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Randomized Controlled Trial
. 2021 Oct;19(5):468.e1-468.e5.
doi: 10.1016/j.clgc.2021.03.018. Epub 2021 Apr 3.

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

Michael Szarek  1 , Michael N Needle  2 , Brian I Rini  3 , Sumanta K Pal  4 , David F McDermott  5 , Michael B Atkins  6 , Thomas E Hutson  7 , Bernard J Escudier  8
Affiliations
Free article
Randomized Controlled Trial

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

Michael Szarek et al. Clin Genitourin Cancer. 2021 Oct.
Free article

Abstract

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.

Clinical trial information: NCT02627963.

Keywords: Q-TWiST; Renal cell carcinoma; Sorafenib; Tivozanib.

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Conflict of interest statement

Disclosures M Szarek has served as a consultant to AVEO, Spectrum, and Verastem. M.N. Needle is an employee of AVEO. B.I. Rini has served as a consultant to Arrowhead and received research funding from Peloton and research funding and honoraria from AstraZeneca, AVEO, Pfizer, Bristol-Myers Squibb, Roche, and Merck. S.K. Pal has received honoraria from and served as a consultant to Pfizer, Novartis, AVEO, Genentech, Exelixis, Bristol-Myers Squibb, Astellas, Eisai, Roche, and Ipsen. D.F. McDermorr has served as a consultant to Array BioPharm, Genentech, Alkermes, Jounce Therapeutics, Peloton, EMD Serono, and Eli Lilly; received research funding from X4 Pharma, Prometheus, Genentech, and Alkermes; and served as a consultant to and received research funding from Bristol-Myers Squibb, Pfizer, Merck, Novartis, and Exelius. M.B. Atkins has served as an advisor to and received honoraria from AVEO, Merck, Bristol-Myers Squibb, Eisai, Pfizer, Exelixis, Roche, Novartis, and Arrowhead. T.E. Hutson has served as an advisor to Pfizer, Exelexis, Bristol-Myers Squibb, AVEO, and Janssen. B.J. Escudier has received research funding from AVEO, Bristol-Myers Squibb, and Novartis and honoraria from Bristol-Myers Squibb, Roche, Pfizer, Oncorena, AVEO, and Ipsen.

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