Evidence map›Paper›PMID 37399894›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2023

Niraparib plus abiraterone acetate with prednisone in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: second interim analysis of the randomized phase III MAGNITUDE trial.

K N Chi, S Sandhu, M R Smith, G Attard, M Saad, D Olmos, E Castro, G Roubaud, A J Pereira de Santana Gomes, E J Small and 12 more

Open access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 100 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
100citing papers in PubMed, 11 pooled it
42.1field-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.

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

100 citing papers in PubMed, 11 syntheses or guidelines pooled it, 183 citations in OpenAlex.

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  19. Bridging the gap: integrating hereditary cancer into precision oncology.European journal of human genetics : EJHG · 2026
    Review
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40 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 16 institutions in 10 countries.

K N ChiUniversity of British Columbia, BC Cancer-Vancouver Center, Vancouver, Canada. Electronic address: kchi@bccancer.bc.ca.
S SandhuPeter MacCallum Cancer Center, Melbourne, Australia; University of Melbourne, Melbourne, Australia.
M R SmithMassachusetts General Hospital Cancer Center, Boston, USA; Harvard Medical School, Boston, USA.
G AttardUniversity College London Cancer Institute, London, UK; University College London Hospitals, London, UK.
M SaadDepartment of Clinical Oncology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
D OlmosDepartment of Medical Oncology, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital 12 de Octubre (imas12), Madrid.
E CastroDepartment of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.
G RoubaudDepartment of Medical Oncology, Institut Bergonié, Bordeaux, France.
A J Pereira de Santana GomesLiga Norte Riograndense Contra o Câncer, Natal, Brazil.
E J SmallHelen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco.
D E RathkopfMemorial Sloan Kettering Cancer Center, New York, USA; Weill Cornell Medicine, New York, USA.
H GurneyMacquarie University, Macquarie Park, Australia.
W JungKeimyung University Dongsan Hospital, Daegu, South Korea.
G E MasonJanssen Research & Development, LLC, Spring House.
S DibajJanssen Research & Development, LLC, San Diego.
D WuJanssen Research & Development, LLC, Los Angeles.
B DiorioJanssen Research & Development, LLC, Titusville.
K UrtishakJanssen Research & Development, LLC, Spring House.
A Del CorralJanssen Research & Development, LLC, Raritan.
P FrancisJanssen Research & Development, LLC, Bridgewater.
W KimJanssen Research & Development, LLC, Los Angeles.
E EfstathiouHouston Methodist Cancer Center, Houston, USA.
Janssen (Belgium) · BEJanssen (Switzerland) · CHJanssen (United States) · USBC Cancer Agency · CAHarvard University · USHospital Universitario 12 De Octubre · ESHouston Methodist · USInstitut Bergonié · FRKeimyung University · KRMacquarie University · AUMemorial Sloan Kettering Cancer Center · USResearch Institute Hospital 12 de Octubre · ESRoyal London Hospital · GBThe University of Melbourne · AUUniversity of California, San Francisco · USUniversity of Malaya · MY

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundPatients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA alterations have poor outcomes. MAGNITUDE found patients with homologous recombination repair gene alterations (HRR+), particularly BRCA1/2, benefit from first-line therapy with niraparib plus abiraterone acetate and prednisone (AAP). Here we report longer follow-up from the second prespecified interim analysis (IA2). PATIENTS AND

methodsPatients with mCRPC were prospectively identified as HRR+ with/without BRCA1/2 alterations and randomized 1 : 1 to niraparib (200 mg orally) plus AAP (1000 mg/10 mg orally) or placebo plus AAP. At IA2, secondary endpoints [time to symptomatic progression, time to initiation of cytotoxic chemotherapy, overall survival (OS)] were assessed.

resultsOverall, 212 HRR+ patients received niraparib plus AAP (BRCA1/2 subgroup, n = 113). At IA2 with 24.8 months of median follow-up in the BRCA1/2 subgroup, niraparib plus AAP significantly prolonged radiographic progression-free survival {rPFS; blinded independent central review; median rPFS 19.5 versus 10.9 months; hazard ratio (HR) = 0.55 [95% confidence interval (CI) 0.39-0.78]; nominal P = 0.0007} consistent with the first prespecified interim analysis. rPFS was also prolonged in the total HRR+ population [HR = 0.76 (95% CI 0.60-0.97); nominal P = 0.0280; median follow-up 26.8 months]. Improvements in time to symptomatic progression and time to initiation of cytotoxic chemotherapy were observed with niraparib plus AAP. In the BRCA1/2 subgroup, the analysis of OS with niraparib plus AAP demonstrated an HR of 0.88 (95% CI 0.58-1.34; nominal P = 0.5505); the prespecified inverse probability censoring weighting analysis of OS, accounting for imbalances in subsequent use of poly adenosine diphosphate-ribose polymerase inhibitors and other life-prolonging therapies, demonstrated an HR of 0.54 (95% CI 0.33-0.90; nominal P = 0.0181). No new safety signals were observed.

conclusionsMAGNITUDE, enrolling the largest BRCA1/2 cohort in first-line mCRPC to date, demonstrated improved rPFS and other clinically relevant outcomes with niraparib plus AAP in patients with BRCA1/2-altered mCRPC, emphasizing the importance of identifying this molecular subset of patients.

Indexed as

Abiraterone AcetateProstatic Neoplasms, Castration-ResistantAntineoplastic Combined Chemotherapy ProtocolsBRCA1 ProteinBRCA2 ProteinHumansIndazolesMalePiperidinesPrednisoneRecombinational DNA RepairTreatment OutcomeAbiraterone AcetateBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanIndazolesniraparibPiperidinesPrednisoneabiraterone acetateBRCAhomologous recombination repairmetastatic castration-resistant prostate cancerniraparib

Identifiers

PMID37399894
PMCPMC10849465
OpenAlexW4382794886

What OpenQuestion holds

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LicenceTDM
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.