Senologie - Zeitschrift für Mammadiagnostik und -therapie, Inhaltsverzeichnis Senologie - Zeitschrift für Mammadiagnostik und -therapie 2019; 16(03): 179-182DOI: 10.1055/a-0978-3389 Aktuell diskutiert © Georg Thieme Verlag KG Stuttgart · New York Stellungnahme der DGS zu Ribociclib (Kisquali®) Artikel empfehlen Abstract Artikel einzeln kaufen Volltext Referenzen Literatur 1 Cardoso F, Senkus E, Costa A. et al. 4th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4)dagger. Ann Oncol 2018; 29: 1634-1657 2 Leitlinienprogramm Onkologie (Deutsche Krebsgesellschaft, Deutsche Krebshilfe, AWMF): S3-Leitlinie Früherkennung, Diagnose, Therapie und Nachsorge des Mammakarzinoms, Version 4.1, 2018 AWMF. Im Internet: http://www.leitlinienprogramm-onkologie.de/leitlinien/mammakarzinom/ . Stand: 17.7.2019 3 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 4 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 5 Arbeitsgemeinschaft Gynäkologische Onkologie e. V. Diagnosis and Treatment of Patients with Primary and Metastatic Breast Cancer – Version 1. 2019 6 Cardoso F, Bischoff J, Brain E. et al. A review of the treatment of endocrine responsive metastatic breast cancer in postmenopausal women. Cancer Treat Rev 2013; 39: 457-465 7 Hamilton E, Infante JR. Targeting CDK4/6 in patients with cancer. Cancer Treat Rev 2016; 45: 129-138 8 Finn RS, Martin M, Rugo HS. et al. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med 2016; 375: 1925-1936 9 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 10 Turner NC, Ro J, Andre F. et al. Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer. N Engl J Med 2015; 373: 209-219 11 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 12 Sledge GW, Toi M, Neven P. et al. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. J Clin Oncol 2017; 35: 2875-2884 13 Slamon DJ, Neven P, Chia S. et al. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3. J Clin Oncol 2018; 36: 2465-2472 14 Tripathy D, Im SA, Colleoni M. et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol 2018; 19: 904-915 15 Taylor CW, Green S, Dalton WS. et al. Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients with receptor-positive metastatic breast cancer: an intergroup study. J Clin Oncol 1998; 16: 994-999 16 AstraZeneca. Fachinformation Zoladex® (Goserelin) 3,6 mg Implantat. Stand April 2015 17 Hartkopf AD, Huober J, Volz B. et al. Treatment landscape of advanced breast cancer patients with hormone receptor positive HER2 negative tumors – Data from the German PRAEGNANT breast cancer registry. Breast 2018; 37: 42-51 18 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. IQWiG-Bericht Nr. 752 – Ribociclib (Mammakarzinom) – Nutzenbewertung gemäß § 35a SGB V. 2019. https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/430/#tab/nutzenbewertung ; zuletzt aufgerufen am 03.05.2019 19 Novartis. Dossier zur Nutzenbewertung gemäß § 35a SGB – Ribociclib (Kisquali) – Modul 1. https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/430/#tab/dossier ; zuletzt aufgerufen am 03.05.2019. 2019 20 Turner NC, Slamon DJ, Ro J. et al. Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer. N Engl J Med 2018; 379: 1926-1936 21 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 2018; 37: 154-160 22 Fasching PA, Esteva FJ, Pivot X. et al. Patient-reported outcomes in advanced breast cancer treated with ribociclib + fulvestrant: results from MONALEESA-3. ESMO Jahrestagung, 2018 23 Schnipper LE, Davidson NE, Wollins DS. et al. Updating the American Society of Clinical Oncology Value Framework: Revisions and Reflections in Response to Comments Received. J Clin Oncol 2016; 34: 2925-2934 24 Cherny NI, Sullivan R, Dafni U. et al. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Ann Oncol 2015; 26: 1547-1573 25 Harbeck N, Vázquez RV, Franke F. et al. Ribociclib + tamoxifen or a non-steroidal aromatase inhibitor in premenopausal patients with hormone receptor-positive, HER2-negative advanced breast cancer: MONALEESA-7 patient-reported outcomes. ESMO Jahrestagung 2018 26 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 27 Hu W, Sung T, Jessen BA. et al. Sacaan. Mechanistic Investigation of Bone Marrow Suppression Associated with Palbociclib and its Differentiation from Cytotoxic Chemotherapies. Clin Cancer Res 2016; 22: 2000-2008 28 Beck JT, Neven P, Sohn J. et al. Ribociclib treatment benefit in patients with advanced breast cancer with ≥1 dose reduction: Data from the MONALEESA-2, -3, and -7 trials. Cancer Res 2019;