Introduction

Limited data are available on the effects of treatment for advanced breast cancer (ABC) in older patients because this population has limited enrollment in clinical trials. Data generated from the prospective, noninterventional POLARIS study of patients with hormone receptor-positive/human epidermal growth factor receptor 2–negative ABC may help bridge the gap in our understanding of the tolerability and outcomes in this vulnerable population.

Materials and Methods

We evaluated measures of geriatric impairments and activities of daily living in patients with ABC aged ≥70 years in POLARIS to evaluate the change within six months of palbociclib initiation. Geriatric impairments and activities of daily living (functional) status were assessed using the Geriatric 8 (G8) and Activities of Daily Living (ADL) screening tools. The G8, ADL, and Eastern Cooperative Oncology Group performance status (ECOG PS) scores were assessed at baseline and month six through end of treatment with palbociclib. ECOG PS scores were also stratified by G8 and ADL score severity subgroups (G8: ≤14 = impaired subgroup; >14 = not at all impaired subgroup; ADL: <18 = dependent subgroup, 18 = independent subgroup).

Results

At data cutoff in November 2020, of 1282 POLARIS patients of all ages, 287 (22.4%) were ≥ 70 years old and completed ≥6 months of palbociclib therapy. At baseline, 117 (45%; n = 260) of these patients had an ECOG PS score of 0, 143 (55%; n = 260) had ECOG PS score > 0, 248 (86%) had G8 scores (mean [SD] 13.6 [2.14]), and 256 (89%) had ADL scores (17.7 [1.03]) among the available 287 patients. At six months, 102 (40%; n = 255) had an ECOG PS score of 0, 153 (60%; n = 255) had ECOG PS score > 0, 198 (69%) had G8 scores (13.6 [1.99]), and 211 (74%) had ADL scores (17.6 [1.22]) among the 287 available patients. There was no mean change (standard deviation) from baseline to 6 months in mean ECOG PS scores (0.0 [0.61], P = 0.24), G8 scores (0.0 [2.17], P = 0.89), or ADL scores (0.0 [1.00], P = 0.62).

Discussion

In this subgroup analysis of older patients with ABC from POLARIS, functional status and impairment outcomes were preserved in older patients receiving palbociclib. G8, ADL, and ECOG PS scores were generally maintained during the first six months of palbociclib therapy.

ClinicalTrials.gov identification number.

NCT03280303

中文翻译：

---

接受哌柏西利治疗晚期乳腺癌的老年患者的功能状态测量

介绍

关于老年患者晚期乳腺癌 (ABC) 治疗效果的数据有限，因为该人群参与临床试验的人数有限。对激素受体阳性/人表皮生长因子受体 2 阴性 ABC 患者进行的前瞻性、非干预性 POLARIS 研究产生的数据可能有助于弥合我们对这一弱势群体的耐受性和结果的理解差距。

材料和方法

我们在 POLARIS 中评估了 70 岁以上 ABC患者的老年损伤和日常生活活动指标，以评估哌柏西利开始治疗后 6 个月内的变化。使用老年 8 (G8) 和日常生活活动 (ADL) 筛查工具评估老年损伤和日常生活活动（功能）状态。在基线和第 6 个月直至哌柏西利治疗结束时评估 G8、ADL 和东部肿瘤合作组体能状态 (ECOG PS) 评分。ECOG PS 评分还按 G8 和 ADL 评分严重程度亚组进行分层（G8：≤14 = 受损亚组；>14 = 完全不受损亚组；ADL：<18 = 依赖亚组，18 = 独立亚组）。

结果

截至 2020 年 11 月数据截止，在 1282 名各年龄段的 POLARIS 患者中，287 名 (22.4%) 患者年龄≥ 70 岁，并完成了≥6 个月的哌柏西利治疗。基线时，这些患者中有 117 名（45%；n  = 260）的 ECOG PS 评分为 0，143 名（55%；n = 260）名患者的 ECOG PS 评分 > 0，248 名（86%）的 G8 评分（平均 [ SD] 13.6 [2.14]），在 287 名患者中，有 256 名（89%）有 ADL 评分（17.7 [1.03]）。六个月时，102 名 (40%; n = 255) 的 ECOG PS 评分为 0，153 名 (60%; n = 255) 的 ECOG PS 评分 > 0，198 名 (69%) 的 G8 评分 (13.6 [1.99]) ），在 287 名可用患者中，有 211 名（74%）有 ADL 评分（17.6 [1.22]）。平均 ECOG PS 评分 (0.0 [0.61], P  = 0.24)、G8 评分 (0.0 [2.17], P  = 0.89) 或 ADL 评分 (0.0 [1.00)从基线到 6 个月没有平均变化（标准差）]，P  = 0.62）。

讨论

在这项来自 POLARIS 的老年 ABC 患者亚组分析中，接受哌柏西利的老年患者保留了功能状态和损伤结果。在哌柏西利治疗的前六个月内，G8、ADL 和 ECOG PS 评分通常保持不变。

ClinicalTrials.gov 识别号。

NCT03280303