Evidence map›Paper›PMID 28702806›Full record

Trial reportTargeted oncology2017

Efficacy and Safety of Nintedanib Plus Docetaxel in Patients with Advanced Lung Adenocarcinoma: Complementary and Exploratory Analyses of the Phase III LUME-Lung 1 Study.

Maya Gottfried, Jaafar Bennouna, Igor Bondarenko, Jean-Yves Douillard, David F Heigener, Maciej Krzakowski, Anders Mellemgaard, Silvia Novello, Sergei Orlov, Yvonne Summers and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Targeted oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00805194 (Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral BIBF 1120 Plus Standard Docetaxel Therapy Compared to Placebo Plus Standard Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent Non Small Cell Lung Cancer After Failure of First Line Chemotherapy), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 7% 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.

NCT00805194 phase3completednot on this map

Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral BIBF 1120 Plus Standard Docetaxel Therapy Compared to Placebo Plus Standard Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent Non Small Cell Lung Cancer After Failure of First Line Chemotherapy

TypeinterventionalSponsorBoehringer IngelheimRan2008 to 2017Enrolled1,314ConditionsCarcinoma, Non-Small-Cell LungArmsplacebo plus docetaxel, BIBF 1120 plus docetaxel
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Observational
  4. High tumor burden in non-small-cell lung cancer: A review of the literature.Journal of clinical and translational research · 2022
    Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Treatment options beyond immunotherapy in patients with wild-type lung adenocarcinoma: a Delphi consensus.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
    Article
  10. Article
  11. Efficacy of nintedanib and docetaxel in patients with advanced lung adenocarcinoma treated with first-line chemotherapy and second-line immunotherapy in the nintedanib NPU program.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2019
    Article
  12. Article
  13. Article
  14. Article
  15. Antiangiogenic therapies in non-small-cell lung cancer.Current oncology (Toronto, Ont.) · 2018
    Review
  16. Article
  17. 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

14 authors at 12 institutions in 8 countries.

Maya GottfriedLung Cancer Unit, Meir Medical Center, 4428164, Kfar Saba, Israel. Maya.Gottfried@clalit.org.il.
Jaafar BennounaDépartement D'Oncologie Médicale, ICO René Gauducheau, 44805, Saint Herblain Cedex, France.
Igor BondarenkoDnepropetovsk Medical Academy, Municipal Clinical Hospital #4, Dnipropetrovsk, 49102, Ukraine.
Jean-Yves DouillardDépartement D'Oncologie Médicale, ICO René Gauducheau, 44805, Saint Herblain Cedex, France.
David F HeigenerDepartment of Thoracic Oncology, LungenClinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), 22927, Grosshansdorf, Germany.
Maciej KrzakowskiOncology Institute, 02-781, Warsaw, Poland.
Anders MellemgaardDepartment of Oncology, Herlev Hospital, 2730, Herlev, Denmark.
Silvia NovelloThoracic Oncology Unit, AUO San Luigi, Department of Oncology, University of Turin, 10124, Torino, Italy.
Sergei OrlovDepartment of Thoracic Oncology, GOU VPO St Petersburg State Medical University, St Petersburg, 197022, Russia.
Yvonne SummersDepartment of Medical Oncology, Christie Hospital NHS Foundation Trust, Manchester, M20 4BX, UK.
Joachim von PawelAsklepios Fachkliniken München-Gauting, 82131, Gauting, Germany.
Julia StöhrBoehringer Ingelheim Pharma GmbH & Co. KG, 88400, Biberach, Germany.
Rolf KaiserBoehringer Ingelheim Pharma GmbH & Co. KG, 55216, Ingelheim am Rhein, Germany.
Martin ReckDepartment of Thoracic Oncology, LungenClinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), 22927, Grosshansdorf, Germany.
Institut Génétique Nantes Atlantique · FRAsklepios Fachkliniken München-Gauting · DEBoehringer Ingelheim (Germany) · DEDnipro State Medical University · UAGerman Center for Lung Research · DEHerlev Hospital · DKJohannes Gutenberg University Mainz · DELungenClinic Grosshansdorf · DEMeir Medical Center · ILSaint Petersburg State Pediatric Medical University · RUThe Christie NHS Foundation Trust · GBUniversity of Turin · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNintedanib is a triple angiokinase inhibitor approved with docetaxel for adenocarcinoma non-small cell lung cancer after first-line chemotherapy (FLT). In the phase III LUME-Lung 1 study, overall survival (OS) was significantly longer with nintedanib/docetaxel than with placebo/docetaxel in all adenocarcinoma patients and those with time from start of FLT (TSFLT) <9 months.

objectiveThis study sought to extend analyses from the LUME-Lung 1 study, specifically for adenocarcinoma patients, to explore the impact of clinically relevant characteristics on outcomes such as time to progression after FLT. PATIENTS AND

methodsExploratory analyses were conducted of the overall and European LUME-Lung 1 adenocarcinoma population according to age, prior therapy, and tumor dynamics. Analyses also used TSFLT and time from end of FLT (TEFLT).

resultsTreatment with nintedanib/docetaxel significantly improved OS in European patients independently of age or prior therapy. Analyses of several patient subgroups showed improvements in median OS: TSFLT <6 months, 9.5 versus 7.5 months (hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.55-0.98); chemorefractory to FLT, 9.1 versus 6.9 months (HR 0.72, 95% CI 0.52-0.99); progressive disease (PD) as best response to FLT, 9.8 versus 6.3 months (HR 0.62, 95% CI 0.41-0.94); TEFLT ≤6 months, 11.3 versus 8.2 months (HR 0.75, 95% CI 0.61-0.92); and TEFLT <3 months, 11.0 versus 8.0 months (HR 0.74, 95% CI 0.58-0.94).

conclusionsNintedanib/docetaxel demonstrated significant OS benefits in adenocarcinoma patients, which were more pronounced in patients with shorter TSFLT or TEFLT, or with PD as best response to FLT. This study was registered at ClinicalTrials.gov: NCT00805194.

Indexed as

AdenocarcinomaAdenocarcinoma of LungAntineoplastic Combined Chemotherapy ProtocolsDocetaxelDouble-Blind MethodEuropeFemaleHumansIndolesLung NeoplasmsMaleMiddle AgedSurvival AnalysisTaxoidsDocetaxelIndolesnintedanibTaxoids

Identifiers

PMID28702806
OpenAlexW2734335426

What OpenQuestion holds

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Read underepoch 390

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.