Background:Despite early diagnosis, approximately 20% of patients with ER-positive and HER2-negative breast cancer (BC) will experience disease recurrence. Improved survival has been reported with adjuvant treatment combining cyclin-dependent kinase 4/6 inhibitors with endocrine therapy, in high-risk patients with ER-positive and HER2-negative BC, regardless of age. Older patients have higher rates of ER-positive/HER2-negative BC than younger patients.Methods:In this real-world data analysis, MonarchE and NataLEE high-risk patients accounted for 9.5% and 33% of patients undergoing upfront surgery, respectively. Significantly higher eligibility rates were observed in patients who underwent a mastectomy, >70 years and ≤40 years for adjuvant abemaciclib and ribociclib, and in patients >80 years for ribociclib.Results:Eligibility rates in patients ≤40 years and >80 years who underwent mastectomy were 27.8% and 24.7% for abemaciclib, respectively, and 56.6% and 65.2% for ribociclib, respectively. A higher discontinuation rate for abemaciclib was reported in patients aged ≥65 years and it can be assumed that discontinuation rates may increase in even older patients.Conclusions:If the results of the NataLEE trial translate into clinical practice, the number of patients potentially eligible for adjuvant CDK4/6 inhibitors may increase, especially in the elderly population.
背景:尽管实现了早期诊断,仍有约20%的雌激素受体阳性、人表皮生长因子受体2阴性乳腺癌患者会出现疾病复发。研究表明,无论年龄大小,高危型雌激素受体阳性、人表皮生长因子受体2阴性乳腺癌患者在接受细胞周期蛋白依赖性激酶4/6抑制剂联合内分泌治疗的辅助治疗后生存率有所提高。相较于年轻患者,老年患者中雌激素受体阳性/人表皮生长因子受体2阴性乳腺癌的比例更高。 方法:本次真实世界数据分析显示,在直接接受手术的患者中,符合MonarchE和NataLEE研究高风险标准的患者分别占9.5%和33%。接受乳房切除术的患者、70岁以上及40岁以下患者对阿贝西利辅助治疗的适用率显著更高,而80岁以上患者对瑞波西利的适用率尤为突出。 结果:在接受乳房切除术的≤40岁和>80岁患者中,阿贝西利的适用率分别为27.8%和24.7%,瑞波西利的适用率分别为56.6%和65.2%。数据显示65岁及以上患者中阿贝西利的停药率较高,据此推测更年长患者的停药率可能进一步上升。 结论:若NataLEE试验结果能够转化为临床实践,符合辅助性CDK4/6抑制剂治疗条件的患者数量或将增加,这一趋势在老年群体中尤为明显。