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. 2025 Jun 1;117(6):1125-1133.
doi: 10.1093/jnci/djae315.

Omission of postoperative radiotherapy after breast-conserving surgery in low-risk breast cancer

Affiliations

Omission of postoperative radiotherapy after breast-conserving surgery in low-risk breast cancer

Sofia Palmér et al. J Natl Cancer Inst. .

Abstract

Background: This prospective cohort study aimed to assess whether postoperative radiotherapy could safely be omitted in women aged 65 years and older with low-risk, estrogen receptor-positive T1N0 breast cancer treated with breast-conserving surgery and adjuvant endocrine therapy.

Methods: Eligible patients were women aged 65 years and older with unifocal, nonlobular, grade 1 or 2, estrogen receptor-positive, pT1N0 breast cancer treated with breast-conserving surgery and endocrine therapy for 5 years. Patients were followed up with mammography at least annually for 10 years. The primary endpoint was local recurrence. Secondary endpoints were contralateral breast cancer, recurrence-free survival, and overall survival.

Results: The final study cohort included 601 patients with a median age of 71 years (range = 65-90 years) and a median tumor size of 11 mm (range = 3-20 mm). Median follow-up time was 119 months (interquartile range = 103-121 months). The cumulative incidence of local recurrence was 1.5% (95% confidence interval [CI] = 0.8% to 2.8%) and 5.5% (95% CI = 3.8% to 7.6%) at 5 and 10 years, respectively. The cumulative incidence of contralateral breast cancer was 1.7% (95% CI = 0.9% to 3.0%) at 5 years and 4.5% (95% CI = 3.0% to 6.6%) at 10 years. The overall survival rate at 10 years was 83.1% (95% CI = 80.8% to 85.4%). In total, 3 (0.5%) patients died because of breast cancer.

Conclusion: Our results support the possibility to omit radiotherapy after breast-conserving surgery in a well-defined subgroup of women aged 65 years and older with low-risk, estrogen receptor-positive, pT1N0 breast cancer receiving adjuvant endocrine therapy.

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Conflict of interest statement

Antonis Valachis has received institutional unrestricted grants from Roche and MSD unrelated to current work. The other authors have no relevant conflicts of interest to report.

Figures

Figure 1.
Figure 1.
Flowchart showing the process of inclusion and causes for study termination. Patient relocation and clinically significant comorbidity preventing further participation were defined as known reasons for loss to follow-up. Of the 55 patients who withdrew from the study, 4 cited adverse events to endocrine therapy as the cause for withdrawal.
Figure 2.
Figure 2.
Cumulative incidence of local recurrence. The shaded area around the curve indicates the 95% confidence interval. The inset shows the same data on an expanded y axis.
Figure 3.
Figure 3.
Cumulative incidence of regional recurrence. The shaded area around the curve indicates the 95% confidence interval. The inset shows the same data on an expanded y axis.
Figure 4.
Figure 4.
Cumulative incidence of contralateral breast cancer. The shaded area around the curve indicates the 95% confidence interval. The inset shows the same data on an expanded y axis.
Figure 5.
Figure 5.
Kaplan–Meier curves showing (A) recurrence-free survival and (B) overall survival in the study cohort.

Comment in

References

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