Schultze-Seemann Wolfgang, Schulz Holger, Tschechne Barbara, Häckl Manuel
University Hospital Freiburg (Albert-Ludwigs-University) Urology, Freiburg, Germany
PIOH Study and Management GbR, Frechen, Germany.
Anticancer Res. 2019 Feb;39(2):875-882. doi: 10.21873/anticanres.13188.
BACKGROUND/AIM: The combination of bevacizumab (BEV) plus interferon alpha-2a (IFN) constitutes an option for first-line treatment of metastatic renal cell carcinoma. Real-world data from routine clinical practice are rare and were, therefore, collected during this non-interventional study (NIS).
A total of 359 patients received at least one dose of BEV (safety set population; SAF), 354 patients had at least one post-dose effectiveness assessment and formed the full analysis set (FAS) of the final analysis.
Progression-free survival (10.2 months, 95% CI=8.6-12.6) and overall response rate (27.2%) outcomes match the results from the phase III trials AVOREN and CALGB 90206. Longer overall survival (28.7 months, 95% CI=24.5-38.3) probably is an effect of patient characteristics and follow-up therapies. Safety findings were comparable to the results of the Phase III trials, although comprehensive severity assessments were not provided.
Overall, efficacy and safety data from BEV plus IFN administered in routine clinical practice in an observational NIS are in line with results from the controlled phase III trials. (NCT02627144).
背景/目的：贝伐单抗（BEV）联合干扰素α-2a（IFN）是转移性肾细胞癌一线治疗的一种选择。来自常规临床实践的真实世界数据很少，因此在这项非干预性研究（NIS）中进行了收集。
共有359例患者接受了至少一剂BEV（安全集人群；SAF），354例患者进行了至少一次给药后疗效评估，并构成了最终分析的全分析集（FAS）。
无进展生存期（10.2个月，95%CI = 8.6 - 12.6）和总缓解率（27.2%）结果与III期试验AVOREN和CALGB 90206的结果相符。更长的总生存期（28.7个月，95%CI = 24.5 - 38.3）可能是患者特征和后续治疗的作用。安全性结果与III期试验结果相当，尽管未提供全面的严重程度评估。
总体而言，在一项观察性NIS的常规临床实践中给予BEV加IFN的疗效和安全性数据与对照III期试验的结果一致。（NCT02627144）
