N Engl J Med 2015 Jul 23
Internal Mammary and Medial Supraclavicular Irradiation in Breast Cancer.
ABSTRACT
BACKGROUND
The effect of internal mammary and medial supraclavicular lymph-node irradiation (regional nodal irradiation) added to whole-breast or thoracic-wall irradiation after surgery on survival among women with early-stage breast cancer is unknown.
METHODS
We randomly assigned women who had a centrally or medially located primary tumor, irrespective of axillary involvement, or an externally located tumor with axillary involvement to undergo either whole-breast or thoracic-wall irradiation in addition to regional nodal irradiation (nodal-irradiation group) or whole-breast or thoracic-wall irradiation alone (control group). The primary end point was overall survival. Secondary end points were the rates of disease-free survival, survival free from distant disease, and death from breast cancer.
RESULTS
Between 1996 and 2004, a total of 4004 patients underwent randomization. The majority of patients (76.1%) underwent breast-conserving surgery. After mastectomy, 73.4% of the patients in both groups underwent chest-wall irradiation. Nearly all patients with node-positive disease (99.0%) and 66.3% of patients with node-negative disease received adjuvant systemic treatment. At a median follow-up of 10.9 years, 811 patients had died. At 10 years, overall survival was 82.3% in the nodal-irradiation group and 80.7% in the control group (hazard ratio for death with nodal irradiation, 0.87; 95% confidence interval [CI], 0.76 to 1.00; P=0.06). The rate of disease-free survival was 72.1% in the nodal-irradiation group and 69.1% in the control group (hazard ratio for disease progression or death, 0.89; 95% CI, 0.80 to 1.00; P=0.04), the rate of distant disease-free survival was 78.0% versus 75.0% (hazard ratio, 0.86; 95% CI, 0.76 to 0.98; P=0.02), and breast-cancer mortality was 12.5% versus 14.4% (hazard ratio, 0.82; 95% CI, 0.70 to 0.97; P=0.02). Acute side effects of regional nodal irradiation were modest.
CONCLUSIONS
In patients with early-stage breast cancer, irradiation of the regional nodes had a marginal effect on overall survival. Disease-free survival and distant disease-free survival were improved, and breast-cancer mortality was reduced. (Funded by Fonds Cancer; ClinicalTrials.gov number, NCT00002851.).
Related Questions
How much will you weigh the demonstrated disease-free survival, including distant disease-free survival, in your recommendations?
New comment by Radiation Oncologist at Cleveland Clinic ( July 4, 2018)
I would respectfully disagree. An improvement in DFS is meaningful for patients and there are subsets that may have an OS advantage to the addition of RNI (ex. ER negative).
...
Assume patient had 15 nodes removed. What if 1 or 2 nodes were positive?
New answer by Radiation Oncologist at Varian Medical Systems/Allegheny health network (January 18, 2018)
I agree with above. At present, if the breast cancer is triple negative with any node positive disease, I routinely treat with RNI.
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At present I don't, but once Canadian and EORTC studies are published with full details available, it may change practice patterns.
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