晚期乳腺癌化疗期间间歇性能量限制加抗阻运动与单纯抗阻运动的随机2期筛查试验
Randomised phase-2 screening trial of intermittent energy restriction plus resistance exercise versus resistance exercise alone during chemotherapy for advanced breast cancer.
作者信息
Harvie Michelle, Pegington Mary, Howell Anthony, Lim Yit, Livingstone Karen, Rose Danielle, McMullan Debbie, Maxwell Anthony, Barrett Emma, Sellers Katharine, Krizak Suzanne, Howell Sacha J
机构信息
Nightingale/Prevent Breast Cancer Centre, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, M23 9LT, UK.
Division of Cancer Sciences, The University of Manchester, Manchester, UK.
出版信息
Br J Cancer. 2025 Jul 31. doi: 10.1038/s41416-025-03129-8.
BACKGROUND
Weight control and energy restriction could improve survival in patients with advanced breast cancer (ABC) but randomised data are lacking. A randomised screening trial was conducted to assess an intermittent energy restricted diet and resistance exercise intervention (IER + RE) vs RE alone (RE) on progression free survival (PFS), toxicity and Quality of Life (QoL) during chemotherapy for ABC.
METHODS
Sixty-eight women were randomised to IER + RE (n = 35) or RE (n = 33) with one-sided significance assessed at the 20% threshold. The primary end point was PFS secondary endpoints included chemotherapy toxicity, weight change and QoL.
RESULTS
The adjusted hazard rate for progression comparing IER + RE vs RE was 0.729 (0.391-1.361) and the median PFS 42.0 vs 26.1 weeks respectively (p = 0.160). Toxicity was low and comparable between groups. Comparing IER + RE vs RE alone at cycle 3 the median (interquartile range) changes were: weight -1.8 kg (-4.2 to -0.7) vs +0.2 kg (-0.74, 2.59) (p < 0.001), FACT-B + 4.0 (-0.8, 11) vs +1.0 (-4.0, 4.0) (p = 0.031) and Hospital Anxiety Depression Score -2.0 (-3.5, +0.5) vs +1.0 (-2, 3.5) (p = 0.022).
CONCLUSION
IER + RE improved PFS and QoL without evidence of harms warranting a further larger randomised study in ABC.
TRIAL REGISTRATION
背景
体重控制和能量限制可能会改善晚期乳腺癌（ABC）患者的生存率，但缺乏随机数据。开展了一项随机筛查试验，以评估间歇性能量限制饮食和抗阻运动干预（IER + RE）与单纯抗阻运动（RE）相比，对ABC化疗期间无进展生存期（PFS）、毒性和生活质量（QoL）的影响。
方法
68名女性被随机分为IER + RE组（n = 35）或RE组（n = 33），以20%的阈值评估单侧显著性。主要终点是PFS，次要终点包括化疗毒性、体重变化和QoL。
结果
比较IER + RE与RE，进展的调整风险率为0.729（0.391 - 1.361），中位PFS分别为42.0周和26.1周（p = 0.160）。毒性较低且两组间相当。在第3周期比较IER + RE与单纯RE，中位数（四分位间距）变化为：体重 -1.8 kg（-4.2至 -0.7） vs +0.2 kg（-0.74，2.59）（p < 0.001），FACT - B +4.0（-0.8，11） vs +1.0（-4.0，4.0）（p = 0.031），医院焦虑抑郁量表评分 -2.0（-3.5，+0.5） vs +1.0（-2，3.5）（p = 0.022）。
结论
IER + RE改善了PFS和QoL，且无有害证据，因此有必要在ABC中开展进一步的大型随机研究。
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