Q-TWiST Analysis of Tivozanib Versus Sorafenib in Patients With Advanced Renal Cell Carcinoma in the TIVO-3 Study

In TIVO-3, tivozanib increased progression-free survival relative to sorafenib in patients with metastatic renal cell carcinoma. In the current analysis, tivozanib also increased quality-adjusted time without symptoms of disease and toxicity (Q-TWiST). As an outcome that integrates the quantity and quality of survival, Q-TWiST may be considered an alternative patient-centered measure of tivozanib benefit in renal cell carcinoma. Background: In TIVO-3, tivozanib increased progression-free survival with no difference in overall survival relative to sorafenib as third- or fourth-line therapy in patients with metastatic renal cell carcinoma. We applied quality-adjusted time without symptoms of disease and toxicity (Q-TWIST) methods to quantify the net health benefits of tivozanib, in the presence of similar survival, when compared with sorafenib. Methods: The mean Q-TWiST was calculated by applying utility coefficients of 0.5, 1.0, and 0.5 to the 36-month restricted mean health states of time with toxicity (TOX), TWIST, and time after progression/relapse, respectively. The relative Q-TWiST gain was defined as the mean absolute Q-TWiST difference divided by the sorafenib mean overall survival. Results: The mean TWIST was longer for tivozanib than for sorafenib, mean time after progression/relapse was shorter for tivozanib, with no difference in mean TOX. Mean Q-TWiST was 15.04 months and 12.78 months for tivozanib and sorafenib, respectively (P = .0493). The tivozanib relative gain was 11.2%. Discussion: Tivozanib increased Q-TWiST relative to sorafenib, primarily through an increase in TWIST, which is generally considered to be the highest utility state. Conclusion: Q-TWiST may be considered an alternative patient-centered measure of benefit of tivozanib in as a third- or fourth-line therapy in patients with renal cell carcinoma. (C) 2021 The Author(s). Published by Elsevier Inc.