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年龄与早期乳腺癌女性接受紫杉醇诱导的神经病变风险的关系(Alliance A151411):来自癌症和白血病组 B(CALGB)40101 的 1881 例患者的结果。

Age and the Risk of Paclitaxel-Induced Neuropathy in Women with Early-Stage Breast Cancer (Alliance A151411): Results from 1,881 Patients from Cancer and Leukemia Group B (CALGB) 40101.

机构信息

Northwell Health Cancer Institute, New York New York, USA.

Department of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona, USA.

出版信息

Oncologist. 2019 May;24(5):617-623. doi: 10.1634/theoncologist.2018-0298. Epub 2018 Nov 8.

DOI:10.1634/theoncologist.2018-0298
PMID:30409792
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6516126/
Abstract

PURPOSE

A few previous studies report a direct relationship between older age and chemotherapy-induced neuropathy. This study further evaluated this adverse event's age-based risk.

METHODS

CALGB 40101 investigated adjuvant paclitaxel (80 mg/m once per week or 175 mg/m every 2 weeks) in patients with breast cancer and served as a platform for the current study that investigated age-based differences in neuropathy. Grade 2 or worse neuropathy, as per Common Terminology Criteria for Adverse Events version 4, was the primary endpoint; patients were assessed at baseline, every 6 months for 2 years, and then annually for 15 years.

RESULTS

Among these 1,881 patients, 230 were 65 years of age or older, 556 were 55-64 years, and 1,095 were younger than 55; 1,226 neuropathy events (commonly grade 1 or 2) were reported in 65% of the cohort. The number of grade 2 or worse events was 63 (27%), 155 (28%), and 266 (24%) within respective age groups ( = .14). In univariate analysis, only motor neuropathy had a higher age-based incidence: 19 (8%), 43 (8%), and 60 (5%), respectively ( = .04); in multivariate analyses, this association was no longer statistically significant. Other endpoints, such as time to onset of neuropathy (time from trial enrollment to neuropathy development) and time to improvement (time from maximal grade sensory neuropathy to a one-category improvement), showed no statistically significant age-based differences. In contrast, obesity was associated with neuropathy, and every 2-week paclitaxel was associated with trends toward neuropathy.

CONCLUSION

Although paclitaxel-induced neuropathy is common, older age is not an independent risk factor. . NCT00041119 (CALGB 40101).

IMPLICATIONS FOR PRACTICE

Age alone is not an independent risk factor for paclitaxel-induced neuropathy.

摘要

目的

有几项先前的研究报告称,年龄较大与化疗引起的神经病变之间存在直接关系。本研究进一步评估了这种不良事件的年龄相关风险。

方法

CALGB 40101 研究了辅助紫杉醇(80mg/m,每周一次或 175mg/m,每 2 周一次)在乳腺癌患者中的应用,该研究为目前这项研究提供了平台,旨在研究神经病变的年龄差异。根据不良事件通用术语标准 4.0 版,2 级或更高级别的神经病变为主要终点;患者在基线时、前 2 年每 6 个月评估一次,然后每年评估一次,共 15 年。

结果

在这 1881 名患者中,230 名患者年龄在 65 岁或以上,556 名患者年龄在 55-64 岁,1095 名患者年龄小于 55 岁;在队列的 65%中报告了 1226 次神经病变事件(通常为 1 级或 2 级)。在各自的年龄组中,2 级或更高级别的事件数量分别为 63(27%)、155(28%)和 266(24%)(=.14)。在单变量分析中,只有运动性神经病变的发生率与年龄有关:19(8%)、43(8%)和 60(5%)(=.04);在多变量分析中,这种关联不再具有统计学意义。其他终点,如神经病变的发病时间(从试验入组到神经病变发生的时间)和改善时间(从最大感觉神经病变到一级改善的时间),均未显示出统计学上的年龄差异。相比之下,肥胖与神经病变相关,每两周紫杉醇治疗与神经病变趋势相关。

结论

尽管紫杉醇引起的神经病变很常见,但年龄并不是一个独立的危险因素。. NCT00041119(CALGB 40101)。

临床意义

年龄本身不是紫杉醇引起的神经病变的独立危险因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f422/6516126/fb3a3cef606d/onco12734-fig-0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f422/6516126/fb3a3cef606d/onco12734-fig-0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f422/6516126/fb3a3cef606d/onco12734-fig-0001.jpg

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