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If chemotherapy given before surgery clears the lymph nodes completely, irradiating those nodes afterwards adds nothing. Fewer than one woman in ten had the cancer come back either way, and the difference between the two groups was within chance.
B-51 asked whether the response to chemotherapy, rather than the stage at diagnosis, should decide the radiotherapy. Patients with clinical T1 to T3, N1, M0 breast cancer and biopsy-proven axillary disease who reached pathologically node-negative status after chemotherapy were randomised to regional nodal irradiation or to none. 1,641 were enrolled and 1,556 were analysed, 772 in the irradiation group and 784 without.
After a median 59.5 months there had been 109 primary endpoint events, 50 in the irradiation group and 59 without. Regional nodal irradiation did not significantly lengthen the invasive breast cancer recurrence-free interval (hazard ratio 0.88, 95 percent confidence interval 0.60 to 1.28, p=0.51), and the point estimates of survival free from those events were 92.7 and 91.8 percent. It did not improve the locoregional recurrence-free interval, the distant recurrence-free interval, disease-free survival or overall survival. No deaths were attributed to the protocol therapy; grade 4 adverse events occurred in 0.5 percent of the irradiation group and 0.1 percent of the other.
This is a negative trial in the useful sense: it removes a treatment. Roughly four in ten patients with node-positive disease at diagnosis reach a complete nodal response with modern chemotherapy, and for those patients B-51 says the nodes can be left alone. It is the radiotherapy counterpart of what ATNEC is asking about surgery.
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.
1,641 registered.
50 events; point estimate of survival free from primary endpoint events 92.7 percent · 59 events; point estimate 91.8 percent
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Invasive breast cancer recurrence-free intervalprimary | Regional nodal irradiation | 772 | 0.88 hazard ratio | 0.88 (0.6 to 1.28) | 0.51 | link |
| No regional nodal irradiation | 784 | 59 events; point estimate 91.8 percent |
Shares Drugs before or after the operation, Targeted axillary dissection, ACOSOG Z1071 (Alliance), ATNEC.
Shares Radiotherapy after mastectomy, NSABP Foundation, NRG Oncology, HER2-positive breast cancer.
Shares NSABP Foundation, NRG Oncology, HER2-positive breast cancer, Breast cancer (all types).
Shares Radiotherapy after mastectomy, HER2-positive breast cancer, Breast cancer (all types), Triple-negative breast cancer (TNBC).
Shares NSABP Foundation, HER2-positive breast cancer, Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer.
Shares SUPREMO (BIG 2-04), Radiotherapy after mastectomy, HER2-positive breast cancer, Breast cancer (all types).
Shares Radiotherapy after mastectomy, HER2-positive breast cancer, Breast cancer (all types), IMRT / IGRT (modern external beam).
Shares NSABP Foundation, NRG Oncology, HER2-positive breast cancer, Breast cancer (all types).