Evidence map›Paper›PMID 29129443›Full record

Trial reportThe Lancet. Oncology2017

Adjuvant chemotherapy with or without bevacizumab in patients with resected non-small-cell lung cancer (E1505): an open-label, multicentre, randomised, phase 3 trial.

Heather A Wakelee, Suzanne E Dahlberg, Steven M Keller, William J Tester, David R Gandara, Stephen L Graziano, Alex A Adjei, Natasha B Leighl, Seena C Aisner, Jan M Rothman and 14 more

Open access · greenAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in The Lancet. Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 85 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
85citing papers in PubMed, 6 pooled it
13.7field-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

85 citing papers in PubMed, 6 syntheses or guidelines pooled it, 170 citations in OpenAlex.

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  12. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer.The New England journal of medicine · 2018
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  20. Stage III NSCLC treatment options: too many choices.Breathe (Sheffield, England) · 2024
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25 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 20 institutions in 3 countries.

Heather A WakeleeDepartment of Medicine (Oncology), Stanford Cancer Institute, Stanford University, Stanford, CA, USA. Electronic address: hwakelee@stanford.edu.
Suzanne E DahlbergDana-Farber Cancer Institute and Harvard T H Chan School of Public Health, Boston, MA, USA.
Steven M KellerDepartment of Cardiovascular and Thoracic Surgery, Montefiore Medical Center, Bronx, NY, USA.
William J TesterAlbert Einstein Medical Center, Philadelphia, PA, USA.
David R GandaraUC Davis Comprehensive Cancer Center, Sacramento, CA, USA.
Stephen L GrazianoDivision of Medical Oncology, SUNY Upstate Medical University, Syracuse, NY, USA.
Alex A AdjeiDepartment of Medicine, Roswell Park Cancer Institute, Buffalo, NY, USA.
Natasha B LeighlPrincess Margaret Cancer Centre, Toronto, ON, Canada.
Seena C AisnerRutgers New Jersey Medical School and Cancer Institute of New Jersey, Newark, NJ, USA.
Jan M RothmanThe Regional Cancer Center, Erie, PA, USA.
Jyoti D PatelDepartment of Medicine (Oncology), Northwestern University, Chicago, IL, USA.
Mark D SborovEdina Clinic, Edina, MN, USA.
Sean R McDermottDepartment of Medical Oncology, Tallaght University Hospital, Dublin, Ireland; Cancer Trials Ireland, Dublin, Ireland.
Roman Perez-SolerDepartment of Oncology, Montefiore Medical Center, Bronx, NY, USA.
Anne M TraynorDepartment of Medicine (Oncology), University of Wisconsin, Madison, WI, USA.
Charles ButtsDivision of Oncology, University of Alberta, Edmonton, AB, Canada.
Tracey EvansDepartment of Medicine (Oncology), University of Pennsylvania, Philadelphia, PA, USA.
Atif ShafqatHeartland Cancer Research NCORP and Missouri Baptist Cancer Center, St Louis, MO, USA.
Andrew E ChapmanDepartment of Medical Oncology, Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, PA, USA.
Samer S KasbariSoutheast Clinical Oncology Research Consortium NCORP, Winston-Salem, NC, USA.
Leora HornDepartment of Medicine (Oncology), Vanderbilt University Medical Center, Nashville, TN, USA.
Suresh S RamalingamWinship Cancer Institute, Emory University, Atlanta, GA, USA.
Joan H SchillerDivision of Hematology/Oncology, University of Texas Southwestern, Dallas, TX, USA.
ECOG-ACRIN
Montefiore Medical Center · USDana-Farber Cancer Institute · USEinstein Medical Center Philadelphia · USEmory University · USHeartland Cancer Research · USNorthwestern University · USPrincess Margaret Cancer Centre · CARegional Cancer Center · USRoswell Park Comprehensive Cancer Center · USRutgers, The State University of New Jersey · USSidney Kimmel Cancer Center · USSoutheast Clinical Oncology Research Consortium · USStanford University · USSUNY Upstate Medical University · USTallaght University Hospital · IEThe University of Texas Southwestern Medical Center · USUC Davis Comprehensive Cancer CenterUniversity of Alberta · CAUniversity of Pennsylvania · USUniversity of Wisconsin–Madison · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 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
NCIC Clinical Trials Group - Canadian Collaborating Clinical Trials NetworkU10CA180863 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI Janet Ellen Dancey · 2014 to 2026
$40.4M
Southeast Clinical Oncology Research Consortium, Inc. (SCOR)UG1CA189858 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI Judith O Hopkins, William J Irvin · 2014 to 2026
$38.8M
Montefiore Academic Community NCORP ProgramUG1CA189859 · NCI · MONTEFIORE MEDICAL CENTER (BRONX, NY) · PI Balazs Halmos, Della Makower · 2014 to 2026
$10.8M
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
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
NCI NCTN-Network Lead Academic Site at UPCIU10CA180844 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BRUFSKY, ADAM M, EDWARDS, ROBERT PAGE · 2014 to 2018
$4.5M
NCI NIH HHS U10 CA180790NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180799NCI NIH HHS U10 CA180816NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180844NCI NIH HHS U10 CA180846NCI NIH HHS U10 CA180847NCI NIH HHS U10 CA180863NCI NIH HHS U10 CA180864NCI NIH HHS U10 CA180866NCI NIH HHS U10 CA180870NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189830NCI NIH HHS UG1 CA189858NCI NIH HHS UG1 CA189859NCI NIH HHS UG1 CA189863NCI NIH HHS UG1 CA232760NCI NIH HHS UG1 CA233270NCI NIH HHS UG1 CA233340
6 · The paper itself

Abstract

backgroundAdjuvant chemotherapy for resected early-stage non-small-cell lung cancer (NSCLC) provides a modest survival benefit. Bevacizumab, a monoclonal antibody directed against VEGF, improves outcomes when added to platinum-based chemotherapy in advanced-stage non-squamous NSCLC. We aimed to evaluate the addition of bevacizumab to adjuvant chemotherapy in early-stage resected NSCLC.

methodsWe did an open-label, randomised, phase 3 trial of adult patients (aged ≥18 years) with an Eastern Cooperative Oncology Group performance status of 0 or 1 and who had completely resected stage IB (≥4 cm) to IIIA (defined by the American Joint Committee on Cancer 6th edition) NSCLC. We enrolled patients from across the US National Clinical Trials Network, including patients from the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) affiliates in Europe and from the Canadian Cancer Trials Group, within 6-12 weeks of surgery. The chemotherapy regimen for each patient was selected before randomisation and administered intravenously; it consisted of four 21-day cycles of cisplatin (75 mg/m

findingsBetween June 1, 2007, and Sept 20, 2013, 1501 patients were enrolled and randomly assigned to the two treatment groups: 749 to group A (chemotherapy alone) and 752 to group B (chemotherapy plus bevacizumab). 383 (26%) of 1458 patients (with complete staging information) had stage IB, 636 (44%) had stage II, and 439 (30%) had stage IIIA disease (stage of disease data were missing for 43 patients). Squamous cell histology was reported for 422 (28%) of 1501 patients. All four cisplatin-based chemotherapy regimens were used: 377 (25%) patients received vinorelbine, 343 (23%) received docetaxel, 283 (19%) received gemcitabine, and 497 (33%) received pemetrexed. At a median follow-up of 50·3 months (IQR 32·9-68·0), the estimated median overall survival in group A has not been reached, and in group B was 85·8 months (95% CI 74·9 to not reached); hazard ratio (group B vs group A) 0·99 (95% CI 0·82-1·19; p=0·90). Grade 3-5 toxicities of note (all attributions) that were reported more frequently in group B (the bevacizumab group) than in group A (chemotherapy alone) were overall worst grade (ie, all grade 3-5 toxicities; 496 [67%] of 738 in group A vs 610 [83%] of 735 in group B), hypertension (60 [8%] vs 219 [30%]), and neutropenia (241 [33%] vs 275 [37%]). The number of deaths on treatment did not differ between the groups (15 deaths in group A vs 19 in group B). Of these deaths, three in group A and ten in group B were considered at least possibly related to treatment.

interpretationAddition of bevacizumab to adjuvant chemotherapy did not improve overall survival for patients with surgically resected early-stage NSCLC. Bevacizumab does not have a role in this setting and should not be considered as an adjuvant therapy for patients with resected early-stage NSCLC.

fundingNational Cancer Institute of the National Institutes of Health.

Indexed as

Antineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarcinoma, Non-Small-Cell LungLung NeoplasmsAdultAgedChemotherapy, AdjuvantDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesHumansMaleMiddle AgedPatient SelectionAntineoplastic Agents, ImmunologicalBevacizumab

Identifiers

PMID29129443
PMCPMC5789803
OpenAlexW2767470081

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.