Galván-Banqueri M, Ubago-Pérez R, Molina-López T
Andalusian Agency for Health Technology Assessment, Seville, Spain.
J Clin Pharm Ther. 2016 Jun;41(3):285-9. doi: 10.1111/jcpt.12390. Epub 2016 Apr 15.
Melanoma causes the majority of skin cancer-related deaths. The outcome of melanoma depends on its stage at diagnosis. Currently, for patients with advanced melanoma, two MEK inhibitors (trametinib and cobimetinib) have been authorized by the European Medicines Agency. The main objective of this study was to compare the relative efficacy of trametinib-dabrafenib and cobimetinib-vemurafenib in patients with advanced melanoma through adjusted indirect treatment comparisons (ITCs).
A search was made up to the 3rd of November 2015. Databases consulted were MEDLINE, the Cochrane Library and the Centre for Reviews and Dissemination. Randomized controlled trials (RCTs) which compared the efficacy of trametinib-dabrafenib or cobimetinib-vemurafenib versus a common treatment comparator, in which outcomes of overall survival, progression-free survival (PFS) and overall response rate (ORR) were considered. ITCs were carried out using the method proposed by Bucher et al.
Two RCTs were included (one for each drugs combination). The results of the adjusted ITCs showed that there were no statistically significant differences between the two combinations in terms of PFS and ORR.
The ITCs indicate no difference in efficacy between both treatments. However, there should be an independent, head-to-head trial of both combinations to confirm the results.
黑色素瘤导致了大多数与皮肤癌相关的死亡。黑色素瘤的预后取决于其诊断时的分期。目前，对于晚期黑色素瘤患者，两种MEK抑制剂（曲美替尼和考比替尼）已获欧洲药品管理局批准。本研究的主要目的是通过调整后的间接治疗比较（ITC）来比较曲美替尼-达拉非尼和考比替尼-维莫非尼在晚期黑色素瘤患者中的相对疗效。
检索截至2015年11月3日的文献。检索的数据库包括MEDLINE、Cochrane图书馆和综述与传播中心。纳入比较曲美替尼-达拉非尼或考比替尼-维莫非尼与共同对照治疗疗效的随机对照试验（RCT），其中考虑总生存、无进展生存（PFS）和总缓解率（ORR）等结局。使用Bucher等人提出的方法进行ITC。
纳入两项RCT（每种药物组合各一项）。调整后的ITC结果显示，两种组合在PFS和ORR方面无统计学显著差异。
ITC表明两种治疗在疗效上无差异。然而，应该进行两种组合的独立、直接比较试验以证实结果。
