Michael Szarek, PhD, on the Rationale Behind Conducting a Q-TWiST Analysis of the Phase 3 TIVO-3 Study

An analysis of tivozanib versus sorafenib in patients with advanced renal cell carcinoma (RCC) included in the phase 3 TIVO-3 study revealed that, as a third- or fourth-line treatment, tivozanib significantly increased quality-adjusted time without symptoms of disease and toxicity (Q-TWiST) compared with sorafenib, primarily through an increase in TWiST.¹

Overall, these results, presented at the American Society of Clinical Oncology (ASCO) 2021 Genitourinary Cancers Symposium, suggestQ-TWiST may be considered an alternative patient-centered measure of benefit of tivozanib in these settings.

In an interview with CancerNetwork®, Michael Szarek, PhD, of the SUNY Downstate Medical Center, discussed the rationale behind conducting this analysis.

Transcription:

The TIVO-3 study was [for the] third- or fourth-line treatment of patients with metastatic renal cell carcinoma. The primary results were published in Lancet Oncology in 2019,² and the final overall survival results were presented at ASCO last year.³ And so, the study showed that tivozanib relative to sorafenib increased progression-free survival, with no apparent difference in overall survival. The authors in the Lancet Oncology paper also noted that there seemed to be better tolerability with tivozanib relative to sorafenib.

In this poster that was presented [at ASCO GU], we wanted to look at Q-TWiST, which is quality-adjusted time without symptoms or toxicity, and it’s a way to basically take a patient's survival and quantify it, qualitatively and quantitatively. [Ultimately,] the study showed an increase in progression-free survival. The question is, was that also associated with a better quality of life essentially, so that was the basic motivation.

References:

1. Szarek M, Needle MN, Rini BI, et al. Q-TWiST analysis of tivozanib (T) versus sorafenib (S) in patients with advanced renal cell carcinoma (RCC) in the TIVO-3 study. J Clin Oncol. 2021;39(suppl 6):298. doi: 10.1200/JCO.2021.39.6_suppl.298

2. Rini BI, Pal SK, Escudier BJ, et al. Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study. Lancet Oncol. 2020;21(1):95-104. doi: 10.1016/S1470-2045(19)30735-1

3. Pal SK, Escudier B, Atkins MB, et al. TIVO-3: Final OS analysis of a phase III, randomized, controlled, multicenter, open-label study to compare tivozanib to sorafenib in subjects with metastatic renal cell carcinoma (RCC). J Clin Oncol. 2020;38(suppl 15):5062. doi: 10.1200/JCO.2020.38.15_suppl.5062