CC BY-NC-ND 4.0 · Geburtshilfe Frauenheilkd 2020; 80(11): 1134-1142
DOI: 10.1055/a-1286-2917
GebFra Science
Original Article

Treatment Landscape and Prognosis After Treatment with Trastuzumab Emtansine

Behandlungslandschaft und Prognose nach der Therapie mit Trastuzumab Emtansin
Elena Laakmann
1   Department of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, Germany
,
Julius Emons
2   Erlangen University Hospital, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany
,
Florin-Andrei Taran
3   Department of Gynecology, Zurich University Hospital, Zurich, Switzerland
,
Wolfgang Janni
4   Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany
,
Sabrina Uhrig
2   Erlangen University Hospital, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany
,
Friedrich Overkamp
5   Oncologianova GmbH, Recklinghausen, Germany
,
Hans-Christian Kolberg
6   Department of Marienhospital Bottrop, Bottrop, Germany
,
Peyman Hadji
7   Frankfurt Center of Bone Health Frankfurt, Frankfurt, Germany
,
Hans Tesch
8   Oncology Practice at Bethanien Hospital Frankfurt, Frankfurt, Germany
,
Lothar Häberle
2   Erlangen University Hospital, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany
9   Biostatistics Unit, University Hospital Erlangen, Department of Gynecology and Obstetrics, Erlangen, Germany
,
Johannes Ettl
10   Department of Obstetrics and Gynecology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany
,
Diana Lüftner
11   Charité University Hospital, Berlin, Department of Hematology, Oncology and Tumour Immunology, Berlin, Germany
,
Markus Wallwiener
12   Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Germany
,
Carla Schulmeyer
2   Erlangen University Hospital, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany
,
Volkmar Müller
1   Department of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, Germany
,
Matthias W. Beckmann
2   Erlangen University Hospital, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany
,
Erik Belleville
13   ClinSol GmbH & Co. KG, Würzburg, Germany
,
Pauline Wimberger
14   National Center for Tumor Diseases (NCT), Dresden, Germany
15   German Cancer Research Center (DKFZ), Heidelberg, Germany
16   Carl Gustav Carus Faculty of Medicine and University Hospital, TU Dresden, Dresden, Germany
17   Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Dresden, Germany
,
Carsten Hielscher
18   g.SUND Center for Gynecologic Oncology Stralsund, Stralsund, Germany
,
Christian Kurbacher
19   Department of Gynecology I (Gynecologic Oncology), Gynecologic Center Bonn-Friedensplatz, Bonn, Germany
,
Rachel Wuerstlein
20   Department of Gynecology and Obstetrics, Breast Center and CCC Munich, University Hospital Munich LMU, Munich, Germany
,
Christoph Thomssen
21   Department of Gynaecology, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany
,
Michael Untch
22   Department of Gynecology and Obstetrics, Helios Clinics Berlin Buch, Berlin, Germany
,
Bernhard Volz
23   Ansbach University of Applied Sciences, Ansbach, Germany
,
Peter A. Fasching
2   Erlangen University Hospital, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany
,
Tanja N. Fehm
24   Department of Gynecology and Obstetrics, University Hospital Düsseldorf, Düsseldorf, Germany
,
Diethelm Wallwiener
25   Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany
,
Sara Y. Brucker
25   Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany
,
Andreas Schneeweiss
26   National Center for Tumor Diseases, Heidelberg University Hospital, German Cancer Research Center (DKFZ), Heidelberg, Germany
,
Michael P. Lux
27   Department of Gynecology and Obstetrics, Frauenklinik St. Louise, Paderborn, St. Josefs-Krankenhaus, Salzkotten, Germany; Kooperatives Brustzentrum Paderborn, Paderborn, Germany
,
Andreas D. Hartkopf
25   Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany
› Author Affiliations

Abstract

Purpose Pertuzumab and T-DM1 are two efficient anti-HER2 treatments for patients with HER2-positive advanced breast cancer. While pertuzumab is usually given in first-line treatment and T-DM1 in second-line treatment, standard therapy options seem to be exhausted up to now after the treatment of patients with these two therapy options. Therefore, it is important to have data that describes the therapy situation and prognosis after T-DM1 treatment.

Methods The PRAEGNANT metastatic breast cancer registry (NCT02338167) is a prospective registry for breast cancer patients with a focus on molecular biomarkers. Patients of all therapy lines with any kind of treatment are eligible. Collected data comprises therapies, adverse events, quality of life and other patient reported outcomes. Here we report on the patient characteristics and descriptive prognostic data for HER2-positive patients who have completed a treatment with T-DM1. Therapy patterns after T-DM1 and progression-free survival are reported as well as overall survival.

Results A total of 85 patients were identified for the study who were prospectively observed during therapy after the termination of T-DM1. The main reason for T-DM1 termination was progress. Following T-DM1, lapatinib, trastuzumab and chemotherapy were the main therapy choices. Median progression-free survival was 4.8 months (95% CI: 3.2 – 6.3) and median overall survival was 18.4 months (95% CI: 15.5 – 21.3).

Conclusions Therapy options after T-DM1 in a real-world setting seem to exhibit a relevant clinical efficacy, supporting the concept of continuous anti-HER2 treatments in the advanced therapy setting for breast cancer patients. Novel therapies are needed to improve the rather short median progression-free survival.

Zusammenfassung

Ziel Pertuzumab und T-DM1 sind 2 wirksame Anti-HER2-Therapien, die zur Behandlung von Patientinnen mit fortgeschrittenem HER2-positiven Brustkrebs eingesetzt werden. Die Primärtherapie besteht meist aus Pertuzumab und die Second-Line-Therapie aus T-DM1. Bisher waren die Standard-Behandlungsoptionen erschöpft, nachdem Patientinnen eine Behandlung mit diesen beiden Therapieoptionen erhalten hatten. Das Sammeln von Daten über die Therapielandschaft und zur Prognose nach Abschluss einer T-DM1-Behandlung ist daher wichtig.

Methoden Das PRAEGNANT-Brustkrebsregister von Frauen mit metastasiertem Mammakarzinom (NCT02338167) ist ein prospektives Register mit einem Schwerpunkt im Bereich molekularer Biomarker. Daten von Patientinnen über alle Therapielinien hinweg sowie nach allen Behandlungsoptionen werden ins Register aufgenommen. Die gesammelten Daten umfassen eingesetzte Therapien, unerwünschte Ereignisse, Lebensqualität sowie weitere Patient reported Outcomes. Wir berichten hier über Patientinnenmerkmale und deskriptive prognostische Daten von HER2-positiven Patientinnen nach Abschluss einer Therapie mit T-DM1. Therapieschemata nach T-DM1, progressionsfreies Überleben sowie Gesamtüberleben wurden untersucht.

Ergebnisse Es wurden ingesamt 85 Patientinnen für diese Studie ermittelt, die während der Therapie nach Beendigung der T-DM1-Behandlung prospektiv observiert wurden. Der Hauptgrund für die Beendigung der Therapie mit T-DM1 war das Fortschreiten der Erkrankung. Nach T-DM1 waren Lapatinib, Trastuzumab und Chemotherapie die wichtigsten Therapieoptionen. Das mittlere progressionsfreie Überleben war 4,8 Monate (95%-K: 3,2 – 6,3), und die durchschnittliche Gesamtüberlebenszeit betrug 18,4 Monate (95%-KI 15,5 – 21,3).

Schlussfolgerungen Die Behandungsoptionen nach T-DM1 in der realen Welt zeigten eine klinisch relevante Effizienz und stützten damit das Konzept einer fortlaufenden Anti-HER2-Behandlung als fortgeschrittene Therapie zur Behandlung von Brustkrebspatientinnen mit progredienter Erkrankung. Neuartige Therapien werden benötigt, um die eher kurze durchschnittliche progressionsfreie Überlebenszeit zu verlängern.

Supporting Information



Publication History

Received: 03 October 2020

Accepted after revision: 07 October 2020

Article published online:
06 November 2020

© 2020. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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Rüdigerstraße 14, 70469 Stuttgart, Germany

 
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