Savard M F, Ibrahim M, Saunders D, Pond G R, Ng T L, Awan A A, Sehdev S, Alqahtani N, Vandermeer L, MacDonald F, Beltran-Bless A A, Fallowfield L, Clemons M
Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, ON, Canada.
Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
NPJ Breast Cancer. 2025 May 29;11(1):49. doi: 10.1038/s41523-025-00762-7.
The time of day of administration (chronotherapy) of certain medications can affect both their toxicity and efficacy. In this pragmatic, multicenter trial, women starting adjuvant endocrine therapy (ET) for hormone receptor-positive early-stage breast cancer were randomized (1:1) to either morning or evening administration. The primary endpoint was endocrine toxicity/tolerability measured by the change in total Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) score from baseline to 12-weeks. Secondary endpoints included: endocrine toxicity/tolerability and quality of life (FACT-ES and FACT-B) from baseline to 4, 8, 12, and 52 weeks, non-persistence or non-adherence, and patient preference for timing of ET. Between June 30, 2021, and March 18, 2022, 245 eligible participants were randomized to either morning (122/245, 49.8%) or evening ET (123/245, 50.2%). In the overall population, there was no statistical difference in the change in total FACT-ES score from baseline to 12 weeks (p = 0.086). There were no statistically significant differences for any of the secondary endpoints between the two groups. The study provides evidence for the enthusiasm of patients and investigators to take part in chronotherapy studies. Additional prospective studies should be performed to assess how the timing of ET affects survival outcomes to ensure optimal patient care. Trial Registration: ClinicalTrials.gov, NCT04864405.
某些药物的给药时间（时辰疗法）会影响其毒性和疗效。在这项实用的多中心试验中，开始接受激素受体阳性早期乳腺癌辅助内分泌治疗（ET）的女性被随机（1:1）分为早晨给药组或晚上给药组。主要终点是通过癌症治疗功能评估 - 内分泌子量表（FACT - ES）总分从基线到12周的变化来衡量内分泌毒性/耐受性。次要终点包括：从基线到4、8、12和52周的内分泌毒性/耐受性和生活质量（FACT - ES和FACT - B）、不持续用药或不依从情况，以及患者对ET给药时间的偏好。在2021年6月30日至2022年3月18日期间，245名符合条件的参与者被随机分为早晨ET组（122/245，49.8%）或晚上ET组（123/245，50.2%）。在总体人群中，从基线到12周FACT - ES总分的变化没有统计学差异（p = 0.086）。两组之间的任何次要终点均无统计学显著差异。该研究为患者和研究者参与时辰疗法研究的积极性提供了证据。应进行更多前瞻性研究，以评估ET给药时间如何影响生存结果，以确保为患者提供最佳护理。试验注册：ClinicalTrials.gov，NCT04864405。
