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一项回顾性观察分析,评估贝伐珠单抗单药或与伊立替康联合用于复发性胶质母细胞瘤的治疗。

A retrospective observational analysis to evaluate the off-label use of bevacizumab alone or with irinotecan in recurrent glioblastoma.

机构信息

Pharmacy Department, Careggi Hospital, Florence, Italy.

出版信息

Int J Clin Pharm. 2013 Jun;35(3):483-7. doi: 10.1007/s11096-013-9765-0. Epub 2013 Mar 28.

Abstract

BACKGROUND

Recurrent glioblastoma is nearly always fatal, with median survival rates of approximately 12-14 months. Previous phase II clinical trials showed promising results with bevacizumab, alone or in combination with irinotecan, in patients with recurrent glioblastoma.

OBJECTIVE

To assess whether the survival of patients with recurrent glioblastoma receiving bevacizumab alone or with irinotecan in everyday practice is comparable to that reported in clinical trials.

SETTING

This was a retrospective observational study conducted at a single hospital in Italy.

METHOD

Patients with recurrent glioblastoma who had received bevacizumab alone or with irinotecan from January 2009 to September 2011 were included in our study.

MAIN OUTCOME MEASURE

Progression-free survival (PFS) and overall survival (OS), and rates of PFS and OS at 6 months.

RESULTS

Median PFS was 5.1 months in the bevacizumab group (n = 9) and 15.4 months in the bevacizumab + irinotecan group (n = 10), with 6-month PFS rates of 45 and 69%, respectively. Median OS was 6.8 months for bevacizumab alone and 11.1 months for bevacizumab + irinotecan, with 6-month OS rates of 100 and 90%, respectively.

CONCLUSION

Although the number of patients included is not sufficient to allow a conclusive statement about the place of bevacizumab in the treatment of recurrent glioblastoma, the data appear promising, and are consistent with the results of clinical trials.

摘要

背景

复发性胶质母细胞瘤几乎总是致命的,中位生存率约为 12-14 个月。之前的 II 期临床试验表明,贝伐单抗单独或与伊立替康联合治疗复发性胶质母细胞瘤患者具有良好的效果。

目的

评估在日常实践中接受贝伐单抗单独或联合伊立替康治疗的复发性胶质母细胞瘤患者的生存率是否与临床试验报告的结果相当。

设置

这是一项在意大利一家医院进行的回顾性观察性研究。

方法

我们纳入了 2009 年 1 月至 2011 年 9 月期间接受贝伐单抗单独或联合伊立替康治疗的复发性胶质母细胞瘤患者。

主要观察指标

无进展生存期(PFS)和总生存期(OS),以及 6 个月时的 PFS 和 OS 率。

结果

贝伐单抗组(n=9)的中位 PFS 为 5.1 个月,贝伐单抗+伊立替康组(n=10)为 15.4 个月,6 个月时的 PFS 率分别为 45%和 69%。贝伐单抗组的中位 OS 为 6.8 个月,贝伐单抗+伊立替康组为 11.1 个月,6 个月时的 OS 率分别为 100%和 90%。

结论

尽管纳入的患者数量不足以对贝伐单抗在复发性胶质母细胞瘤治疗中的地位做出结论性的评价,但数据看起来很有希望,与临床试验结果一致。

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