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

Massachusetts General HospitalHarvard Medical School

Date 06/01/2007

Breast Cancer in the Older Woman - Is Radiation

Necessary?

American Society of Breast SurgeonsPhoenix, Arizona

2012

1.9 cm, ER+, clinical N0 Cancer1.9 cm, ER+, clinical N0 Cancer

Lumpectomy

Plus

Radiation/Boost

Tamoxifen

Sentinel Node

Chemotherapy

BRCA testing

1.9 cm, ER+, clinical N0 Cancer1.9 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

Can we Vs should we?

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, Barbara L. Smith, Beryl McCormick, Hyman B.

Muss, Clifford Hudis, Eric Winer

Cancer and Leukemia Group BRadiation Therapy Oncology Group

Eastern Cooperative Oncology Group

Concerns regarding this study

• Patients randomized to no radiation would be inappropriately under-treated

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

CALGB 9343 ELIGIBILITYELIGIBILITY

Age Age 70 70

ClinicallyClinically Node Negative Node Negative

Lumpectomy,Lumpectomy, Negative Margin Negative Margin

Tumor size Tumor size 2 cm 2 cm

ER Positive orER Positive or Indeterminate Indeterminate

STRATIFICATIONSTRATIFICATION

AgeAge < 75 < 75 75 75

Axillary DissectionAxillary DissectionYesYesNoNo

Radiation Radiation

TamoxifenTamoxifen

TamoxifenTamoxifen

RRAANNDDOOMMIIZZEE

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

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%)

IBTR (Ipsilateral Breast Tumor Recurrence)

91%

98%

Ipsilateral cancer risk

Radiation decreases local recurrence by ~7%

Does it do anything else?

No RT

Mastectomy

Lumpectomy

IBTR 27

RT

IBTR6

4

18

10

Actuarial survival for given ages at entry

D. Berry8/28/11

Ultimate Outcome

Breast Recurrence Less

Ultimate Mastectomy Same

Second primary cancer Same

Distant metastasis Same

Death Same

Death Other Causes Same

Death from breast cancer Same

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

AS OF 2007, LITTLE CHANGE IN PRACTICE