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随机临床试验:运动和营养对女性乳腺癌化疗完成和病理完全缓解的影响:生活方式、运动和营养早期诊断研究。

Randomized Trial of Exercise and Nutrition on Chemotherapy Completion and Pathologic Complete Response in Women With Breast Cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis Study.

机构信息

Yale University School of Medicine, New Haven, CT.

Yale Cancer Center, New Haven, CT.

出版信息

J Clin Oncol. 2023 Dec 1;41(34):5285-5295. doi: 10.1200/JCO.23.00871. Epub 2023 Sep 1.

Abstract

PURPOSE

Successful completion of chemotherapy is critical to improve breast cancer outcomes. Relative dose intensity (RDI), defined as the ratio of chemotherapy delivered to prescribed, is a measure of chemotherapy completion and is associated with cancer mortality. The effect of exercise and eating a healthy diet on RDI is unknown. We conducted a randomized trial of an exercise and nutrition intervention on RDI and pathologic complete response (pCR) in women diagnosed with breast cancer initiating chemotherapy.

METHODS

One hundred seventy-three women with stage I-III breast cancer were randomly assigned to usual care (UC; n = 86) or a home-based exercise and nutrition intervention with counseling sessions delivered by oncology-certified registered dietitians (n = 87). Chemotherapy dose adjustments and delays and pCR were abstracted from electronic medical records. T-tests and chi-square tests were used to examine the effect of the intervention versus UC on RDI and pCR.

RESULTS

Participants randomly assigned to intervention had greater improvements in exercise and diet quality compared with UC ( < .05). RDI was 92.9% ± 12.1% and 93.6% ± 11.1% for intervention and UC, respectively ( = .69); the proportion of patients in the intervention versus UC who achieved ≥85% RDI was 81% and 85%, respectively ( = .44). The proportion of patients who had at least one dose reduction and/or delay was 38% intervention and 36% UC ( = .80). Among 72 women who received neoadjuvant chemotherapy, women randomly assigned to intervention were more likely to have a pCR than those randomly assigned to UC (53% 28%; = .037).

CONCLUSION

Although a diet and exercise intervention did not affect RDI, the intervention was associated with a higher pCR in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative and triple-negative breast cancer undergoing neoadjuvant chemotherapy.

摘要

目的

完成化疗是改善乳腺癌预后的关键。相对剂量强度(RDI)定义为所给予的化疗与规定剂量的比值,是衡量化疗完成情况的指标,与癌症死亡率相关。运动和健康饮食对 RDI 的影响尚不清楚。我们开展了一项随机试验,比较了运动和营养干预对接受化疗的乳腺癌患者 RDI 和病理完全缓解(pCR)的影响。

方法

173 名 I-III 期乳腺癌患者被随机分为常规护理组(UC;n=86)或家庭为基础的运动和营养干预组,后者由肿瘤学认证的注册营养师提供咨询(n=87)。从电子病历中提取化疗剂量调整和延迟以及 pCR 数据。使用 t 检验和卡方检验比较干预组与 UC 组之间 RDI 和 pCR 的差异。

结果

与 UC 组相比,随机分配到干预组的患者在运动和饮食质量方面有更大的改善(<0.05)。干预组和 UC 组的 RDI 分别为 92.9%±12.1%和 93.6%±11.1%(=0.69);干预组和 UC 组中达到≥85%RDI 的患者比例分别为 81%和 85%(=0.44)。干预组和 UC 组中至少有一次剂量减少和/或延迟的患者比例分别为 38%和 36%(=0.80)。在 72 名接受新辅助化疗的女性中,随机分配到干预组的女性比随机分配到 UC 组的女性更有可能获得 pCR(53% vs. 28%;=0.037)。

结论

尽管饮食和运动干预并未影响 RDI,但在接受新辅助化疗的激素受体阳性/人表皮生长因子受体 2 阴性和三阴性乳腺癌患者中,该干预与更高的 pCR 相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0733/10691793/461b0206b347/jco-41-5285-g001.jpg

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