Lumpectomy plus tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer.
BACKGROUND
In women 70 years of age or older who have early breast cancer, it is unclear whether lumpectomy plus tamoxifen is as effective as lumpectomy followed by tamoxifen plus radiation therapy.


METHODS
Between July 1994 and February 1999, we randomly assigned 636 women who were 70 years of age or older and who had clinical stage I (T1N0M0 according to the tumor-node-metastasis classification), estrogen-receptor-positive breast carcinoma treated by lumpectomy to receive tamoxifen plus radiation therapy (317 women) or tamoxifen alone (319 women). Primary end points were the time to local or regional recurrence, the frequency of mastectomy for recurrence, breast-cancer-specific survival, the time to distant metastasis, and overall survival.


RESULTS
The only significant difference between the two groups was in the rate of local or regional recurrence at five years (1 percent in the group given tamoxifen plus irradiation and 4 percent in the group given tamoxifen alone, P<0.001). There were no significant differences between the two groups with regard to the rates of mastectomy for local recurrence, distant metastases, or five-year rates of overall survival (87 percent in the group given tamoxifen plus irradiation and 86 percent in the tamoxifen group, P=0.94). Assessment by physicians and patients of cosmetic results and adverse events uniformly rated tamoxifen plus irradiation inferior to tamoxifen alone.


CONCLUSIONS
Lumpectomy plus adjuvant therapy with tamoxifen alone is a realistic choice for the treatment of women 70 years of age or older who have early, estrogen-receptor-positive breast cancer.
Hughes
Kevin S
KS
Avon Comprehensive Breast Evaluation Center, Breast/Ovarian Cancer Genetics and Risk Assessment Program, Massachusetts General Hospital, Division of Surgical Oncology, Boston 02114, USA. kshughes@partners.org
Schnaper
Lauren A
LA
Berry
Donald
D
Cirrincione
Constance
C
McCormick
Beryl
B
Shank
Brenda
B
Wheeler
Judith
J
Champion
Lorraine A
LA
Smith
Thomas J
TJ
Smith
Barbara L
BL
Shapiro
Charles
C
Muss
Hyman B
HB
Winer
Eric
E
Hudis
Clifford
C
Wood
William
W
Sugarbaker
David
D
Henderson
I Craig
IC
Norton
Larry
L
D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008207:Lymphatic Metastasis; D015412:Mastectomy, Segmental / Q000009:adverse effects; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery; D011379:Prognosis; D011878:Radiotherapy / Q000009:adverse effects; D016019:Survival Analysis; D013629:Tamoxifen / Q000009:adverse effects / Q000627:therapeutic use*
D018931:Antineoplastic Agents, Hormonal; D013629:Tamoxifen