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DOI: 10.1055/s-0031-1280244
© Georg Thieme Verlag KG Stuttgart · New York
Frühes Mammakarzinom – Lebensqualität nach Switch von Tamoxifen auf Exemestan
Ergebnisse einer nicht interventionellen Studie Results of a Non-interventional StudyEarly Breast CancerQuality of Life after Switching from Tamoxifen to ExemestanePublication History
eingereicht 21.8.2011
akzeptiert 31.8.2011
Publication Date:
02 November 2011 (online)
![](https://www.thieme-connect.de/media/gebfra/201110/lookinside/thumbnails/10.1055-s-0031-1280244-1.jpg)
Zusammenfassung
Fragestellung: Nebenwirkungen der adjuvanten endokrinen Therapie des Mammakarzinoms können zu einer Beeinträchtigung der Lebensqualität und zu mangelnder Compliance führen. Ziel dieser nicht interventionellen Studie war die Erfassung des Einflusses der Therapie mit Exemestan nach Tamoxifenvorbehandlung auf die Lebensqualität der Patientinnen sowie die Erfassung der Verträglichkeit und Nebenwirkungen. Material und Methodik: In die nicht interventionelle Studie (NIS) wurden 924 postmenopausale Brustkrebspatientinnen aus 735 deutschen Zentren eingeschlossen, die eine adjuvante Switchtherapie mit Tamoxifen, gefolgt von Exemestan, erhielten. Im Verlauf einer 1-jährigen adjuvanten Behandlung mit Exemestan (25 mg p. o. täglich, Aromasin®) wurde die Lebensqualität mittels des IBCSG-(International-Breast-Cancer-Study-Group-)QOL-Core-Fragebogens (IBCSG QOL Core, IBCSG QOL Module 24–26, SF-12) zur Selbstbeurteilung evaluiert. Des Weiteren wurden Verträglichkeit und Nebenwirkungen der Therapien erfasst. Ergebnisse: Im Verlauf der Exemestanbehandlung besserten sich alle Items des IBCSG-QOL-Core-Fragebogens zur Erfassung der globalen und brustkrebsspezifischen QOL signifikant im Vergleich zur Vortherapie mit Tamoxifen. Außerdem ergab die Analyse eine signifikante Besserung der mithilfe des SF-(Short-Form-)12-Fragebogens evaluierten körperlichen und mentalen Gesundheit. Die Verträglichkeit von Exemestan war bei 88,4 % der Patientinnen sehr gut oder gut. Die häufigsten Nebenwirkungen bestanden in Arthralgien (2,4 %) und Knochenschmerzen (1,1 %). Mit Ausnahme der Gelenk-/Knochenschmerzen besserten sich im Verlauf der NIS alle im IBCSG-QOL-Module-24–26-Fragebogen erfassten endokrinen Nebenwirkungen signifikant. Gelenk-/Knochenschmerzen wurden nach 12 Monaten Therapie mit Exemestan mit nur geringfügig höheren Scores als bei Behandlungsbeginn bewertet. Schlussfolgerung: Im Verlauf des 1. Jahres der Exemestanbehandlung nach Switch von Tamoxifen zeigte sich eine signifikante Verbesserung der globalen und der brustkrebsspezifischen QOL.
Abstract
Purpose: The side effects of adjuvant endocrine therapy for breast cancer can have a negative impact on patients' quality of life (QoL) and reduce patient compliance. The purpose of this non-interventional trial was to evaluate the quality of life (QoL), adverse events and tolerance of therapy with exemestane after switching from tamoxifen to exemestane. Material and Methods: A total of 924 postmenopausal patients receiving exemestane after tamoxifen from 735 German centers participated in this non-interventional trial (NIT). During 1 year of exemestane treatment (25 mg p. o. daily, Aromasin®) QoL was assessed using the IBCSG (International Breast Cancer Study Group) QoL core questionnaires (IBCSG QOL modules 24–26, SF-12). Side effects and tolerance were evaluated. Results: Subjects receiving exemestane following 2–3 years of treatment with tamoxifen experienced a significant improvement in both general and breast cancer-related QoL during the first year on exemestane. A significant improvement in physical and mental health was assessed using the SF (Short Form) 12 questionnaire. Exemestane was considered safe and was generally well tolerated, with a low percentage of treatment-related adverse effects (AEs). The most common treatment-related AEs were arthralgia (2.4 %) and bone pain (1.1 %). With the exception of arthralgia, all AEs covered in the IBCSG-QOL module-24–26 questionnaire improved during the NIT. Arthralgia increased only slightly in the NIT. Conclusion: General and breast cancer-related QoL improved in the first year of treatment with exemestane after tamoxifen treatment.
Schlüsselwörter
frühes Mammakarzinom - Quality of Life - endokrine Therapie - Tamoxifen - Exemestan
Key words
early breast cancer - quality of life - endocrine therapy - tamoxifen - exemestane
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Michaela Bossart
Universitäts-Frauenklinik
Hugstetter Straße 55
79106 Freiburg
Email: michaela.bossart@uniklinik-freiburg.de