Evidence map›Paper›PMID 19403935›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2009

Phase II study of sunitinib in men with advanced prostate cancer.

M Dror Michaelson, M M Regan, W K Oh, D S Kaufman, K Olivier, S Z Michaelson, B Spicer, C Gurski, P W Kantoff, M R Smith

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00299741 (A Phase II Study of SU011248 in Men With Advanced Prostate Cancer), which is not on this map. Cited by 73 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 3 pooled it
19.1field-weighted citation impact, top 1% 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.

NCT00299741 phase2completednot on this map

A Phase II Study of SU011248 in Men With Advanced Prostate Cancer

TypeinterventionalSponsorMassachusetts General HospitalRan2006 to 2008Enrolled36ConditionsProstate CancerArmsSunitinib
3 · Its place in the literature

Who cites it

73 citing papers in PubMed, 3 syntheses or guidelines pooled it, 150 citations in OpenAlex.

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  13. Unveiling the Molecular Landscape ofInternational journal of molecular sciences · 2023
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13 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

M Dror MichaelsonDivision of Hematology/Oncology, Massachusetts General Hospital, Boston, MA 02114, USA. dmichaelson1@partners.org
M M Regan
W K Oh
D S Kaufman
K Olivier
S Z Michaelson
B Spicer
C Gurski
P W Kantoff
M R Smith
Harvard University · USMassachusetts General Hospital · USDana-Farber Cancer Institute · US

Funding

Midcareer Investigator AwardK24CA121990 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI SMITH, MATTHEW RAYMOND · 2007 to 2016
$1.9M
NCI NIH HHS 5K24CA121990-02NCI NIH HHS K24 CA121990
6 · The paper itself

Abstract

backgroundThis study explored the efficacy and tolerability of sunitinib, an inhibitor of tyrosine kinase receptors, in men with castration-resistant prostate cancer (CRPC).

methodsMen with no prior chemotherapy (group A) and men with docetaxel (Taxotere)-resistant prostate cancer (group B) were treated with sunitinib. The primary end point was confirmed 50% prostate-specific antigen (PSA) decline. Secondary end points included objective response rate and safety. Serum-soluble biomarkers were measured.

resultsSeventeen men were enrolled in each group. One confirmed PSA response was observed in each group, and an additional eight men and seven men had stable PSA at week 12 in groups A and B, respectively. Improvements in imaging were observed in the absence of post-treatment PSA declines. Common adverse effects included fatigue, nausea, diarrhea, myelosuppression and transaminase elevation. Significant changes following sunitinib treatment were observed in serum-soluble biomarkers including soluble vascular endothelial growth factor receptor-2, platelet-derived growth factor aa, placental growth factor and leptin.

conclusionsSunitinib monotherapy resulted in few confirmed 50% post-treatment declines in PSA in men with CRPC. Serum markers of angiogenesis confirmed on-target effects of sunitinib. Assessments of radiographic disease status were often discordant with changes in PSA, indicating that alternate end points are important in future trials.

Indexed as

AdenocarcinomaAgedAged, 80 and overAngiogenesis InhibitorsAngiogenic ProteinsAntineoplastic Agents, PhytogenicDocetaxelDrug Resistance, NeoplasmHumansIndolesMaleMiddle AgedProstate-Specific AntigenProstatic NeoplasmsProtein Kinase InhibitorsPyrrolesAngiogenesis InhibitorsAngiogenic ProteinsAntineoplastic Agents, PhytogenicDocetaxelIndolesProstate-Specific AntigenProtein Kinase InhibitorsPyrrolesSunitinibTaxoids

Identifiers

PMID19403935
PMCPMC2674960
OpenAlexW2049820493

What OpenQuestion holds

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Registered trials

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.