CALGB 9343
CALGB 9343 showed that older women with small hormone-sensitive breast cancers taking tamoxifen gain only a small reduction in local recurrence from radiotherapy and no survival benefit, opening the door to omitting it.
Overview
CALGB 9343 randomised 636 women aged 70 or older with clinical stage I oestrogen receptor-positive breast cancer treated by lumpectomy to tamoxifen alone or tamoxifen plus radiotherapy. At ten years, locoregional recurrence was 10 percent without and 2 percent with radiotherapy, with no difference in mastectomy rates, distant disease or overall survival (Hughes and colleagues, New England Journal of Medicine 2004 and Journal of Clinical Oncology 2013). Guidelines now list radiotherapy omission as an option in this group.
- 10 vs 2 out of 100 reached this endpoint at 10 years with Tamoxifen alone compared with Tamoxifen plus radiotherapy; 8 more per 100.
- Roughly one extra person helped for every 13 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Women aged 70 or over with small oestrogen receptor-positive breast cancer after lumpectomy: tamoxifen alone versus tamoxifen plus whole-breast radiotherapy. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
636 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Locoregional recurrence at 10 yearsprimary | Tamoxifen alone | 319 | 10% | - | - | - |
| Tamoxifen plus radiotherapy | 317 | 2% |
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