Zusammenfassung
Seit über 10 Jahren wird, basierend auf Ergebnissen mit dem Bisphosphonat Clodronsäure, diskutiert, ob die Gabe von Bisphosphonaten das Auftreten von Metastasen beim Mammakarzinom verhindern oder zumindest verzögern kann. Die Ergebnisse neuerer Studien z.B. mit den Bisphosphonaten Zoledronsäure oder Ibandronsäure erscheinen auf den ersten Blick nicht zuletzt wegen des therapeutischen Bekanntheitsgrades der Bisphosphonate in der Therapie von Osteoporose und ossären Komplikationen von Malignomen sowie deren Nebenwirkungsspektrum und derzeit anerkannten Wirkungsmechanismus hoffnungsvoll. Vielfach wird schon davon ausgegangen, dass die jetzige Datenlage eindeutig einen Stellenwert der Bisphosphonate in der adjuvanten Therapie des Mammakarzinoms zeige. Signifikante relative Risikoreduktionen von z.B. 36% für das krankheitsfreie Überleben sind eindrucksvoll, die entsprechenden absoluten Werte von 3,2% werden erst in zweiter Linie kommuniziert. Werden die bisher publizierten Studien aber unter dem Aspekt der evidenzbasierten Medizin ausgewertet, ergeben sich noch viele ungeklärte Fragen, und methodische Schwächen der bisher publizierten Studien werden offenkundig. Für Wirksamkeit und Nutzen eines im adjuvanten Therapieansatz verabreichten Bisphosphonats bei Mammakarzinom liegen bisher noch keine evidenzbasierten Daten vor. Vor diesem Hintergrund hat als bisher einzige Fachgesellschaft die Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) eine adjuvante Therapie mit Bisphosphonaten in Kombination mit der endokrinen Therapie im Rahmen von Studienteilnahmen empfohlen.
Abstract
For more than 10 years, based on the results with the bisphosphonate clodronic acid, it has been discussed, whether the occurence of breast cancer metastases can be avoided or at least delayed by administration of bisphosphonates. The published results of recent studies applying, e.g., the bisphosphonates zoledronic and ibandronic acid, respectively, seem promising at first glance, especially, if the therapeutic acceptance of bisphosphonates in the indications osteoporosis and bone-related complications of malignancies, respectively, as well as their spectrum of side effects are taken into account and their putative mechanism of action is considered. There is a broad consensus that the existing data basis suffices to demonstrate importance of bisphosphonates in an adjuvant therapeutic setting of breast cancer. Significant relative risk reductions of, e.g., 36% in disease-free survival are very impressing and the corresponding absolute values of 3.2% are second-line communications. However, evaluation of all studies published so far according to the criteria of evidence-based medicine demonstrates many open questions and several methodical insufficiencies. Therefore, effectiveness and benefit of an adjuvant therapeutic application of bisphosphonates in breast cancer patients cannot be drawn out of evidence-based data. A recommendation of this therapy is given only by the German Working Pool of Gynecologic Oncology (AGO), but limited to study participation.
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Deuber, H.J., Theiss, F. Bisphosphonate in der adjuvanten Therapie des Mammakarzinoms. Med Klin 105, 635–646 (2010). https://doi.org/10.1007/s00063-010-1103-x
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DOI: https://doi.org/10.1007/s00063-010-1103-x