Emerging Approaches for (Neo)Adjuvant Therapy for ER+ Breast Cancer

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1 Emerging Approaches for (Neo)Adjuvant Therapy for E+ Breast Cancer Cynthia X. Ma, M.D., Ph.D. Associate Professor of Medicine Washington University in St. Louis

2 Outline Current status of adjuvant endocrine therapy for postmenopausal women with E+ breast cancer Ongoing trials of multi-gene profiling to avoid adjuvant chemotherapy Emerging concept of neoadjuvant endocrine therapy

3 Outline Current status of adjuvant endocrine therapy for postmenopausal women with E+ breast cancer Ongoing trials of Multi-gene profiling to avoid adjuvant chemotherapy Emerging concept with neoadjuvant endocrine therapy

4 ecurrence (%) Mortality (%) Benefit of Adjuvant x 5 years for E+ Breast Cancer (EBCTCG Overview 2011) ecurrence 28.7% 16.4% 40.1% N=10,645, node+ 44%, Chemo 51% 25.9% Control 46.2% 30.0% 0.61 (95% CI ) Log-rank 2p< year gain 13.2% (SE 1.1) Breast Control Cancer Mortality 11.9% 8.6% 25.1% 5 years 17.9% Control 33.1% 23.9% 0.70 (95% CI ) Log-rank 2p< year gain 9.2% (SE 1.0) (years) (years) Event ecurrence Breast Cancer Death Years Control (% per year) (% per year) ate ratio (Log rank analysis)

5 Benefit of Adjuvant x 5 years for E+ Breast Cancer (EBCTCG Overview 2011) Benefit of tamoxifen was independent of: Progesterone receptor status (or level) Age Nodal status Use of chemotherapy EBCTCG Lancet 2011

6 Phase III Trials of Aromatase Inhibitors for Postmenopausal Women in the Adjuvant Setting Upfront Sequential Extended * andomize Lin N U, Winer E P JCO 2008;26:

7 5 years 5 yrs Adjuvant AI vs Meta-analysis of ATAC (anastrozole) and BIG 1-98 (letrozole) trials AI ecurrence 5-year gain, 2.9% (SE, 0.7%) 8-year gain, 3.9% (SE, 1.0%) Log-rank 2P < AI Mortality 12.6% 9.6% 19.2% 15.3% 10.5% 10.0% n = 9,856; mean FU 5.8 yrs Dowsett et al. JCO 2010

8 5 yrs vs Sequential and AI Meta-analysis of 4 trials 5 years ecurrence 3-year gain, 3.1% (SE, 0.6%) 6-year gain, 3.6% (SE, 1.1%) Log-rank 2P < AI Mortality 3-year gain, 0.7% (SE, 0.3%) 6-year gain, 1.7% (SE, 0.8%) Log-rank 2P =.02 AI 8.1% 5.0% 16.0% 12.6% 7.9% 6.3% n > 9,000 Dowsett et al. JCO 2010

9 Cuzick, J. et al Lancet Oncol Annual Harzard ates (%) Patients (%) 10-year Analysis of the ATAC Trial Anastrozole 24.0% Time to ecurrence 12.5% 9.8% 19.7% yrs Annual Hazard rates

10 BIG 1-98 Trial Design A N D O M I Z E A B C D Letrozole Letrozole Letrozole 2-arm option 3/98-3/ patients 4-arm option 9/99-5/ patients YEAS

11 Disease-free survival (%) Overall survival (%) Survival Advantage of Letrozole 5 Years Over 5 Years BIG 1-98 at 8.1 years median follow-up DFS Letrozole OS 5-y DFS 8-y DFS Letrozole 85.5% 76.4% 82.0% 72.0% H 0.82 (95% CI ) p= y OS 8-y OS Letrozole 91.8% 85.4% 90.3% 81.4% H 0.79 (95% CI ) p= egan, M et al Lancet Oncology 2011

12 Equivalent Outcome of Sequential vs Letrozole Monotherapy BIG 1-98 at 8 1 years median follow-up Favours letrozole tamoxifen Favours letrozole Favours tamoxifen letrozole Favours letrozole egan, M et al Lancet Oncology 2011

13 TEAM trial: Exemestane Adjuvant Multinational phase III Trial Van de Velde Lancet 2011 Exemestane Exemestane

14 Extended Adjuvant Letrozole followed 5 years of tamoxifen (MA.17) Jin H et al. JCO 2012;30:

15 MA27 Trial N=7576 Equivalent in DFS for both agents

16 Current status of adjuvant endocrine therapy for postmenopausal women An AI is indicated in the adjuvant setting for postmenopausal women with E+ breast cancer Upfront for 5 years then AI for a total of 5 years AI then tamoxifen for a total of 5 years for 5 years then AI for 5 years The three AIs are likely equivalent in efficacy

17 Outline Current status of adjuvant endocrine therapy for postmenopausal women with E+ breast cancer Ongoing trials of multi-gene profiling to avoid adjuvant chemotherapy Emerging concept with neoadjuvant endocrine therapy

18 ECOG/Int TAILOx PI: Sparano Pre-EGISTE 21 GENE ECUENCE SCOE ASSAY EGISTE Specimen Banking N=7,047 E+ Node - Secondary Study Group 1 S < 11 ~29% of Population Primary Study Group S ~44% of Population Secondary Study Group 2 S > 25 ~27% of Population AM A Hormonal Therapy Alone ANDOMIZE AM D Chemotherapy Plus Hormonal Therapy AM B Hormonal Therapy AM C Chemotherapy Plus Hormonal Therapy

19

20 EGISTATION S1007 E+ Node + (1-3) S > 25 (N= 3,800) Discuss alternative trials for high risk patients ECUENCE SCOE N= 5,600 S < 25 efuse N= 1,600 ecord chosen therapy Accept A N D O M I Z E N= 2,000 Chemotherapy; appropriate endocrine therapy N= 2,000 No Chemotherapy; appropriate endocrine therapy andomization stratified by: 1. S 0-13 vs Menopausal status 3. Axillary node dissection vs. Sentinel node biopsy

21 Outline Current status of adjuvant endocrine therapy for postmenopausal women with E+ breast cancer Ongoing trials of Multi-gene profiling to avoid adjuvant chemotherapy Emerging concept of neoadjuvant endocrine therapy

22 Neoadjuvant Endocrine Therapy to Improve Breast Conserving Surgery ate P024 E+ Stage 2/3 Letrozole S U G E Y L T IMPACT E+ Stage 2/3 2-week Biopsy Anastrozole Combination S U G E Y A T C

23 Neoadjuvant Endocrine Therapy For Outcome Prediction Preoperative Endocrine Prognostic Index (PEPI: T, N, E, Ki67) Ki wks 3-4 mons

24 Preoperative Endocrine Prognostic Index (PEPI) P024 E+ Stage 2/3 Letrozole S U G E Y Ellis MJ, Tao Y, Luo J, et al: Outcome prediction for estrogen receptor-positive breast cancer based on postneoadjuvant endocrine therapy tumor characteristics. J Natl Cancer Inst 100:1380-8, 2008

25 Preoperative Endocrine Prognostic Index (PEPI) Pathology, Biomarkers Factors Tumor size T1/2 T3/4 Node status No Yes Ln Ki67 level FS BCS H Points H Points E Allred Ellis et al JNCI 2008: 100,

26 Disease Free Survival Preoperative Endocrine Prognostic Index (PEPI) Data from P024 and POL and trial Months PEPI 0 PEPI non PEPI 0 pt1/2 pn0 Ki67 2.7% E Allred 3-8 Data from Matthew Ellis P024 E+ Stage 2/3 Letrozole S U G E Y POL E+ Stage 2/3 4-week Biopsy Letrozole S U G E Y

27 Neoadjuvant Endocrine Therapy For Outcome Prediction Preoperative Endocrine Prognostic Index (PEPI: T, N, E, Ki67) Ki wks 3-4 mons

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29

30 Ki67 Ki67 Suppression from Baseline During Treatment (IMPACT Trial) Weeks 12 T C T C A A A v T p=0.004 A v T p<0.001 A>T=C ATAC E+ Stage 2/3 Biopsy BL 2-w 12-w Anastrozole Combo S U G E Y

31 Ki67 Ki67 Suppression from Baseline During Treatment (Z1031 Trial) 0-10 Z1031 Biopsy BL 16-w E A L E+ Stage 2/3 Exemestane Anastrozole Letrozole S U G E Y E v A p= 0.56 E v L p= 0.32 A v L p= 0.16 E=A MA27

32 Adjuvant Trial (elapse ate) BIG 1-98 N=8010 ATAC N=9366 MA27 N=7576 Letrozole > Anastrozole > = Combination Anastrozole = Exemestane Neoadjuvant Trial (Ki67 Suppression) P024 N=185 IMPACT N=259 Z1031 N=266 Letrozole > Anastrozole > = Combination Anastrozole = Exemestane > better = equal

33 ACOSOG Z1031 Cohort B Eligibility: Postmenopausal Clinical Stage II or III E+ (Allred 6-8) HE2- Exemestane Letrozole Anastrozole 2-4 week biopsy Ki67 > 10% Chemotherapy or Immediate Surgery SUGEY FOLLOW Path C rate? Ki67 10% Continue AI therapy S U G E Y PEPI score 0 stage 1/0 No Chemo PEPI > 0 Stage > 1 MD decision F O L L O W Adherence with recommendation for no chemotherapy on PEPI score 0 Stage 1?

34 # Arm A Anastrozole (A) x 6 mos Arm F Fulvestrant (F) x 6 mos Arm A/F (A + F) x 6 mos 4-week or 12-week Ki67 > 10% * Neoadjuvant Chemotherapy SUGEY *Weekly paclitaxel x 12 (optional d2 biopy) or standard NCCN neochemo # # required biopsy ALTENATE Study Schema # S U G E Y PEPI 0 Adjuvant Chemo not recommended PEPI >0 Adjuvant Chemotherapy Physician s Choice Endocrine therapy per physician choice Arm A A x 4.5 years Arm F F x 1.5 yrs A x 3 yrs Arm A/F (A + F) x 1.5 yrs A x 3 yrs Sample size: Maximum N=2820 1st phase (n=400 in each arm) 2 nd phase (an additional 540 in each arm) F O L L O W

35 Conclusion Adjuvant endocrine therapy reduces breast cancer recurrence Multi-gene assays are being tested to avoid chemotherapy in low to intermediate risk E+ breast cancer Neoadjuvant endocrine therapy provides a new platform assessing endocrine responsiveness and drug development

36 Adjuvant Approach AI therapy alone Low risk Molecular profiling Clinical & pathological features High risk Alternative therapy in addition to AI

37 Evolving Approach Endocrine resistant (Ki67 High) AI therapy alone? PEPI wks AI 3-6 mos AI Endocrine resistant PEPI > 0

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