预处理转移性乳腺癌患者有氧运动的可行性、安全性和有效性：一项随机对照试验。
Feasibility, safety, and efficacy of aerobic training in pretreated patients with metastatic breast cancer: A randomized controlled trial.
机构信息
Memorial Sloan Kettering Cancer Center, New York, New York.
Weill Cornell Medical College, New York, New York.
出版信息
Cancer. 2018 Jun 15;124(12):2552-2560. doi: 10.1002/cncr.31368. Epub 2018 Apr 6.
BACKGROUND
The investigation of exercise training in metastatic breast cancer has received minimal attention. This study determined the feasibility and safety of aerobic training in metastatic breast cancer.
METHODS
Sixty-five women (age, 21-80 years) with metastatic (stage IV) breast cancer (57% were receiving chemotherapy, and >40% had ≥ 2 lines of prior therapy) were allocated to an aerobic training group (n = 33) or a stretching group (n = 32). Aerobic training consisted of 36 supervised treadmill walking sessions delivered thrice weekly between 55% and 80% of peak oxygen consumption (VO ) for 12 consecutive weeks. Stretching was matched to aerobic training with respect to location, frequency, duration, and intervention length. The primary endpoint was aerobic training feasibility, which was a priori defined as the lost to follow-up (LTF) rate (<20%) and attendance (≥70%). Secondary endpoints were safety, objective outcomes (VO and functional capacity), and patient-reported outcomes (PROs; quality of life).
RESULTS
One of the 33 patients (3%) receiving aerobic training was LTF, whereas the mean attendance rate was 63% ± 30%. The rates of permanent discontinuation and dose modification were 27% and 49%, respectively. Intention-to-treat analyses indicated improvements in PROs, which favored the attention control group (P values > .05). Per protocol analyses indicated that 14 of 33 patients (42%) receiving aerobic training had acceptable tolerability (relative dose intensity ≥ 70%), and this led to improvements in VO and functional capacity (P values < .05).
CONCLUSIONS
Aerobic training at the dose and schedule tested is safe but not feasible for a significant proportion of patients with metastatic breast cancer. The acceptable feasibility and promising benefit for select patients warrant further evaluation in a dose-finding phase 1/2 study. Cancer 2018;124:2552-60. © 2018 American Cancer Society.
背景
运动训练在转移性乳腺癌中的研究受到的关注较少。本研究旨在确定有氧运动训练在转移性乳腺癌中的可行性和安全性。
方法
将 65 名（年龄 21-80 岁）转移性（IV 期）乳腺癌女性（57%正在接受化疗，超过 40%的患者有≥2 线既往治疗）分为有氧运动训练组（n=33）和拉伸组（n=32）。有氧运动训练包括 36 次有监督的跑步机步行，每周 3 次，强度为峰值耗氧量（VO ）的 55%-80%，持续 12 周。拉伸训练与有氧运动训练在地点、频率、时长和干预时长方面相匹配。主要终点是有氧运动训练的可行性，其定义为失访率（<20%）和参与率（≥70%）。次要终点是安全性、客观结局（VO 和功能能力）和患者报告的结局（PRO；生活质量）。
结果
接受有氧运动训练的 33 名患者中有 1 名（3%）失访，平均参与率为 63%±30%。永久性停药和剂量调整的发生率分别为 27%和 49%。意向治疗分析表明 PRO 有所改善，且优势偏向于对照组（P 值>.05）。按方案分析表明，接受有氧运动训练的 33 名患者中有 14 名（42%）具有可接受的耐受性（相对剂量强度≥70%），这导致 VO 和功能能力的改善（P 值<.05）。
结论
对于相当一部分转移性乳腺癌患者，按照测试剂量和方案进行的有氧运动训练是安全的，但可行性不高。对于部分患者具有可接受的可行性和有前景的获益，因此需要进一步在剂量探索的 1/2 期研究中进行评估。癌症 2018；124：2552-60。©2018 美国癌症协会。
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