Evidence map›Paper›PMID 34965947›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2022

The Effect of Corticosteroids on Prostate Cancer Outcome Following Treatment with Enzalutamide: A Multivariate Analysis of the Phase III AFFIRM Trial.

Jimmy L Zhao, Karim Fizazi, Fred Saad, Kim N Chi, Mary-Ellen Taplin, Cora N Sternberg, Andrew J Armstrong, Johann S de Bono, William T Duggan, Howard I Scher

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00974311 (Affirm), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 26% 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.

NCT00974311 phase3completednot on this map

Affirm: A Multinational Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy And Safety Study Of Oral Mdv3100 In Patients With Progressive Castration-resistant Prostate Cancer Previously Treated With Docetaxel Based Chemotherapy

TypeinterventionalSponsorPfizerRan2009 to 2017Enrolled1,199ConditionsCastration-Resistant Prostate CancerArmsEnzalutamide, Placebo
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. 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

10 authors at 9 institutions in 5 countries.

Jimmy L ZhaoGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Karim FizaziDepartment of Cancer Medicine at Institut Gustave Roussy, Villejuif, France.
Fred SaadDepartment of GU Oncology, University of Montreal Hospital Centre (CHUM), Montreal, Canada.
Kim N ChiVancouver Prostate Centre, Vancouver, Canada.
Mary-Ellen TaplinMedical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Cora N SternbergEnglander Institute for Precision Medicine, Sandra and Edward Meyer Cancer Center, New York, New York.ORCID 0000-0003-3938-2627
Andrew J ArmstrongMedical Oncology, Duke Cancer Center, Durham, North Carolina.ORCID 0000-0001-7012-1754
Johann S de BonoThe Institute of Cancer Research and Royal Marsden Hospital, London, United Kingdom.ORCID 0000-0002-2034-595X
William T DugganPfizer Inc., Groton, Connecticut.
Howard I ScherGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Memorial Sloan Kettering Cancer Center · USCentre Hospitalier de l’Université de Montréal · CAConnecticut Sea Grant · USDana-Farber Cancer Institute · USDuke Medical Center · USInstitut Gustave Roussy · FRLander Institute · ILRoyal Marsden Hospital · GBThe Prostate Centre · GB

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
SPORE In Prostate CancerP50CA092629 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI JAMES A EASTHAM · 2001 to 2026
$63.0M
MSK Paul Calabresi Career Development Award for Clinical OncologyK12CA184746 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI Omar Abdel-Wahab, Simon N. Powell · 2015 to 2026
$8.3M
NCI NIH HHS K12 CA184746NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA092629NIH HHS P50-CA92629Paul Calabresi Career Development Award for Clinical Oncology K12CA184746Prostate Cancer Foundation Young Investigator Award 20YOUN22
6 · The paper itself

Abstract

purposeThe clinical impact of concurrent corticosteroid use (CCU) on enzalutamide-treated patients with metastatic castration-resistant prostate cancer (mCRPC) is unknown. We investigated the association of CCU with overall survival (OS), radiographic progression-free survival (rPFS), and time to prostate-specific antigen progression (TTPP) in post-chemotherapy, enzalutamide-treated patients with mCRPC. PATIENTS AND

methodsPost hoc analysis of AFFIRM (NCT00974311) with patients (n = 1,199) randomized 2:1 to enzalutamide 160 mg/day or placebo. Treatment group, CCU, and known prognostic factors were evaluated for impact on OS, rPFS, and TTPP using a multivariate Cox proportional hazards model. CCU was defined as "baseline" (use started at baseline) or "on-study" (baseline plus use that was started during the trial).

resultsEnzalutamide significantly improved OS, rPFS, and TTPP independent of baseline CCU but was associated with inferior clinical outcomes when compared with no baseline CCU, including a shorter OS [10.8 months vs. not reached (NR); HR for use vs. no use, 2.13; 95% confidence interval (CI), 1.79-2.54], rPFS (5.2 months vs. 8.0 months; HR, 1.49; 95% CI, 1.29-1.72], and TTPP (4.6 months vs. 5.7 months; HR, 1.50; 95% CI, 1.25-1.81). These findings held in a multivariate analysis adjusting for baseline prognostic factors wherein baseline CCU was independently associated with decreased OS (HR, 1.71; 95% CI, 1.43-2.04; P < 0.0001) and rPFS (HR, 1.28; 95% CI, 1.11-1.48; P = 0.0007).

conclusionsPatients with mCRPC benefited from enzalutamide treatment independent of CCU, but CCU was associated with worse baseline prognostic factors and outcomes.

Indexed as

Antineoplastic AgentsProstatic Neoplasms, Castration-ResistantAdrenal Cortex HormonesBenzamidesDisease-Free SurvivalHumansMaleMultivariate AnalysisNitrilesPhenylthiohydantoinTreatment OutcomeAdrenal Cortex HormonesAntineoplastic AgentsBenzamidesenzalutamideNitrilesPhenylthiohydantoin

Identifiers

PMID34965947
PMCPMC9366341
OpenAlexW4200388798

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.