| 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. © 2019 The Authors This study assessed the net health benefits of treatment with nivolumab versus everolimus among patients with advanced renal cell carcinoma by assessing the quality (ie, patient preferences) and quantity of survival (ie, time spent with significant toxicities, in progression, or before progression and without significant toxicities). Nivolumab resulted in a 3.3-month quality-adjusted survival gain versus everolimus that was statistically significant and clearly clinically meaningful. © 2019 The Authors |
