Impact of adding palbociclib on treatment adherence to ongoing adjuvant endocrine treatment in the global randomized PALLAS randomized trial in patients with early breast cancer.

IF 3 3区医学 Q2 ONCOLOGY

Breast Cancer Research and Treatment Pub Date : 2025-03-27 DOI:10.1007/s10549-025-07653-2

Eileen Shinn, David Zahrieh, Angela DeMichele, Nick Zdenkowski, Julie Lemieux, Jun Mao, Vesna Bjelic-Radisic, Michelle J Naughton, Georg Pfeiler, Karen Gelmon, Justin M Balko, Daniel Egle, Gabriele Zoppoli, Tiffany Traina, Miguel Martin Jimenez, Silvia Antolin Novoa, Tufia Haddad, Arlene Chan, Alistair Ring, Antonio Wolff, William Fraser Symmans, Jose Ponce Lorenzo, Dhanusha Sabanathan, Hal J Burstein, Zbigniew Ireneusz Nowecki, Gunda Pristauz-Telsnigg, Adam Brufsky, Meritxell Bellet-Ezquerra, Theodoros Foukakis, Yelena Novik, Gabor Rubovszky, Christian F Singer, Karoline Muehlbacher, Otto Metzger Filho, Theodora Goulioti, Ernest Law, Ann H Partridge, Lisa A Carey, Alex Zoroufy, Dominik Hlauschek, Christian Fesl, Erica L Mayer, Michael Gnant

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引用次数: 0

Abstract

Purpose: Using patient-reported outcomes (PROs) and more objective measures, we evaluated adherence to adjuvant palbociclib and ET in the PALLAS trial, and the impact of palbociclib on ET adherence.

Methods: The open-label, global, phase 3 PALLAS trial randomized patients with hormone receptor-positive (HR+), HER2-negative stage II-III breast cancer (1:1) to either 26 cycles of palbociclib (125 mg/day for 21 days and then 7 days off) plus adjuvant ET, versus ET alone. After 23.7 months median follow-up, palbociclib was stopped due to futility of the intervention and patients were moved to follow-up. For each cycle, daily adherence to ET was measured with study diaries; for palbociclib, study diaries and pill counts. At cycles 2, 3, 6, 12, 18 and 24, patients completed the Morisky Medication Adherence Scale-4 plus an additional item and the McHorney Adherence Questionnaire. Mean persistence was defined in months from treatment initiation to cessation.

Results: Four thousand six hundred eighty-eight of 5796 total PALLAS participants were included. Across all cycles, mean daily ET adherence values measured by study diary were > 98.0% and did not differ between treatment arms. Mean persistence to ET was similar between arms (19.2 months for palbociclib + ET vs. 19.6 months for ET alone). However, patient-reported maximal ET adherence was higher across time for palbociclib + ET compared to ET alone (p ≤ 0.0001, modified MMAS-4; p = 0.05, McHorney).

Conclusion: In the PALLAS trial, addition of palbociclib did not decrease adherence to adjuvant ET. Though numbers declined over time, daily adherence for palbociclib and ET remained relatively high at each cycle.

Trial registration: The trial is registered with ClinicalTrials.gov (NCT02513394; 07-31-2015) and EudraCT (2014-005181-30).

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早期乳腺癌患者全球随机PALLAS随机试验中加入帕博西尼对辅助内分泌治疗依从性的影响

目的：使用患者报告的结果（PROs）和更客观的测量方法，我们评估了PALLAS试验中辅助帕博西尼和ET的依从性，以及帕博西尼对ET依从性的影响。方法：开放标签的全球3期PALLAS试验将激素受体阳性（HR+）， her2阴性的II-III期乳腺癌患者（1:1）随机分为26个周期的帕博西尼（125 mg/天，21天，然后休息7天）加辅助ET与单独ET。中位随访23.7个月后，因干预无效停用帕博西尼，转入随访。在每个周期中，研究人员用研究日记来测量每日对ET的依从性；对于帕博西尼，研究日记和药片计数。在第2、3、6、12、18和24个周期，患者完成Morisky药物依从性量表-4加上一个附加项目和McHorney依从性问卷。平均持续时间定义为从治疗开始到停止的月数。结果：5796名PALLAS参与者中有4,688人被纳入。在所有周期中，研究日记测量的平均每日ET依从性值为98.0%，治疗组之间无差异。各组间ET的平均持续时间相似（帕博西尼+ ET组19.2个月，单独ET组19.6个月）。然而，患者报告的帕博西尼+ ET的最大ET依从性高于单独ET (p≤0.0001，改良MMAS-4；p = 0.05, McHorney)。结论：在PALLAS试验中，帕博西尼的加入并没有降低辅助ET的依从性。尽管随着时间的推移，帕博西尼和ET的每日依从性仍然相对较高。试验注册：该试验已在ClinicalTrials.gov注册(NCT02513394；07-31-2015)和EudraCT（2014-005181-30）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Breast Cancer Research and Treatment 医学-肿瘤学

CiteScore

6.80

自引率

2.60%

发文量

342

审稿时长

1 months

期刊介绍： Breast Cancer Research and Treatment provides the surgeon, radiotherapist, medical oncologist, endocrinologist, epidemiologist, immunologist or cell biologist investigating problems in breast cancer a single forum for communication. The journal creates a "market place" for breast cancer topics which cuts across all the usual lines of disciplines, providing a site for presenting pertinent investigations, and for discussing critical questions relevant to the entire field. It seeks to develop a new focus and new perspectives for all those concerned with breast cancer.