How can we Personalize RT as part of Breast-Conserving Therapy?

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1 How can we Personalize RT as part of Breast-Conserving Therapy? Jay R. Harris Dana-Farber Cancer Institute (DFCI) Brigham and Women s Hospital (BWH) Harvard Medical School

2 Disclosures I have no COI disclosures

3 Current Results with BCT Our results from DF/BWCC and MGH are illustrative of the current excellent results seen with BCT Our initial results* were also the first to illustrate the importance of biologic subtypes in BCT * Nguyen P et al JCO 2008

4 Nguyen P et al JCO 2008 Approximated biologic subtype using standard markers was the only variable in the final model No other variables, including margins, dose, grade, stage and age were in the final model

5 Our Updated Experience 1434 BCT patients T1 80%, pn0 67% Margins: Negative 89%, close 8% ST used in 91% (No Herceptin) Median FU = 85 months (7.1 years) 5-year rate of LR = 2.1%! Ref: Arvold N et al JCO :3885

6 New Definitions of Subtypes Luminal A = HR+, HER2-, Gr 1-2 (905) Luminal B = HR+, HER2-, Gr 3 (198) Luminal-HER = HR+, HER2+ (105) HER2 = HR-, HER2+ (55) Triple Negative = HR-, HER2- (171)

7 Subtype: the Main Prognostic Factor HER2 No Trastuzumab HER2 (No Herceptin) TN Triple - Lum B Lum B Lum A Lum-HER2

8 Age is also Prognostic (note scale) < Age Age > 64

9 Conclusions New definition of subtype is useful Both subtype and to a lesser extent age are prognostic for LR LR rates are much lower than in the past

10 Reasons for Excellent Outcomes Better imaging with mammography (not MRI); use of MRI controversial Better evaluation of the resected breast specimens, especially margins Use of systemic therapy (ST), which greatly improves results of RT

11 10-Year LR in NSABP Trials (Ref: Anderson SJ et al. JCO 2005, 27: 2466) Trial ER Status 10-Year LR (%) B-13 No Chemo B-13 Chemo B-14 No Tamoxifen B-14 Tamoxifen B-19 Chemo B-20 Tam +/- Chemo B-23 Chemo - 4.3

12 Adjuvant Trastuzumab reduces LR in HER2+ Cancers NSABP B31 N9831 CTX 2.8% 2.7% CTX + H 1.7% 1.5% Ref: Romand, NEJM 2005;353:1673

13 Is Bigger Surgery Better for Triple Negative Breast Cancer? Studies from Canada, MSKCC and MD Anderson have shown that if anything LR is lower with BCT than with mastectomy Abdulkarim B, JCO 2011;29:2852 Ho A et al, Cancer 2012;118:4944 Adkins F et al, Ann Surg Oncol 2011;18:3164

14 Conventional Fractionation Gy WB with boost to 60 Gy With long-term FU, shown to be safe and effective However, there is growing interest in hypofractionated breast RT

15 Rationale for Hypofractionation Convenience and Cost Major improvements in RT delivery with higher energies, 3-D dose calculation and beam modulation -> much greater 3-D dose homogeneity More refined radiobiologic estimate of dose equivalence

16 Major 1 st Generation Trials Canadian Start A UK* Start B UK # Pts Med FU 12 yrs 9.3 yrs 9.9 yrs Arms (Gy x # Fx) 2 x 25 in 5 wks 2.66 x 16 in 3+ wks 2 x 25 in 5 wks 3 x 13 in 5 wks 3.2 x 13 in 5 wks 2 x 25 in 5 wks 2.66 x 15 in 3 wks * Trial performed to determine α/β Ratio

17 Major 1 st Generation Trials Canadian Start B UK # Pts Arms (Gy x # Fx) Use of a Boost 2 x 25 in 5 wks 2.66 x 16 in 3+ wks Not Allowed 2 x 25 in 5 wks 2.66 x 15 in 3 wks Allowed (Used in half)

18 Major 1 st Generation Trials The Canadian Trial with 12 years of FU was practice-changing in the US Updated results of the START trials were published in Lancet Oncol in 2013 Together, they provide justification for increased use of hypofractionation Refs: Whelan T et al NEJM 362:513, 2010 Haviland J et al Lancet Oncol 14: 1086, 2013

19 Canadian Trial Results 35 Fair + poor cosmesis (%) Local tumor relapse (%) Gy/16F 42.5Gy/16F Gy/25F 50Gy/25F F 5 25F 10 Years since Randomization Ref: Whelan T et al, NEJM: 362; 513, 2010

20 START B Results % Free of adverse effects 40Gy 50Gy 40 vs 50GY HR = 0.77 ( ) Rate of local tumor relapse 40 vs 50GY HR = 0.77 ( ) 50 Gy 40 Gy Time from randomization (years) Ref: Haviland J et al Lancet Oncol 14: 1086, 2013

21 START B Hazard Ratio Results DM Any BC Event OS 200 x x p =.01 p =.02 p =.04 Ref: Haviland J et al Lancet Oncol 14: 1086, 2013

22 Concerns/Uncertainties Potential effects on late-responding normal tissue (late toxicity) -> need long-term follow up? Interaction with systemic therapies, especially chemotherapy Patient selection which patients?

23 Patients in the Major Trials Canadian Start B ER- 27% 12% Gr 3 19% 23% Age < 50 25% 21% Boost 0% 43% Nodal RT 0% 7% Chemo 11% 22%

24 Generalizability of these Results Patients in the these trials were older with favorable cancers Chemotherapy and boost not routine However, in START B, cosmetic results were the same with and without chemotherapy

25 Case: Need for Long FU 1981 BK presents with T1N0 cancer treated with BCT including nodal RT 2001 (20 yrs later) She develops numbness of right hand; no evident recurrence -> Dx brachial plexopathy 2001-> present Progressive loss of motor function to useless arm

26 Clinical Trials in Progress FAST UK IMPORT High UK IMPORT Low UK SHARE France RTOG US # Pts Arms (Gy x # Fx) 2 x x 5 6 x 5 All in 5 weeks 2.4 x 15 integrated boost 2.67 x 15 -> boost 2.67 x x 15 integrated boost APBI 2.67 x 15 2 x x x 15 APBI 4 x x 25 -> boost 2.67 x 15 integrated boost

27 ASTRO Guidelines (2011) Age/Stage > 50 yrs, T1,2 N- Surgery BCS Chemotherapy None Fractionation 266 cgy x 16 Heart in Field 0 Boost No Agreement Dose Homogeneity < 7% Ref: Smith B et al IJROBP : 59

28 New DFCI/BWH Approach Age/Stage > 50 yo, DCIS > 60, Tangents only Surgery Chemotherapy BCS OK Fractionation 266 cgy x Heart in Field 0 Boost 250 cgy x 2-4 Dose Homogeneity < 7%

29 Hypofractionation The available RCTs, particularly the Canadian and START B Trials, provide increased support for hypofractionation This approach is clearly indicated in many patients and will likely be increasingly used

30 Personalized BCT based on Subtype, Age (DFCI/BWH) Luminals > 60: 266 x 16, no boost Luminals 50-60: 266 x 15, 250 x 2 HER2+ > 50: 266 x 15, 250 x 4 < 50: 200 x x 8 = 60 Gy TN: Conventional + concurrent platinum on protocol

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