Berlin, 23.03.2018 – Stellungnahme der Deutschen Gesellschaft für Gynäkologie und Geburtshilfe (DGGG) zur Dossierbewertung A17-45 Ribociclib (Mammakarzinom)

Das metastasierte Mammakarzinom ist eine unheilbare, aber behandelbare („incurable but treatable“) Erkrankung [1]. Die wesentlichen therapeutischen Ziele sind zum einen die Kontrolle der Erkrankung mit Verzögerung einer Progression und zum anderen die Erhaltung der Lebensqualität (QoL) [1].

• 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
• 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
• 3 Thill M, Liedtke C, Solomayer E. et al. AGO Recommendations for the Diagnosis and Treatment of Patients with Advanced and Metastatic Breast Cancer: Update 2017. Breast Care (Basel) 2017; 12: 184-191
• 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: 21.01.2018
• 5 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
• 6 Finn RS, Martin M, Rugo HS. et al. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med 2016; 375: 1925-1936
• 7 Saad ED. Endpoints in advanced breast cancer: methodological aspects & clinical implications. Indian J Med Res 2011; 134: 413-418
• 8 Broglio KR, Berry DA. Detecting an overall survival benefit that is derived from progression-free survival. J Natl Cancer Inst 2009; 101: 1642-1649
• 9 Kaklamani VG. Clinical Implications of the Progression-Free Survival Endpoint for Treatment of Hormone Receptor-Positive Advanced Breast Cancer. Oncologist 2016; 21: 922-930
• 10 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
• 11 Müller V, Nabieva N, Häberle 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
• 12 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
• 13 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
• 14 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
• 15 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
• 16 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
• 17 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
• 18 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
• 19 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
• 20 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
• 21 Wilkerson J, Fojo T. Progression-free survival is simply a measure of a drugʼs effect while administered and is not a surrogate for overall survival. Cancer J 2009; 15: 379-385
• 22 Fiteni F, Bonnetain F. Surrogate end points for overall survival in breast cancer trials: A review. Breast 2016; 29: 44-48
• 23 Adunlin G, Cyrus JW, Dranitsaris G. Correlation between progression-free survival and overall survival in metastatic breast cancer patients receiving anthracyclines, taxanes, or targeted therapies: a trial-level meta-analysis. Breast Cancer Res Treat 2015; 154: 591-608
• 24 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
• 25 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
• 26 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
• 27 Turner NC, Ro J, Andre F. et al. Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer. N Engl J Med 2015; 373: 209-219
• 28 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
• 29 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
• 30 Iacobucci G. NICE recommends routine NHS funding for new breast cancer drugs. BMJ 2017; 359: j5309
• 31 National Institute for Health and Care Excellence (NICE). Palbociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer (2017). Online: https://www.nice.org.uk/guidance/ta495 Stand: 22.01.2018
• 32 National Institute for Health and Care Excellence (NICE). Ribociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer (2017). Online: https://www.nice.org.uk/guidance/ta496 Stand: 22.01.2018