Adjuvant Endocrine Therapy: How Long is Long Enough?

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1 Adjuvant Endocrine Therapy: How Long is Long Enough? Harold J. Burstein, MD, PhD Dana-Farber Cancer Institute Harvard Medical School Boston, Massachusetts

2 I have no conflicts to disclose.

3 Early vs Late Recurrence

4 Time Dependence of Breast Cancer Recurrence in Subsets Defined by Genomic Assays Intrinsic/ PAM50 MammaPrint OncotypeDX Jatoi I et al. JCO 2011;29:

5 It is tautological to say, but the sine qua non for a late recurrence is not having an early recurrence

6 BIG 1-98 DFS Predictors of Early Recurrence (first 2 years) Mauriac Ann Oncol 2007:18:859 T stage N stage LVI HER2+ ER or PR neg Grade Note: lots of these correlate with ER expression OS Coates, A. S. et al. J Clin Oncol; 25:

7 Just because patients are at jeopardy for late recurrence does not necessarily mean that additional treatment will help Examples: HERA (2 vs 1 year of trastuzumab) Adjuvant Chemo (12 m vs 6 m)

8 Tamoxifen Why did we stop at 5 years anyway?

9 Tamoxifen 5 yrs vs. Not Tam Nil EBCTG Overview 2000

10 Duration of Tamoxifen: NSABP B-14 Fisher, et al. JNCI 2001 NSABP B-14 ER+, LN neg Placebo Tamoxifen x 5 yrs Disease Free at 5 yrs n=1172 Placebo n=579 Tamoxifen x 5 years n=593

11 Duration of Tamoxifen: NSABP B-14 Fisher, et al. JNCI 2001; median f/u 7 years post-rerandomization

12 Scottish Trial of Extended Tamoxifen Stewart HJ, et al. Brit J Cancer 1996;74:

13 ECOG Trial of Extended Tamoxifen Beyond 5 Years Tormey DC, et al. JNCI 1996;88:

14 TAM AI Upfront ATAC BIG 1-98 ABCSG 12 TEAM TAM TAM TAM AI Sequential BIG 1-98 IES ITA NSAS BC-03 ARNO 95 ABCSG 8* Plac AI Extended MA.17 ABCSG 6a NSABP B Years After Diagnosis

15 ER+ Breast Cancer What happens in years 6 to 10?

16 Goss PE et al. N Engl J Med 2003;349: MA 27: Letrozole or Placebo after 5 years of Tamoxifen

17 Late Introduction of AI Therapy in MA17 DFS DDFS Late switchers were: Younger Higher stage (N+, T2/T3) Had more adj chemo Goss P E et al. JCO 2008;26:

18 MA17: DFS by treatment and menopausal status (at time of diagnosis). Goss P E et al. Ann Oncol 2013;24:

19 NSABP B-33: disease-free survival with exemestane versus placebo (intent-to-treat) Mamounas E P et al. JCO 2008;26: by American Society of Clinical Oncology

20 Sites of first event with exemestane versus placebo. Mamounas E P et al. JCO 2008;26: by American Society of Clinical Oncology

21 Cumulative incident plots of contralateral breast cancers according to initial randomization to letrozole or placebo on MA.17. Ingle J N et al. Ann Oncol 2008;19:

22

23 ATLAS population

24 Disease-free Survival Overall Survival

25

26 attom: Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years in 6,953 women with early breast cancer Richard Gray, Daniel Rea, Kelly Handley & 17 others on behalf of the attom Collaborators

27 10 vs 5 years of tamoxifen: Recurrence by treatment ASCO vs 672 recurrences RR=0.85 (95%CI ) p=0.003 An additional 143 vs 216 recurrences since 2008

28 10 vs 5 years of Tamoxifen: Breast Cancer Death by Treatment Allocation 404 vs 452 breast cancer deaths RR=0.88 (95%CI ; p=0.05) p=0.06

29 10 year EFS by stage, grade, and age for ER+ breast cancers not relapsing by year 5 from diagnosis: British Columbia Data. Lohrisch et al. SABCS 2013 Stage and grade Age > 50 years at Diagnosis N Event % 10 year EFS (95% CI) Age <50 years at diagnosis N Event % 10 year EFS (95% CI) Stage I (93.8, 95.6) (92.8, 96.3) grade (93.7, 96.6) (94.0, 98.8) grade (93.1, 95.7) (90.0, 95.6) grade (91.8, 96.8) (88.0, 97.5) Stage II (85.0, 87.5) (86.0, 90.2) grade (90.5, 94.9) (87.7, 96.9) grade (84.8, 88.2) (84.4, 90.4) grade (78.9,84.5) (83.8, 91.1) Stage III (69.1, 77.8) (73.6, 85.6) grade (59.6, 86.0) (50.8, 98.7) grade (67.8, 79.8) (66.7, 84.8) grade (62.8, 79.3) (70.0, 90.3)

30 Late recurrence in endocrine-treated cancers. Cuzick et al. SABCS 2013 ATAC N=9366 ABCSG-8 N=3714 Excluded: -Combination arm -Chemotherapy -No blocks received -Insufficient tumour material transatac* N=1125 Tissue database N=1620 Excluded: -No tissue specimen -No consent Excluded: -Insufficient residual RNA -Failed PAM50 QC PAM50 N=1007 PAM50 N=1478 Excluded: -Insufficient residual RNA -Failed PAM50 QC Excluded: -Not recurrence free at 5 years (N=145) *RNA extracted by GHI Combined N=862 dataset N=1275 N=2137 Excluded: -Not recurrence free at 5 years (N=203)

31 Distant recurrence (%) Luminal A vs Luminal B HR (95% CI) P-value Luminal A (N=1530 (71.6%)) - - Luminal B (N=542 (25.4%)) 2.89 ( ) < Luminal B Luminal A 12.9% 4.1% Follow-up time [years]

32 WHY NOT JUST TREAT EVERYONE FOREVER, ANYWAY?

33 Patient-reported Reasons for Stopping Endocrine Therapy (N = 77) Patient-related Side effects Concern about adverse effects from therapy Cost Dislike of having to be on medications Wanted to move on from the cancer % Doctor-related Told to stop by doctor Completion of recommended course of treatment 16 9 (Not mutually exclusive) Pini, ASCO 2011

34 Persistent Risks of Therapy Tamoxifen Uterine cancer Thromboembolism Aromatase Inhibitors Osteoporosis Myalgias/arthralgias

35 ATAC: annual bone fracture rates ATAC Trialists, Lancet Oncology 2008;9:45

36 Real Choices I Premenopausal Start with tamoxifen At 5 years If premenopausal, continue tamoxifen If postmenopausal (for sure), continue tamoxifen or switch to an AI

37 Real Choices II Postmenopausal Start with tamoxifen or an AI If starting with tamoxifen, option of extended adjuvant treatment with either tamoxifen or an AI If starting with an AI, data may be available in 5 years to guide your choice at that timepoint

38 Real Choices III Patients can usually tell you their preference

39 The spectrum of patients on tamoxifen

40 Real Choices III Patients can usually tell you their preference Benefits of extended adjuvant therapy are relatively modest, and baseline risk probably is relevant Low threshold for discontinuing treatment if not well tolerate

41 Final Point After decades, we are still optimizing adjuvant endocrine therapy There is a movement to minimize the relationship between oncologists and breast cancer survivors by shifting care to other clinicians or survivorship clinics Ironically, in the largest population of cancer survivors, we are still amending treatment plans 5+ years out from diagnosis.

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