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Clinical Trial
. 2025 Nov 6;393(18):1771-1783.
doi: 10.1056/NEJMoa2412225.

Ten-Year Survival after Postmastectomy Chest-Wall Irradiation in Breast Cancer

Ian H Kunkler  1 , Nicola S Russell  2 , Niall Anderson  3 , Richard Sainsbury  4 , J Michael Dixon  5 , David Cameron  1 , Juliette Loncaster  6 , Matthew Hatton  7 , Helen Westenberg  8 , Jackie Clarke  9 , Heather McCarty  9 , Rhun Evans  9 , Konstantinos Geropantas  10 , Virginia Wolstenholme  11 , Abdulla Alhasso  12 , Pamela Woodings  13 , Lisa Barraclough  6 , Neil Bayman  6 , Richard Welch  14 , Fidelis Muturi  15 , Tracy McEleney  15 , Jacqueline Burns  15 , Kathleen Riddle  15 , Eve Macdonald  15 , Joanna Dunlop  15 , Nicole Sergenson  16 , Geertjan van Tienhoven  17 , Karen J Taylor  1 , John M S Bartlett  1 , Tammy Piper  1 , Galina Velikova  18 , Edwin Aird  19 , Boon Chua  20 , Coen Hurkmans  21 , Karen Venables  19 , Linda J Williams  22 , Jeremy S Thomas  23 , Andrew M Hanby  18 , Marjory Maclennan  24 , Susan Cleator  25 , Eldo T Verghese  18 , Yexiong Li  26 , Shulian Wang  26 , Peter Canney  12 ; SUPREMO Trial Investigators; Sunil
Collaborators, Affiliations
Clinical Trial

Ten-Year Survival after Postmastectomy Chest-Wall Irradiation in Breast Cancer

Ian H Kunkler et al. N Engl J Med. .

Abstract

Background: The role of postmastectomy chest-wall irradiation in patients with breast cancer classified as pN1 (with involvement of one to three axillary nodes) or pN0 (pathologically node negative) with additional risk factors is uncertain.

Methods: In this international, phase 3, randomized trial, we evaluated the omission of chest-wall irradiation in women with "intermediate-risk" breast cancer - defined as cancer that was stage pT1N1, pT2N1, or pT3N0 or stage pT2N0 with a histologic grade of 3, lymphovascular invasion, or both (tumor size: T1, ≤2 cm; T2, >2 cm to 5 cm; or T3, >5 cm) - that was treated with mastectomy, an axillary procedure, and systemic therapy. Patients were assigned to undergo chest-wall irradiation (40 to 50 Gy; the irradiation group) or not to undergo chest-wall irradiation (the no-irradiation group). The primary end point was overall survival, with 10 years of follow-up. Chest-wall recurrence, regional recurrence, disease-free survival, distant metastasis-free survival, causes of death, and radiation-related adverse events were also assessed.

Results: The intention-to-treat population included 808 patients in the irradiation group and 799 in the no-irradiation group. The median follow up was 9.6 years. Overall survival was 81.4% with chest-wall irradiation and 81.9% with no chest-wall irradiation according to 10-year Kaplan-Meier estimates (hazard ratio for death, 1.04; 95% confidence interval [CI], 0.82 to 1.30; P = 0.80). A total of 29 patients had a chest-wall recurrence - 9 (1.1%) in the irradiation group and 20 (2.5%) in the no-irradiation group (between-group difference, <2 percentage points; hazard ratio, 0.45; 95% CI, 0.20 to 0.99). Disease-free survival was 76.2% in the irradiation group and 75.5% in the no-irradiation group (hazard ratio for recurrence or death, 0.97; 95% CI, 0.79 to 1.18), and distant metastasis-free survival was 78.2% and 79.2%, respectively (hazard ratio for distant metastasis or death, 1.06; 95% CI, 0.86 to 1.31).

Conclusions: In this trial, chest-wall irradiation did not result in higher overall survival than no chest-wall irradiation among patients with intermediate-risk, early breast cancer treated with mastectomy and contemporary adjuvant systemic therapy. (Funded by the Medical Research Council and others; SUPREMO ISRCTN Clinical Study Registry number, 61145589.).

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Figures

Figure 1
Figure 1. CONSORT Diagram
Figure 2
Figure 2. Kaplan-Meier plot for unadjusted overall survival in ITT population.
Note that for clarity, the horizontal scale has been truncated at 10 years (excluding a small proportion of follow-up extending beyond this time period).
Figure 3
Figure 3. Kaplan-Meier plots for unadjusted secondary endpoints in ITT population.
Note that for clarity, the horizontal scale excludes follow-up longer than 10 years. A: Chest wall recurrence-free survival. B: Locoregional recurrence-free survival. C: Distant metastasis-free survival. D: Disease-free survival.
Figure 3
Figure 3. Kaplan-Meier plots for unadjusted secondary endpoints in ITT population.
Note that for clarity, the horizontal scale excludes follow-up longer than 10 years. A: Chest wall recurrence-free survival. B: Locoregional recurrence-free survival. C: Distant metastasis-free survival. D: Disease-free survival.
Figure 3
Figure 3. Kaplan-Meier plots for unadjusted secondary endpoints in ITT population.
Note that for clarity, the horizontal scale excludes follow-up longer than 10 years. A: Chest wall recurrence-free survival. B: Locoregional recurrence-free survival. C: Distant metastasis-free survival. D: Disease-free survival.
Figure 3
Figure 3. Kaplan-Meier plots for unadjusted secondary endpoints in ITT population.
Note that for clarity, the horizontal scale excludes follow-up longer than 10 years. A: Chest wall recurrence-free survival. B: Locoregional recurrence-free survival. C: Distant metastasis-free survival. D: Disease-free survival.
Figure 4
Figure 4. Forest plot for subgroup analyses of primary endpoint of overall survival in ITT population.
Subgroups considered are age groups, nodal status and molecular subtype. For comparison, the HR for randomised treatment (stratified only by center) is provided at the bottom of the plot.
Figure 4
Figure 4. Forest plot for subgroup analyses of primary endpoint of overall survival in ITT population.
Subgroups considered are age groups, nodal status and molecular subtype. For comparison, the HR for randomised treatment (stratified only by center) is provided at the bottom of the plot.
See this image and copyright information in PMC

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