Geburtshilfe Frauenheilkd 2008; 68(10): 1008-1012
DOI: 10.1055/s-2008-1038944
Originalarbeit

© Georg Thieme Verlag KG Stuttgart · New York

Wirkung des 3-Monats-Depot Leuprorelinacetat (Trenantone®) beim prämenopausalen Mammakarzinom – Ergebnisse einer Anwendungsbeobachtung

Effect of a 3 Month Depot Injection of Leuprorelin Acetate (Trenantone®) on Pre-menopausal Breast Cancer – Results of a Post-Marketing Surveillance StudyE.-M. Grischke1 , T. Fehm1 , E. Solomayer1 , H. Hillger2 , D. Wallwiener1
  • 1Universitätsfrauenklinik Tübingen
  • 2Takeda Pharma GmbH, Aachen
Weitere Informationen

Publikationsverlauf

eingereicht 2.3.2008 revidiert 25.7.2008

akzeptiert 5.8.2008

Publikationsdatum:
02. Oktober 2008 (online)

Zusammenfassung

Fragestellung: Untersuchung von Wirksamkeit und Verträglichkeit einer Ovarialablation mit Trenantone® bei prämenopausalen Patientinnen mit hormonabhängigem Mammakarzinom. Material und Methodik: 133 Dokumentationen zur adjuvanten Behandlung wurden über einen Behandlungszeitraum von 6 Monaten im Rahmen einer Anwendungsbeobachtung bei niedergelassenen Gynäkologen gesammelt. Ergebnisse: Die mittleren Östradiolspiegel lagen nach drei Monaten Behandlung bei 18,1 pg/ml und nach 6 Monaten bei 17,4 pg/ml. Die Amenorrhörate lag nach 6 Monaten Therapie bei 93 %. Insgesamt zeigte sich über den Zeitraum der Behandlung tendenziell eine Verbesserung der Lebensqualität der betroffenen Frauen. Schlussfolgerung: Die Behandlung des hormonabhängigen Mammakarzinoms mit dem 3-Monats-Depot von Leuprorelinacetat führt zu einer adäquaten Downregulation der Östradiolwerte bei guter Verträglichkeit.

Abstract

Purpose: Aim of the following analysis was to evaluate the efficacy and tolerability of ovarian downregulation with Trenantone® in pre-menopausal patients with hormone-sensitive breast cancer. Material and Methods: Data of 133 patients given adjuvant therapy of breast cancer with Trenantone by their gynaecologists over a period of 6 months were collected (post-marketing surveillance study). Results: Median blood levels of oestradiol were 18.1 pg/ml after a treatment period of three months and 17.4 pg/ml after 6 months. Rate of amenorrhoea was 93 % after 6 months. There was a tendency towards an improvement of quality of life in all patients during the time of treatment. Conclusion: Treatment of hormone-sensitive breast cancer with leuprorelin in the form of a 3-month depot injection leads to an adequate decrease in oestradiol levels over time and is a well tolerated therapy.

Literatur

  • 1 Goldhirsch A, Wood W C, Gelber R D, Coates A S, Thürlimann B, Senn H-J. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer.  Ann Oncol. 2007;  18 1133-1144
  • 2 Early Breast Cancer Trialists' Collaborative Group . Ovarian ablation in early breast cancer: overview of the randomised trials.  Lancet. 1996;  348 1189-1196
  • 3 Early Breast Cancer Trialists' Collaborative Group . Polychemotherapy for early breast cancer: an overview of the randomised trials.  Lancet. 1998;  352 930-942
  • 4 Schmid P, Untch M, Kosse V, Bondar G, Vassiljev L, Tarutinov V, Lehmann U, Maubach L, Meurer J, Wallwiener D, Possinger K. Leuprorelin acetate every-3-months depot versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant treatment in premenopausal patients with node-positive breast cancer: The TABLE study.  J Clin Oncol. 2007;  25 2609-2616
  • 5 Jonat W, Kaufmann M, Sauerbrei W. Goserelin versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy in premenopausal patients with node-positive breast cancer: The Zoladex Early Breast Cancer Research Association study.  J Clin Oncol. 2002;  20 4628-4635
  • 6 Kaufmann M, Graf E, Jonat W. A randomized trial of goserelin versus control after adjuvant, risk-adapted chemotherapy in premenopausal patients with primary breast cancer – GABG‐IV B‐93.  Eur J Cancer. 2007;  43 2351-2358
  • 7 Boccardo F, Rubagotti A, Amoroso D. Cyclophosphamide, methotrexate, and fluorouracil versus tamoxifen plus ovarian suppression as adjuvant treatment of estrogen receptor-positive pre-/perimenopausal breast cancer patients: results of the Italian Breast cancer Adjuvant Study Group 02 randomized trial.  J Clin Oncol. 2000;  18 2718-2727
  • 8 Roche H, Kerbrat P, Bonneterre J. Complete hormonal blockade versus epirubicin-based chemotherapy in premenopausal, one to three node-positive, and receptor-positive, early breast cancer patients: 7 years follow-up results of French Adjuvant Study group 06 randomized trial.  Ann Oncol. 2006;  17 1221-1227
  • 9 Jakesz R, Hausmanniger H, Kibista E. Randomized adjuvant trial of tamoxifen and goserelin versus cyclophosphamid, methotrexate, and fluorouracil: evidence for the superiority of treatment with endocrine blockade in premenopausal patients with hormone-responsive breast-cancer – Austrian breast and colorectal cancer study group Trial 5.  J Clin Oncol. 2002;  20 4621-4627
  • 10 LHRH-agonists in Early Breast Cancer Overview group . Use of luteinising-hormone-releasing hormone agonists as adjuvant treatment in premenopausal patients with hormone-receptor-positive breast cancer: a meta-analysis of individual patient data from randomised adjuvant trials.  Lancet. 2007;  369 1711-1723
  • 11 Tan S-H, Wolff A C. Luteinizing hormone-releasing hormone agonists in premenopausal hormone receptor-positive breast cancer.  Clinical Breast Cancer. 2007;  7 455-464
  • 12 AGO-Empfehlungen Version 2008.10, www.ago-online.de
  • 13 S3-Leitlinien der DKG Version 1.2008, www.krebsgesellschaft.de

Prof. Dr. med. Eva-Maria Grischke

Universitäts-Frauenklinik

Calwer Straße 7

72076 Tübingen

eMail: eva-maria.grischke@med.uni-tuebingen.de