 randomized TOSYMA trial was executed in 17 screening units between 07/2018 and 12/2020. This sub-analysis included 49,762 women in the test arm (DBT+SM) and 49,796 women in the control arm (DM). The true-positive reading results (invasive breast cancers and ductal carcinoma in situ) from 83 readers were determined and merged in a double reading result.

Results

DBT+SM screening detected 416 women with breast cancer and DM screening detected 306. Double readings of DBT+SM examinations led to a single true-positive together with a single false-negative result in 26.9 % of cancer cases (112/416), and in 22.2 % of cases (68/306) in the DM examinations. The cancer detection rate with discordant reading results was 2.3 per 1,000 women screened with DBT+SM and 1.4 per 1,000 with DM. Discordant reading results occurred most often for invasive breast cancers [DBT+SM 75.9 % (85/112), DM 67.6 % (46/68)], category T1 [DBT+SM 67.9 % (76/112), DM 55.9 % (38/68)], and category 4a [DBT+SM: 67.6 % (73/112); DM: 84.6 % (55/68)].

Conclusion

The higher breast cancer detection rate with DBT screening includes a relevant percentage of breast cancers that were only detected by one reader in an independent double reading. As in digital mammography, independent double reading continues to be justified in screening with digital breast tomosynthesis.

Key Points

• The percentages of discordant cancer reading results were 26.9 % and 22.2 % for DBT+SM and DM, respectively.

• The single true-positive detection rate was 2.3 ‰ for DBT+ SM and 1.4 ‰ for DM.

• A relevant proportion of screening-detected cancers resulted from a single true-positive reading.

Keywords

breast cancer - digital breast tomosynthesis - independant double reading - screening

Publication History

Received: 25 August 2023

Accepted: 15 November 2023

Article published online:
10 March 2025

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