Evidence map›Paper›PMID 22454414›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2012

Randomized, double-blind, placebo-controlled phase III trial comparing docetaxel and prednisone with or without bevacizumab in men with metastatic castration-resistant prostate cancer: CALGB 90401.

William Kevin Kelly, Susan Halabi, Michael Carducci, Daniel George, John F Mahoney, Walter M Stadler, Michael Morris, Philip Kantoff, J Paul Monk, Ellen Kaplan and 2 more

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

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01859221 (Phase II Stereotactic Body Radiotherapy), which is not on this map. Cited by 277 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
277citing papers in PubMed, 16 pooled it
36.0field-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.

NCT01859221 nacompletednot on this mapstarted 2013, after this paper: background citation

Phase II Stereotactic Body Radiotherapy (SBRT) and Stereotactic Hypofractionated Radiotherapy (SHRT) for Oligometastatic Prostate Cancer

TypeinterventionalSponsorUniversity of FloridaRan2013 to 2022Enrolled39ConditionsOligometastatic Prostate CancerArmsStereotactic radiation
3 · Its place in the literature

Who cites it

277 citing papers in PubMed, 16 syntheses or guidelines pooled it, 481 citations in OpenAlex.

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  5. Clinical outcomes in men of diverse ethnic backgrounds with metastatic castration-resistant prostate cancer.Annals of oncology : official journal of the European Society for Medical Oncology · 2020
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  6. Overall Survival of Black and White Men With Metastatic Castration-Resistant Prostate Cancer Treated With Docetaxel.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
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  9. Meta-Analysis Evaluating the Impact of Site of Metastasis on Overall Survival in Men With Castration-Resistant Prostate Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016
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217 more citing papers are in PubMed but not listed here.

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

12 authors at 1 institution in 1 country.

William Kevin KellyThomas Jefferson University, Philadelphia, PA, USA. wm.kevin.kelly@jefferson.edu
Susan Halabi
Michael Carducci
Daniel George
John F Mahoney
Walter M Stadler
Michael Morris
Philip Kantoff
J Paul Monk
Ellen Kaplan
Nicholas J Vogelzang
Eric J Small
Johns Hopkins University · US

Funding

CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
NCI NIH HHS CA33601NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA033601
6 · The paper itself

Abstract

purposeA randomized, placebo-controlled study based on preclinical and clinical data that supports the potential role of vascular endothelial growth factor in prostate cancer was performed to evaluate the addition of bevacizumab to standard docetaxel and prednisone therapy in patients with metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND

methodsPatients with chemotherapy-naive progressive mCRPC with Eastern Cooperative Oncology Group performance status ≤ 2 and adequate bone marrow, hepatic, and renal function were randomly assigned to receive docetaxel 75 mg/m(2) intravenously (IV) over 1 hour for 21 days plus prednisone 5 mg orally twice per day (DP) with either bevacizumab 15 mg/kg IV every 3 weeks (DP + B) or placebo. The primary end point was overall survival (OS), and secondary end points were progression-free survival (PFS), 50% decline in prostate-specific antigen, objective response (OR), and toxicity.

resultsIn total, 1,050 patients were randomly assigned. The median OS for patients given DP + B was 22.6 months compared with 21.5 months for patients treated with DP (hazard ratio, 0.91; 95% CI, 0.78 to 1.05; stratified log-rank P = .181). The median PFS time was superior in the DP + B arm (9.9 v 7.5 months, stratified log-rank P < .001) as was the proportion of patients with OR (49.4% v 35.5%; P = .0013). Grade 3 or greater treatment-related toxicity was more common with DP + B (75.4% v 56.2%; P ≤ .001), as was the number of treatment-related deaths (4.0% v 1.2%; P = .005).

conclusionDespite an improvement in PFS and OR, the addition of bevacizumab to docetaxel and prednisone did not improve OS in men with mCRPC and was associated with greater toxicity.

Indexed as

Drug Resistance, NeoplasmAdenocarcinomaAgedAndrogen AntagonistsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBevacizumabChi-Square DistributionDisease-Free SurvivalDocetaxelDouble-Blind MethodHumansKaplan-Meier EstimateMaleMiddle AgedAndrogen AntagonistsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, HormonalBevacizumabDocetaxelPlacebosPrednisoneProstate-Specific AntigenTaxoids

Identifiers

PMID22454414
PMCPMC3383121
OpenAlexW2165088640

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.