Evidence map›Paper›PMID 20191303›Full record

Trial reportInvestigational new drugs2011

A phase II trial of sorafenib in first-line metastatic urothelial cancer: a study of the PMH Phase II Consortium.

Srikala S Sridhar, Eric Winquist, Andrea Eisen, Sebastien J Hotte, Elaine McWhirter, Ian F Tannock, Som D Mukherjee, Lisa Wang, Chantale Blattler, John J Wright and 1 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
7.4field-weighted citation impact, top 3% 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

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 77 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Review
  7. Emerging biomarkers in urothelial carcinoma: Challenges and opportunities.Cancer treatment and research communications · 2020
    Article
  8. Interleukin-27 augments the inhibitory effects of sorafenib on bladder cancer cells.Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2017
    Article
  9. Incorporating VEGF-targeted therapy in advanced urothelial cancer.Therapeutic advances in medical oncology · 2017
    Review
  10. Review
  11. Review
  12. Review
  13. Targeted therapy in advanced bladder cancer: what have we learned?The Urologic clinics of North America · 2015
    Review
  14. Review
  15. The role of genomics in the management of advanced bladder cancer.Current treatment options in oncology · 2015
    Review
  16. Article
  17. Multiple mechanisms mediate resistance to sorafenib in urothelial cancer.International journal of molecular sciences · 2014
    Article
  18. Optimal treatment for metastatic bladder cancer.Current oncology reports · 2014
    Review
  19. Targeted therapies in urothelial carcinoma.Current opinion in oncology · 2014
    Review
  20. New treatments for bladder cancer: when will we make progress?Current treatment options in oncology · 2014
    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

11 authors at 6 institutions in 5 countries.

Srikala S SridharPrincess Margaret Hospital, Phase II Consortium, 610 University Avenue, Suite 5-222, Toronto, Ontario M5G 2M9, Canada. srikala.sridhar@uhn.on.ca
Eric Winquist
Andrea Eisen
Sebastien J Hotte
Elaine McWhirter
Ian F Tannock
Som D Mukherjee
Lisa Wang
Chantale Blattler
John J Wright
Malcolm J Moore
Juravinski Cancer Centre · CAPrincess Margaret Hospital · HKNational Cancer Institute · MYPrincess Margaret Cancer Centre · CAPrincess Margaret Hospital · NZRegional Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSorafenib is an oral multikinase inhibitor that blocks cell proliferation via the ERK pathway and angiogenesis via the VEGF pathway. This phase II trial was conducted to determine the efficacy and tolerability of sorafenib for the treatment of patients with metastatic urothelial cancer (UC) who had not had prior chemotherapy for advanced disease. PATIENTS AND

methodsSeventeen chemo-naïve UC patients with adequate performance status and organ function were treated with sorafenib 400 mg twice daily on a continuous basis until progression or unacceptable toxicity. The primary endpoint was objective tumor response rate as measured by RECIST criteria. Secondary endpoints included rate of prolonged stable disease (>3 months), time to progression, median and 1 yr survival and safety and tolerability.

resultsThere were no objective responses. Only one patient had stable disease by RECIST criteria and remained on treatment more than 3 months. Three patients had stable disease by RECIST criteria but were on treatment less than 3 months due to progressive disease (PD) or adverse events (AE). Eight patients had PD by RECIST criteria as their best overall response. Two patients had symptomatic PD prior to cycle 2 evaluation, and three patients were inevaluable (1 death, 1 AE, 1 withdrew consent).The time to progression was 1.9 months (range 0.7-8.7 months) and median survival was 5.9 months. The most common grade 3+ toxicities were abdominal pain, back pain, hand-foot reaction and bladder infection.

conclusionsSorafenib does not show sufficient activity as a single agent in first-line metastatic urothelial cancer to warrant further investigation.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsBenzenesulfonatesFemaleHumansMaleMiddle AgedNeoplasm MetastasisNiacinamidePhenylurea CompoundsProtein Kinase InhibitorsPyridinesSorafenibTreatment OutcomeAntineoplastic AgentsBenzenesulfonatesNiacinamidePhenylurea CompoundsProtein Kinase InhibitorsPyridinesSorafenib

Identifiers

PMID20191303
OpenAlexW1991064094

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.