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首页> 外文期刊>Journal of skin cancer >A Matching-Adjusted Indirect Comparison of Sonidegib and Vismodegib in Advanced Basal Cell Carcinoma
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A Matching-Adjusted Indirect Comparison of Sonidegib and Vismodegib in Advanced Basal Cell Carcinoma

机译：SONIDEGIB和VISMODEGIB在高级基础细胞癌中的匹配调整的间接比较

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Objectives. Based on single-arm trial data (BOLT), sonidegib was approved in the US and EU to treat locally advanced basal cell carcinomas (BCCs) ineligible for curative surgery or radiotherapy. Vismodegib, the other approved targeted therapy, also was assessed in a single-arm trial (ERIVANCE). We examined the comparative effectiveness of the two drugs using a matching-adjusted indirect comparison (MAIC) versus an unadjusted indirect comparison. Methods. After comparing trials and identifying potential prognostic factors, an MAIC was conducted to adjust for differences in key patient baseline characteristics. Due to BOLT s small sample size, the number of matching variables was restricted to two. Efficacy results for sonidegib were generated so that selected baseline characteristics matched those from ERIVANCE and were compared with published ERIVANCE results. Results. Matching variables were baseline percentages of patients receiving prior radiotherapy and surgery. After weighting, sonidegib objective response rate (ORR) and median progression-free survival (PFS) were effectively unchanged (prematched versus postmatched ORR and PFS, 56.1% versus 56.7% and 22.1 versus 22.1 months, resp.). Vismodegibs ORR and PFS were 47.6% and 9.5 months. Conclusions. Comparative effectiveness of sonidegib versus vismodegib remains unchanged after adjusting BOLT patient-level data to match published ERIVANCE baseline percentages of patients receiving prior surgery and radiotherapy.
机译：目标。基于单臂试验数据（螺栓），SONIDEGIB在美国和EU批准，以治疗局部晚期的基础细胞癌（BCC），没有资格用于治疗手术或放射治疗。 Vismodegib，其他批准的靶向治疗也被评估在单臂试验（偶变）中进行评估。我们使用匹配调整的间接比较（MAIC）对两种药物的比较有效性与未经调整的间接比较进行了检查。方法。在比较试验并鉴定潜在的预后因素后，进行了麦克族以调整关键患者基线特征的差异。由于螺栓的小样本大小，匹配变量的数量限制为两个。生成SONIDEGIB的功效结果，使得所选基线特征与偶变的基线特征相匹配，并与公开的兼容结果进行比较。结果。匹配变量是接受预科和手术的患者的基线百分比。在加权之后，SONIDEGIB客观反应率（ORR）和中值的无进展生存期（PFS）有效地保持不变（超级与关断层和PFS，56.1％与56.7％和22.1与22.1个月，REAC。）。 Vismodegibs ORR和PFS为47.6％和9.5个月。结论。在调整螺栓患者级数据以匹配接受前后手术和放射治疗的患者的公开偶像基线百分比，对Sonidegib的比较效果保持不变。

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