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).
Patients and methods: 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.
Results: 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.
Conclusion: 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).
Keywords: Renal cell carcinoma; advanced disease; bevacizumab (Avastin®); metastatic disease; non-interventional study.
Copyright© 2019, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.