A Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) Analysis of Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma (aRCC)

Ruchitbhai Shah, Marc Botteman*, Caitlyn T. Solem, Linlin Luo, Justin Doan, David Cella, Robert J. Motzer

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)356-365.e1
JournalClinical Genitourinary Cancer
Volume17
Issue number5
DOIs
StatePublished - Oct 2019

Keywords

  • CheckMate 025
  • Immunotherapy
  • Kidney cancer
  • Quality-adjusted survival
  • Risk-benefit

ASJC Scopus subject areas

  • Oncology
  • Urology

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