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Abstract
Objective: Comparing prognostic factors for overall survival (OS) in community-practice metastatic renal cell carcinoma (mRCC) patients receiving second-line everolimus with those previously reported in clinical trials.
Research design and methods: Two separate chart sets (2009 – 2012) were used to develop and validate a prognostic model for patients initiating second-line everolimus after first-line tyrosine kinase inhibitor (TKI).
Main outcome measures: Prognostic factors for OS have been identified and validated in separate samples.
Results: One-year OS probabilities in the study (n = 220) and validation (n = 97) samples were 68 and 67%; median OS was 19 and 23 months – higher than the 1-year OS of 60% and median OS of 14.8 months of RECORD-1. Karnofsky performance score < 80%, duration of mRCC < 1 year, progression on first-line TKI, liver metastasis and clear cell histology were significant prognostic factors for shorter survival. One-year OS estimates were 84% for validation sample patients with 0 – 2 risk factors, 63% for 3 risk factors and 22% for 4 – 5 risk factors (log-rank p < 0.001).
Conclusion: Real-world prognostic factors for OS following second-line everolimus for mRCC were largely consistent with those previously identified in trial data; however, OS was longer in the practice setting than in clinical trials and was not associated with type of first-line TKI.
Acknowledgments
A synopsis of the current research was presented in poster format at the 12th International Kidney Cancer Symposium, which took place in Chicago, Illinois, during 25–26 October 2013. The authors would like to thank Ana Bozas, PhD, an employee of Analysis Group, Inc., for helping with the drafting and editing of the manuscript, and William M. Reichmann, PhD, Ella X. Du, MS, and Cynthia Z. Qi, BS, for helping with several data analysis sections of the project.
Author contributions
All authors participated in the design of the study and contributed to the manuscript development. The study was designed by the senior academic authors and the sponsor, Novartis. Data were collected by Analysis Group and analyzed and interpreted in collaboration with the academic authors. Manuscript drafts were prepared by the authors with editorial assistance from a professional medical writer paid by the sponsor. All the authors vouch for the accuracy and completeness of the data reported and the adherence of the study to the protocol, and all the authors made the decision to submit the manuscript for publication.
Declaration of interest
The study was sponsored by Novartis Pharmaceuticals Corp. E Jonasch has been a consultant for Novartis, GSK and Pfizer as well as has received grant funding from Exelixis, GSK, Novartis and Pfizer. SK Pal has been a consultant for Novartis, Pfizer, Aveo, Dendreon and Myriad and has spoken at Novartis, Pfizer and Medivation. JE Signorovitch and PL Lin have disclosed that they are employees of Analysis Group, Inc., a company that received funding from Novartis Pharmaceuticals Corp. to conduct this study. Z Liu, X Wang and K Culver are employees of Novartis Pharmaceuticals Corp. DJ Goerge has been a consultant for Bayer, Exelixis, GSK, and Aveo as well as has received grant funding from Novartis, Pfizer, GSK, Genentech, Exelixis and BMS and has spoken at Novartis and Pfizer. NJ Vogelzang has been a consultant for Novartis, Amgen, Celgene, Medivation, Eisai, Exelixis, Roche, has spoken at Novartis, Astellas, Johnson and Johnson, Pfizer, Dendreon, Bayer/Algeta, GSK and Veridex/Janssen and has received research support from Novartis, Bayer, Exelixis, Progenics, Bavarian Nordic and Viamet. Writing assistance was utilized in the preparation of the manuscript and was carried out by Ana Bozas, PhD, an employee of Analysis Group, Inc. This was funded by Novartis Pharmaceuticals. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.