التفاصيل البيبلوغرافية
| العنوان: |
Long-Term Survival in Patients With Relapsed/Refractory Advanced Renal Cell Carcinoma Treated With Tivozanib: Analysis of the Phase III TIVO-3 Trial. |
| المؤلفون: |
Beckermann, Kathryn E, Asnis-Alibozek, Aviva G, Atkins, Michael B, Escudier, Bernard, Hutson, Thomas E, Kasturi, Vijay, McDermott, David F, Pal, Sumanta K, Porta, Camillo, Rini, Brian I, Verzoni, Elena |
| المصدر: |
Oncologist; Mar2024, Vol. 29 Issue 3, p254-262, 9p |
| مصطلحات موضوعية: |
RENAL cell carcinoma, STATISTICS, RESEARCH, CONFIDENCE intervals, CANCER relapse, PROTEIN-tyrosine kinase inhibitors, TREATMENT effectiveness, RANDOMIZED controlled trials, COMPARATIVE studies, DESCRIPTIVE statistics, SORAFENIB, RESEARCH funding, VASCULAR endothelial growth factors, STATISTICAL sampling, PROGRESSION-free survival, DATA analysis, OVERALL survival, PATIENT safety, LONGITUDINAL method |
| مستخلص: |
Background Tivozanib is an oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) with efficacy in advanced renal cell carcinoma (RCC). Long-term exploratory analyses from the TIVO-3 trial in relapsed/refractory (R/R) RCC including patients (26%) with prior immuno-oncology (IO) therapy are reported. Methods Patients with R/R advanced RCC that progressed with 2 or 3 prior systemic therapies (≥1 VEGFR TKI) were randomized to tivozanib 1.5 mg QD or sorafenib 400 mg BID, stratified by IMDC risk and previous therapy. Safety, investigator-assessed long-term progression-free survival (LT-PFS), and serial overall survival (OS) were assessed. Results Mean time on treatment was 11.0 months with tivozanib (n = 175) and 6.3 months with sorafenib (n = 175). Fewer grade ≥3 treatment-related adverse events occurred with tivozanib (46%) than sorafenib (55%). Dose modification rates were lower with tivozanib than sorafenib across age/prior IO subgroups; prior IO therapy did not impact dose reductions or discontinuations in either arm. Landmark LT-PFS rates were higher with tivozanib (3 years: 12.3% vs 2.4%; 4 years: 7.6% vs 0%). After 22.8 months mean follow-up, the OS HR was 0.89 (95% CI, 0.70-1.14); when conditioned on 12-month landmark PFS, tivozanib showed significant OS improvement over sorafenib (HR, 0.45; 95% CI, 0.22-0.91; 2-sided P = .0221). Conclusions Tivozanib demonstrated a consistent safety profile and long-term survival benefit in patients with R/R advanced RCC who were alive and progression free at 12 months. These post hoc exploratory analyses of LT-PFS and conditional OS support a clinically meaningful improvement with tivozanib versus sorafenib in this advanced RCC population. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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