Aim: To evaluate how efficacy outcomes from real-world data (RWD) can support those from randomized controlled trials (RCTs), in the context of first-line tyrosine kinase inhibitor treatment of metastatic renal cell carcinoma. Patients & methods: PubMed, Ovid, MEDLINE and EMBASE were searched for RCTs and RWD studies with ≥50 adult patients per arm published in 2000-2017. Outcome measures were median progression-free survival, median overall survival and objective response rate. Results: A total of 13 RCTs and 22 RWD studies met eligibility criteria; 31, 28 and 25 studies, respectively, reported median progression-free survival, median overall survival and objective response rate. Summary outcome measures were similar in RWD and RCTs. Conclusion: RWD validates efficacy-based outcomes from RCTs and may provide supportive evidence to inform clinical decisions.
Future oncology (London, England). 2019 Oct 18 [Epub ahead of print]
Michael Moran, Dana Nickens, Katherine Adcock, Meg Bennetts, Natalie Charnley, Kate Fife
Pfizer GmbH, Pfizer Oncology, Berlin 10785, Germany., Pfizer Global, La Jolla, CA 90630, USA., Pfizer Ltd, Walton Oaks, UK., Pfizer R&D UK Ltd, Sandwich, UK., Lancashire Teaching Hospitals, Cancer Services, Lancashire, UK., Cambridge University Hospital, Cancer Services, Cambridge, UK.