Department of Medical Oncology, Institut Curie/Saint-Cloud, Paris, France.
Pfizer Inc., New York, NY, USA.
Target Oncol. 2024 May;19(3):303-320. doi: 10.1007/s11523-024-01046-z. Epub 2024 Mar 28.
Palbociclib in combination with endocrine therapy is approved for treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. In addition to clinical trials, several real-world studies have evaluated the effectiveness of palbociclib. With increased life expectancy in the general population, breast cancer in older women is also expected to increase.
The aim was to systematically review evidence from both clinical trials and real-world studies for palbociclib treatment outcomes in older patients with HR+/HER2- advanced/metastatic breast cancer (a/mBC). Older patients are often underrepresented in clinical trials, and real-world evidence (RWE) will enrich the analysis of palbociclib outcomes in this subgroup of patients.
A systematic literature search in PubMed, EMBASE, and Cochrane Library through May 4, 2023, yielded 2355 unique articles. A total of 52 articles (13 and 39 articles reporting results from seven randomized controlled trials [RCTs] and 37 RWE studies, respectively) were included based on study eligibility criteria.
All RCTs used age cutoffs of ≥ 65 years to define older population (n = 722; 437 received palbociclib); all RWE studies, except one with an age cutoff of > 60 years, had age cutoffs of ≥ 65 years or higher to define older population (n = 9840; 7408 received palbociclib). Overall, in studies that compared efficacy (progression-free survival [seven RCTs, 20 RWE studies], overall survival [four RCTs, 11 RWE studies], tumor response [three RWE studies], and clinical benefit rate [one RCT, two RWE studies]) and safety outcomes (three RCTs, three RWE studies) between older and younger patients, palbociclib showed similar benefits, regardless of age. Results from two RCTs and two RWE studies showed that global quality of life (QoL) was maintained in older patients receiving palbociclib. Overall, palbociclib dose modifications (two RWE studies), dose reductions (one RCT, seven RWE studies), and treatment discontinuation rates (three RCTs, three RWE studies) were higher in older patients compared with younger patients; however, these differences did not appear to adversely impact efficacy outcomes.
In this systematic review, data from RCTs showed that palbociclib was effective, well tolerated, and maintained QoL in older patients with HR+/HER2- a/mBC. Palbociclib treatment in older patients in real-world settings was associated with similar clinical benefit as in RCTs.
CRD42023444195.
哌柏西利联合内分泌治疗获批用于治疗激素受体阳性（HR+）/人表皮生长因子受体 2 阴性（HER2-）晚期乳腺癌。除临床试验外，多项真实世界研究也评估了哌柏西利的疗效。随着普通人群预期寿命的延长，老年女性的乳腺癌也预计会增加。
旨在系统回顾临床试验和真实世界研究中哌柏西利治疗 HR+/HER2-晚期/转移性乳腺癌（a/mBC）老年患者的疗效证据。老年患者通常在临床试验中代表性不足，真实世界证据（RWE）将丰富该亚组患者的哌柏西利疗效分析。
通过 2023 年 5 月 4 日在 PubMed、EMBASE 和 Cochrane Library 进行的系统文献检索，共获得 2355 篇独特的文章。根据研究纳入标准，共有 52 篇文章（13 篇和 39 篇分别报道了 7 项随机对照试验[RCT]和 37 项真实世界研究结果）被纳入。
所有 RCT 均使用年龄≥65 岁的截止值来定义老年人群（n=722；437 例接受哌柏西利治疗）；除一项年龄截止值>60 岁的研究外，所有 RWE 研究均使用年龄≥65 岁或更高的截止值来定义老年人群（n=9840；7408 例接受哌柏西利治疗）。总体而言，在比较疗效（无进展生存期[7 项 RCT、20 项 RWE 研究]、总生存期[4 项 RCT、11 项 RWE 研究]、肿瘤反应[3 项 RWE 研究]和临床获益率[1 项 RCT、2 项 RWE 研究]）和安全性结局（3 项 RCT、3 项 RWE 研究）的研究中，无论年龄大小，哌柏西利均显示出相似的获益。两项 RCT 和两项 RWE 研究的结果表明，接受哌柏西利治疗的老年患者的总体生活质量（QoL）得以维持。总体而言，与年轻患者相比，老年患者中哌柏西利的剂量调整（两项 RWE 研究）、剂量减少（一项 RCT、7 项 RWE 研究）和治疗中止率（3 项 RCT、3 项 RWE 研究）更高；然而，这些差异似乎并未对疗效结局产生不利影响。
在本系统综述中，RCT 数据表明，哌柏西利在 HR+/HER2-晚期/转移性乳腺癌老年患者中有效、耐受良好且维持 QoL。在真实世界环境中，哌柏西利治疗老年患者与 RCT 中相似，具有相似的临床获益。
CRD42023444195。
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