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晚期乳腺癌老年女性间歇性口服长春瑞滨的研究

On and off metronomic oral vinorelbine in elderly women with advanced breast cancer.

作者信息

De Iuliis Francesca, Salerno Gerardo, Taglieri Ludovica, Lanza Rosina, Scarpa Susanna

机构信息

Experimental Medicine Department, Sapienza University of Rome, Rome - Italy.

出版信息

Tumori. 2015 Jan-Feb;101(1):30-5. doi: 10.5301/tj.5000207. Epub 2015 Feb 5.

Abstract

BACKGROUND

Elderly patients with metastatic breast cancer (MBC) have more problems receiving chemotherapy than younger patients, especially with the presence of multiple comorbidities, adverse drug events and functional decline. Low-dose oral administration of cytotoxic agents such as vinorelbine, a semisynthetic vinca alkaloid that interferes with microtubule assembly, leading to arrest of cell division, is usually effective and well tolerated.

METHODS

From February 2010 to February 2014, 32 patients with MBC, median age 76 years (range 69-83) were treated with oral vinorelbine 30 mg (total dose), one day on and one day off, until disease progression or unacceptable toxicity levels were reported. Toxicity, quality of life and clinical benefit were evaluated. Matched t-tests were conducted to discern whether quality-of-life indicator (p<0.05 was considered significant) differed before and 6 months after treatment. Statistical analysis was performed using Graph Pad Prism 5.0 (GraphPad Software Inc., San Diego, CA, USA).

RESULTS

No grade 3 and 4 adverse events were reported. A clinical benefit of 50% was found in our cohort. On and off metronomic vinorelbine oral administration resulted in good tolerability and safe profile in our selected elderly population, and improved patient adherence to therapy.

CONCLUSIONS

The present study demonstrated that metronomic vinorelbine might be a potential treatment in elderly patients by reducing adverse effects and increasing quality of life, setting the stage for future extensive clinical trials.

摘要

背景

转移性乳腺癌(MBC)老年患者在接受化疗时比年轻患者面临更多问题,尤其是存在多种合并症、药物不良事件和功能衰退时。低剂量口服细胞毒性药物,如长春瑞滨,一种干扰微管组装、导致细胞分裂停滞的半合成长春花生物碱,通常有效且耐受性良好。

方法

2010年2月至2014年2月,32例MBC患者,中位年龄76岁(范围69 - 83岁),接受口服长春瑞滨30mg(总剂量),服药一天,停药一天,直至疾病进展或出现不可接受的毒性水平。评估毒性、生活质量和临床获益情况。进行配对t检验以判断治疗前和治疗6个月后生活质量指标是否存在差异(p<0.05被认为具有统计学意义)。使用Graph Pad Prism 5.0(美国加利福尼亚州圣地亚哥的GraphPad软件公司)进行统计分析。

结果

未报告3级和4级不良事件。在我们的队列中发现临床获益率为50%。在我们选定的老年人群中,口服节拍性长春瑞滨具有良好的耐受性和安全性,提高了患者对治疗的依从性。

结论

本研究表明,节拍性长春瑞滨可能是老年患者的一种潜在治疗方法,可减少不良反应并提高生活质量,为未来广泛的临床试验奠定了基础。

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