Evidence map›Paper›PMID 24101053›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

Randomized phase II trial of Onartuzumab in combination with erlotinib in patients with advanced non-small-cell lung cancer.

David R Spigel, Thomas J Ervin, Rodryg A Ramlau, Davey B Daniel, Jerome H Goldschmidt, George R Blumenschein, Maciej J Krzakowski, Gilles Robinet, Benoit Godbert, Fabrice Barlesi and 10 more

Open access · bronzeAbstract 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, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 251 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
251citing papers in PubMed, 8 pooled it
50.0field-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

251 citing papers in PubMed, 8 syntheses or guidelines pooled it, 476 citations in OpenAlex.

  1. Pooled it
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  3. Update on recent key publications in lung oncology: picking up speed.European respiratory review : an official journal of the European Respiratory Society · 2021
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  18. Randomized Phase II Trial of Seribantumab in Combination With Paclitaxel in Patients With Advanced Platinum-Resistant or -Refractory Ovarian Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016
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191 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 2 institutions in 2 countries.

David R SpigelDavid R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jerome H. Goldschmidt Jr, Blue Ridge Cancer Care, Christianburg, VA; George R. Blumenschein Jr, The University of Texas MD Anderson Cancer Center, Houston, TX; Gilles Robinet, University Hospital Morvan, Brest; Benoit Godbert, Centre Hospitalier Universitaire Nancy, Vandoeuvre-lès-Nancy; Fabrice Barlesi, Assistance Publique-Hôpitaux de Marseille, Aix Marseille University, Marseille, France; Ramaswamy Govindan, Washington University School of Medicine, St Louis, MO; Taral Patel, Mid Ohio Oncology/Hematology, Columbus, OH; Sergey V. Orlov, St Petersburg Pavlov State Medical University, St Petersburg, Russia; Wei Yu, Robert L. Yauch, Premal H. Patel, and See-Chun Phan, Genentech; Amy C. Peterson, Medivation, San Francisco, CA; and Jiping Zha, Crown Bioscience, Taicang City, China.
Thomas J Ervin
Rodryg A Ramlau
Davey B Daniel
Jerome H Goldschmidt
George R Blumenschein
Maciej J Krzakowski
Gilles Robinet
Benoit Godbert
Fabrice Barlesi
Ramaswamy Govindan
Taral Patel
Sergey V Orlov
Michael S Wertheim
Wei Yu
Jiping Zha
Robert L Yauch
Premal H Patel
See-Chun Phan
Amy C Peterson
Bioscience (China) · CNCentre Hospitalier Régional et Universitaire de Nancy · FR

Funding

Comprehensive Cancer Center of Wake Forest University CCOP Research BaseU10CA081851 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI SHAW, EDWARD G · 1999 to 2013
$22.0M
NCI NIH HHS U10 CA081851NCI NIH HHS U10 CA 081851-06S2NCI NIH HHS U10 CA081851-06S2
6 · The paper itself

Abstract

purposeIncreased hepatocyte growth factor/MET signaling is associated with poor prognosis and acquired resistance to epidermal growth factor receptor (EGFR) -targeted drugs in patients with non-small-cell lung cancer (NSCLC). We investigated whether dual inhibition of MET/EGFR results in clinical benefit in patients with NSCLC. PATIENTS AND

methodsPatients with recurrent NSCLC were randomly assigned at a ratio of one to one to receive onartuzumab plus erlotinib or placebo plus erlotinib; crossover was allowed at progression. Tumor tissue was required to assess MET status by immunohistochemistry (IHC). Coprimary end points were progression-free survival (PFS) in the intent-to-treat (ITT) and MET-positive (MET IHC diagnostic positive) populations; additional end points included overall survival (OS), objective response rate, and safety.

resultsThere was no improvement in PFS or OS in the ITT population (n = 137; PFS hazard ratio [HR], 1.09; P = .69; OS HR, 0.80; P = .34). MET-positive patients (n = 66) treated with erlotinib plus onartuzumab showed improvement in both PFS (HR, .53; P = .04) and OS (HR, .37; P = .002). Conversely, clinical outcomes were worse in MET-negative patients treated with onartuzumab plus erlotinib (n = 62; PFS HR, 1.82; P = .05; OS HR, 1.78; P = .16). MET-positive control patients had worse outcomes versus MET-negative control patients (n = 62; PFS HR, 1.71; P = .06; OS HR, 2.61; P = .004). Incidence of peripheral edema was increased in onartuzumab-treated patients.

conclusionOnartuzumab plus erlotinib was associated with improved PFS and OS in the MET-positive population. These results combined with the worse outcomes observed in MET-negative patients treated with onartuzumab highlight the importance of diagnostic testing in drug development.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCross-Over StudiesDisease-Free SurvivalDouble-Blind MethodErlotinib HydrochlorideFemaleHumansImmunohistochemistryKaplan-Meier EstimateLung NeoplasmsMaleAntibodies, MonoclonalErlotinib HydrochlorideonartuzumabProto-Oncogene Proteins c-metQuinazolines

Identifiers

PMID24101053
PMCPMC4878106
OpenAlexW2101581271

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.