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Comparison Of Lumpectomy Plus Tamoxifen With And Without Radiotherapy (RT) In Women 70 Years Of Age Or Older Who Have Clinical Stage I, Estrogen Receptor Positive (ER+) Breast Carcinoma

Diana Stripp, MD

University of Pennsylvania Cancer
Ultima Vez Modificado: 15 de mayo del 2001

Presenter: Kevin S. Hughes
Affiliation: Massachusetts General Hospital

Background:

1. No survival impact of RT from previous studies.
2. Tumor in this group of pts grow slowly, therefore, less time at risk.
3. This study is designed to assess, in this population, whether RT, when added to tamoxifen: 1) decreases locoregional recurrence, 2) decreases eventual mastectomy, or 3) affects survival, disease-free survival and breast cancer specific mortality.

Materials and Methods:

1. 647 women entered the study (636 treated).
2. All were 70 and older with clinical stage I, ER+ breast cancer treated by lumpectomy
3. Patients were randomized to tamoxifen plus RT (T+RT) or tamoxifen alone (T).

Results:

1. With a median time on study of 28 months, the rate of locoregional failure was extremely low. 6/319 women developed locoregional recurrences (4 breast, 2 axilla) on T [annual rate=0.9%] vs. 0/317 on T+RT (P=NS). Only 1 required mastectomy.
2. 1/319 women developed distant metastases on T vs. 3/317 on T+RT (P=NS).
3. 20/319 died on T vs. 19/317 on T+RT (P=NS). Only 1 death was breast cancer related (T arm).
4. 4/319 developed contralateral breast cancer on T vs. 5/317 on T+RT.
5. Physicians and patients considered breast appearance and texture worse on T+RT.

Authors' Conclusions

1. In this population, RT, when added to tamoxifen, led to fewer locoregional recurrences (P=NS). Longer follow up is need to fully assess this decrease is clinical important.
2. Death from 2nd cancer exceeded in breast recurrence.
3. Contralateral breast cancer was as common as locoregional recurrence.
4. At this period of follow up, the addition of RT has no impact on ultimate breast conservation, survival, disease-free survival and breast cancer specific mortality.
5. RT has a detrimental effect on breast texture and appearance.

Clinical/Scientific Implications:

1. Despite the relatively short follow-up, the high incidence of death from other causes, the low rate of in breast recurrence (similar to contralateral breast cancer rate), and the feasibility of breast preservation after in- breast recurrence raises the possibility that RT may not have clinical benefit in this population.
2. In area where access to a RT facility is limited and in pts with co-morbidity, Tam alone, without RT may be a reasonable alternative for this group of women.