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乳腺癌康复运动:两项随机对照试验的探索性生存分析。

Exercise following breast cancer: exploratory survival analyses of two randomised, controlled trials.

机构信息

Institute of Health and Biomedical Innovation, School of Public Health and Social Work, Queensland University of Technology, Brisbane, Australia.

QIMR Berghofer Medical Research Institute, Brisbane, Australia.

出版信息

Breast Cancer Res Treat. 2018 Jan;167(2):505-514. doi: 10.1007/s10549-017-4541-9. Epub 2017 Oct 23.

Abstract

PURPOSE

The Exercise for Health trials were randomised, controlled trials designed to evaluate an 8-month pragmatic exercise intervention, commencing 6 weeks post-surgery for women with newly diagnosed breast cancer residing in urban or rural/regional Australia. For these exploratory analyses, the primary and secondary outcomes were overall survival (OS) and disease-free survival (DFS), respectively.

METHODS

Consenting urban- (n = 194) and rural/regional-residing women (n = 143) were randomised to exercise (intervention delivered face-to-face or by telephone) or usual care. Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CI) for survival outcomes (exercise group, n = 207, 65% urban women; usual care group, n = 130, 46% urban women).

RESULTS

After a median follow-up of 8.3 years, there were 11 (5.3%) deaths in the exercise group compared with 15 (11.5%) deaths in the usual care group (OS HR for the exercise group: 0.45, 95% CI 0.20-0.96; p = 0.04). DFS events for the exercise versus usual care group were 25 (12.1%) and 23 (17.7%), respectively (HR: 0.66, 95% CI 0.38-1.17; p = 0.16). HRs for OS favoured exercise irrespective of age, body mass index, stage of disease, intervention compliance, and physical activity levels at 12 months post-diagnosis, although were stronger (p < 0.05) for younger women, women with stage II + disease, women with 1 + comorbidity at time of diagnosis, higher intervention compliance and for those who met national physical activity guidelines at 12 months post-diagnosis.

CONCLUSION

An exercise intervention delivered during and beyond treatment for breast cancer, and that was designed to cater for all women irrespective of place of residence and access to health services, has clear potential to benefit survival. Trial numbers: ACT RN: 012606000233527; ACT RN: 12609000809235.

摘要

目的

“锻炼与健康”试验是一项随机对照试验,旨在评估一项为期 8 个月的实用锻炼干预措施,该措施从女性乳腺癌确诊后 6 周开始实施,研究对象为居住在澳大利亚城市或农村/地区的女性。对于这些探索性分析,主要和次要结局分别为总生存(OS)和无病生存(DFS)。

方法

同意参加的城市(n=194)和农村/地区居住的女性(n=143)被随机分配到锻炼(干预通过面对面或电话进行)或常规护理组。使用 Cox 比例风险模型估计生存结局的风险比(HR)和 95%置信区间(CI)(锻炼组 n=207,65%为城市女性;常规护理组 n=130,46%为城市女性)。

结果

中位随访 8.3 年后,锻炼组有 11 例(5.3%)死亡,常规护理组有 15 例(11.5%)死亡(锻炼组 OS 的 HR:0.45,95%CI 0.20-0.96;p=0.04)。与常规护理组相比,锻炼组的 DFS 事件分别为 25 例(12.1%)和 23 例(17.7%)(HR:0.66,95%CI 0.38-1.17;p=0.16)。无论年龄、体重指数、疾病分期、干预依从性以及诊断后 12 个月的体力活动水平如何,OS 的 HR 均有利于锻炼,但在年轻女性、疾病分期为 II+的女性、诊断时合并症为 1+的女性、更高的干预依从性以及诊断后 12 个月符合国家体力活动指南的女性中更强(p<0.05)。

结论

在乳腺癌治疗期间和之后进行的锻炼干预措施,旨在为所有女性提供服务,无论其居住地点和获得卫生服务的情况如何,都有可能显著改善生存。试验编号:ACT RN:012606000233527;ACT RN:12609000809235。

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