Evidence map›Paper›PMID 38484203›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Efficacy of Poly(ADP-ribose) Polymerase Inhibitors by Individual Genes in Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer: A US Food and Drug Administration Pooled Analysis.

Jaleh Fallah, Jianjin Xu, Chana Weinstock, Xin Gao, Brian L Heiss, William F Maguire, Elaine Chang, Sundeep Agrawal, Shenghui Tang, Laleh Amiri-Kordestani and 3 more

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 3 pooled it
18.9field-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

43 citing papers in PubMed, 3 syntheses or guidelines pooled it, 67 citations in OpenAlex.

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  7. 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
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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

13 authors at 1 institution in 1 country.

Jaleh FallahCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0001-7365-2104
Jianjin XuCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0001-9312-6339
Chana WeinstockCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Xin GaoCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-7383-6453
Brian L HeissCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-7858-841X
William F MaguireCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-3288-8863
Elaine ChangCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0001-6255-2853
Sundeep AgrawalCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Shenghui TangCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-0437-665X
Laleh Amiri-KordestaniCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-0056-5437
Richard PazdurCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-4771-9923
Paul G KluetzCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Daniel L SuzmanCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
United States Food and Drug Administration · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe performed a pooled analysis of multiple trials of poly(ADP-ribose) polymerase inhibitors (PARPi) in metastatic castration-resistant prostate cancer (mCRPC) to investigate the efficacy of PARPi in each individual homologous recombination repair (HRR) mutated (m) gene. PATIENTS AND

methodsWe pooled patient-level data from trials of PARPi in mCRPC that reported mutation status in individual HRR genes. Any HRR gene with available data across all the randomized trials of PARPi in first-line mCRPC was selected. The hazard ratios (HRs; 95% CI) for radiographic progression-free survival (rPFS; by blinded independent review) and overall survival (OS) of a PARPi plus an androgen receptor pathway inhibitor (ARPI) relative to placebo plus an ARPI in the pool of three randomized trials in first-line mCRPC were calculated using Kaplan-Meier estimates and a Cox proportional hazards model.

resultsIn

conclusionIn this pooled analysis, benefit from PARPi appeared greatest for patients with

Indexed as

BRCA2 ProteinMutationPoly(ADP-ribose) Polymerase InhibitorsProstatic Neoplasms, Castration-ResistantRandomized Controlled Trials as TopicRecombinational DNA RepairAgedAndrogen Receptor AntagonistsAntineoplastic Combined Chemotherapy ProtocolsAtaxia Telangiectasia Mutated ProteinsBRCA1 ProteinCheckpoint Kinase 2Cyclin-Dependent KinasesFanconi Anemia Complementation Group N ProteinHumansMaleAndrogen Receptor AntagonistsAtaxia Telangiectasia Mutated ProteinsATM protein, humanBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanCDK12 protein, humanCheckpoint Kinase 2CHEK2 protein, humanCyclin-Dependent KinasesFanconi Anemia Complementation Group N ProteinPoly(ADP-ribose) Polymerase InhibitorsReceptors, Androgen

Identifiers

PMID38484203
PMCPMC11095872
OpenAlexW4392795047

What OpenQuestion holds

Textmetadata
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.