Department of Medical Oncoly and Department of Supportive Care, Institut Curie, PSL Research University, Saint-Cloud, France.
Department of Biostatistics, Institut Curie, PSL Research University, Saint-Cloud, France.
Breast Cancer Res Treat. 2022 Feb;191(3):577-587. doi: 10.1007/s10549-021-06467-2. Epub 2022 Jan 5.
Older cancer patients are underrepresented in clinical trials. We aimed to evaluate the enrollment of older women aged 70 years old (yo) or over with metastatic breast cancer (MBC) in clinical trials.
We used the national Epidemio-Strategy and Medical Economics MBC Data Platform, a French multi-center real-life database. We selected MBC women over 70yo, without central nervous system metastases, with at least one line of systemic treatment, between January 1st, 2008 and December 31st, 2016, and had no other cancer in the 5 years before MBC. The primary objective was to evaluate the proportion of patients enrolled in clinical trials according to their age. Secondary objective was to identify variables associated with enrollment in older ones.
5552 women were aged ≥ 70 (median 74yo; IQR 72-77). 14,611 were less than 70. Of the older ones, 239 (4%) were enrolled in a clinical trial during first line of treatment, compared with 1529 (10.5%) for younger ones. Multivariable analysis of variables predicting for enrollment during first line of treatment in older patients were younger age (OR 0.50 [95%CI 0.33-0.76] for the 80-85yo class; OR 0.17 [95%CI 0.06-0.39] for the 85yo and more class), good ECOG Performance Status (PS 0-1) (OR 0.15 [95%CI 0.08-0.27] for the PS 2-4 class), HER2 + disease (OR 1.78 [95%CI 1.27-2.48]), type of treatment (chemotherapy/targeted therapy/immunotherapy OR 5.01 [95%CI 3.13-8.18]), and period (OR 1.65 [95%CI 1.22-2.26] for 2012-2016, compared to 2008-2011).
In this large database, few older MBC patients were enrolled in a trial compared with younger ones.
老年癌症患者在临床试验中代表性不足。本研究旨在评估转移性乳腺癌（MBC） 70 岁及以上老年女性患者的临床试验入组情况。
我们使用了法国多中心真实世界数据库——Epidemio-Strategy 和 Medical Economics MBC Data Platform。我们选择了 70 岁以上、无中枢神经系统转移、至少接受过一线系统治疗且在 MBC 前 5 年内无其他癌症的 MBC 女性患者。主要目的是根据年龄评估患者入组临床试验的比例。次要目的是确定与老年患者入组相关的变量。
5552 名女性年龄≥70 岁（中位数 74 岁；IQR 72-77），14611 名女性年龄＜70 岁。在年龄较大的患者中，239 名（4%）在一线治疗期间入组临床试验，而年龄较小的患者中，1529 名（10.5%）入组临床试验。多变量分析显示，年龄较大患者一线治疗期间入组的预测变量包括年龄较小（80-85 岁组 OR 0.50 [95%CI 0.33-0.76]；85 岁及以上组 OR 0.17 [95%CI 0.06-0.39]）、ECOG 表现状态（PS）较好（PS 2-4 组 OR 0.15 [95%CI 0.08-0.27]）、HER2 阳性疾病（OR 1.78 [95%CI 1.27-2.48]）、治疗类型（化疗/靶向治疗/免疫治疗 OR 5.01 [95%CI 3.13-8.18]）和研究时间（2012-2016 年 OR 1.65 [95%CI 1.22-2.26]，2008-2011 年）。
在这个大型数据库中，与年轻患者相比，接受试验治疗的老年 MBC 患者很少。
