Berlin, 2. Mai 2016 – Stellungnahme zum Vorbericht A10-03 „Aromatasehemmer 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