Berlin, 29.04.2019 – 280. Stellungnahme der Kommission Mamma der Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) e. V. in der Deutschen Gesellschaft für Gynäkologie und Geburtshilfe e. V. (DGGG) zur Arzneimittelrichtlinie Ribociclib

doi:10.1055/a-0973-7800

GebFra - DGGG-Gesellschaftsausgaben, Table of Contents

Geburtshilfe Frauenheilkd 2019; 79(08): 785-794
DOI: 10.1055/a-0973-7800

DGGG

Mitteilungen aus der Deutschen Gesellschaft für Gynäkologie und Geburtshilfe e. V. (DGGG)

Georg Thieme Verlag KG Stuttgart · New York

Berlin, 29.04.2019 – 280. Stellungnahme der Kommission Mamma der Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) e. V. in der Deutschen Gesellschaft für Gynäkologie und Geburtshilfe e. V. (DGGG) zur Arzneimittelrichtlinie Ribociclib

Abstract

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References

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: 29.04.2019
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 Carlson RW, Theriault R, Schurman CM. et al. Phase II trial of anastrozole plus goserelin in the treatment of hormone receptor-positive, metastatic carcinoma of the breast in premenopausal women. J Clin Oncol 2010; 28: 3917-3921 doi:10.1200/JCO.2009.24.9565
9 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 doi:10.1200/JCO.2018.78.9909
10 Buzdar AU, Jonat W, Howell A. et al. Anastrozole versus megestrol acetate in the treatment of postmenopausal women with advanced breast carcinoma: results of a survival update based on a combined analysis of data from two mature phase III trials. Arimidex Study Group. Cancer 1998; 83: 1142-1152
11 Kaufmann M, Bajetta E, Dirix LY. et al. Exemestane is superior to megestrol acetate after tamoxifen failure in postmenopausal women with advanced breast cancer: results of a phase III randomized double-blind trial. The Exemestane Study Group. J Clin Oncol 2000; 18: 1399-1411 doi:10.1200/JCO.2000.18.7.1399
12 Muss HB, Paschold EH, Black WR. et al. Megestrol acetate v tamoxifen in advanced breast cancer: a phase III trial of the Piedmont Oncology Association (POA). Semin Oncol 1985; 12 (1 Suppl. 1): 55-61
13 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 doi:10.1056/NEJMoa1810527
14 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
15 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
16 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
17 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
18 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
19 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
20 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
21 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
22 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
23 Tripathy D, Im S, 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 doi:10.1016/S1470-2045(18)30292-4
24 Burstein HJ, Lacchetti C, Anderson H. et al. Adjuvant Endocrine Therapy for Women With Hormone Receptor-Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update on Ovarian Suppression. J Clin Oncol 2016; 34: 1689-1701 doi:10.1200/JCO.2015.65.9573
25 Saad ED. Endpoints in advanced breast cancer: methodological aspects & clinical implications. Indian J Med Res 2011; 134: 413-418
26 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
27 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
28 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
29 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;
30 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
31 Klijn JG, Blamey RW, Boccardo F. et al. Combined tamoxifen and luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist alone in premenopausal advanced breast cancer: a meta-analysis of four randomized trials. J Clin Oncol 2001; 19: 343-353 doi:10.1200/JCO.2001.19.2.343
32 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
33 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
34 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
35 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
36 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
37 Costa WA, Monteiro MN, Queiroz JF. et al. Pain and quality of life in breast cancer patients. Clinics (Sao Paulo) 2017; 72: 758-763 doi:10.6061/clinics/2017(12)07
38 Galipeau N, Klooster B, Krohe M. et al. Understanding key symptoms, side effects, and impacts of HR+/HER2- advanced breast cancer: qualitative study findings. J Patient Rep Outcomes 2019; 3: 10 doi:10.1186/s41687-019-0098-1
39 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Ribociclib (Mammakarzinom) – Nutzenbewertung gemäß § 35a SGB V. Dossierbewertung A19-06. Version 1.0; 11.04.2019. Online: https://www.iqwig.de/de/projekte-ergebnisse/projekte/arzneimittelbewertung/2019/a19-06-ribociclib-mammakarzinom-nutzenbewertung-gemaess-35a-sgb-v.11476.htm Stand: 29.04.2019