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Geburtshilfe Frauenheilkd 2019; 79(08): 780-785
DOI: 10.1055/a-0969-8243
DOI: 10.1055/a-0969-8243
DGGG
Mitteilungen aus der Deutschen Gesellschaft für Gynäkologie und Geburtshilfe e. V. (DGGG)
Berlin, 19.02.2019 – 279. Stellungnahme der Deutschen Gesellschaft für Gynäkologie und Geburtshilfe (DGGG) zu Abemaciclib (Mammakarzinom; Kombination mit einem Aromatasehemmer) – Nutzenbewertung gemäß § 35a SGB V
Further Information
Publication History
Publication Date:
12 August 2019 (online)

Im Namen der Kommission Mamma der Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) e. V. in der Deutschen Gesellschaft für Gynäkologie und Geburtshilfe e. V. (DGGG) geben wir zur Dossierbewertung A18-72 des Instituts für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) nach kritischer Diskussion folgende Stellungnahme ab:
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Literatur
- 1 Cardoso F, Senkus E, Costa A. et al. 4th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC4)†. Ann Oncol 2018; 29: 1634-1657 doi:10.1093/annonc/mdy192
- 2 Rugo HS, Rumble RB, Macrae E. et al. Endocrine Therapy for Hormone Receptor-Positive Metastatic Breast Cancer: American Society of Clinical Oncology Guideline. J Clin Oncol 2016; 34: 3069-3103 doi:10.1200/JCO.2016.67.1487
- 3 Thill M, Liedtke C, Muller V. et al. AGO Recommendations for the Diagnosis and Treatment of Patients with Advanced and Metastatic Breast Cancer: Update 2018. Breast Care (Basel) 2018; 13: 209-215 doi:10.1159/000489331
- 4 AWMF. Leitlinie „Früherkennung, Diagnostik, Therapie und Nachsorge des Mammakarzinoms“. Registernummer 032–045OL. 2017. Online: http://www.awmf.org/uploads/tx_szleitlinien/032-045OLl_S3_Mammakarzinom_2017-12.pdf Stand: 19.02.2019
- 5 Goetz MP, Toi M, Campone M. et al. MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. J Clin Oncol 2017; 35: 3638-3646 doi:10.1200/JCO.2017.75.6155
- 6 Hortobagyi GN, Stemmer SM, Burris HA. et al. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med 2016; 375: 1738-1748 doi:10.1056/NEJMoa1609709
- 7 Finn RS, Martin M, Rugo HS. et al. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med 2016; 375: 1925-1936 doi:10.1056/NEJMoa1607303
- 8 Saad ED. Endpoints in advanced breast cancer: methodological aspects & clinical implications. Indian J Med Res 2011; 134: 413-418
- 9 Broglio KR, Berry DA. Detecting an overall survival benefit that is derived from progression-free survival. J Natl Cancer Inst 2009; 101: 1642-1649 doi:10.1093/jnci/djp369
- 10 Kaklamani VG. Clinical Implications of the Progression-Free Survival Endpoint for Treatment of Hormone Receptor-Positive Advanced Breast Cancer. Oncologist 2016; 21: 922-930 doi:10.1634/theoncologist.2015-0366
- 11 Cortazar P, Justice R, Johnson J. et al. US Food and Drug Administration approval overview in metastatic breast cancer. J Clin Oncol 2012; 30: 1705-1711 doi:10.1200/JCO.2011.39.2613
- 12 Muller V, Nabieva N, Haberle L. et al. Impact of disease progression on health-related quality of life in patients with metastatic breast cancer in the PRAEGNANT breast cancer registry. Breast 2017;
- 13 Hurvitz SA, Lalla D, Crosby RD. et al. Use of the metastatic breast cancer progression (MBC-P) questionnaire to assess the value of progression-free survival for women with metastatic breast cancer. Breast Cancer Res Treat 2013; 142: 603-609 doi:10.1007/s10549-013-2734-4
- 14 Mouridsen H, Gershanovich M, Sun Y. et al. Phase III study of letrozole versus tamoxifen as first-line therapy of advanced breast cancer in postmenopausal women: analysis of survival and update of efficacy from the International Letrozole Breast Cancer Group. J Clin Oncol 2003; 21: 2101-2109 doi:10.1200/JCO.2003.04.194
- 15 Nabholtz JM, Buzdar A, Pollak M. et al. Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial. Arimidex Study Group. J Clin Oncol 2000; 18: 3758-3767 doi:10.1200/JCO.2000.18.22.3758
- 16 Bonneterre J, Thurlimann B, Robertson JF. et al. Anastrozole versus tamoxifen as first-line therapy for advanced breast cancer in 668 postmenopausal women: results of the Tamoxifen or Arimidex Randomized Group Efficacy and Tolerability study. J Clin Oncol 2000; 18: 3748-3757 doi:10.1200/JCO.2000.18.22.3748
- 17 Robertson JFR, Bondarenko IM, Trishkina E. et al. Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial. Lancet 2016; 388: 2997-3005 doi:10.1016/S0140-6736(16)32389-3
- 18 Zhang J, Huang Y, Wang C. et al. Efficacy and safety of endocrine monotherapy as first-line treatment for hormone-sensitive advanced breast cancer: A network meta-analysis. Medicine (Baltimore) 2017; 96: e7846 doi:10.1097/MD.0000000000007846
- 19 Gibson L, Lawrence D, Dawson C. et al. Aromatase inhibitors for treatment of advanced breast cancer in postmenopausal women. Cochrane Database Syst Rev 2009; (04) CD003370
- 20 Muss HB, Wells HB, Paschold EH. et al. Megestrol acetate versus tamoxifen in advanced breast cancer: 5-year analysis–a phase III trial of the Piedmont Oncology Association. J Clin Oncol 1988; 6: 1098-1106 doi:10.1200/JCO.1988.6.7.1098
- 21 Muss HB, Case LD, Atkins JN. et al. Tamoxifen versus high-dose oral medroxyprogesterone acetate as initial endocrine therapy for patients with metastatic breast cancer: a Piedmont Oncology Association study. J Clin Oncol 1994; 12: 1630-1638 doi:10.1200/JCO.1994.12.8.1630
- 22 OʼShaughnessy J, Miles D, Vukelja S. et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 2002; 20: 2812-2823 doi:10.1200/JCO.2002.09.002
- 23 Sledge GW, Neuberg D, Bernardo P. et al. Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J Clin Oncol 2003; 21: 588-592 doi:10.1200/JCO.2003.08.013
- 24 Di Leo A, Jerusalem G, Petruzelka L. et al. Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol 2010; 28: 4594-4600 doi:10.1200/JCO.2010.28.8415
- 25 Turner NC, Ro J, Andre F. et al. Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer. N Engl J Med 2015; 373: 209-219 doi:10.1056/NEJMoa1505270
- 26 Harbeck N, Iyer S, Turner N. et al. Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial. Ann Oncol 2016; 27: 1047-1054 doi:10.1093/annonc/mdw139
- 27 Thill M, Schmidt M. Management of adverse events during cyclin-dependent kinase 4/6 (CDK4/6) inhibitor-based treatment in breast cancer. Ther Adv Med Oncol 2018; 10: 1758835918793326 doi:10.1177/1758835918793326
- 28 Hu W, Sung T, Jessen BA. et al. Mechanistic Investigation of Bone Marrow Suppression Associated with Palbociclib and its Differentiation from Cytotoxic Chemotherapies. Clin Cancer Res 2016; 22: 2000-2008 doi:10.1158/1078-0432.CCR-15-1421
- 29 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Abemaciclib (Mammakarzinom; Kombination mit einem Aromatasehemmer) – Nutzenbewertung gemäß § 35a SGB V. Dossierbewertung A18–72. Version 1.0; 30.01.2019. Online: https://www.iqwig.de/de/projekte-ergebnisse/projekte/arzneimittelbewertung/2018/a18-72-abemaciclib-in-kombination-mit-einem-aromatasehemmer-mammakarzinom-nutzenbewertung-gemaess-35a-sgb-v.10908.html Stand: 19.02.2019