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
Last Modified: May 15, 2001
Presenter: Kevin S. Hughes
Affiliation: Massachusetts General Hospital
- No survival impact of RT from previous studies.
- Tumor in this group of pts grow slowly, therefore, less time at risk.
- 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:
- 647 women entered the study (636 treated).
- All were 70 and older with clinical stage I, ER+ breast cancer treated by lumpectomy
- Patients were randomized to tamoxifen plus RT (T+RT) or tamoxifen alone (T).
- 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.
- 1/319 women developed distant metastases on T vs. 3/317 on T+RT (P=NS).
- 20/319 died on T vs. 19/317 on T+RT (P=NS). Only 1 death was breast cancer related (T arm).
- 4/319 developed contralateral breast cancer on T vs. 5/317 on T+RT.
- Physicians and patients considered breast appearance and texture worse on T+RT.
- 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.
- Death from 2nd cancer exceeded in breast recurrence.
- Contralateral breast cancer was as common as locoregional recurrence.
- 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.
- RT has a detrimental effect on breast texture and appearance.
- 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.
- 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.