Evidence map›Paper›PMID 29547835›Full record

Trial reportEuropean journal of cancer (Oxford, England : 1990)2018

Efficacy of tivozanib treatment after sorafenib in patients with advanced renal cell carcinoma: crossover of a phase 3 study.

Ana M Molina, Thomas E Hutson, Dmitry Nosov, Piotr Tomczak, Oleg Lipatov, Cora N Sternberg, Robert Motzer, Tim Eisen

Abstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in European journal of cancer (Oxford, England : 1990), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. The Treatment of Metastatic Renal Cell Carcinoma.Deutsches Arzteblatt international · 2024
    Review
  6. Review
  7. Review
  8. Review
  9. A new scenario in metastatic renal cell carcinoma: a SOG-GU consensus.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
    Review
  10. Editorial Commentary:Annals of translational medicine · 2020
    Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. Tivozanib for the treatment of renal cell carcinoma: patient selection and perspectives.International journal of nephrology and renovascular disease · 2019
    Review
  16. Article
  17. Review
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

8 authors.

Ana M MolinaWeill Cornell Medicine, New York, NY, USA. Electronic address: amm9052@med.cornell.edu.
Thomas E HutsonTexas Oncology-Baylor Charles A. Sammons Cancer Center, 3410 Worth Street, Suite 400, Dallas, TX, 75254, USA. Electronic address: Thomas.Hutson@USONCOLOGY.COM.
Dmitry NosovN.N. Blokhin Cancer Research Center, Department of Clinical Pharmacology & Chemotherapy, 24 Kashirskoye Shosse, Moscow, 115478, Russia. Electronic address: nosov@mail.ru.
Piotr TomczakClinical Hospital Number 1 of Poznan University of Medical Sciences, Szamarzewskiego 82/84, 60-569, Poznan, Poland. Electronic address: piotr.tomczak@skpp.edu.pl.
Oleg LipatovRepublican Clinical Oncology Dispensary, 73/1 Oktiabria Pr., Ufa, 450054, Russia. Electronic address: lipatovoleg@bk.ru.
Cora N SternbergSan Camillo-Forlanini Hospital, Department of Medical Oncology, Padiglione Flajani, 1st Floor, Circonvallazione Gianicolense 87, 00152, Rome, Italy. Electronic address: cnsternberg@corasternberg.com.
Robert MotzerMemorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY, 10065, USA. Electronic address: motzerr@mskcc.org.
Tim EisenCambridge University Health Partners, R4 Block, Box 193, Cambridge Biomedical Campus, Hills Road, Cambridge, England, CB2 0QQ, UK. Electronic address: tgqe2@medschl.cam.ac.uk.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundTivozanib is a selective inhibitor of vascular endothelial growth factor receptors 1, 2 and 3 tyrosine kinases. This open-label, crossover clinical study (AV-951-09-902) provided access to tivozanib for patients who progressed on sorafenib in TIVO-1, comparing tivozanib with sorafenib in patients with advanced renal cell carcinoma (RCC).

methodsPatients enrolled in this single-arm, phase 2 crossover study were previously randomised to sorafenib on TIVO-1, progressed and then crossed over to tivozanib. Patients received tivozanib (1.5 mg/day orally; 3 weeks on/1 week off) within 4 weeks after their last sorafenib dose.

findingsCrossover patients were exposed to tivozanib for a median of eight cycles. From the start of tivozanib treatment, median progression-free survival was 11.0 months (95% confidence interval [CI]: 7.3-12.7) and median overall survival was 21.6 months (95% CI: 17.0-27.6). Best overall response was partial response in 29 (18%) patients and stable disease in 83 (52%) patients, with a median duration of response of 15.2 and 12.7 months, respectively. About 77% of patients experienced adverse events, most frequently hypertension (26%), followed by diarrhoea (14%) and fatigue (13%); 53% of patients had treatment-related adverse events, including 24% grade ≥3. About 9% and 16% of patients had dose reductions and dose interruptions due to adverse events, respectively. A total of 30% of patients had serious adverse events, and 4% had treatment-related serious adverse events.

interpretationThis crossover study of patients with advanced RCC demonstrated potent tivozanib anti-tumour activity. Safety and tolerability profiles were acceptable and consistent with the established adverse event profile of tivozanib.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, Renal CellCross-Over StudiesDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateKidney NeoplasmsMaleMiddle AgedPhenylurea CompoundsQuinolinesSorafenibAntineoplastic AgentsPhenylurea CompoundsQuinolinesSorafenibtivozanibFirst-line therapyMetastatic renal cell carcinomaSorafenibTivozanib

Identifiers

PMID29547835
PMCPMC6774240

What OpenQuestion holds

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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.