N Engl J Med 2015 Jul 23
Regional Nodal Irradiation in Early-Stage Breast Cancer.
ABSTRACT
BACKGROUND
Most women with breast cancer who undergo breast-conserving surgery receive whole-breast irradiation. We examined whether the addition of regional nodal irradiation to whole-breast irradiation improved outcomes.
METHODS
We randomly assigned women with node-positive or high-risk node-negative breast cancer who were treated with breast-conserving surgery and adjuvant systemic therapy to undergo either whole-breast irradiation plus regional nodal irradiation (including internal mammary, supraclavicular, and axillary lymph nodes) (nodal-irradiation group) or whole-breast irradiation alone (control group). The primary outcome was overall survival. Secondary outcomes were disease-free survival, isolated locoregional disease-free survival, and distant disease-free survival.
RESULTS
Between March 2000 and February 2007, a total of 1832 women were assigned to the nodal-irradiation group or the control group (916 women in each group). The median follow-up was 9.5 years. At the 10-year follow-up, there was no significant between-group difference in survival, with a rate of 82.8% in the nodal-irradiation group and 81.8% in the control group (hazard ratio, 0.91; 95% confidence interval [CI], 0.72 to 1.13; P=0.38). The rates of disease-free survival were 82.0% in the nodal-irradiation group and 77.0% in the control group (hazard ratio, 0.76; 95% CI, 0.61 to 0.94; P=0.01). Patients in the nodal-irradiation group had higher rates of grade 2 or greater acute pneumonitis (1.2% vs. 0.2%, P=0.01) and lymphedema (8.4% vs. 4.5%, P=0.001).
CONCLUSIONS
Among women with node-positive or high-risk node-negative breast cancer, the addition of regional nodal irradiation to whole-breast irradiation did not improve overall survival but reduced the rate of breast-cancer recurrence. (Funded by the Canadian Cancer Society Research Institute and others; MA.20 ClinicalTrials.gov number, NCT00005957.).
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).
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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.
New comment by Radiation Oncologist at SSM Cancer Center/St Louis CyberKnife ( January 24, 2019)
Thanks for your response @Benjamin D. Smith. As a follow-up to the OP's questions, how should the total number of nodes removed affect our decision (i.e. 3 nodes positive out ...
In other words, have the results of the MA.20 and EORTC trials changed your practice?
New answer by Radiation Oncologist at Northwestern University (September 17, 2013)
I hope that this question can be answered more definitively in the near future. At the present time, I await publication (and untimately more maturity) of the MA-20 data set a...
Or for that matter, offer PMRT on the basis of a patient having triple negative disease?
New answer by Radiation Oncologist at Varian Medical Systems/Allegheny health network (February 5, 2014)
At present I don't, but once Canadian and EORTC studies are published with full details available, it may change practice patterns.
Did the EBCTCG meta-analysis change your practice?
New comment by Radiation Oncologist at UNC School of Medicine ( August 2, 2023)
These are very challenging questions. The randomized data demonstrated an improvement in overall survival treated comprehensively (chest wall and nodes). So, it seems prudent ...
After the publication of ACOSOG Z11 we are seeing these patients in increasing numbers.
New answer by Radiation Oncologist at University of Maryland Shore Medical Center at Easton (March 20, 2018)
Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS):a randomised, multicentre, open-label, phase 3non-inferiority ...
Would it be acceptable to treat a patient with locally advanced breast cancer (ex pT2N2a) s/p lumpectomy with a short course 4 week treatment ins...
New answer by Radiation Oncologist at Varian Medical Systems/Allegheny health network (February 20, 2020)
We routinely offer HFRT for PMRT for non inflammatory breast cancer or for patients without immediate reconstruction (we offer them the NRG study). We use 40 Gy in 15 fraction...
Is it still acceptable to deliver hypofractionation for what was previously a Stage I TN breast cancer, now Stage IIIA? Should RNI be considered? Or e...
New answer by Radiation Oncologist at New York University School of Medicine (May 2, 2017)
The new stage should not in and of itself change management as the data and studies remain unchanged. Thus, for triple negative cancers, I would continue to hypofractionate if...
New answer by Radiation Oncologist at Varian Medical Systems/Allegheny health network (September 29, 2017)
The data in a node negative situation is lacking /limited but in 1-3 positive node, pec fascia involvement was associated with high risk of recurrence even when surgeon excise...