Evidence map›Paper›PMID 29801465›Full record

Trial reportBMC cancer2018

Erlotinib as single agent first line treatment in locally advanced or metastatic activating EGFR mutation-positive lung adenocarcinoma (CEETAC): an open-label, non-randomized, multicenter, phase IV clinical trial.

Zsolt Markóczy, Veronika Sárosi, Iveta Kudaba, Gabriella Gálffy, Ülkü Yilmaz Turay, Ahmet Demirkazik, Gunta Purkalne, Attila Somfay, Zsolt Pápai-Székely, Erzsébet Rásó and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01609543 (Open Label Study of Erlotinib), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
–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.

NCT01609543 phase4completednot on this map

Open Label Study of Erlotinib (Tarceva®) as Single Agent First Line Treatment of Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With Activating Epidermal Growth Factor Receptor (EGFR) Mutations

TypeinterventionalSponsorHoffmann-La RocheRan2012 to 2015Enrolled62ConditionsNon-Squamous Non-Small Cell Lung CancerArmserlotinib [Tarceva]
3 · Its place in the literature

Who cites it

16 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib in Patients With c-Met Protein-Expressing Non-Small-Cell Lung Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Article
  14. Article
  15. Review
  16. Review
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.

Zsolt MarkóczyNational Koranyi Institute of TB and Pulmonology, Piheno ut 1, Budapest, H-1122, Hungary.
Veronika SárosiDivision of Pulmonology, University of Pecs, Pecs, Hungary.
Iveta KudabaRiga East University Hospital Oncology Center, Riga, Latvia.
Gabriella GálffyDepartment of Pulmonology, Semmelweis University, Budapest, Hungary.
Ülkü Yilmaz TurayClinic of Chest Diseases, Ataturk Chest Diseases and Chest Surgery Training and Research Hospital, Ankara, Turkey.
Ahmet DemirkazikDepartment of Medical Oncology, Ibn-i Sina Hospital, Ankara University Medical Faculty, Ankara, Turkey.
Gunta PurkalneOncology Institute, Riga Stradins University, Riga, Latvia.
Attila SomfayDepartment of Pulmonology, University of Szeged, Szeged, Hungary.
Zsolt Pápai-SzékelySt. George Hospital of Fejer County, Szekesfehervar, Hungary.
Erzsébet Rásó2nd Department of Pathology, Semmelweis University, Budapest, Hungary.
Gyula OstorosNational Koranyi Institute of TB and Pulmonology, Piheno ut 1, Budapest, H-1122, Hungary. ostoros@koranyi.hu.ORCID http://orcid.org/0000-0001-5339-7257

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundErlotinib is approved for the first line treatment of epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer. Since the number of prospective studies in Caucasian patients treated in routine clinical setting is limited we conducted a multicenter, phase IV clinical trial to determine the efficacy and safety of erlotinib and to demonstrate the feasibility of the validated standardized companion diagnostic method of EGFR mutation detection.

methods651 chemonaive, cytologically or histologically verified advanced stage lung adenocarcinoma patients from Hungary, Turkey and Latvia were screened for exon19 microdeletions and exon21 L858R EGFR mutations using the companion diagnostic EGFR test. EGFR mutation-positive, locally advanced or metastatic lung adenocarcinoma patients received as first line treatment erlotinib at 150 mg/day. The primary endpoint was progression-free survival (PFS).

results62 EGFR mutation-positive patients (9.5% of screened) were included in the safety/intent-to-treat cohort. Median PFS was 12.8 months (95%CI, 9.9-15.8), objective response rate and one-year survival was 66.1% and 82.5%, respectively. Most frequent treatment related adverse events were diarrhoea and rash. Eastern Oncology Cooperative Group Performance Status (ECOG PS), smoking status and M1a/M1b disease stage were significant prognosticators of PFS (p = 0.017, p = 0.045 and p = 0.002, respectively). There was no significant difference in PFS between the subgroups stratified by gender, age or exon19 vs exon21 mutation.

conclusionsOur study confirmed the efficacy and safety of first line erlotinib monotherapy in Caucasian patients with locally advanced or metastatic lung adenocarcinoma carrying activating EGFR mutations based on the screening with the approved companion diagnostic procedure.

trial registrationClinicalTrials.gov Identifier: NCT01609543.

Indexed as

Adenocarcinoma of LungAdultAgedAged, 80 and overDNA Mutational AnalysisErbB ReceptorsErlotinib HydrochlorideExonsFeasibility StudiesFemaleFollow-Up StudiesGenetic TestingHumansLungLung NeoplasmsMaleEGFR protein, humanErbB ReceptorsErlotinib HydrochlorideProtein Kinase InhibitorsEGFRErlotinibLung adenocarcinomaNon-small cell lung cancer

Identifiers

PMID29801465
PMCPMC5970529

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.