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转移性乳腺癌:内脏转移和非内脏转移的乳腺癌在治疗效果上是否存在差异?

Metastatic Breast Cancer: Is There a Differential Therapy Efficacy between Visceral and Non-Visceral Metastatic Breast Cancer?

作者信息

Kolben Thomas, Bardenhewer Maximilian, Kolben Theresa M, Rickerl Laura, Degenhardt Tom, Mahner Sven, Harbeck Nadia, Wuerstlein Rachel

机构信息

Department of Obstetrics and Gynecology, Breast Center, University Hospital, LMU Munich, Munich, Germany.

出版信息

Breast Care (Basel). 2020 Oct;15(5):527-533. doi: 10.1159/000504527. Epub 2019 Dec 4.

Abstract

PURPOSE

Differential efficacy of newly registered therapies in subgroups of metastatic breast cancer (MBC) is an important consideration for subsequent use in clinical practice. Unfortunately, such subgroup analyses often are exploratory and rarely statistically adequately powered and may thus be misleading. This analysis aimed to explore a potentially different treatment response to i.v. therapies between visceral and non-visceral MBC.

METHODS

In a systematic literature analysis (PubMed) comprising phase III registration studies for MBC from 1994 to 2014, differences in outcome were evaluated regarding progression-free survival, time to progression, overall survival (OS), and visceral versus non-visceral disease. The impact of HER2 and hormone receptor status was also considered. A total of 16 studies comprising 13,083 patients were selected by considering the information given in the medical product's professional information and the decision of the US Food and Drug Administration or the European Medicine Agency for approval of the respective therapeutic agents now used in the treatment of MBC.

RESULTS

No statistically significant differences regarding treatment response and therapy benefit were found in MBC patients with visceral versus non-visceral metastases based on reported hazard ratios and confidence intervals in registration trials. Interesting but nonsignificant differences were found regarding a distinct therapy benefit regarding different metastasis locations in 4 studies.

CONCLUSION

For targeted i.v. therapies based on biomarker selection, there is a trend - although not significant - toward a benefit (OS) from combination therapies favoring visceral disease. However, at the present time, metastasis localization should not be used as a predictive marker for choice of systemic therapy in MBC.

摘要

目的

新注册疗法在转移性乳腺癌(MBC)亚组中的疗效差异是临床实践后续应用时的重要考量因素。遗憾的是,此类亚组分析往往是探索性的,统计学效力很少足够,因此可能会产生误导。本分析旨在探讨内脏型与非内脏型MBC对静脉内治疗的潜在不同反应。

方法

在一项系统文献分析(PubMed)中,纳入1994年至2014年MBC的III期注册研究,评估无进展生存期、进展时间、总生存期(OS)以及内脏型与非内脏型疾病在结局方面的差异。还考虑了HER2和激素受体状态的影响。通过参考医疗产品专业信息中给出的信息以及美国食品药品监督管理局或欧洲药品管理局批准目前用于治疗MBC的相应治疗药物的决定,共筛选出16项研究,涉及13083例患者。

结果

根据注册试验中报告的风险比和置信区间,在内脏型与非内脏型转移的MBC患者中,未发现治疗反应和治疗获益方面的统计学显著差异。在4项研究中,发现了关于不同转移部位的明显治疗获益存在有趣但不显著的差异。

结论

对于基于生物标志物选择的靶向静脉内治疗,存在一种趋势——尽管不显著——即联合治疗对内脏型疾病有获益(OS)。然而,目前转移部位不应作为MBC全身治疗选择的预测标志物。

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