Berlin, 2. Mai 2016 – Stellungnahme zum Vorbericht A10-03 „Aromatasehemmer beim Mammakarzinom der Frau“

Stellungnahme der Arbeitsgemeinschaft Gynäkologische Onkologie (AGO)/ Kommission Mamma als Untergruppe der Deutschen Gesellschaft für Gynäkologie und Geburtshilfe (DGGG), der Deutschen Krebsgesellschaft (DKG), sowie der Deutschen Gesellschaft für Senologie (DGS) zur vorläufigen Nutzenbewertung der Aromatasehemmer (AI) beim Mammakarzinom der Frau.

• Literatur (Adjuvante Therapie)

• 1 Regan MM, Price KN, Giobbie-Hurder A, Thürlimann B, Gelber RD. International Breast Cancer Study Group and BIG 1-98 Collaborative Group. Interpreting Breast International Group (BIG) 1-98: a randomized, double-blind, phase III trial comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive, early breast cancer. Breast Cancer Res 2011; 13: 209
• 2 Regan MM, Neven P, Giobbie-Hurder A et al. BIG 1-98 Collaborative Group; International Breast Cancer Study Group (IBCSG). Assessment of letrozole and tamoxifen alone and in sequence for postmenopausal women with steroid hormone receptor-positive breast cancer: the BIG 1-98 randomised clinical trial at 8·1 years median follow-up. Lancet Oncol 2011; 12: 1101-1108
• 3 Mann BS, Johnson JR, Kelly R et al. Letrozole in the extended adjuvant treatment of postmenopausal women with history of early-stage breast cancer who have completed 5 years of adjuvant tamoxifen. Clin Cancer Res 2005; 11: 5671-5677
• 4 Goss PE, Ingle JN, Martino S et al. Impact of premenopausal status at breast cancer diagnosis in women entered on the placebo-controlled NCIC CTG MA17 trial of extended adjuvant letrozole. Ann Oncol 2013; 24: 355-361
• 5 Mamounas EP, Jeong JH, Wickerham DL et al. Benefit from exemestane as extended adjuvant therapy after 5 years of adjuvant tamoxifen: intention-to-treat analysis of the National Surgical Adjuvant Breast And Bowel Project B-33 trial. J Clin Oncol 2008; 26: 1965-1971
• 6 Gnant M, Pfeiler G, Stöger H et al. The predictive impact of body mass index on the efficacy of extended adjuvant endocrine treatment with anastrozole in postmenopausal patients with breast cancer: an analysis of the randomised ABCSG-6a trial. Br J Cancer 2013; 109: 589-596
• 7 Ellis MJ, Ma C. Letrozole in the neoadjuvant setting: the P024 trial. Breast Cancer Res Treat 2007; 105 Suppl 1: 33-43
• 8 Eiermann W, Paepke S, Appfelstaedt J et al. Preoperative treatment of postmenopausal breast cancer patients with letrozole: A randomized double-blind multicenter study. Ann Oncol 2001; 12: 1527-1532
• 9 Smith IE, Dowsett M, Ebbs SR et al. Neoadjuvant treatment of postmenopausal breast cancer with anastrozole, tamoxifen, or both in combination: The Immediate Preoperative Anastrozole, Tamoxifen, or Combined with Tamoxifen (IMPACT) multi-center double-blind randomized trial. J Clin Oncol 2005; 23: 5108-5116
• 10 Ellis MJ, Suman VJ, Hoog J et al. Randomized phase II neoadjuvant comparison between letrozole, anastrozole, and exemestane for postmenopausal women with estrogen receptor-rich stage 2 to 3 breast cancer: clinical and biomarker outcomes and predictive value of the baseline PAM50-based intrinsic subtype-ACOSOG Z1031. J Clin Oncol 2011; 29: 2342-2349

• Literatur (Fortgeschrittene Erkrankungssituation)

• 1 Nabholtz JM, Buzdar A, Pollak M, Harwin W, Burton G, Mangalik A. Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial. J Clin Oncol 2000; 18: 3758-3767
• 2 Thuerlimann B, Robertson JFR, Nabholtz JM et al. Efficacy of tamoxifen following anastrozole (‚Arimidex‘) compared with anastrozole following tamoxifen as first-line treatment for advanced breast cancer in postmenopausal women. Eur J Cancer 2003; 39: 2310-2317
• 3 Paridaens R, Dirix L, Lohrisch C, Beex L, Nooji M, Cameron D. Mature results of a randomized phase II multicenter study of exemextane versus tamoxifen as first-line hormone therapy for postmenopausal women with metastatic breast cancer. Ann Oncol 2003; 14: 1391-1398
• 4 Ferretti G, Bria E, Giannarelli D et al. Second- and third-generation aromatase inhibitors as first-line endocrine therapy in postmenopausal metastatic breast cancer patients: a pooled analysis of the randomised trials. Br J Cancer 2006; 94: 1789-1796
• 5 Gibson L, Lawrence D, Dawson C, Bliss J. Aromatase inhibitors for treatment of advanced breast cancer in postmenopausal women. Cochrane Database Syst Rev 2009; (4) CD003370
• 6 Kaufmann M, Bajetta E, Dirix LY et al. Exemestane improves survival compared with megestrol acetate in postmenopausal patients with advanced breast cancer who have failed on tamoxifen: results of a double-blind randomised phase III trial. Eur J Cancer 2000; 36 Suppl 4: S86-87
• 7 Mauri D, Pavlidis N, Polyzos NP, Ioannidis JP. Survival with aromatase inhibitors and inactivators versus standard hormonal therapy in advanced breast cancer: meta-analysis. J Natl Cancer Inst 2006; 98: 1285-1291
• 8 Piccart M, Hortobagyi GN, Campone M et al. Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2. Ann Oncol 2014; 25: 2357-2362
• 9 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
• 10 Cristofanilli M, Turner NC, Bondarenko I et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol 2016; pii S1470-2045(15)00613-0