Evidence map›Paper›PMID 32111923›Full record

Observational studyProstate cancer and prostatic diseases2020

Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the PROCEED registry.

Oliver Sartor, Andrew J Armstrong, Chiledum Ahaghotu, David G McLeod, Matthew R Cooperberg, David F Penson, Philip W Kantoff, Nicholas J Vogelzang, Arif Hussain, Christopher M Pieczonka and 12 more

Registry-linked trialOpen access · hybridAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Prostate cancer and prostatic diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01306890 (A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer), which is not on this map. Cited by 83 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed, 4 pooled it
14.1field-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.

NCT01306890 completednot on this map

A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer

TypeobservationalSponsorDendreonRan2011 to 2017Enrolled1,976ConditionsAdvanced Prostate Cancer, Prostatic NeoplasmsArmssipuleucel-T
3 · Its place in the literature

Who cites it

83 citing papers in PubMed, 4 syntheses or guidelines pooled it, 143 citations in OpenAlex.

  1. Pooled it
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  11. Randomized Phase II Trial of Sipuleucel-T with or without Radium-223 in Men with Bone-metastatic Castration-resistant Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Trial
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23 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

22 authors at 17 institutions in 1 country.

Oliver Sartor *Tulane Medical School, New Orleans, LA, USA. osartor@tulane.edu.
Andrew J Armstrong *Duke Prostate and Urologic Cancer Center, Duke Cancer Institute, Durham, NC, USA.ORCID http://orcid.org/0000-0001-7012-1754
Chiledum AhaghotuMedStar Southern Maryland Hospital Center, Maryland, MD, USA.
David G McLeodCenter for Prostate Disease Research at the Uniformed Services University of Health Sciences, Bethesda, MD, USA.
Matthew R CooperbergDepartments of Urology and Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.ORCID http://orcid.org/0000-0003-4339-6685
David F PensonVanderbilt University Medical Center, Nashville, TN, USA.
Philip W KantoffMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Nicholas J VogelzangComprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.
Arif HussainUniversity of Maryland School of Medicine, Baltimore, MD, USA.
Christopher M PieczonkaAssociated Medical Professionals, Syracuse, NY, USA.
Neal D ShoreDepartment of Urology, Carolina Urologic Research Center, Myrtle Beach, SC, USA.
David I QuinnNorris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.
Eric J SmallUCSF Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.
Elisabeth I HeathKarmanos Cancer Institute, Wayne State University School of Medicine, Detroit, MI, USA.
Ronald F TutroneChesapeake Urology Research Associates, Towson, MD, USA.
Paul F SchellhammerDepartment of Urology, Eastern Virginia Medical School Urology of Virginia, Virginia, VA, USA.
Matthew HarmonDendreon Pharmaceuticals LLC, Seattle, WA, USA.
Nancy N ChangDendreon Pharmaceuticals LLC, Seattle, WA, USA.
Nadeem A SheikhDendreon Pharmaceuticals LLC, Seattle, WA, USA.
Bruce BrownDendreon Pharmaceuticals LLC, Seattle, WA, USA.
Stephen J FreedlandCenter for Integrated Research in Cancer and Lifestyle, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Celestia S HiganoUniversity of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Dendreon (United States) · USUniversity of California, San Francisco · USCarolina Urologic Research Center · USCedars-Sinai Medical Center · USChesapeake Urology Associates · USComprehensive Cancer Centers of Nevada · USDuke Medical Center · USEastern Virginia Medical School · USMemorial Sloan Kettering Cancer Center · USSUNY Upstate Medical University · USTulane Medical Center · USUniformed Services University of the Health Sciences · USUniversity of Maryland, Baltimore · USUniversity of Southern California · USUniversity of Washington · USVanderbilt University Medical Center · USWayne State University · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Targeting convergent oncogenic signaling during AR inhibition to overcome metastasis and immune evasion in prostate cancerR01CA233585 · NCI · DUKE UNIVERSITY · PI ARMSTRONG, ANDREW J · 2019 to 2023
$2.2M
NCI NIH HHS P30 CA008748NCI NIH HHS R01 CA233585
6 · The paper itself

Abstract

purposeAfrican Americans experience greater prostate cancer risk and mortality than do Caucasians. An analysis of pooled phase III data suggested differences in overall survival (OS) between African American and Caucasian men receiving sipuleucel-T. We explored this in PROCEED (NCT01306890), an FDA-requested registry in over 1900 patients with metastatic castration-resistant prostate cancer (mCRPC) treated with sipuleucel-T. PATIENTS AND

methodsOS for patients who received ≥1 sipuleucel-T infusion was compared between African American and Caucasian men using an all patient set and a baseline prostate-specific antigen (PSA)-matched set (two Caucasians to every one African American with baseline PSAs within 10% of each other). Univariable and multivariable analyses were conducted. Survival data were examined using Kaplan-Meier and Cox proportional hazard methodologies.

resultsMedian follow-up was 46.6 months. Overall survival differed between African American and Caucasian men with hazard ratios (HR) of 0.81 (95% confidence interval [CI]: 0.68-0.97, P = 0.03) in the all patient set and 0.70 (95% CI: 0.57-0.86, P < 0.001) in the PSA-matched set. Median OS was longer in African Americans than in Caucasian men for both analysis sets, e.g., 35.3 and 25.8 months, respectively, in the PSA-matched set. Similar results were observed in the all patient set. Differences were larger when treatment began at lower baseline PSA; curves were more similar among patients with higher baseline PSA. In patients with baseline PSA below the median, the HR was 0.52 (95% CI: 0.37-0.72, P < 0.001), with median OS of 54.3 versus 33.4 months. Known prognostic factors and African American race (multivariable analyses; HR: 0.60, 95% CI: 0.48-0.74, P < 0.001) were independently associated with OS. Use of post-sipuleucel-T anticancer interventions was balanced between races.

conclusionIn this exploratory analysis of a registry including nearly 12% African American men with mCRPC, OS was significantly different between African Americans and Caucasians, indicating further research is warranted.

Indexed as

Health Status DisparitiesAdultAgedAged, 80 and overBlack or African AmericanCancer VaccinesDisease ProgressionFollow-Up StudiesHumansInfusions, IntravenousKallikreinsKaplan-Meier EstimateMaleMiddle AgedProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantCancer VaccinesKallikreinsKLK3 protein, humanProstate-Specific Antigensipuleucel-TTissue Extracts

Identifiers

PMID32111923
PMCPMC7423504
OpenAlexW3008585547

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.