1. Kevin S.Hughes, MD, FACS Co-Director, Avon Comprehensive Breast Evaluation Center Massachusetts General Hospital Harvard Medical School Date 06/01/2007 Breast Cancer in the Older Woman - Is Radiation Necessary? American Society of Breast Surgeons Phoenix, Arizona 2012

2. 1.9 cm, ER+, clinical N0 Cancer Lumpectomy Plus Radiation/Boost Tamoxifen Sentinel Node Chemotherapy BRCA testing

3. 1.9 cm, ER+, clinical N0 Cancer Lumpectomy Plus Radiation/Boost Tamoxifen Sentinel Node Chemotherapy BRCA testing Lumpectomy Plus Radiation/Boost Tamoxifen/AI Sentinel Node Chemotherapy BRCA testing

4. Can we Vs should we?

5. CALGB 9343 Comparison of Lumpectomy Plus Tamoxifen With and Without Irradiation in Women 70 or Older with Clinical Stage I, ER+ Breast Carcinoma Kevin S. Hughes, Lauren A. Schnaper, Constance Cirrincione, Donald Berry, Barbara L. Smith, Beryl McCormick, Hyman B. Muss, Clifford Hudis, Eric Winer Cancer and Leukemia Group B Radiation Therapy Oncology Group Eastern Cooperative Oncology Group

6. Concerns regarding this study Patients randomized to no radiation would be inappropriately under- treated

7. Concerns regarding this study Patients randomized to receive no radiation would be inappropriately under-treated Patients randomized to radiation therapy would be inappropriately over-treated

8. CALGB 9343 ELIGIBILITY Age  70 ELIGIBILITY Age  70Clinically Node Negative Lumpectomy, Negative Margin Tumor size  2 cm Node Negative Lumpectomy, Negative Margin Tumor size  2 cm ER Positive or Indeterminate STRATIFICATION Age < 75  75 Axillary Dissection Yes No RadiationTamoxifen Tamoxifen RANDOMIZERANDOMIZERANDOMIZERANDOMIZE

9. CALGB 9343 Opened July 15, 1994 Closed February 26, 1999 647 patients –Eligible 631 –Ineligible 5 –Canceled/Never treated 11 Median follow-up 12 years

10. Patient characteristics RT+Tam Tam Total treated 317 319 Age >75 176 (56%)172 (54%) ER Positive308 (97%)310 (97%) Size < 2cm295 (93%)296 (93%) No Ax dissection 200 (63%)203 (64%)

11. IBTR (Ipsilateral Breast Tumor Recurrence) 91% 98%

12. Ipsilateral cancer risk

13. Radiation decreases local recurrence by ~7% Does it do anything else?

15. No RT Mastectomy Lumpectomy IBTR 27 RT IBTR 6 4 18 10

20. Actuarial survival for given ages at entry D. Berry 8/28/11

21. Ultimate Outcome

22. Breast Recurrence Less Ultimate Mastectomy Same Second primary cancer Same Distant metastasis Same Death Same Death Other CausesSame Death from breast cancerSame 22 women With modern margins and AI’s, RT will likely have even less benefit CONCLUSION: In older women, the benefits of radiation after lumpectomy are small

23. AS OF 2007, LITTLE CHANGE IN PRACTICE