Abstract
Introduction
Tivozanib, vascular endothelial growth factor receptor inhibitor, met the primary
endpoint of improved progression free survival compared to sorafenib in the phase
3 TIVO-3 study in patients with previously treated metastatic renal cell carcinoma.
In this study we sought to understand the temporal characteristics of treatment related
adverse events (TRAEs) and frequency and timing of the dose modifications.
Materials and Methods
In this open label, randomized, phase 3 TIVO-3 study, previously treated patients
with a diagnosis of metastatic renal cell carcinoma and with measurable disease were
included. Patients were randomized to receive either tivozanib 1.5 mg orally once
daily in 4-week cycles or sorafenib 400 mg orally twice daily continuously. Based
on updated safety analysis data (cutoff date of August 15, 2019), time to onset of
the most commonly reported TRAEs, duration of toxicity, rate of dose modifications
was calculated for each treatment arm.
Results
Overall, 350 patients were randomly assigned to receive tivozanib or sorafenib;173
patients from the tivozanib arm and 170 patients from the sorafenib arm were included
in this analysis. Patients received a median of 11.9 cycles (336 days) and 6.7 cycles
(192 days) of tivozanib and sorafenib, respectively. Dose reductions, interruptions
and treatment discontinuations were 25%, 50%, and 21%, and 39%, 50%, and 30% in the
tivozanib and sorafenib arms, respectively, with a longer time to onset of TRAEs in
the tivozanib arm.
Conclusion
Tivozanib was associated with less TRAEs, fewer dose modifications, a longer time
to onset and a shorter duration of TRAEs compared to sorafenib.
Keywords
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Article info
Publication history
Published online: August 22, 2022
Accepted:
August 14,
2022
Received in revised form:
August 11,
2022
Received:
February 27,
2022
Identification
Copyright
© 2022 Elsevier Inc. All rights reserved.
