Evidence map›Paper›PMID 27655223›Full record

Trial reportJournal of neuro-oncology2017

Veliparib in combination with whole-brain radiation therapy for patients with brain metastases from non-small cell lung cancer: results of a randomized, global, placebo-controlled study.

Pierre Chabot, Te-Chun Hsia, Jeong-Seon Ryu, Vera Gorbunova, Cristobal Belda-Iniesta, David Ball, Ebenezer Kio, Minesh Mehta, Katherine Papp, Qin Qin and 4 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of neuro-oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01657799 (A Randomized, Double-Blind, Phase 2, Dose-Ranging Study to Evaluate the Safety and Efficacy of Veliparib and Whole Brain Radiation Therapy Versus Placebo and Whole Brain Radiation Therapy in Subjects With Brain Metastases From Non-Small Cell Lung Cancer), which is not on this map. Cited by 43 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 6 pooled it
5.6field-weighted citation impact, top 4% 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.

NCT01657799 phase2completednot on this map

A Randomized, Double-Blind, Phase 2, Dose-Ranging Study to Evaluate the Safety and Efficacy of Veliparib and Whole Brain Radiation Therapy Versus Placebo and Whole Brain Radiation Therapy in Subjects With Brain Metastases From Non-Small Cell Lung Cancer

TypeinterventionalSponsorAbbVie (prior sponsor, Abbott)Ran2012 to 2015Enrolled307ConditionsBrain Metastases From Non-small Cell Lung CancerArmsVeliparib, Placebo, Whole brain radiation therapy
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 6 syntheses or guidelines pooled it, 91 citations in OpenAlex.

  1. Pooled it
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  17. Zinc finger proteins: guardians of genome stability.Frontiers in cell and developmental biology · 2024
    Review
  18. DNA as the main target in radiotherapy-a historical overview from first isolation to anti-tumour immune response.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2023
    Review
  19. Phase I Study of Niraparib in Combination with Radium-223 for the Treatment of Metastatic Castrate-Resistant Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  20. 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

14 authors at 10 institutions in 7 countries.

Pierre ChabotHôpital Maisonneuve-Rosemont, Montreal, QC, Canada.
Te-Chun HsiaChina Medical University Hospital, China Medical University, Taichung, Taiwan, People's Republic of China.
Jeong-Seon RyuInha University Hospital, Jung-Gu, Incheon, South Korea.
Vera GorbunovaN.N. Blokhin Russian Cancer Research Center, Moscow, Russia.
Cristobal Belda-IniestaCentro Integral Oncológico Clara Campal HM Sanchinarro, Madrid, Spain.
David BallPeter MacCallum Cancer Centre, Melbourne, VIC, Australia.
Ebenezer KioIU Health Goshen Center for Cancer Care, Goshen, IN, USA.
Minesh MehtaUniversity of Maryland, College Park, MD, USA.
Katherine PappAbbVie Inc., Chicago, IL, USA.
Qin QinAbbVie Inc., Chicago, IL, USA.
Jane QianAbbVie Inc., Chicago, IL, USA.
Kyle D HolenAbbVie Inc., Chicago, IL, USA.
Vince GirandaAbbVie Inc., Chicago, IL, USA.
John H SuhCleveland Clinic, 9500 Euclid Ave, Cleveland, OH, 44195, USA. suhj@ccf.org.
AbbVie (United States) · USChina Medical University · TWCleveland Clinic · USGoshen Health · USHôpital Maisonneuve-Rosemont · CAHospital Universitario HM Sanchinarro · ESInha University Hospital · KRPeter MacCallum Cancer Centre · AURussian Cancer Research Center NN Blokhin · RUUniversity of Maryland, College Park · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Veliparib is a potent, orally bioavailable, poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor that crosses the blood-brain barrier and has been shown to potentiate the effects of radiation in preclinical and early clinical studies. This phase 2, randomized, global study evaluated the efficacy and safety of veliparib in combination with whole-brain radiation therapy (WBRT) in patients with brain metastases from non-small cell lung cancer (NSCLC). Three-hundred and seven patients with brain metastases from NSCLC were randomized 1:1:1 to WBRT (30 Gy in 10 fractions) plus 50 mg veliparib twice daily (BID; n = 103), 200 mg veliparib BID (n = 102), or placebo BID (n = 102). Treatment began within 28 days of diagnosis. Tumor response and safety were assessed; the primary endpoint was overall survival (OS). Patients who received ≥1 dose of treatment were included in the safety analysis. All randomized patients were included in the efficacy endpoint analyses. Patient characteristics were well balanced between treatment arms. Median OS was 185 days for patients treated with WBRT plus placebo and 209 days for WBRT plus veliparib (50 or 200 mg). No statistically significant differences in OS, intracranial response rate, and time to clinical or radiographic progression between any of the treatment arms were noted. No differences were observed in adverse events (all grades) across treatment arms; nausea, fatigue, alopecia, and headache were the most commonly reported. No new safety signals were identified for veliparib. A significant unmet need for therapies that improve the outcomes of patients with brain metastases from NSCLC remains.

Indexed as

Brain NeoplasmsAdultAgedAged, 80 and overAntineoplastic AgentsBenzimidazolesCarcinoma, Non-Small-Cell LungCranial IrradiationDouble-Blind MethodFemaleHumansLongitudinal StudiesLung NeoplasmsMaleMiddle AgedTreatment OutcomeAntineoplastic AgentsBenzimidazolesveliparibBrain metastasesNon-small cell lung cancerPARP inhibitorRandomized clinical trialVeliparibWhole-brain radiation therapy

Identifiers

PMID27655223
PMCPMC5258788
OpenAlexW2523463218

What OpenQuestion holds

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LicenceCC BY
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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.