Berlin, 25.04.2019 – 277. Stellungnahme der Kommission Mamma der Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) e. V. in der Deutschen Gesellschaft für Gynäkologie und Geburtshilfe e. V. zu Palbociclib (Mammakarzinom) – Nutzenbewertung gemäß § 35a SGB V

doi:10.1055/a-0900-3204

Geburtshilfe und Frauenheilkunde, Inhaltsverzeichnis

Geburtshilfe Frauenheilkd 2019; 79(06): 574-579
DOI: 10.1055/a-0900-3204

DGGG

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

Georg Thieme Verlag KG Stuttgart · New York

Berlin, 25.04.2019 – 277. Stellungnahme der Kommission Mamma der Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) e. V. in der Deutschen Gesellschaft für Gynäkologie und Geburtshilfe e. V. zu Palbociclib (Mammakarzinom) – Nutzenbewertung gemäß § 35a SGB V

Abstract

Volltext

Referenzen

Literatur
1 Cardoso F, Costa A, Senkus E. et al. 3rd ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC3). Ann Oncol 2017; 28: 16-33 doi:10.1093/annonc/mdw544
2 Harbeck N, Gnant M. Breast cancer. Lancet 2016;
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 doi:10.1200/JCO.2016.67.1487
4 Liedtke C, Jackisch C, Thill M. 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
5 Wockel A, Festl J, Stuber T. et al. Interdisciplinary Screening, Diagnosis, Therapy and Follow-up of Breast Cancer. Guideline of the DGGG and the DKG (S3-Level, AWMF Registry Number 032/045OL, December 2017) – Part 2 with Recommendations for the Therapy of Primary, Recurrent and Advanced Breast Cancer. Geburtsh Frauenheilk 2018; 78: 1056-1088 doi:10.1055/a-0646-4630
6 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: 15.01.2019
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 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
9 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
10 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
11 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
12 Reinert T, Barrios CH. Overall survival and progression-free survival with endocrine therapy for hormone receptor-positive, HER2-negative advanced breast cancer: review. Ther Adv Med Oncol 2017; 9: 693-709 doi:10.1177/1758834017728928
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 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
15 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
16 Fribbens C, OʼLeary B, Kilburn L. et al. Plasma ESR1 Mutations and the Treatment of Estrogen Receptor-Positive Advanced Breast Cancer. J Clin Oncol 2016; 34: 2961-2968 doi:10.1200/JCO.2016.67.3061
17 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: 15.01.2019
18 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 doi:10.1016/j.breast.2017.10.002
19 Bartsch R, Bago-Horvath Z, Berghoff A. et al. Ovarian function suppression and fulvestrant as endocrine therapy in premenopausal women with metastatic breast cancer. Eur J Cancer 2012; 48: 1932-1938 doi:10.1016/j.ejca.2012.03.002
20 Burstein HJ, Temin S, Anderson H. et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: american society of clinical oncology clinical practice guideline focused update. J Clin Oncol 2014; 32: 2255-2269 doi:10.1200/JCO.2013.54.2258
21 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
22 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
23 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
24 Finn RS, Crown JP, Lang I. et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol 2015; 16: 25-35 doi:10.1016/S1470-2045(14)71159-3
25 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Palbociclib (Mammakarzinom) – Nutzenbewertung gemäß § 35a SGB V. Dossierbewertung A18-63. Version 1.0. 20.12.2018 Online: https://www.iqwig.de/de/projekte-ergebnisse/projekte/arzneimittelbewertung/2018/a18-63-palbociclib-mammakarzinom-nutzenbewertung-gemaess-35a-sgb-v-ablauf-befristung.10624.html Stand: 12.01.2019