Evidence map›Paper›PMID 37951974›Full record

ArticleBritish journal of cancer2024

Apalutamide efficacy, safety and wellbeing in older patients with advanced prostate cancer from Phase 3 randomised clinical studies TITAN and SPARTAN.

John Shen, Simon Chowdhury, Neeraj Agarwal, Lawrence I Karsh, Stéphane Oudard, Benjamin A Gartrell, Susan Feyerabend, Fred Saad, Christopher M Pieczonka, Kim N Chi and 9 more

2 registry-linked trialsOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in British journal of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
3.6field-weighted citation impact, top 6% 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.

NCT01946204 phase3active not recruitingnot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer

TypeinterventionalSponsorAragon Pharmaceuticals, Inc.Ran2013 to 2027Enrolled1,207ConditionsProstatic NeoplasmsArmsApalutamide, Placebo
NCT02489318 phase3active not recruitingnot on this map

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

TypeinterventionalSponsorAragon Pharmaceuticals, Inc.Ran2015 to 2027Enrolled1,052ConditionsProstate CancerArmsApalutamide, Placebo, Androgen Deprivation Therapy (ADT)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
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  5. Review
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

19 authors at 13 institutions in 5 countries.

John ShenJonsson Comprehensive Cancer Center, University of California Los Angeles, Los Angeles, CA, USA. JohnShen@mednet.ucla.edu.ORCID 0000-0002-6455-5553
Simon ChowdhuryGuy's, King's, and St. Thomas' Hospitals, and Sarah Cannon Research Institute, London, UK.
Neeraj AgarwalHuntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.
Lawrence I KarshThe Urology Center of Colorado, Denver, CO, USA.
Stéphane OudardGeorges Pompidou Hospital, University of Paris Cité, Paris, France.
Benjamin A GartrellMontefiore Medical Center, Bronx, NY, USA.
Susan FeyerabendStudienpraxis Urologie, Nürtingen, Germany.
Fred SaadCentre Hospitalier de l'Université de Montréal, Université de Montréal, Montréal, QC, Canada.ORCID 0000-0003-2986-5617
Christopher M PieczonkaAssociated Medical Professionals of NY, Syracuse, NY, USA.
Kim N ChiBC Cancer and Vancouver Prostate Centre, Vancouver, BC, Canada.
Sabine D Brookman-MayLudwig-Maximilians-University (LMU), Munich, Germany.
Brendan RooneyJanssen Research & Development, High Wycombe, UK.
Amitabha BhaumikJanssen Research & Development, Titusville, NJ, USA.
Sharon A McCarthyJanssen Research & Development, Raritan, NJ, USA.
Katherine B BevansJanssen Research & Development, Horsham, PA, USA.
Suneel D MundleJanssen Research & Development, Raritan, NJ, USA.
Eric J SmallHelen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.
Matthew R SmithMassachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA, USA.
Julie N GraffVA Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.
Janssen (United States) · USCentre Hospitalier de l’Université de Montréal · CAHarvard University · USJanssen (United Kingdom) · GBMontefiore Medical Center · USOregon Health & Science University · USSt Thomas' Hospital · GBSUNY Upstate Medical University · USThe Urology Center of Colorado · USUniversité Paris Cité · FRUniversity of California, Los Angeles · USUniversity of California, San Francisco · USUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundApalutamide plus androgen-deprivation therapy (ADT) improved outcomes in metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-resistant PC (nmCRPC) in the Phase 3 randomised TITAN and SPARTAN studies, respectively, and maintained health-related quality of life (HRQoL). Apalutamide treatment effect by patient age requires assessment.

methodsPost-hoc analysis assessed patients receiving 240 mg/day apalutamide (525 TITAN and 806 SPARTAN) or placebo (527 TITAN and 401 SPARTAN) with ongoing ADT, stratified by age groups. Prostate-specific antigen declines, radiographic progression-free survival, metastasis-free survival, overall survival (OS), HRQoL and safety were assessed using descriptive statistics, Kaplan-Meier method, Cox proportional-hazards model and mixed-effects model for repeated measures.

resultsHazard ratios (95% confidence intervals) generally favoured apalutamide plus ADT versus ADT alone across all endpoints regardless of age; e.g., OS values were 0.57 (0.40-0.80), 0.70 (0.54-0.91) and 0.74 (0.40-1.39) (TITAN) and 0.39 (0.19-0.78), 0.89 (0.69-1.16) and 0.81 (0.58-1.15) (SPARTAN) in patients aged <65, 65-79 and ≥80 years. Regardless of age, apalutamide also maintained HRQoL and was tolerated well with a potential trend in rates of adverse events increasing with age. Limitations include post-hoc nature and variability in sample size of age groups.

conclusionsApalutamide plus ADT was an effective and well-tolerated option maintaining HRQoL in patients with mCSPC and nmCRPC regardless of age. CLINICAL

trial registrationTITAN (NCT02489318); SPARTAN (NCT01946204).

Indexed as

Prostatic Neoplasms, Castration-ResistantAgedAndrogen AntagonistsHumansMaleQuality of LifeThiohydantoinsAndrogen AntagonistsapalutamideThiohydantoins

Identifiers

PMID37951974
PMCPMC10781967
OpenAlexW4388600728

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.