@article{d6325c7a13a4488980bd8cd08710e601,
title = "A Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) Analysis of Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma (aRCC)",
abstract = "Background: This analysis compared quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST) between nivolumab and everolimus among previously treated patients with advanced renal cell carcinoma enrolled in the phase III CheckMate 025 trial (NCT01668784). Materials and Methods: At 45-month follow-up, overall survival (OS) was partitioned into 3 health states: TWiST, time with grade ≥ 3 toxicity (TOX), and time after progression (REL). Mean Q-TWiST was determined by multiplying each state's duration with its utility (TWiST, 1.0; TOX, 0.5; REL, 0.5). Relative Q-TWiST gains (calculated as Q-TWiST difference divided by everolimus OS) of ≥ 10% were predefined as clinically important. Immuno-oncology-specific sensitivity analyses considered 4 alternative progression definitions: Tumor size increase ≥ 25% from nadir; treatment discontinuation; ≥ 2-point reduction from baseline in Functional Assessment of Cancer Therapy-Kidney Symptom Index Disease-Related Symptoms scores; and a composite definition. A scenario incorporating grade ≥ 2 toxicities was tested. Results: Compared with everolimus, nivolumab was associated with a significant Q-TWiST improvement of 3.3 months (P <. 001). In all sensitivity analyses, nivolumab was associated with Q-TWiST gains (relative gain %) ranging from 3.3 months (14.4%) to 4.8 months (20.9%). Conclusions: Nivolumab is associated with a statistically significant and clinically meaningful gain in quality-adjusted OS versus everolimus among previously treated patients with advanced renal cell carcinoma.",
keywords = "CheckMate 025, Immunotherapy, Kidney cancer, Quality-adjusted survival, Risk-benefit",
author = "Ruchitbhai Shah and Marc Botteman and Solem, {Caitlyn T.} and Linlin Luo and Justin Doan and David Cella and Motzer, {Robert J.}",
note = "Funding Information: R.S. is employed by Pharmerit International. R.S.{\textquoteright}s institution has received consulting or advisory role and research funding from Bristol-Myers Squibb and numerous other sponsors from the pharmaceutical industry. M.F.B. is employed by Pharmerit International and has stock or ownership interests in Pharmerit. M.F.B.{\textquoteright}s institution has received consulting or advisory role and research funding from Bristol-Myers Squibb and numerous other sponsors from the pharmaceutical industry. C.T.S. is employed by Pharmerit International. C.T.S.{\textquoteright}s institution has received consulting or advisory role and research funding from Bristol-Myers Squibb and numerous other sponsors from the pharmaceutical industry. L.L. is employed by Pharmerit International. L.L.{\textquoteright}s institution has received consulting or advisory role and research funding from Bristol-Myers Squibb and numerous other sponsors from the pharmaceutical industry. J.D. is an employee of Bristol-Myers Squibb and owns Bristol-Myers Squibb stock. D.C. is a consultant and reports personal fees from Bristol-Myers Squibb, Pfizer, Abbvie, and Novartis, outside the submitted work. R.M. reports grants from Bristol-Myers Squibb during the conduct of the study; grants and personal fees from Pfizer, Novartis, Eisai, Exelixis, and Genentech/Roche outside the submitted work. Funding Information: This study was funded by Bristol-Myers Squibb . The authors would like to acknowledge the following Pharmerit project team members in providing medical writing assistance for this manuscript: Youngmin Kwon and Catherine Mirvis. ",
year = "2019",
month = oct,
doi = "10.1016/j.clgc.2019.05.010",
language = "English (US)",
volume = "17",
pages = "356--365.e1",
journal = "Clinical Genitourinary Cancer",
issn = "1558-7673",
publisher = "Elsevier",
number = "5",
}