Evidence map›Paper›PMID 38262444›Full record

ArticleThe oncologist2024

Long-Term Survival in Patients With Relapsed/Refractory Advanced Renal Cell Carcinoma Treated With Tivozanib: Analysis of the Phase III TIVO-3 Trial.

Kathryn E Beckermann, Aviva G Asnis-Alibozek, Michael B Atkins, Bernard Escudier, Thomas E Hutson, Vijay Kasturi, David F McDermott, Sumanta K Pal, Camillo Porta, Brian I Rini and 1 more

Open access · goldAbstract read
In one paragraph

Article in The oncologist, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
4.2field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 10 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 9 institutions in 3 countries.

Kathryn E BeckermannDivision of Hematology Oncology, Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.ORCID 0000-0002-4616-6140
Aviva G Asnis-AlibozekClinical Development and Medical Affairs, AVEO Oncology, Boston, MA, USA.
Michael B AtkinsDepartment of Medical Oncology, Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.ORCID 0000-0003-3901-9924
Bernard EscudierDepartment of Medical Oncology, Gustave Roussy, Villejuif, France.
Thomas E HutsonTexas A&M College of Medicine, Bryan, TX, USA.
Vijay KasturiClinical Development and Medical Affairs, AVEO Oncology, Boston, MA, USA.
David F McDermottDepartment of Medicine, Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute/Harvard Cancer Center, Boston, MA, USA.
Sumanta K PalDepartment of Medical Oncology and Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Camillo PortaInterdisciplinary Department of Medicine, University of Bari Aldo Moro and Policlinico Consorziale di Bari, Bari, Italy.
Brian I RiniDivision of Hematology Oncology, Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.ORCID 0000-0002-2212-080X
Elena VerzoniDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
AVEO Oncology (United States) · USVanderbilt University · USBeth Israel Deaconess Medical Center · USBryan College · USCity of Hope · USFondazione IRCCS Istituto Nazionale dei Tumori · ITGeorgetown University Medical Center · USInstitut Gustave Roussy · FRUniversity of Bari Aldo Moro · IT

Funding

AVEO Pharmaceuticals, Inc
6 · The paper itself

Abstract

backgroundTivozanib 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.

methodsPatients 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.

resultsMean 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).

conclusionsTivozanib 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.

Indexed as

Antineoplastic AgentsCarcinoma, Renal CellKidney NeoplasmsQuinolinesClinical Trials, Phase III as TopicHumansPhenylurea CompoundsProtein Kinase InhibitorsRandomized Controlled Trials as TopicReceptors, Vascular Endothelial Growth FactorSorafenibVascular Endothelial Growth Factor AAntineoplastic AgentsPhenylurea CompoundsProtein Kinase InhibitorsQuinolinesReceptors, Vascular Endothelial Growth FactorSorafenibtivozanibVascular Endothelial Growth Factor Acarcinomalong-term progression free survivalrelapsed kidney cancerrenal celltivozanibvascular endothelial growth factor

Identifiers

PMID38262444
PMCPMC10911910
OpenAlexW4391126183

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.