Evidence map›Paper›PMID 31152080›Full record

Trial reportThe oncologist2019

Phase II, Multicenter, Randomized Trial of Docetaxel plus Prednisone with or Without Cediranib in Men with Chemotherapy-Naive Metastatic Castrate-Resistant Prostate Cancer.

Elisabeth Heath, Lance Heilbrun, Heather Mannuel, Glenn Liu, Primo Lara, J Paul Monk, Thomas Flaig, Amado Zurita, Philip Mack, Ulka Vaishampayan and 8 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The oncologist, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 19% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. 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

18 authors at 13 institutions in 1 country.

Elisabeth HeathDepartment of Oncology, Wayne State University School of Medicine and Karmanos Cancer Institute, Detroit, Michigan, USA heathe@karmanos.org.
Lance HeilbrunDepartment of Oncology, Wayne State University School of Medicine and Karmanos Cancer Institute, Detroit, Michigan, USA.
Heather MannuelDivision of Hematology/Oncology, University of Maryland School of Medicine and Greenebaum Cancer Center, Baltimore, Maryland, USA.
Glenn LiuDivision of Hematology/Oncology, University of Wisconsin School of Medicine and Public Health and Carbone Cancer Center, Madison, Wisconsin, USA.
Primo LaraDivision of Hematology/Oncology, University of California Davis School of Medicine and Cancer Center, Sacramento, California, USA.
J Paul MonkDivision of Medical Oncology, Ohio State University School of Medicine and Cancer Center - James, Columbus, Ohio, USA.
Thomas FlaigDivision of Medical Oncology, University of Colorado School of Medicine, Aurora, Colorado, USA.
Amado ZuritaDivision of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Philip MackDivision of Hematology/Oncology, University of California Davis School of Medicine and Cancer Center, Sacramento, California, USA.
Ulka VaishampayanDepartment of Oncology, Wayne State University School of Medicine and Karmanos Cancer Institute, Detroit, Michigan, USA.
Philip StellaIHA Hematology/Oncology, Ypsilanti, Michigan, USA.
Daryn SmithDepartment of Oncology, Wayne State University School of Medicine and Karmanos Cancer Institute, Detroit, Michigan, USA.
Susan BoltonDepartment of Oncology, Wayne State University School of Medicine and Karmanos Cancer Institute, Detroit, Michigan, USA.
Arif HussainDivision of Hematology/Oncology, University of Maryland School of Medicine and Greenebaum Cancer Center, Baltimore, Maryland, USA.
Anas Al-JanadiMichigan State University Breslin Cancer Center, Lansing, Michigan, USA.
Daniel SilbigerCase Western Reserve University School of Medicine University Hospitals, Cleveland, Ohio, USA.
Muhammad UsmanDepartment of Oncology, Wayne State University School of Medicine and Karmanos Cancer Institute, Detroit, Michigan, USA.
S Percy IvyNational Institutes of Health National Cancer Institute, Bethesda, Maryland, USA.
The Barbara Ann Karmanos Cancer Institute · USWayne State University · USUniversity of California, Davis · USIHA Hematology Oncology Consultants · USMichigan State University · USNational Cancer Institute · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USThe University of Texas MD Anderson Cancer Center · USU-M Rogel Cancer CenterUniversity of Colorado Denver · USUniversity of Maryland, Baltimore · USUniversity of Wisconsin Carbone Cancer Center · USUniversity School · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
Tissue/InformaticsP50CA186786 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Ganesh S Palapattu · 2014 to 2026
$27.6M
Phase I Molecular and Clinical Pharmacodynamic Trials ETCTNUM1CA186717 · NCI · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · PI A. Dimitrios Colevas, Alexey V. Danilov · 2014 to 2026
$19.8M
UM1 Supplement for Early Therapeutic Trials with Phase 2 IntentUM1CA186712 · NCI · OHIO STATE UNIVERSITY · PI SUSANNE M ARNOLD, WILLIAM E. CARSON · 2014 to 2026
$19.3M
NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA186786NCI NIH HHS UM1 CA186712NCI NIH HHS UM1 CA186717
6 · The paper itself

Abstract

lessons learnedThe negative results are consistent with the negative results of large phase III trials in which docetaxel plus antiangiogenic agents were used in patients with metastatic castrate-resistant prostate cancer (mCRPC).The negative data underscore that, despite a sound biological rationale and supportive early-phase clinical results, adding antiangiogenic agents to docetaxel for mCRPC is a great challenge.

backgroundInhibition of vascular endothelial growth factor (VEGF) signaling abrogates tumor-induced angiogenesis to constrain tumor growth, and can be exploited therapeutically by using cediranib, an oral tyrosine kinase inhibitor of VEGF receptor signaling. Our preliminary phase I trial data showed that adding cediranib to docetaxel plus prednisone (DP) was safe and feasible, with early evidence for efficacy in patients with metastatic castrate-resistant prostate cancer (mCRPC).

methodsThis multicenter phase II trial assessed whether adding cediranib to DP improves efficacy of DP in patients with mCRPC. Chemotherapy-naive patients with mCRPC were randomly assigned to receive either docetaxel (75 mg/m

resultsThe 6-month PFS rate in a total of 58 patients was only numerically higher in the DP+C arm (61%) compared with the DP arm (57%). Similarly, the 6-month OS rate, objective tumor and PSA response rates, and biomarkers were not significantly different between the two arms. Increased baseline levels of interleukin 6 (IL-6), however, were significantly associated with increased risk of progression. Neutropenia was the only grade 4 toxicity (38% in the DP+C arm vs. 18% in the DP arm).

conclusionCombining cediranib with docetaxel + prednisone failed to demonstrate superior efficacy, compared with docetaxel + prednisone, and added toxicity. Our data do not support pursuing the combination further in patients with mCRPC.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDocetaxelHumansIndolesKallikreinsMaleMiddle AgedNeoplasm MetastasisPrednisoneProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantQuinazolinesSurvival RateTreatment OutcomecediranibDocetaxelIndolesKallikreinsKLK3 protein, humanPrednisoneProstate-Specific AntigenQuinazolinesVascular Endothelial Growth Factor AVEGFA protein, human

Identifiers

PMID31152080
PMCPMC6738301
OpenAlexW2947924818

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.