Survival Analysis in Patients with Metastatic Merkel Cell Carcinoma Treated with Avelumab

作者：Tereza Lanitis, Irina Proskorovsky, Apoorva Ambavane, Matthias Hünger, Ying Zheng, Murtuza Bharmal, Hemant Phatak · 发表于：Advances in Therapy · 年份：2019 · DOI：10.1007/s12325-019-01034-0 · 被引用次数：15 · 研究领域：Polyomavirus and related diseases、Multiple Sclerosis Research Studies、Bacteriophages and microbial interactions

INTRODUCTION: Complex underlying risk functions associated with immuno-oncology treatments have led to exploration of different methods (parametric survival, spline, landmark, and cure-fraction models) to estimate long-term survival outcomes. The objective of this study was to examine differences in estimated short- and long-term survival in previously treated metastatic Merkel cell carcinoma (mMCC) patients receiving avelumab, when using alternative extrapolation approaches. METHODS: Efficacy data from the phase 2 JAVELIN Merkel 200 trial (part A) with at least 12 months of follow-up were analyzed. Standard parametric survival analyses and analyses of overall survival (OS) as a function of surrogate outcomes comprised of response (landmark analyses) and progression-free survival plus post-progression survival (PFS + PPS) were used to project OS. Overall survival throughout lifetime was projected and compared with the observed OS data with at least 24 months of follow-up. RESULTS: Estimated OS from all three approaches provided a good fit to the observed OS curve from at least 12 months of follow-up. However, performance compared with OS data from at least 24 months showed that the landmark approach followed by PFS + PPS provided a better fit to the data as compared to standard parametric analysis. Mean life expectancy estimated with avelumab was 2.48 years with best-fitting parametric function (a log-normal distribution), 3.15 years with the landmark approach, and 3.54 years...