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 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.

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.

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%.

Tivozanib increased Q-TWiST relative to sorafenib, primarily through an increase in TWiST, which is generally considered to be the highest utility state.

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.

NCT02627963.

Clinical genitourinary cancer. 2021 Apr 03 [Epub ahead of print]

Michael Szarek, Michael N Needle, Brian I Rini, Sumanta K Pal, David F McDermott, Michael B Atkins, Thomas E Hutson, Bernard J Escudier

CPC Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO; SUNY Downstate Medical Center, Brooklyn, NY. Electronic address: ., AVEO Oncology, Boston, MA., Vanderbilt-Ingram Cancer Center, Nashville, TN., City of Hope Comprehensive Cancer Center, Duarte, CA., Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA., Georgetown Lombardi Comprehensive Cancer Center, Washington, DC., Texas A&M College of Medicine, Bryan, TX., Gustave Roussy, Villejuif, France.