Evidence map›Paper›PMID 28772281›Full record

Trial reportBritish journal of cancer2017

Randomised Phase 2 study of maintenance linsitinib (OSI-906) in combination with erlotinib compared with placebo plus erlotinib after platinum-based chemotherapy in patients with advanced non-small cell lung cancer.

Tudor-Eliade Ciuleanu, Samreen Ahmed, Joo-Hang Kim, Jörg Mezger, Keunchil Park, Michael Thomas, Jihong Chen, Srinivasu Poondru, Jan M VanTornout, Debbie Whitcomb and 1 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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

20 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. IGF-1R targeting in cancer - does sub-cellular localization matter?Journal of experimental & clinical cancer research : CR · 2023
    Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. 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.

Tudor-Eliade CiuleanuOncological Institute I Chiricuta and UMF Iuliu Hatieganu, Cluj-Napoca, Romania.
Samreen AhmedLeicester Royal Infirmary, Leicester, UK.
Joo-Hang KimCHA Bundang Medical Center, CHA University, Gyeonggi-do, Korea.
Jörg MezgerSaint Vincentius-Kliniken Karlsruhe, Karlsruhe, Germany.
Keunchil ParkSamsung Medical Center Sungkyunkwan University School of Medicine, Seoul, Korea.
Michael ThomasTranslational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), Heidelberg, Germany.
Jihong ChenAstellas Pharma Global Development, Northbrook, IL, USA.
Srinivasu PoondruAstellas Pharma Global Development, Northbrook, IL, USA.
Jan M VanTornoutAstellas Pharma Global Development, Northbrook, IL, USA.
Debbie WhitcombAstellas Pharma Global Development, Northbrook, IL, USA.
Fiona BlackhallManchester University and The Christie Hospital NHS Foundation Trust, Manchester, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMaintenance therapy is important in advanced/metastatic non-small cell lung cancer (NSCLC). Erlotinib as switch maintenance following platinum-based chemotherapy increases survival. Cross-talk between the epidermal growth factor receptor and insulin-like growth factor receptor (IGFR) pathways mediate resistance to individual receptor blockade. This study compared maintenance linsitinib plus erlotinib vs erlotinib plus placebo in patients with NSCLC.

methodsIn this Phase II randomised trial, patients without progression following four cycles of first-line platinum-based chemotherapy (N=205) received continuous schedule maintenance oral linsitinib 150 mg or placebo BID combined with erlotinib 150 mg QD for 21-day cycles. The primary endpoint was progression-free survival (PFS).

resultsThe study was unblinded early due to linsitinib non-superiority. No difference was found between the two treatment groups in median PFS of 125 days linsitinib vs 129 days placebo (P=0.601); no difference in overall survival (OS) was observed. Tolerability was similar, although in the linsitinib group, treatment-related adverse events and discontinuations were more frequent. No drug-drug interaction was implicated.

conclusionsLinsitinib maintenance therapy added to erlotinib did not improve PFS or OS in non-progressing NSCLC patients. This highlights the need for robust biomarkers of response for combinations that incorporate IGFR-targeted therapies in maintenance or other therapeutic settings.

Indexed as

Maintenance ChemotherapyAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungErlotinib HydrochlorideFemaleHumansImidazolesKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedPlacebosPlatinum Compounds3-(8-amino-1-(2-phenylquinolin-7-yl)imidazo(1,5-a)pyrazin-3-yl)-1-methylcyclobutanolErlotinib HydrochlorideImidazolesPlacebosPlatinum CompoundsPyrazinesReceptors, Somatomedin

Identifiers

PMID28772281
PMCPMC5589984

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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.