Evidence map›Paper›PMID 28761724›Full record

ArticleESMO open2017

Time since start of first-line therapy as a predictive clinical marker for nintedanib in patients with previously treated non-small cell lung cancer.

Birgit Gaschler-Markefski, Patricia Sikken, John V Heymach, Maya Gottfried, Anders Mellemgaard, Silvia Novello, Claudia-Nanette Gann, José Barrueco, Martin Reck, Nasser H Hanna and 1 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in ESMO open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.4field-weighted citation impact, top 18% 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

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. High tumor burden in non-small-cell lung cancer: A review of the literature.Journal of clinical and translational research · 2022
    Review
  3. Article
  4. Article
  5. 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

11 authors at 10 institutions in 5 countries.

Birgit Gaschler-MarkefskiBoehringer Ingelheim Pharmaceuticals GmbH & Co. KG, Biberach, Germany.
Patricia SikkenBoehringer Ingelheim Pharmaceuticals GmbH & Co. KG, Biberach, Germany.
John V HeymachUniversity of Texas, MD Anderson Cancer Center, Houston, Texas, USA.
Maya GottfriedLung Cancer Unit, Meir Medical Center, Kfar Saba, Israel.
Anders MellemgaardDepartment of Oncology, Herlev University Hospital, Herlev, Denmark.
Silvia NovelloDepartment of Oncology, University of Turin, Orbassano, Italy.
Claudia-Nanette GannGlobal Medical Affairs Oncology, Merck KGaA, Darmstadt, Germany.
José BarruecoBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA.
Martin ReckDepartmentof Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North(ARCN), Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.
Nasser H HannaIndiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, USA.
Rolf KaiserBoehringer Ingelheim Pharmaceuticals GmbH & Co. KG, Biberach, Germany.
Boehringer Ingelheim (Germany) · DEBoehringer Ingelheim (United States) · USGerman Center for Lung Research · DEHerlev Hospital · DKIndiana University Health · USMeir Medical Center · ILMerck (Germany) · DEThe University of Texas MD Anderson Cancer Center · USUniversity of Göttingen · DEUniversity of Turin · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNo predictive clinical or genetic markers have been identified or validated for antiangiogenic agents in lung cancer. We aimed to identify a predictive clinical marker of benefit for nintedanib, an angiokinase inhibitor, using data from two large second-line non-small cell lung cancer Phase III trials (LUME-Lung 1 ([LL1] and LUME-Lung 2).

methodsPredictive marker identification was conducted in a multi-step process using data from both trials; a hypothesis was generated, confirmed and validated. Statistical analyses included a stepwise selection approach, a recursive partitioning method and the evaluation of HRs, including treatment-by-covariate interactions. The marker was finally validated using a prospectively defined hierarchical testing procedure and treatment-by-covariate interaction for overall survival (OS) based on LL1.

resultsTime since start of first-line therapy (TSFLT) was identified as the only predictive clinical marker. A cut-off of 9 months was chosen for further analysis, based on HRs and recursive partitioning. The prospectively defined final validation using OS data from LL1 established the strong relationship between TSFLT and treatment with nintedanib. Patients with adenocarcinoma with TSFLT <9 months showed a greater survival benefit (median OS 10.9 vs 7.9 months, HR 0.75 [95% CI 0.60-0.92]; p=0.0073) compared with patients in the TSFLT >9 months group (median OS 17.0 vs 15.1 months, HR 0.89 [95% CI 0.66-1.19]).

conclusionsPatients with shorter TSFLT derive a greater progression-free survival and OS benefit from nintedanib. This clinical marker could be used for patient selection and further investigation is warranted regarding pathways promoting aggressive tumour growth and antiangiogenic tyrosine kinase inhibitor benefit.

Indexed as

AdenocarcinomaClinical markerNintedanibNon-small cell lung cancerTime since first-line treatment

Identifiers

PMID28761724
PMCPMC5519785
OpenAlexW2606004114

What OpenQuestion holds

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LicenceCC BY-NC
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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.