Evidence map›Paper›PMID 30523756›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Randomized Phase II Trial of Cisplatin and Etoposide in Combination With Veliparib or Placebo for Extensive-Stage Small-Cell Lung Cancer: ECOG-ACRIN 2511 Study.

Taofeek K Owonikoko, Suzanne E Dahlberg, Gabriel L Sica, Lynne I Wagner, James L Wade, Gordan Srkalovic, Bradley W Lash, Joseph W Leach, Ticiana B Leal, Charu Aggarwal and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01642251 (Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination With Veliparib), which is not on this map. Cited by 102 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
102citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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.

NCT01642251 phase1 / phase2completednot on this map

Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination With Veliparib (ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2012 to 2018Enrolled156ConditionsExtensive Stage Small Cell Lung Carcinoma, Large Cell Lung Carcinoma, Neuroendocrine Carcinoma, Small Cell CarcinomaArmsCisplatin, Etoposide, Veliparib, Placebo
3 · Its place in the literature

Who cites it

102 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
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  7. Trial
  8. Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab Plus Talazoparib in Patients With SLFN11 Positive Extensive-Stage SCLC: S1929.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2025
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  14. Durvalumab in Combination with Olaparib in Patients with Relapsed SCLC: Results from a Phase II Study.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2019
    Trial
  15. Review
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42 more citing papers are in PubMed but not listed here.

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

11 authors.

Taofeek K Owonikoko1 Emory University, Atlanta, GA.
Suzanne E Dahlberg2 Dana-Farber Cancer Institute, Boston, MA.
Gabriel L Sica1 Emory University, Atlanta, GA.
Lynne I Wagner3 Northwestern University, Chicago, IL.
James L Wade4 Decatur Memorial Hospital, Decatur, IL.
Gordan Srkalovic5 Sparrow Regional Cancer Center, Lansing, MI.
Bradley W Lash6 Guthrie Clinic-Robert Packer Hospital, Sayre, PA.
Joseph W Leach7 Metro Minnesota National Cancer Institute Community Oncology Research Program, Minneapolis, MN.
Ticiana B Leal8 University of Wisconsin, Madison, WI.
Charu Aggarwal9 University of Pennsylvania, Philadelphia, PA.
Suresh S Ramalingam1 Emory University, Atlanta, GA.

Funding

ECOG-ACRIN NCORP Research Base - TMISTUG1CA189828 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$199.7M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO · 2014 to 2026
$111.2M
Metro-Minnesota Community Oncology Research Consortium (MMCORC)UG1CA189863 · NCI · PARK NICOLLET INSTITUTE · PI JOLEEN M HUBBARD, Yan Ji · 2014 to 2026
$43.2M
Heartland Cancer Research NCORPUG1CA189830 · NCI · DECATUR MEMORIAL HOSPITAL · PI Bryan A. Faller · 2014 to 2026
$40.9M
Michigan Cancer Research Consortium NCORPUG1CA189971 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI Tareq Al baghdadi · 2014 to 2026
$36.6M
Naional Cancer Institute, Naitonal Clinical Trials Network U10 Lead Academic SiteU10CA180790 · NCI · MAYO CLINIC ROCHESTER · PI ALBERTS, STEVEN R, BOUGHEY, JUDY CAROLINE · 2014 to 2018
$6.6M
Winship Cancer Institute, National Clinical Trials Network Lead Academic ParticipU10CA180864 · NCI · EMORY UNIVERSITY · PI BEITLER, JONATHAN, RAMALINGAM, SURESH S · 2014 to 2018
$2.9M
National Clinical Trials Network Research at the University of WisconsinU10CA180799 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI ANDERSON, BETHANY M, KUSHNER, DAVID M · 2014 to 2018
$2.8M
Novel systemic therapy to improve clinical outcome in small cell lung cancerK23CA164015 · NCI · EMORY UNIVERSITY · PI OWONIKOKO, TAOFEEK K · 2011 to 2015
$815k
NCI NIH HHS K23 CA164015NCI NIH HHS U10 CA180790NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180799NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180864NCI NIH HHS UG1 CA189828NCI NIH HHS UG1 CA189830NCI NIH HHS UG1 CA189863NCI NIH HHS UG1 CA189971
6 · The paper itself

Abstract

purposeVeliparib, a poly (ADP ribose) polymerase inhibitor, potentiated standard chemotherapy against small-cell lung cancer (SCLC) in preclinical studies. We evaluated the combination of veliparib with cisplatin and etoposide (CE; CE+V) doublet in untreated, extensive-stage SCLC (ES-SCLC). MATERIALS AND

methodsPatients with ES-SCLC, stratified by sex and serum lactate dehydrogenase levels, were randomly assigned to receive four 3-week cycles of CE (75 mg/m

resultsA total of 128 eligible patients received treatment on protocol. The median age was 66 years, 52% of patients were men, and Eastern Cooperative Oncology Group performance status was 0 for 29% of patients and 1 for 71%. The respective median PFS for the CE+V arm versus the CE+P arm was 6.1 versus 5.5 months (unstratified hazard ratio [HR], 0.75 [one-sided P = .06]; stratified HR, 0.63 [one-sided P = .01]), favoring CE+V. The median overall survival was 10.3 versus 8.9 months (stratified HR, 0.83; 80% CI, 0.64 to 1.07; one-sided P = .17) for the CE+V and CE+P arms, respectively. The overall response rate was 71.9% versus 65.6% (two-sided P = .57) for CE+V and CE+P, respectively. There was a significant treatment-by-strata interaction in PFS: Male patients with high lactate dehydrogenase levels derived significant benefit (PFS HR, 0.34; 80% CI, 0.22 to 0.51) but there was no evidence of benefit among patients in other strata (PFS HR, 0.81; 80% CI, 0.60 to 1.09). The following grade ≥ 3 hematology toxicities were more frequent in the CE+V arm than the CE+P arm: CD4 lymphopenia (8% v 0%; P = .06) and neutropenia (49% v 32%; P = .08), but treatment delivery was comparable.

conclusionThe addition of veliparib to frontline chemotherapy showed signal of efficacy in patients with ES-SCLC and the study met its prespecified end point.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesCisplatinDouble-Blind MethodEtoposideFemaleHumansLung NeoplasmsMaleMiddle AgedPlacebosProgression-Free SurvivalSmall Cell Lung CarcinomaSurvival RateBenzimidazolesCisplatinEtoposidePlacebosveliparib

Identifiers

PMID30523756
PMCPMC6338394

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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.