Choosing between different hormonal therapies. Rudy Van den Broecke UZ Ghent

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1 Choosing between different hormonal therapies Rudy Van den Broecke UZ Ghent

2 What is the golden standard in premenopausal hormonal sensitive early breast cancer?

3 Ovarian Suppression alone 5 years Tamoxifen OS + AI Tamoxifen followed by AI OS + Tam CT followed by +/- LHRH-a +/- Tam Ovarian protection with LHRH-a

4 Ovarian Suppression alone 5 years Tamoxifen OS + AI Tamoxifen followed by AI OS + Tam CT followed by +/- LHRH-a +/- Tam Ovarian protection with LHRH-a

5 How to increase survival? EBCTCG Lancet 2005 Vol 365:

6 15-y follow-up Tamoxifen vs. control Recurrence rates EBCTCG The Lancet 2003

7 15-y follow-up Tamoxifen vs. Control Deaths rates EBCTCG The Lancet 2003

8 Ovarian Suppression + AI High risk patients Contra-indications for Tamoxifen Studies: SOFT TEXT Informed consent Risk for osteoporose 2 to 5 years LHRH-a? When is the patient menopausal?

9 Tamoxifen followed by AI Peri-menopausal woman When is the patient menopausal? What when she starts bleeding again?

10 Ovarian Suppression alone 5 years Tamoxifen OS + AI Tamoxifen followed by AI OS + Tam CT followed by +/- LHRH-a +/- Tam Ovarian protection with LHRH-a

11 What is the golden standard in Postmenopausal hormonal sensitive early breast cancer?

12 UPFRONT SWITCH SEQUENTIAL EXTENDED SUPPOPULATIONS CYP2D6 CONTRA-INDCATIONS FOR TAMOXIFEN More than 5y AI s

13 UPFRONT SWITCH SEQUENTIAL EXTENDED SUBPOPULATIONS CYP2D6 CONTRA-INDCATIONS FOR TAMOXIFEN More than 5y AI s

14 Subgroup analysis 2 types of error Attributing an effect to a subgroup when there is no overall effect Claiming a lack of effect in a subgroup when the overall effect is significant * The more subgroups into which a data set is devided, the more likely it is that a statistically significant difference will be found by chance J. Cuzick: The Breast April 2008

15 Overview trials AI s Randomisation Median follow-up periode Tamoxifen 5y Anastrozole 5y Tamoxifen 5y Letrozole 5y Tam 2y Letro 3y Letro 2y Tam 3y ATAC 100 months BIG months Tam 2-3y Exe 2-3y Placebo Letrozole 5y IES 55.7 months MA years

16 UPFRONT SWITCH SEQUENTIAL EXTENDED SUBPOPULATIONS CYP2D6 CONTRA-INDCATIONS FOR TAMOXIFEN More than 5y AI S

17 Prominent early peak of recurrences 25 Total Tumour size (>3 cm) Node 0 ER +ve 20 Node 1-3 ER -ve Node (4+) Premenopausal Hazard of recurrence by yearly interval Tumour size (<1 cm) Tumour size (1.1-3 cm) Postmenopausal Time (years) ER, oestrogen receptor Saphner T et al. J Clin Oncol 1996 Baum M. ASCO 2005, poster 612

18 Aromatase inhibitors as initial therapy Initial adjuvant trial (ATAC, BIG 1-98) Randomisation Patients Newly Diagnosed 5 years Tamoxifen 5 years Aromatase Inhibitor 0 5 Time (years) AI upfront Background Data ATAC Anastrozole vs Tamoxifen ATAC Anastrozole vs Tamoxifen BIG 1-98 Letrozole vs Tamoxifen FU DFS(HR+ patients) 68 mths HR=0.83 SS 100 mths HR=0.85 SS 51 mths HR=0.82 SS TTR(HR+ patients) HR=0.74 SS HR=0.76 SS HR=0.78 SS TTDR(HR+ patients) HR=0.84 NS HR=0.84 SS HR=0.81 SS OS(HR+ patients) HR=0.97 NS HR=0.97 NS HR=0.91 NS ATAC: Lancet Oncology 2008; 9: ATAC: Lancet 2005; 365: BIG 1-98: Coates AS et al. J Clin Oncol 2007; 25(5)

19 Time to recurrence ATAC HR+ patients Patients (%) HR+ HR % CI (0.67, 0.87) p-value % Tamoxifen (T) Anastrozole (A) 12.5% 17.0% % 0 Absolute difference 2.8% 4.8% Follow-up time (years) The ATAC Trialists Group. Lancet Oncol 2008; 9: 45-53

20 TTR: Carryover effect in post-treatment period Recurrence rates continued to be lower with anastrozole after treatment completion¹ There is a statistically significantly difference in TTR (HR=0.75, 95% CI , p=0.01)¹, which shows a larger carryover effect for anastrozole TTR, time to recurrence ¹The ATAC Trialists Group. Lancet Oncol 2008; 9: 45-53

21 BIG1-98 Treatment arm of 5 years Tamoxifen is unblinded (June 2005) New methode of statistical analysis was proposed on ESMO Sept 2008 and data will be present in San Antonio 2008

22 Switching Analysis [TAM LET] vs TAM [LET TAM] vs LET 5 Prospective Additional Sequence analysis [TAM LET] vs LET [TAM LET] vs TAM [LET TAM] vs LET [LET TAM] vs TAM [TAM LET] vs [LET TAM] Ref. BIG 1-98, Poster at ESMO 09/2008

23 UPFRONT SWITCH SEQUENTIAL EXTENDED SUBPOPULATIONS CYP2D6 CONTRA-INDCATIONS FOR TAMOXIFEN More than 5y AI s

24 Aromatase Inhibitors: After 2-3 y Tamoxifen Randomisation Switch trial (ITA, ARNO/ABCSG 8, IES) 2-3 years prior Tamoxifen 3-2 y Tamoxifen 3-2 y Aromatase Inh 0 5 Time (years) ARNO Anastrozole vs Tamoxifen ARNO/ABCSG8 Anastrozole vs Tamoxifen ARNO/ABCSG8/ITA Anastrozole vs tam FU DFS OS 30.1 mths HR=0.66 SS 28 mths HR=0.60 SS 30 mths HR=0.59 SS HR=0.53 SS ND HR=0.71 SS IES Exemestane vs tam 55.7 mths HR=0.76 SS HR=0.85 for ITT pts NS HR=0.83 for ER+/unknown pts SS ARNO: Kaufmann M et al. J Clin Oncol 2007; 25(19) - ARNO/ABCSG 8:Jakesz R et al. Lancet Oncology 2005; 366: ARNO/ABCSG 8/ITA: Jonat W et al. Lancet Oncology 2006; 7: IES: Coombes RC et al. Lancet Feb 2007

25 DFS (%) DFS (%) IES-trial: Exemestane After Tamoxifen: DFS Year Abs diff, % (95% CI) Intent to treat End of treatment HR: 0.76 (95% CI: ) Log rank test: P = ( ) E = 354/2352 T = 454/ Time Since Randomization (Yrs) ( ) ( ) Reprinted from The Lancet Oncology, 2006;7: , Jonat W, et al. Effectiveness of switching from adjuvant tamoxifen to anastrozole in postmenopausal women with hormone-sensitive early-stage breast cancer: a metaanalysis. Copyright (2008), with permission from Elsevier. ER+/Unknown End of treatment HR: 0.75 (95% CI: ) Log rank test: P =.0001 E = 339/2296 T = 438/ Time Since Randomization (Yrs) ( ) Exemestane Tamoxifen

26 Survival in the switch strategy Update on IES: DFS subgroup analysis The size of benefit in DFS for switching to exemestane is consistent across subgroups Coombes R. et al., The Lancet, 2007, vol 369, Issue 9561,

27 UPFRONT SWITCH SEQUENTIAL EXTENDED SUBPOPULATIONS CYP2D6 CONTRA-INDCATIONS FOR TAMOXIFEN More than 5y AI S

28 Aromatase Inhibitors: After 5 y Tamoxifen Randomisation Extended adjuvant trial (MA17, ABCSG 6a, NSABP33) MA 17* Letrozole vs placebo ABCSG 6a Anastrozole vs no treatment 5 years prior tamoxifen 0 5 Time (years) FU DFS DDFS OS 30 mths HR=0.58 SS 60.4 mths HR=0.64 SS HR=0.61 SS Aromatase Inhibitor No treatment HR=0.82 NS HR=0.61 for Node + SS ND NSABP 33** Exemestane vs placebo 30 mths HR=0.68 NS ND *Early unblinded trial **Trial closed prematurely MA 17: Goss PE SABCS 2005 presentation ABCSG 6a: Jakesz R ASCO 2005 Poster 526 NSABP 33: Mamounas E SABCS 2006 Abstr 48

29 Node- Positive Patients Extended Adjuvant Therapy: Letrozole After 5 Years of HR: 0.61* ( ) Tamoxifen MA.17 HR: 0.53* ( ) HR: 0.61* ( ) DFS Distant DFS OS Node- Negative Patients HR: 0.45* ( ) Median follow-up 2.4 years HR: 0.63 ( ) HR: 1.52 ( ) *Statistically significant benefit of letrozole. A similar reduction in local recurrences, new primaries, and distant recurrences occurred in node-positive and node-negative patients Goss PE, et al. J Natl Cancer Inst. 2005;17:

30 Can we identify a superior AI or AI adjuvant strategy? ATAC and BIG1-98 have demonstrated the superiority of AI over TAM in reducing the recurrence risk in the adjuvant setting IES, ABCSG8, ARNO 95 and ITA demonstrated that the switch from TAM to AI after 2-3 years treatment is more effective than continuing TAM for 5 years The different studies can not be directly compared to one another because of the different study groups different definitions of the endpoints

31 Can we identify a superior AI or AI adjuvant strategy? The side effects of the three different AI s seem to be equivalent There appear to be no difference in side effects whether the AI s are used in upfront or in a switch strategy In the switch strategy, the patient population is selected for good respons to endocrine therapy

32 Considering the the high rate of early recurrences, especially early distant metastases, the use of the strongest availlable therapy, in order to reduce most effectively the early relapse risk is certainly warranted

33 UPFRONT SWITCH SEQUENTIAL EXTENDED SUBPOPULATIONS CYP2D6 CONTRA-INDCATIONS FOR TAMOXIFEN More than 5y AI s

34 Additional information FRAGRANCE trial Genomics could be the key to identify women who are particulary endocrine sensitive and who will benefit most from an AI rather than from tamoxifen l

35 What do we know Take home massages (1) Premenopausal: Tamoxifen 5 years LHRH-a as ovarian protection in study or informed consent Verify the menopausal status carefully before starting an AI Ovarian suppression is still an option

36 Take home massages (2) Postmenopausal: Upfront 5y with Anastrozole or letrozole is the only proven treatment strategy for new diagnosed patients that shows an advantages in TTR DFS CLBC TTDR versus 5y Tamoxifen in long follow-up Patient already on Tamoxifen should be switched at the earliest opportunity to an AI. Here the best option is exemestane Patient after 5 years Tamoxifen should switch to letrozole if high risk of recurrence

37 What will we probably know: not know in near future Is a sequence therapy of Tamoxifen followed by Exemestane better than 5 years Exemestane? Open trial TEAM (San Antonio 2008) Is a sequence therapy better than 5 year Letrozole? BIG1-98 (modified protocol San Antonio 2008) Are there differences between the AI s? FACE MA 27 Is longer therapy with a AI better than 5 years? Differents trials ongoing

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