Zusammenfassung
Die ADEBAR-Studie ist eine prospektive multizentrische Phase-III-Studie, die überprüft,
ob Hochrisiko-Mammakarzinompatientinnen (≥ 4 befallene axilläre Lymphknoten) von einem
sequenziellen Anthrazyklin-Docetaxel Regime (E90 C - D: 4 Zyklen Epirubicin [E] 90 mg/m2 KOF plus Cyclophosphamid [C] 600 mg/m2 KOF q21d, gefolgt von 4 Zyklen Docetaxel [D] 100 mg/m2 KOF q21d) gegenüber der Standard-Chemotherapie mit Anthrazyklinen (FE120 C: 6 Zyklen E60 mg/m2 KOF d 1 + 8, 5-Fluorouracil 500 mg/m2 KOF d 1 + 8 und C 75 mg/m2 KOF d 1 - 14, q28d) profitieren. Mit insgesamt 198 aktiv rekrutierenden Zentren und
einem medianen Patientinneneinschluss von 33 Patientinnen/Monat war die ADEBAR-Studie
die bis zum Studienende am besten rekrutierende Studie Deutschlands in ihrem Indikationsbereich.
Methodik: Die teilnehmenden Zentren wurden durch einen standardisierten Fragebogen um Auskunft
gebeten, inwieweit Therapiestrategien und Patientenversorgung durch die Teilnahme
an der ADEBAR-Studie beeinflusst werden. Der Fragebogen umfasste 5 Fragen: früherer
Einschluss von Patientinnen gleichen Tumorstadiums in Studien, die Art der Chemotherapie,
die vergleichbare Patientinnen früher außerhalb der Studie erhielten, Veränderung
in der Intensität der medizinischen Betreuung seit Teilnahme an der ADEBAR-Studie,
der Informationszugewinn durch die Teilnahme an der Studie, und Änderungen in der
Gesamtqualität der medizinischen Betreuung. Ergebnisse: Insgesamt wurden 51 % (n = 98) der Fragebogen beantwortet zurückgesendet. Drei der
zurückgesandten Fragebogen wurden wegen inkompletter Beantwortung der Fragen von der
Analyse ausgeschlossen. Im Jahr vor Beginn der ADEBAR-Studie hatten 63,2 % der teilnehmenden
Zentren ihre Hochrisiko-Patientinnen nicht in klinische Studien eingebracht. 44,2
% der Patientinnen gleicher Indikation hatten vor der Teilnahme am ADEBAR-Protokoll
eine nach heutigem Kenntnisstand inadäquate Therapie, wie CMF, EC/CMF oder 4 × EC
erhalten. 59 % der Zentren bemerkten, dass die Intensität ihrer Patientenversorgung
durch die Teilnahme an der Studie - unabhängig von der rein studienbedingten Zuwendung
- zugenommen habe. Durch die Teilnahme an dem Forschungsnetzwerk, mit regelmäßigem
Informationsfluss über Newsletter, Studientreffen etc., stellten 80 % eine Verbesserung
ihrer Kenntnisse im Bereich Mammakarzinom fest. Darüber hinaus bestätigten 31,6 %
der Zentren seit Beginn der Studie eine Verbesserung der Gesamtqualität der medizinischen
Betreuung. Schlussfolgerung: Die Ergebnisse der Umfrage demonstrieren, dass Ärzte und Patientinnen von der Teilnahme
an klinischen Studien profitieren können, da diese mit einer Optimierung der Therapieentscheidung
und Patientenversorgung einhergeht.
Abstract
The ADEBAR study is a prospective multicenter phase III study which aims to assess
whether high-risk breast carcinoma patients (≥ 4 axillary lymph nodes affected) will
profit from a sequential anthracycline-docetaxel regime (E90 C - D: 4 cycles of epirubicin [E] 90 mg/m2 KOF plus cyclophosphamide [C] 600 mg/m2 KOF q21 d, followed by 4 cycles of docetaxel [D] 100 mg/m2 KOF q21 d) rather than a standard chemotherapy with anthracyclines (F120 C: 6 cycles E60 mg/m2 KOF d 1 + 8, 5-fluorouracil 500 mg/m2 KOF d 1 + 8 and C 75 mg/m2 KOF d 1 - 14, q28 d). With more than 198 actively recruited centers and a median
inclusion of 33 patients/month, up until the conclusion of the study the ADEBAR study
was the study with the highest recruitment in Germany for this range of indications.
Method: Using a standardized questionnaire the participating centers were asked to confirm
to what extent therapy and patient care were influenced by participation in the ADEBAR
study. The questionnaire consisted of 5 questions: earlier inclusion of patients in
the same tumor stages in studies; the type of chemotherapy formerly received by comparable
patients outside of the study; changes in the intensity of medical care since participation
in the ADEBAR study; increase in information through participation in the study and
changes in the overall quality of medical care. Results: A total of 51 % (n = 98) of the questionnaires were returned. Three of the returned
questionnaires were excluded from the analysis as the answers to the questions were
incomplete. In the year prior to the commencement of the ADEBAR study 63.2 % of the
participating centers had not included their high-risk patients in clinical studies.
Prior to participation in the ADEBAR protocol, the therapy administered to 44.2 %
of patients with the same indications - usually CMF, EC/CMF or 4 × EC - was inadequate
according to the current state of knowledge. 59 % of the centers noted that the intensity
of their care of patients had increased through participation in the study, independently
of the amount of increased attention given for study purposes. Through participation
in the research network with its regular flow of information through the newsletter,
meetings of study groups, etc., 80 % noted an improvement in the extent of their knowledge
about breast carcinoma. In addition, 31.6 % of the centers confirmed that since the
beginning of the study the general quality of the medical care had improved. Conclusion: The results of the survey show that both doctors and patients can profit from participation
in clinical studies as these are accompanied by an optimization of decisions concerning
therapy and of patient care.
Schlüsselwörter
Mammakarzinom - Gesamtüberleben - Fernmetastasen - Rezidiv - Prognose - Chemotherapie
- klinische Studie
Key words
Breast cancer - overallsurvival - cancer metastasis - cancer recurrence - prognosis
- chemotherapy - study
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PD Dr. med. Wolfgang Janni
I. Frauenklinik
Maistraße 11
80337 München
Email: wolfgang.janni@med.uni-muenchen.de