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Abstract
Objective: To date, no trial data exist comparing treatment outcomes for everolimus versus sorafenib. The current analysis indirectly compares the overall survival (OS) benefit of everolimus and sorafenib as second-line treatment options.
Research design and methods: A single-arm sorafenib study is selected as a basis to match an everolimus sunitinib-refractory subpopulation of the RECORD-1 trial. Only patients with clear cell histology are included. An adjusted matching approach is taken where 1000 repeated random samples matched to the sorafenib population on risk score distribution are produced, and a 95% CI around the mean of all sampled median OS is generated.
Main outcome measures: The main outcome measures include adjusted median OS and progression-free survival.
Results: In all, 45 clear cell histology sorafenib patients and 1000 samples of N = 41 sunitinib-refractory everolimus patients are considered for analysis. After adjusted matching, the estimated median OS benefit is 32.7 weeks (95% CI: 22, 64) and 81.5 weeks (95% CI: 78, 86) for sorafenib and everolimus patients, respectively.
Conclusion: Results suggest that sunitinib-refractory metastatic renal cell carcinoma patients treated with everolimus may experience significantly improved OS outcomes compared to those treated with sorafenib. However, because this is not a randomized controlled trial, the results should be interpreted as those from an observational study.
Acknowledgment
Editorial assistance was provided by A Perrin, an employee of Analytica International. Funding for the work was provided by Novartis Pharmaceuticals Corp. These data were presented in part at the American Society of Clinical Oncology Annual Meeting, June 4 – 8 2010, Chicago, IL and at the European Society for Medical Oncology 35th Annual Congress, October 8 – 12 2010, Milan, Italy.