Evidence map›Paper›PMID 21785998›Full record

Trial reportInvestigational new drugs2012

A phase II study of sorafenib in combination with bicalutamide in patients with chemotherapy-naive castration resistant prostate cancer.

Emma K Beardsley, Sebastien J Hotte, Scott North, Susan L Ellard, Eric Winquist, Christian Kollmannsberger, Som D Mukherjee, Kim N Chi

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

Trial report in Investigational new drugs, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
5.2field-weighted citation impact, top 4% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Unique Spectrum of Activating BRAF Alterations in Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  7. Article
  8. Article
  9. Article
  10. Observational
  11. Ophiopogonin D', a Natural Product FromFrontiers in pharmacology · 2018
    Article
  12. Driven to metastasize: Kinases as potential therapeutic targets in prostate cancer.Proceedings of the National Academy of Sciences of the United States of America · 2016
    Article
  13. Article
  14. Article
  15. Review
  16. Novel therapeutic approaches for the treatment of castration-resistant prostate cancer.The Journal of steroid biochemistry and molecular biology · 2013
    Review
  17. Article
  18. Article
  19. Article
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 at 4 institutions in 2 countries.

Emma K BeardsleyBC Cancer Agency - Vancouver Cancer Centre, 600 West 10th Avenue, Vancouver, British Columbia, Canada V5Z 4E6.
Sebastien J Hotte
Scott North
Susan L Ellard
Eric Winquist
Christian Kollmannsberger
Som D Mukherjee
Kim N Chi
BC Cancer Agency · CAJuravinski Cancer Centre · CACancer Institute (WIA) · INLondon Health Sciences Centre · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe objective of this trial was to evaluate the clinical effects of sorafenib, a multi-targeted kinase inhibitor, in combination with androgen receptor blockade in patients with castration-resistant prostate cancer.

methodsThis was a multicenter, two-stage, phase 2 trial. Eligible patients had rising PSA, minimal symptoms and were chemotherapy-naïve. Sorafenib 400 mg twice daily was administered with bicalutamide 50 mg once daily on a 28-day cycle. The primary endpoint was PSA response (≥ 50% decline) or stable disease ≥ 6 months.

results39 patients were enrolled including eight without clinical evidence of metastases. Eighteen (47%) patients have had either a PSA response or stable disease ≥ 6 months. PSA declines of ≥ 50% occurred in 12 (32%) of 38 assessable patients, including seven of 27 patients (26%) with prior anti-androgen use. Median time to treatment failure was 5.5 months (95%CI = 4.8.1-8.3). Grade ≥ 3 adverse events included fatigue, skin rash, and hand-foot syndrome.

conclusionsPSA declines and stable disease were observed with a combination of sorafenib and bicalutamide including in patients previously progressing on bicalutamide. Strategies to combine multi-targeted kinase inhibitors with hormonal therapies warrant further study in patients with CRPC.

Indexed as

OrchiectomyAgedAged, 80 and overAnilidesAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBenzenesulfonatesHumansKaplan-Meier EstimateMaleMiddle AgedNiacinamideNitrilesPhenylurea CompoundsProstate-Specific AntigenProstatic NeoplasmsAnilidesAntineoplastic AgentsBenzenesulfonatesbicalutamideNiacinamideNitrilesPhenylurea CompoundsProstate-Specific AntigenPyridinesSorafenibTosyl Compounds

Identifiers

PMID21785998
OpenAlexW2078057935

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.