Palmér Sofia, Valachis Antonis, Lindman Henrik, Smith Daniel Robert, Wickberg Åsa, Killander Fredrika, Bjöhle Judith, Einbeigi Zakaria, Nilsson Greger, Ahlgren Johan, Villman Kenneth
Department of Oncology, Faculty of Medicine and Health, Örebro University Hospital, Örebro University, Örebro SE-70182, Sweden.
Department of Oncology, Uppsala University Hospital, Uppsala 751 85, Sweden.
J Natl Cancer Inst. 2025 Jun 1;117(6):1125-1133. doi: 10.1093/jnci/djae315.
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.
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.
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.
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.
这项前瞻性队列研究旨在评估对于接受保乳手术及辅助内分泌治疗的65岁及以上、低风险、雌激素受体阳性的T1N0乳腺癌女性患者，术后放疗是否可以安全省略。
符合条件的患者为65岁及以上、单灶、非小叶、1或2级、雌激素受体阳性、pT1N0乳腺癌且接受了保乳手术及5年内分泌治疗的女性。患者至少每年接受一次乳房X光检查，随访10年。主要终点是局部复发。次要终点是对侧乳腺癌、无复发生存率和总生存率。
最终研究队列包括601例患者，中位年龄71岁（范围=65-90岁），中位肿瘤大小11毫米（范围=3-20毫米）。中位随访时间为119个月（四分位间距=103-121个月）。5年和10年时局部复发的累积发生率分别为1.5%（95%置信区间[CI]=0.8%至2.8%）和5.5%（95%CI=3.8%至7.6%）。5年和10年时对侧乳腺癌的累积发生率分别为1.7%（95%CI=0.9%至3.0%）和4.5%（95%CI=3.0%至6.6%）。10年时的总生存率为83.1%（95%CI=80.8%至85.4%）。共有3例（0.5%）患者死于乳腺癌。
我们的结果支持对于65岁及以上、低风险、雌激素受体阳性、pT1N0乳腺癌且接受辅助内分泌治疗的特定亚组女性患者，在保乳手术后省略放疗具有可能性。
