Evidence map›Paper›PMID 33754187›Full record

ArticleCancer chemotherapy and pharmacology2021

Niraparib with androgen receptor-axis-targeted therapy in patients with metastatic castration-resistant prostate cancer: safety and pharmacokinetic results from a phase 1b study (BEDIVERE).

Fred Saad, Kim N Chi, Neal D Shore, Julie N Graff, Edwin M Posadas, Jean-Baptiste Lattouf, Byron M Espina, Eugene Zhu, Alex Yu, Anasuya Hazra and 6 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2021. 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 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
3.7field-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.

NCT02924766 phase1completednot on this map

A Safety and Pharmacokinetics Study of Niraparib Plus Androgen Receptor-Targeted Therapy (Apalutamide or Abiraterone Acetate Plus Prednisone) in Men With Metastatic Castration-Resistant Prostate Cancer

TypeinterventionalSponsorJanssen Research & Development, LLCRan2016 to 2019Enrolled34ConditionsProstatic NeoplasmsArmsNiraparib, Apalutamide, Abiraterone Acetate, Prednisone
NCT05717660 phase2unknown statusnot on this mapstarted 2023, after this paper: background citation

APalutamide and stEReotactic Body Radiation Therapy for Low Burden Metastatic Hormone senSItive Prostate Cancer, a rANdomized Trial - PERSIAN

TypeinterventionalSponsorAzienda Ospedaliero-Universitaria CareggiRan2023 to 2025Enrolled180ConditionsOligometastatic Hormone Sensitive Prostate CancerArmsSBRT on all sites of metastatic disease+Apalutamide
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
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  5. Niraparib and Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  6. Trial
  7. Article
  8. Article
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  10. Review
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  14. Development of PARP inhibitors in advanced prostate cancer.Therapeutic advances in medical oncology · 2024
    Review
  15. Article
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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

16 authors at 7 institutions in 3 countries.

Fred SaadCentre Hospitalier de l'Université de Montréal, Montréal, Canada. fred.saad@umontreal.ca.ORCID 0000-0003-2986-5617
Kim N ChiBC Cancer, Vancouver, Canada.
Neal D ShoreCarolina Urologic Research Center, Myrtle Beach, SC, USA.
Julie N GraffKnight Cancer Institute, Oregon Health and Science University, Portland, OR, USA.
Edwin M PosadasCedars-Sinai Medical Center, Los Angeles, CA, USA.
Jean-Baptiste LattoufCentre Hospitalier de l'Université de Montréal, Montréal, Canada.
Byron M EspinaJanssen Research & Development, Los Angeles, CA, USA.
Eugene ZhuJanssen Research & Development, Raritan, NJ, USA.
Alex YuJanssen Research & Development, Spring House, PA, USA.
Anasuya HazraJanssen Research & Development, Spring House, PA, USA.
Marc De MeulderJanssen Research & Development, Antwerp, Belgium.
Rao N V S MamidiJanssen Research & Development, Raritan, NJ, USA.
Branislav BradicJanssen Research & Development, Raritan, NJ, USA.
Peter FrancisJanssen Global Services, Raritan, NJ, USA.
Vinny HayrehJanssen Research & Development, Los Angeles, CA, USA.
Arash Rezazadeh KalebastyNorton Cancer Institute, Louisville, KY, USA.
Janssen (United States) · USCentre Hospitalier de l’Université de Montréal · CACarolina Urologic Research Center · USCedars-Sinai Medical Center · USJanssen (Belgium) · BENorton Healthcare · USOregon Health & Science University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo assess the safety and pharmacokinetics and determine the recommended phase 2 dose (RP2D) of niraparib with apalutamide or abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-resistant prostate cancer (mCRPC).

methodsBEDIVERE was a multicenter, open-label, phase 1b study of niraparib 200 or 300 mg/day with apalutamide 240 mg or AAP (abiraterone acetate 1000 mg; prednisone 10 mg). Patients with mCRPC were previously treated with ≥ 2 lines of systemic therapy, including ≥ 1 androgen receptor-axis-targeted therapy for prostate cancer.

resultsThirty-three patients were enrolled (niraparib-apalutamide, 6; niraparib-AAP, 27). No dose-limiting toxicities (DLTs) were reported when combinations included niraparib 200 mg; five patients receiving niraparib 300 mg experienced DLTs [niraparib-apalutamide, 2/3 patients (66.7%); niraparib-AAP, 3/8 patients (37.5%)]. Although data are limited, niraparib exposures were lower when given with apalutamide compared with historical niraparib monotherapy exposures in patients with solid tumors. Because of the higher incidence of DLTs, the niraparib-apalutamide combination and niraparib 300 mg combination with AAP were not further evaluated. Niraparib 200 mg was selected as the RP2D with AAP. Of 19 patients receiving niraparib 200 mg with AAP, 12 (63.2%) had grade 3/4 treatment-emergent adverse events, the most common being thrombocytopenia (26.3%) and hypertension (21.1%). Five patients (26.3%) had adverse events leading to treatment discontinuation.

conclusionsThese results support the choice of niraparib 200 mg as the RP2D with AAP. The niraparib-AAP combination was tolerable in patients with mCRPC, with no new safety signals. An ongoing phase 3 study is further assessing this combination in patients with mCRPC. TRIAL REGISTRATION NO: NCT02924766 (ClinicalTrials.gov).

Indexed as

AgedAged, 80 and overAndrostenesAntineoplastic Combined Chemotherapy ProtocolsHumansIndazolesMaleMiddle AgedPiperidinesPoly(ADP-ribose) Polymerase InhibitorsPrednisoneProstatic Neoplasms, Castration-ResistantReceptors, AndrogenThiohydantoinsabirateroneAndrostenesapalutamideAR protein, humanIndazolesniraparibPiperidinesPoly(ADP-ribose) Polymerase InhibitorsPrednisoneReceptors, AndrogenThiohydantoinsAndrogen-signaling-targeted therapyDRD genesMCRPCNiraparibPARP inhibitorsPharmacokinetics

Identifiers

PMID33754187
PMCPMC8149334
OpenAlexW3137618571

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.