Evidence map›Paper›PMID 22025157›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2011

Randomized phase II study of erlotinib in combination with placebo or R1507, a monoclonal antibody to insulin-like growth factor-1 receptor, for advanced-stage non-small-cell lung cancer.

Suresh S Ramalingam, David R Spigel, David Chen, Martin B Steins, Jeffrey A Engelman, Claus-Peter Schneider, Silvia Novello, Wilfried E E Eberhardt, Lucio Crino, Kai Habben and 4 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, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 90 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 6 pooled it
13.5field-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

90 citing papers in PubMed, 6 syntheses or guidelines pooled it, 129 citations in OpenAlex.

  1. Pooled it
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  9. Teprotumumab for Thyroid-Associated Ophthalmopathy.The New England journal of medicine · 2017
    Trial
  10. Trial
  11. Trial
  12. Diabetes and cancer: glucose control impact on survival and tumor outcomes.Reviews in endocrine & metabolic disorders · 2026
    Review
  13. Postmarketing Safety Concerns of Teprotumumab: A Real-World Pharmacovigilance Assessment.The Journal of clinical endocrinology and metabolism · 2024
    Article
  14. Review
  15. The Adverse Effects Profile of Teprotumumab.The Journal of clinical endocrinology and metabolism · 2023
    Review
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30 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

14 authors at 7 institutions in 4 countries.

Suresh S RamalingamWinship Cancer Institute of Emory University, Atlanta, GA 30322, USA. suresh.ramalingam@emory.edu
David R Spigel
David Chen
Martin B Steins
Jeffrey A Engelman
Claus-Peter Schneider
Silvia Novello
Wilfried E E Eberhardt
Lucio Crino
Kai Habben
Lian Liu
Pasi A Jänne
Carrie M Brownstein
Martin Reck
University of Turin · ITDana-Farber Cancer Institute · USEmory University · USHeidelberg University · DELungenClinic Grosshansdorf · DEHeidelberg (Poland) · PLUniversity of Perugia · IT

Funding

ECOG-ACRIN Thoracic Malignancies Integrated Translational Science CenterU10CA180950 · NCI · EMORY UNIVERSITY · PI RAMALINGAM, SURESH S · 2014 to 2018
$2.9M
Winship Cancer Institute, National Clinical Trials Network Lead Academic ParticipU10CA180864 · NCI · EMORY UNIVERSITY · PI BEITLER, JONATHAN, RAMALINGAM, SURESH S · 2014 to 2018
$2.9M
NCI NIH HHS U10 CA180950
6 · The paper itself

Abstract

purposeR1507 is a selective, fully human, recombinant monoclonal antibody (immunoglobulin G1 subclass) against insulin-like growth factor-1 receptor (IGF-1R). The strong preclinical evidence supporting coinhibition of IGF-1R and epidermal growth factor receptor (EGFR) as anticancer therapy prompted this study. PATIENTS AND

methodsPatients with advanced-stage non-small-cell lung cancer (NSCLC) with progression following one or two prior regimens, Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2, and measurable disease were eligible. Patients were randomly assigned to receive erlotinib (150 mg orally once a day) in combination with either placebo, R1507 9 mg/kg weekly, or R1507 16 mg/kg intravenously once every 3 weeks. Treatment cycles were repeated every 3 weeks. The primary end point was comparison of the 12-week progression-free survival (PFS) rate.

resultsIn all, 172 patients were enrolled: median age, 61 years; female, 33%; never-smokers, 12%; and performance status 0 or 1, 88%. The median number of R1507 doses was six for the weekly arm and 3.5 for the every-3-weeks arm. Grades 3 to 4 adverse events occurred in 37%, 44%, and 48% of patients with placebo, R1507 weekly, and R1507 every 3 weeks, respectively. The 12-week PFS rates were 39%, 37%, and 44%, and the median overall survival was 8.1, 8.1, and 12.1 months for the three groups, respectively, with statistically nonsignificant hazard ratios. The 12-week PFS rate in patients with KRAS mutation was 36% with R1507 compared with 0% with placebo.

conclusionThe combination of R1507 with erlotinib did not provide PFS or survival advantage over erlotinib alone in an unselected group of patients with advanced NSCLC. Predictive biomarkers are essential for further development of combined inhibition of IGF-1R and EGFR.

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungDisease-Free SurvivalErlotinib HydrochlorideFemaleHumansLung NeoplasmsMaleMiddle AgedPlacebosQuinazolinesReceptor, IGF Type 1Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedErlotinib HydrochloridePlacebosQuinazolinesReceptor, IGF Type 1teprotumumab

Identifiers

PMID22025157
PMCPMC5320944
OpenAlexW2130157823

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.