Luminal early breast cancer: (neo-) adjuvant endocrine therapy

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1 CAMPUS GROSSHADERN CAMPUS INNENSTADT KLINIK UND POLIKLINIK FÜR FRAUENHEILKUNDE UND GEBURTSHILFE DIREKTOR: PROF. DR. MED. SVEN MAHNER Luminal early breast cancer: (neo-) adjuvant endocrine therapy Nadia Harbeck Breast Center, University of Munich, Germany der Universität München Leitung: Prof. Nadia Harbeck

2 Luminal EBC: (Neo-)adjuvant endocrine therapy Treatment concepts Pre- and postmenopausal patients Choice of agents Duration Open questions: Neoadjuvant endocrine therapy Adherence YOUR Questions

3 Therapy strategies in early breast cancer Harbeck & Gnant, Lancet 2017

4

5 LOW ER EXPRESSION IS CORRELATED WITH NON-LUMINAL CHARACTERISTICS Iwamoto et al, JCO 2011

6 LOW ER EXPRESSION AND OUTCOME IN EARLY BREAST CANCER Iwamoto et al, JCO 2011

7 Endocrine therapy for breast cancer Premenopausal GnRH Analogon LH FSH Postmenopausal Postmenopausal Antiestrogenes Estrogenes Breast cancer Breast cancer NNR Antiestrogenes Estrogenes Androgenes Aromataseinhibitors GnRH = Gonadotropin-Releasing Hormone LH = Luteinising hormone FSH = Follicle-stimulating hormone Ovary Modified after Tellez C, et al. Surg Oncol Clin North Am. 1995;4: Peripheral Aromatization

8 EBCTCG METAANALYSIS: TAMOXIFEN AND AGE AT STUDY ENTRY ECBCTG, Lancet 2011

9 EBCTCG METAANALYSIS: TAMOXIFEN AND ER/PR EXPRESSION ECBCTG, Lancet 2011

10 EBCTCG METAANALYSIS: TAMOXIFEN AND ER/PR STATUS ECBCTG, Lancet 2011

11 EBCTCG METAANALYSIS: TAMOXIFEN AND CHEMOTHERAPY ECBCTG, Lancet 2011

12 Luminal EBC: (Neo-)adjuvant endocrine therapy Premenopausal patients

13 ROLE OF OVARIAN SUPPRESSION Lancet 2007

14 Francis et al, SABCS

15 Francis et al, SABCS

16 JOINT ANALYSIS OF TEXT AND SOFT Pagani et al, ASCO 2014

17 Ovarian suppression: How about tolerability? Francis et al, SABCS 2014; Ribi et al, SABCS 2014

18 ABCSG 12 Trial: OS worse with Anastrozole versus Tamoxifen Tam 3 years Local Treatment Goserelin 3 Years Tam 3 years + Zol Ana 3 years HR 1,75 ; CI 1,08-2,83; p=0,02 Premenopausal pts (n=1803) ER a/o PR pos Stage 1 and 2 CHT only preop (in 5%) Primary endpoint: DFS Ana 3 years + Zol Gnant M et al. Lancet Oncol 2011

19 Having amenorrhea is not the same as being postmenopausal! Smith et al, JCO 2016

20 Luminal EBC: (Neo-)adjuvant endocrine therapy Prostmenopausal patients

21 EBCTCG METAANALYSIS: TAMOXIFEN VS. AI (N=31,920 POSTMENOPAUSAL PATIENTS) ECBCTG, Lancet 2015

22 EBCTCG METAANALYSIS: TAMOXIFEN VS. AI (POSTMENOPAUSAL) ECBCTG, Lancet

23 EBCTCG METAANALYSIS: TAMOXIFEN UPFRONT VERSUS SEQUENTIAL TAMOXIFEN AI (POSTMENOPAUSAL) ECBCTG, Lancet

24 Breast cancer recurrence, % Breast cancer recurrence, % BIG 1-98: Breast Cancer Events (TAM LET vs. LET) 20 Total Population 20 According to Nodal Status* 15 TAM LET Letrozole 15 TAM LET Letrozole Node-positive Node-negative Time from randomization, years Time from randomization, years *42% of the population are node positive; 58% are node negative TAM, Tamoxifen; LET, Letrozol Mouridsen H et al. NEJM 2009;361:

25 AGO e. V. in der DGGG e.v. sowie in der DKG e.v. Guidelines Breast Version D

26 PRE- AND POSTMENOPAUSAL PATIENTS: ALGORITHM Papakonstantinou et al, JCO 2016

27 Luminal EBC: Endocrine therapy How long is long enough?

28

29 EBCTCG METAANALYSIS: DURATION OF TAMOXIFEN EBCTCG

30 10 vs 5 years of tamoxifen: Recurrence reduction by nodal status NNT node positive = 20 NNT node negative = 33

31 Endometrial cancers Endometrial cancers Endometrial cancer deaths Continue (3470) Stop (3486) P value <

32

33

34 San Antonio 2016 Prof. Harbeck

35

36 MA.17R: Disease-Free Survival (Median FU 6.3 yrs) 5-year DFS: 95% LET vs. 91% PLAC HR DFS: 0.66 p = 0.01 Letrozole Placebo Let Plac Subjects who had a DFS event 67 (7.0%) 98 (10.2%) Distant recurrence 42 (4.4%) 53 (5.5%) Loco-regional recurrence Bone Contralateral breast cancer CBC 13 (1.4%) 31 (3.2%) 5-year DFS: 95% LET vs. 91% PLAC Presented by: P.E. Goss, ASCO 2016

37

38 TRANSATAC: Identification of late relapses KLINIKUM DER UNIVERSITÄT MÜNCHEN Sestak et al, SABCS 2016

39

40 EDUCATIONAL MATERIALS DO NOT IMPROVE COMPLIANCE

41 CANKADO: a digital patient diary Drug intake (adherence) Per intake, daily Symptoms and Management of adverse effects (based on CTCAE 4.0) Daily Pain scale Daily Quality of Life (QoL) Daily, weekly or other intervals possible Dynamic Questionnaires Daily, weekly or other intervals possible Best of (freie Vorträge)

42 Luminal EBC Neoadjuvant endocrine therapy

43

44 Luminal EBC: Small neoadjuvant trials (n~800) with early response assessment predict outcome of large phase III trials (n~11,000) Dowsett et al, 2005; Howell et al,2007; Kuter et al, 2012; DiLeo et al, 2014; Ellis et al, 2011 & 2017; Smith et al,

45

46 Luminal early breast cancer: Endocrine therapy ET is the adjuvant standard therapy with a standard duration of 5 years it reduces the relative risk of relapse by ~25%. Extended adjuvant therapy 5-10 (15) years is effective, in particular in high-risk patients. Benefit and side effects need to be discussed with patients. For premenopausal patients, tamoxifen is standard; addition of GnRH analoga or AI plus GnRH are options for high-risk young patients For postmenopausal patients, Aromatase inhibitors (AI) or Tamoxifen are evidence-based options (upfront / sequential): Preference for AI upfront in high-risk and lobular tumors. Adherence is key for benefit ehealth ( approaches may be helpful for therapy support and enhanced physician-patient communication

47 EVIDENCE-BASED, PATIENT-ORIENTED BREAST CANCER THERAPY The Digital Diary for Every Patient Annually revised, evidence-based recommendations for diagnosis and treatment AGO (DKG, DGGG)

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