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依维莫司联合舒尼替尼治疗晚期胰腺神经内分泌肿瘤:一项匹配调整间接比较研究。

Everolimus and sunitinib for advanced pancreatic neuroendocrine tumors: a matching-adjusted indirect comparison.

机构信息

Analysis Group, Inc,, 111 Huntington Ave 10th Floor, Boston, MA 02199, USA.

出版信息

Exp Hematol Oncol. 2013 Dec 6;2(1):32. doi: 10.1186/2162-3619-2-32.

Abstract

BACKGROUND

Everolimus and sunitinib have been approved for the treatment advanced pancreatic neuroendocrine tumors, but have not been compared to each other in a randomized trial and have not demonstrated prolonged overall survival compared to placebo. This study aimed to indirectly compare overall and progression-free among everolimus, sunitinib and placebo across separate randomized trials.

METHODS

A matching adjusted indirect comparison was conducted in which individual patient data from the pivotal trial of everolimus (n = 410) were adjusted to match the inclusion criteria and average baseline characteristics reported for the pivotal trial of sunitinib (n = 171). Prior to matching, trial populations differed in baseline performance status and prior treatments. After matching, these and all other available baseline characteristics were balanced between trials.

RESULTS

Compared to the placebo arm in the sunitinib trial, everolimus was associated with significantly prolonged overall survival (HR = 0.61, 95% CI = 0.38-0.98, p = 0.042).Compared to sunitinib, everolimus was associated with similar progression-free (hazard ratio for death (HR) = 0.84, 95% CI = 0.46-1.53, p = 0.578) and overall survival (HR = 0.81, 95% CI = 0.49-1.31, p = 0.383).

CONCLUSION

After adjusting for observed cross-trial differences, everolimus treatment was associated with longer overall survival than the placebo arm in the sunitinib trial for advanced pancreatic neuroendocrine tumors.

摘要

背景

依维莫司和舒尼替尼已被批准用于治疗晚期胰腺神经内分泌肿瘤,但尚未在随机试验中进行比较,与安慰剂相比也未显示出延长的总生存期。本研究旨在通过单独的随机试验,间接比较依维莫司、舒尼替尼和安慰剂之间的总生存期和无进展生存期。

方法

进行了匹配调整的间接比较,其中依维莫司关键试验(n=410)的个体患者数据经过调整,以匹配舒尼替尼关键试验(n=171)的纳入标准和平均基线特征。在匹配之前,试验人群在基线表现状态和先前治疗方面存在差异。匹配后,在试验之间平衡了这些和所有其他可用的基线特征。

结果

与舒尼替尼试验的安慰剂组相比,依维莫司与显著延长的总生存期相关(HR=0.61,95%CI=0.38-0.98,p=0.042)。与舒尼替尼相比,依维莫司与相似的无进展生存期相关(死亡风险比(HR)=0.84,95%CI=0.46-1.53,p=0.578)和总生存期(HR=0.81,95%CI=0.49-1.31,p=0.383)。

结论

在调整观察到的试验间差异后,与舒尼替尼试验的安慰剂组相比,依维莫司治疗与晚期胰腺神经内分泌肿瘤患者的总生存期延长相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0616/4175512/82970b1bc632/2162-3619-2-32-1.jpg

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