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Kevin S. Hughes, MD, FACS Co-Director, Avon Comprehensive Breast Evaluation Center

Is Post-Lumpectomy Radiation Necessary in Older Patients?. Kevin S. Hughes, MD, FACS Co-Director, Avon Comprehensive Breast Evaluation Center Massachusetts General Hospital Associate Professor of Surgery Harvard Medical School Surgeon The Newton-Wellesley Hospital Breast Center.

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Kevin S. Hughes, MD, FACS Co-Director, Avon Comprehensive Breast Evaluation Center

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  1. Is Post-Lumpectomy Radiation Necessary in Older Patients? Kevin S. Hughes, MD, FACS Co-Director, Avon Comprehensive Breast Evaluation Center Massachusetts General Hospital Associate Professor of Surgery Harvard Medical School Surgeon The Newton-Wellesley Hospital Breast Center

  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. CALGB 9343Comparison 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, Beryl McCormick, Hyman B. Muss, Clifford Hudis, Eric Winer, Barbara L. Smith Cancer and Leukemia Group B Radiation Therapy Oncology Group Eastern Cooperative Oncology Group

  5. RANDOMIZE CALGB 9343 ELIGIBILITYAge ³ 70 Clinically Node Negative Lumpectomy, Negative Margin Tumor size£ 2 cm ER Positive or Indeterminate STRATIFICATIONAge < 75³ 75Axillary DissectionYesNo Radiation Tamoxifen Tamoxifen

  6. 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

  7. Patient characteristics RT+Tam Tam Total treated 317 319 Age >75 176 (56%) 172 (54%) ER Positive 308 (97%) 310 (97%) Size < 2cm 295 (93%) 296 (93%) No Ax dissection 200 (63%) 203 (64%)

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

  9. Ipsilateral cancer risk 40 and under RT 70 above no RT LCIS

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

  11. No RT • IBTR 6 • 4 • RT • Mastectomy • 10 • IBTR • 27 • 18 • Lumpectomy

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

  13. Ultimate Outcome

  14. CONCLUSION: In older women, the benefits of radiation after lumpectomy are small 22 women With modern margins and AI’s, RT will likely have even less benefit

  15. 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

  16. 1.9 cm, ER+, clinical N0 Cancer Lumpectomy Plus Radiation + Boost Tamoxifen Sentinel Node Chemotherapy Lumpectomy Tam/AI

  17. When does this woman…become this woman?

  18. CONCLUSION: In older women, the benefits of radiation after lumpectomy are small 22 women Study is mature: 12 years Median, Half of patients dead With modern margins and AI’s, RT will likely have even less benefit

  19. 1.9 cm, ER+, clinical N0 Cancer Lumpectomy Plus RT/Boost Tamoxifen Sentinel Node Chemotherapy BRCA testing Lumpectomy OR Tam/AI OR Tam/AI/RT Agreement: Elderly women need less treatment

  20. 1.9 cm, ER+, clinical N0 Cancer Lumpectomy Plus Radiation + Boost Tamoxifen Sentinel Node Chemotherapy BRCA testing Lumpectomy OR Tam/AI OR Tam/AI/RT Continued discussion: Who are the elderly? Agreement: Elderly women need less treatment

  21. Conclusions • Every elderly woman does not need • lumpectomy,sentinel node,RT+Boost,Tam/AI,Chemo • Breast irradiation provides less benefit with age • Breast irradiation plus Tam/AI is often excessive • Question: Who are the elderly? Elderly women need individualized treatment

  22. Axillary recurrence

  23. Benefits of RT are small 22 women N (% at 10 yeas) N (% at 10 years) Study is mature: 12 years Median, Half of patients dead With modern margins and AI’s, RT will likely have even less benefit

  24. In older women, the benefits of radiation after lumpectomy are small 21 women • Breast recurrence ~7% • Radiate 319 women to avoid 21 in breast recurrences • Ultimate breast preservation NS • Second primary cancer NS • Distant metastases NS • Death breast cancer NS • Death from any cause NS Omitting Radiation in women 70 and above with Clinical Stage I breast cancer is a reasonable alternative for our patients

  25. Managing the elderly • If mastectomy needed • Preop chemo or endocrine possible & needed • Yes=>Try • No=>Do Mastectomy (With sentinel node) • If breast preservation possible • Clinically positive node • Lumpectomy/Axillary dissection • Tumor ER- or over 2 cm • Lumpectomy/Sentinel node • If Clinical Stage I and ER+ • If chemotherapy a possibility • Do sentinel node • If chemotherapy NOT a possibility • Sentinel node optional (Not encouraged)

  26. IBTR 4 • No RT • RT • IBTR • 20

  27. IBTR 4 • 4 • No RT • RT • Mastectomy • 9 • IBTR • 20 • 11 • Lumpectomy

  28. In older women, the benefits of radiation after lumpectomy are small 21 women • Breast recurrence ~7% • Radiate 319 women to avoid 21 in breast recurrences • Ultimate breast preservation NS • Second primary cancer NS • Distant metastases NS • Death breast cancer NS • Death from any cause NS

  29. CONCLUSION: In older women, the benefits of radiation after lumpectomy are small 21 women • Breast recurrence ~7% • Radiate 319 women to avoid 21 in breast recurrences • Ultimate breast preservation NS • Second primary cancer NS • Distant metastases NS • Death breast cancer NS • Death from any cause NS Study is mature: 12 years Median, Half of patients dead With modern margins and AI’s, RT will likely have even less benefit

  30. Axillary recurrence

  31. CALGB 9343: All Patients Dead Other 27% Dead Breast 2 % Alive 71%

  32. Morbidity statistically inferior in RT arm Physician assessmentPatient assessment 4 months Cosmesis Pain Tenderness Fibrosis Skin color changes Skin color changes Breast edema Breast edema 1 year Cosmesis Pain Tenderness Fibrosis Skin color changes Skin color changes Breast edema Fibrosis 2 years Skin color changes Skin color changes Breast edema Cosmesis Fibrosis 4 years No differences No differences

  33. Benefit of RT • LocoRegional recur 5.9% • Ultimate Breast Preservation 0 % • Distant Metastases 0 % • Death Breast Cancer 0 % • Death Any Cause 0 %

  34. Benefit of RT • LocoRegional recur 5.9% • Ultimate Breast Preservation 0 % • Distant Metastases 0 % • Death Breast Cancer 0 % • Death Any Cause 0 % 5 YR results verified at 8.2 YRS

  35. Early 1990’s: Was RT always needed after conservative surgery? • Possible groups • Elderly • Small tumors • Tamoxifen

  36. Summary of Randomized Trials:Lumpectomy + Tam vs Lumpectomy + Tam + RT

  37. Summary of Randomized Trials:Lumpectomy + Tam vs Lumpectomy + Tam + RT

  38. Summary of Randomized Trials:Older Women

  39. Can we Vs should we?

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